Methylphenidate (Lexi-Drugs)

ALERT: US Boxed Warning
  Abuse and dependence:
Pronunciation

(meth il FEN i date)

Brand Names: US

Aptensio XR; Concerta; Cotempla XR-ODT; Daytrana; Metadate CD [DSC]; Metadate ER; Methylin; QuilliChew ER; Quillivant XR; Relexxii; Ritalin; Ritalin LA

Brand Names: Canada

ACT Methylphenidate ER; APO-Methylphenidate; APO-Methylphenidate ER; APO-Methylphenidate SR; Biphentin; Concerta; Foquest; PHL-Methylphenidate HCl [DSC]; PHL-Methylphenidate [DSC]; PMS-Methylphenidate; PMS-Methylphenidate ER; RATIO-Methylphenidate [DSC]; Ritalin; Ritalin SR; SANDOZ Methylphenidate SR; TEVA-Methylphenidate ER-C

Pharmacologic Category

Central Nervous System Stimulant

Dosing: Adult

ADHD: Oral:

Immediate-release (IR) products (tablets, chewable tablets, and solution): Initial: 5 mg twice daily, before breakfast and lunch; increase by 5 to 10 mg daily at weekly intervals; maximum dose: 60 mg/day (in 2 to 3 divided doses).

Extended-release (ER), sustained-release (SR) products (capsules, tablets, chewable tablets, orally disintegrating tablets, and oral suspension):

Concerta: (Adults <65 years):

Patients not currently taking methylphenidate: Initial: 18 to 36 mg once every morning

Patients currently taking immediate release (IR) methylphenidate or sustained release (SR) [Canadian product]: Initial: Note: Dosing based on current regimen and clinical judgment; suggested dosing listed below:

IR methylphenidate:

– Patients taking IR methylphenidate 5 mg 2 to 3 times daily: 18 mg once every morning

– Patients taking IR methylphenidate 10 mg 2 to 3 times daily: 36 mg once every morning

– Patients taking IR methylphenidate 15 mg 2 to 3 times daily: 54 mg once every morning

– Patients taking IR methylphenidate 20 mg 2 to 3 times daily: 72 mg once every morning

SR methylphenidate (Concerta Canadian product labeling 2017):

– Patients taking methylphenidate SR 20 mg daily: 18 mg once every morning

– Patients taking methylphenidate SR 40 mg daily: 36 mg once every morning

– Patients taking methylphenidate SR 60 mg daily: 54 mg once every morning

Dose adjustment: May increase dose in increments of 18 mg at weekly intervals. A dosage strength of 27 mg is available for situations in which a dosage between 18 to 36 mg is desired. Maximum dose: 72 mg/day.

Aptensio XR: Initial: 10 mg once daily; may be titrated in 10 mg increments at weekly intervals; maximum: 60 mg/day.

Biphentin [Canadian product]: Patients not currently taking methylphenidate: Initial: 10 to 20 mg once daily; may be adjusted in 10 mg increments at weekly intervals to a maximum dose of 80 mg/day.

Conversion from immediate-release methylphenidate formulations to Biphentin: Use equivalent total daily dose administered once daily.

Foquest [Canadian product]:

Patients not currently taking methylphenidate: Initial: 25 mg once daily; adjust dose at 5 day intervals as needed to the lowest effective dose (maximum: 100 mg/day).

Patients currently taking methylphenidate: Initiate Foquest with the next lower strength based on total methylphenidate daily dose; adjust dose at 5 day intervals as needed to the lowest effective dose (maximum: 100 mg/day). Note: Do not substitute immediate release formulations or other controlled release formulations with Foquest on a milligram for milligram basis (pharmacokinetic profiles differ).

Jornay PM: Initial: 20 mg once daily in the evening between 6:30 and 9:30 PM (eg, 8:00 PM); may increase in increments of 20 mg/day at weekly intervals; maximum daily dose: 100 mg/day. Note: If converting from another methylphenidate formulation, discontinue previous formulation and titrate Jornay PM using this same schedule; do not substitute on a milligram-per-milligram basis.

Metadate ER, Ritalin-SR: Administer 2 or 3 times daily; replace immediate-release tablets when the divided dosage corresponds to sustained-/extended-release tablet strength (duration of action: ~8 hours); maximum: 60 mg/day

Metadate CD, Quillivant XR: Initial: 20 mg once daily; may be adjusted in 10 to 20 mg increments at weekly intervals; maximum: 60 mg/day

Conversion from other methylphenidate formulations to Quillivant XR: Discontinue previous formulation and titrate using above schedule; do not substitute on a milligram-per-milligram basis

QuilliChew ER: Initial: 20 mg once daily in the morning; may be adjusted by 10, 15 or 20 mg at weekly intervals (tablets are scored and may be broken in half to achieve the 10 mg and 15 mg doses); maximum: 60 mg/day

Conversion from other methylphenidate formulations to QuilliChew ER: Discontinue previous formulation and titrate using above schedule; do not substitute on a milligram-per-milligram basis

Ritalin LA: Initial: 20 mg once daily (10 mg once daily may be considered for some patients); may be adjusted in 10 mg increments at weekly intervals; maximum: 60 mg/day

Conversion from immediate-release or sustained-release methylphenidate formulation to Ritalin LA: Use equivalent total daily dose administered once daily.

Narcolepsy: Oral:

Immediate-release tablets and solution (Methylin, Ritalin): Initial: 5 mg twice daily before breakfast and lunch; increase by 5 to 10 mg daily at weekly intervals; maximum dose: 60 mg/day (in 2 to 3 divided doses).

Extended- and sustained-release tablets (Metadate ER, Ritalin-SR):Administer 2 or 3 times daily. Replace immediate-release tablets when the divided dosage corresponds to sustained-/extended-release tablet strength (duration of action: ~8 hours); maximum: 60 mg/day

Depression (terminal illness, palliative care, medically ill) (off-label use): Oral: Initial: Immediate release: 2.5 to 5 mg once daily before breakfast or twice daily before breakfast and lunch; increase by 2.5 to 5 mg daily every 1 to 3 days in divided doses before breakfast and lunch as tolerated; maximum dose: 20 to 40 mg/day (Hardy 2009; Kerr 2012). Donot use sustained release product.

Fatigue, cancer-related (off-label use): Oral: Immediate release: Initial: 5 mg twice daily (at 8 am and 1 pm); increase based on tolerability in increments of 10 mg/day every 3 days up to a maximum of 40 mg/day (Kerr 2012).

Dosing: Geriatric

ADHD/Narcolepsy: Refer to adult dosing.

Major depressive disorder (antidepressant augmentation; off-label use): Oral: Initial: Immediate release: 2.5 mg twice daily (given at 9 am and 3 pm); increase dosage based on response and tolerability in increments of 2.5 mg twice daily every 3 to 4 days up to 40 mg/day. Average dose in clinical trials was ~15 to 16 mg/day (Lavrestky 2015; Lavrestky 2006).

Dosing: Renal Impairment: Adult

Oral: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); undergoes extensive metabolism to a renally eliminated metabolite with little or no pharmacologic activity.

Transdermal: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Hepatic Impairment: Adult

Oral: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Transdermal: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Pediatric

Attention deficit-hyperactivity disorder (ADHD): Methylphenidate is recommended as first-line therapy for children and adolescents; a discontinuation trial after 6 months of therapy is also recommended to reassess underlying psychopathology (AACAP [Pliszka 2007]; AAP 2011; Cortese 2018; NICE 2018). Note: Discontinue medication if no improvement is seen after appropriate dosage adjustment over a 1-month period of time.

Oral:

Immediate-release products (eg, Methylin, Ritalin):

Children 3 to 5 years, moderate to severe dysfunction: Limited data available; AAP considers first-line agent in this patient population if pharmacological treatment deemed necessary (AAP 2011); the American Academy of Child and Adolescent Psychiatry Preschool Psychopharmacology Working Group recommends a discontinuation trial after 6 months of treatment in preschoolers to reassess underlying psychopathology (Gleason 2007). Response may be variable and less robust than that observed in older pediatric patients (Ghuman 2008); of note, response to methylphenidate was predicted by the number of comorbidities (eg, no or 1 comorbidity predicted a large treatment response [similar to school-aged children] vs ≥3 comorbidities predicted no treatment response) (Ghuman 2008).

Initial: 2.5 mg twice daily, may gradually titrate to 7.5 mg 2 or 3 times daily over 2 to 4 weeks; others have used a rapid titration to 7.5 mg 3 times daily within 1 week (Ghuman 2008; Greenhill 2006); a small percentage of preschool children may benefit from 1.25 mg 3 times daily (Ghuman 2008). In the largest trial, a multicenter, randomized, placebo-controlled, crossover study of 165 preschool children (age range: 3 to 5.5 years) treated with methylphenidate 3.75 to 30 mg/day in 3 divided doses, statistically and clinically significant improvements in ADHD scores were reported with doses of 2.5 mg, 5 mg, and 7.5 mg 3 times daily. In some patients (n=7 [4%]), dose titration to 10 mg 3 times daily was necessary; the mean effective total daily dose: 14.2 ± 8.1 mg/day. Although ADHD scores were statistically and clinically improved with methylphenidate use, the effect size was smaller with this younger patient population than that seen in school-age children (Greenhill 2006). The 10-month continuation phase trial reported continued or stable clinical improvement at a mean dose of 19.98 mg/day at month 10 (Vitiello 2007).

Children ≥6 years and Adolescents: Initial: 2.5 to 5 mg twice daily administered before breakfast and lunch; increase by 5 to 10 mg/day at weekly intervals; some patients may require 3 doses/day (eg, additional dose after school); usual maximum daily dose: 60 mg/day, not to exceed 2 mg/kg/day; however, some patients weighing >50 kg may require and tolerate daily doses up to 100 mg/day with frequent monitoring (AACAP [Pliszka 2007])

Extended-release, sustained-release, and long-acting products:

Aptensio XR: Children ≥6 years and Adolescents: Initial: 10 mg once daily in the morning; may titrate in 10 mg increments at weekly intervals; maximum daily dose: 60 mg/day

Concerta: Children ≥6 years and Adolescents:

Methylphenidate-naive patients: Initial: 18 mg once daily

Patients currently using immediate-release methylphenidate: Initial dose: Dosing based on current regimen and clinical judgment; suggested dosing listed below, monitor closely with any therapy change:

Switching from methylphenidate immediate release 5 mg 2 to 3 times daily: Concerta 18 mg once daily

Switching from methylphenidate immediate release 10 mg 2 to 3 times daily: Concerta 36 mg once daily

Switching from methylphenidate immediate release 15 mg 2 to 3 times daily: Concerta 54 mg once daily

Switching from methylphenidate immediate release 20 mg 2 to 3 times daily: Concerta 72 mg once daily

Dosage adjustment: May increase by Concerta 18 mg/day increments at weekly intervals to effect not to exceed the following maximum daily dose for age. Note: A dosage strength of 27 mg is available for situations in which a dosage between 18 and 36 mg is desired.

Maximum daily dose of Concerta:

Children 6 to 12 years: Usual maximum daily dose: 54 mg/day; however, some patients may require and tolerate daily doses up to 108 mg/day (AACAP [Pliszka 2007])

Adolescents: Usual maximum daily dose: 72 mg/day; however, some patients may require and tolerate daily doses up to 108 mg/day (AACAP [Pliszka 2007])

Cotempla XR-ODT: Children ≥6 years and Adolescents ≤17 years: Initial: 17.3 mg once daily in the morning; may titrate in 8.6 or 17.3 mg increments at weekly intervals; maximum daily dose: 51.8 mg/day

Jornay PM: Children ≥6 years and Adolescents: Initial: 20 mg once daily in the evening between 6:30 and 9:30 PM (eg, 8:00 PM); may increase in increments of 20 mg/day at weekly intervals; maximum daily dose: 100 mg/dayNote: If converting from another methylphenidate formulation, discontinue previous formulation and titrate Jornay PM using above schedule; do not substitute on a milligram-per-milligram basis.

Metadate CD: Children ≥6 years and Adolescents: Initial: 20 mg once daily; may increase by 10 to 20 mg/day increments at weekly intervals; usual maximum daily dose: 60 mg/day; however, some patients weighing >50 kg may require and tolerate daily doses up to 100 mg/day with frequent monitoring (AACAP [Pliszka 2007])

Metadate ER, Ritalin-SR: Children ≥6 years and Adolescents: Replace immediate-release tablets when the 8-hour dosage corresponds to sustained-/extended-release tablet size; Ritalin SR may be administered once or twice daily (AAP 2011). Usual maximum daily dose: 60 mg/day; however, some patients weighing >50 kg may require and tolerate daily doses up to 100 mg/day with frequent monitoring (AACAP [Pliszka 2007]).

QuilliChew ER: Children ≥6 years and Adolescents: Initial: 20 mg once daily in the morning; may be adjusted in 10, 15, or 20 mg increments at weekly intervals (tablets are scored and may be broken in half to achieve dose); maximum daily dose: 60 mg/dayNote: If converting from another methylphenidate formulation, discontinue previous formulation and titrate QuilliChew ER using above schedule; do not substitute on a milligram-per-milligram basis.

Quillivant XR: Children ≥6 years and Adolescents: Initial: 20 mg once daily in the morning; may increase by 10 to 20 mg/day increments at weekly intervals; maximum daily dose: 60 mg/day

Ritalin LA: Children ≥6 years and Adolescents:

Methylphenidate-naive patients: Initial: 20 mg once daily; may increase by 10 mg/day increments at weekly intervals; usual maximum daily dose: 60 mg/day; however, some patients weighing >50 kg may require and tolerate daily doses up to 100 mg/day with frequent monitoring (AACAP [Pliszka 2007]). Note: If a lower initial dose is desired, patients may begin with Ritalin LA 10 mg once daily. Alternatively, patients may begin therapy with an immediate-release product, and switch to Ritalin LA once immediate-release dosage is titrated to 5 mg twice daily (see below).

Patients currently receiving immediate-release methylphenidate: The same total daily dose of Ritalin LA should be used.

Patients currently receiving methylphenidate sustained release (SR): The same total daily dose of Ritalin LA should be used.

Canadian labeling:

Concerta: Children ≥6 years and Adolescents:

Sustained-release methylphenidate [Canadian product] to Concerta: Oral:

Switching from methylphenidate SR 20 mg daily: Concerta 18 mg once every morning

Switching from methylphenidate SR 40 mg daily: Concerta 36 mg once every morning

Switching from methylphenidate SR 60 mg daily: Concerta 54 mg once every morning

Biphentin [Canadian product]: Children ≥6 years and Adolescents:

Methylphenidate naive patients: Oral: Initial: 10 to 20 mg once daily; may be adjusted in 10 mg increments at weekly intervals; maximum daily dose: 60 mg/dayNote:In some children and adolescents, higher doses may be necessary; do not exceed 1 mg/kg/day or the adult maximum of 80 mg/day; monitor closely for adverse events, reduce dose or discontinue if adverse events occur.

Patients currently receiving immediate-release methylphenidate: Use equivalent total daily dose administered once daily.

Topical: Transdermal patch (Daytrana): Children and Adolescents 6 to 17 years: Initial: 10 mg (12.5 cm2) patch once daily; apply to hip 2 hours before effect is needed and remove 9 hours after application (eg, 3 hours before bedtime); titrate dose based on response and tolerability; may increase to next transdermal patch dosage size no more frequently than every week. Patch may be removed before 9 hours if a shorter duration of action is required or if late day adverse effects appear or may be worn for up to 16 hours if extended duration of effects are needed (Arnold 2007). Plasma concentrations usually start to decline when the patch is removed but drug absorption may continue for several hours after patch removal. Note: The manufacturer’s labeling recommends patients converting from another formulation of methylphenidate to the transdermal patch should be initiated at 10 mg regardless of their previous dose and titrated as needed due to the differences in bioavailability of the transdermal formulation. However, some clinicians have supported higher starting patch doses for patients converting from oral methylphenidate doses of >20 mg/day; for example, the 15 mg (18.75 cm2) patch has been investigated to have the same effect as 22.5 mg daily of the immediate-release preparation, 27 mg daily of the osmotic-release preparation (Concerta), or 20 mg daily of the encapsulated bead preparation (Metadate CD) (Arnold 2007).

Approximate oral methylphenidate equivalents, with a 9-hour patch wear time, for the 20 mg and 30 mg patches are (Arnold 2007):

Approximate oral equivalent daily dose
Patch size (Daytrana) Immediate release (mg/day) Osmotic release (eg, Concerta) (mg/day)
15 mg (18.75 cm2) 22.5 27
20 mg (25 cm2) 30 36
30 mg (37.5 cm2) 45 54

Narcolepsy: Children ≥6 years and Adolescents: Oral:

Immediate-release tablets and oral solution (Methylin, Ritalin): Initial: 5 mg twice daily given before breakfast and lunch; increase by 5 to 10 increments mg/day at weekly intervals; 2 to 3 times per day; maximum daily dose: 60 mg/day (in 2 to 3 divided doses)

Extended-/sustained-release tablets (Metadate ER, Ritalin-SR): May be given in place of immediate-release products, once the immediate-release formulation daily dose is titrated and the titrated 8-hour dosage corresponds to sustained- or extended-release tablet size; maximum daily dose: 60 mg/day

Dosing: Renal Impairment: Pediatric

Oral: There are no dosage adjustments provided in manufacturer’s labeling (has not been studied); undergoes extensive metabolism to a renally eliminated metabolite with little or no pharmacologic activity.

Transdermal: There are no dosage adjustments provided in manufacturer’s labeling (has not been studied).

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in manufacturer’s labeling (has not been studied).

Use: Labeled Indications

Attention-deficit/hyperactivity disorder: Treatment of attention-deficit/hyperactivity disorder (ADHD)

Narcolepsy (Methylin, Metadate ER, Ritalin, and Ritalin SR): Symptomatic management of narcolepsy

Use: Off-Label: Adult

  Depression (terminal illness, palliative care, medically ill)Level of Evidence [B]

Data from a randomized, placebo-controlled study of hospice patients Ref, a double-blind, randomized, placebo-controlled crossover trial in older adult patients who were medically ill Ref, and a phase II open-label study in patients with advanced cancer Ref support the use of methylphenidate in the treatment of depression in medically ill older adult patients with terminal illness and/or receiving palliative care. Clinical experience as a systematic review also suggests the utility of methylphenidate in the treatment of this condition Ref. Additional trials may be necessary to further define the role of methylphenidate in the treatment of this condition.

  Fatigue, cancer relatedLevel of Evidence [C, G]

Data from a randomized, placebo-controlled study of hospice patients support the use methylphenidate in the management of cancer-related fatigue in adults with advanced disease Ref. Additional data may be necessary to further define the role of methylphenidate in this condition.

Based on the American Society of Clinical Oncology (ASCO) guidelines for screening, assessment, and management of fatigue in adult survivors of cancer, methylphenidate may be used to manage severe cancer-related fatigue in adult patients with advanced disease or in patients receiving active cancer treatment.

  Major depressive disorder (antidepressant augmentation; geriatric patients)Level of Evidence [B]

Data from a limited number of patients studied suggest that methylphenidate augmentation of antidepressants may be beneficial for the treatment of major depressive disorder in geriatric patients and that it may accelerate treatment response Ref. Additional data may be necessary to further define the role of methylphenidate in this condition.

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

ADHD:

American Academy of Child and Adolescent Psychiatry, “Attention-Deficit/Hyperactivity Disorder,” 2007

American Academy of Pediatrics, “Attention-Deficit/Hyperactivity Disorder,” 2011

Canadian ADHD Resource Alliance (CADDRA), “Canadian ADHD Practice Guidelines,” Third Edition, 2011

Canadian Agency for Drugs and Technologies in Health (CADTH) “Guidelines and Recommendations for ADHD in Children and Adolescents,” October 2011

National Collaborating Centre for Mental Health, “Attention Deficit Hyperactivity Disorder, NICE Guidelines,” 2018

Oncology (fatigue):

American Society of Clinical Oncology (ASCO): Screening, Assessment, and Management of Fatigue in Adult Survivors of Cancer, June 2014

Administration: Oral

Controlled-release capsule (Biphentin, Foquest [Canadian products]): Administer in the morning. Swallow whole with full glass of water (Foquest) or with water or other liquid (Biphentin); do not crush or chew capsules. Alternatively, capsules may be opened and the contents sprinkled onto applesauce, ice cream, or yogurt, but the beads must not be crushed or chewed.

Foquest should be administered immediately after or within 10 minutes of sprinkling capsule contents on food; after administration patients should rinse their mouths with water and swallow. Discard if not administered within 10 minutes of mixing.

Immediate-release (IR) tablet (Ritalin), IR solution (Methylin), IR chewable tablet (Methylin): Administer each dose 30 to 45 minutes before a meal. Ensure last daily dose is administered before 6 pm if difficulty sleeping occurs. Administer chewable tablet with at least 8 ounces of water or other fluid.

Extended-release capsule (Aptensio XR, Jornay PM, Metadate CD, Ritalin LA): Administer with or without food; administer Aptensio XR, Metadate CD, and Ritalin LA in the morning and Jornay PM in the evening between 6:30 to 9:30 pm. Alternatively, capsules may be opened and the contents sprinkled onto a small amount (equal to 1 tablespoon) of cold applesauce. Swallow applesauce mixture immediately without chewing. Do not crush, chew, or divide capsule contents.

Extended-release suspension (Quillivant XR): Administer in the morning with or without food. Shake bottle ≥10 seconds prior to administration. Use the oral dosing dispenser provided; wash after each use.

Extended-release chewable tablet (QuilliChew ER): Administer in the morning with or without food. Tablets are scored and may be halved.

Extended-release orally disintegrating tablet (Cotempla XR-ODT): Administer in the morning consistently with or without food. Remove the tablet from blister pack with dry hands by peeling back (do not push tablet through foil), and administer immediately. Allow the tablet to dissolve on the tongue without chewing or crushing; no liquid is needed.

Extended-release tablet:

Metadate ER: Administer 30 to 45 minutes before a meal. Swallow whole with water or other fluid; do not crush or chew tablet.

Concerta: Administer in the morning. May be taken with or without food, but must be taken with water or other fluid. Do not crush, chew, or divide tablet.

Sustained-release tablet (Ritalin-SR): Swallow whole; do not crush or chew tablet.

Administration: Topical

Transdermal (Daytrana): Apply to clean, dry, non-oily, intact skin to the hip area, avoiding the waistline; do not premedicate the patch site with hydrocortisone or other solutions, creams, ointments, or emollients. Apply at the same time each day to alternating hips. Press firmly for 30 seconds to ensure proper adherence. Avoid exposure of application site to external heat source, which may increase the amount of drug absorbed. If difficulty is experienced when separating the patch from the liner or if any medication (sticky substance) remains on the liner after separation; discard that patch and apply a new patch. Do not use a patch that has been damaged or torn; do not cut patch. If patch should dislodge, may replace with new patch (to different site) but total wear time should not exceed 9 hours; do not reapply with dressings, tape, or common adhesives. Patch may be removed early if a shorter duration of effect is desired or if late day side effects occur. Wash hands with soap and water after handling. Avoid touching the sticky side of the patch. If patch removal is difficult, an oil-based product (eg, petroleum jelly, olive oil) may be applied to the patch edges to aid removal; never apply acetone-based products (eg, nail polish remover) to patch. Dispose of used patch by folding adhesive side onto itself, and discard in toilet or appropriate lidded container.

Administration: Pediatric

Oral: To avoid insomnia, last daily dose of all products except Jornay PM should be administered several hours before retiring.

Immediate-release formulations:

Tablet (Ritalin), oral solution (Methylin): Administer ~30 to 45 minutes before meals. Ensure last daily dose is administered before 6 PM if difficulty sleeping occurs.

Chewable tablet (Methylin): Administer ~30 to 45 minutes before meals with at least 8 ounces of water or other fluid; choking may occur if not enough fluids are taken. Ensure last daily dose is administered before 6 PM if difficulty sleeping occurs.

Extended-/sustained-release formulations:

Tablets:

Concerta: May be administered without regard to food, but must be taken with liquids; administer dose once daily in the morning; do not crush, chew, or divide tablets.

Metadate ER: May be taken with or without food. Swallow whole; do not crush, chew, or break tablets.

Ritalin SR: Administer 30 to 45 minutes before a meal. Swallow whole; do not crush, chew, or break tablets.

Capsules:

Aptensio XR: Administer in the morning with or without food; swallow capsule whole; do not crush, chew, or divide capsule or its contents; capsules may be opened and the contents sprinkled onto applesauce; mixture must be consumed immediately without chewing; do not store for future use.

Biphentin [Canadian product]: Administer in the morning; do not crush or chew capsule or its contents; capsules may be opened and the contents sprinkled onto applesauce, ice cream, or yogurt; mixture must be consumed immediately without chewing; do not store for future use.

Foquest [Canadian product]: Adults: Administer in the morning with a full glass of water; do not crush or chew capsule or its contents; capsules may be opened and the contents sprinkled onto a tablespoon of applesauce, ice cream, or yogurt; mixture must be consumed within 10 minutes without chewing.

Jornay PM: Administer dose once daily in the evening between 6:30 and 9:30 PM; administer consistently either with or without food; swallow capsule whole; do not crush, chew, or divide capsule or its contents; capsules may be opened and the contents sprinkled onto applesauce; mixture must be consumed immediately without chewing; do not store for future use. Missed doses should be taken as soon as remembered if the same evening; if missed dose remembered the following morning, it should be skipped.

Metadate CD: Administer dose once daily in the morning, before breakfast, with liquids; capsule may be swallowed whole; do not crush, chew, or divide or its capsule contents; capsules may be opened and contents sprinkled on a small amount (one tablespoonful) of applesauce; immediately consume drug/applesauce mixture; do not store for future use; swallow applesauce without chewing; drink fluids after consuming drug/applesauce mixture to ensure complete swallowing of beads.

Ritalin LA: Administer dose once daily in the morning; may be administered with or without food (but some food consumed at breakfast may delay absorption); capsule may be swallowed whole; do not crush, chew, or divide capsule or its contents; may be opened and contents sprinkled on a small amount (one spoonful) of applesauce. Note: Applesauce should not be warm; immediately consume drug/applesauce mixture; do not store for future use.

Orally disintegrating tablet (Cotempla XR-ODT): Administer in the morning consistently with or without food. Remove the tablet from blister pack with dry hands by peeling back (do not push tablet through foil), and administer immediately. Allow the tablet to dissolve on the tongue without chewing or crushing; no liquid is needed.

Powder for oral suspension (Quillivant XR): Administer in the morning with or without food. Shake bottle ≥10 seconds prior to administration. Use the oral dosing dispenser provided; wash after each use.

Topical: Transdermal (Daytrana): Apply patch immediately after opening pouch and removing protective liner; do not use patch if pouch seal is broken; do not cut patch; do not use patches that are cut or damaged. If difficulty is experienced when separating the patch from the liner or if any medication (sticky substance) remains on the liner after separation, discard that patch and apply a new patch. Apply to clean, dry, healthy skin on the hip; do not apply to oily, damaged, inflamed, or irritated skin; do not apply to the waistline; do not premedicate the patch site with hydrocortisone or other solutions, creams, ointments, or emollients. Apply at the same time each day, 2 hours before effect is needed. Alternate site of application daily (ie, use alternate hip). Press patch firmly for 30 seconds to ensure proper adherence, especially around the edges. Remove patch typically 9 hours after application. Patch may be removed earlier if a shorter duration of action is required or if late day adverse effects occur or may be worn for up to 16 hours if extended duration of effects are needed (Arnold 2007).

Avoid exposure of application site to external heat source (eg, hair dryers, electric blankets, heating pads, heated water beds), which may significantly increase the rate and amount of drug absorbed. Exposure of patch to water during swimming, bathing, or showering may affect patch adherence. Do not reapply patch with dressings, tape, or other adhesives. If patch should become dislodged, may replace with new patch (to different site) but total wear time for the day should not exceed 9 hours, even if more than one patch is used.

During removal, peel off patch slowly. If needed, patch removal may be helped by applying an oil-based product (ie, mineral oil, olive oil, or petroleum jelly) to the patch edges, gently working it underneath the patch edges. If a patch is not able to be removed, contact a physician or pharmacist. Nonmedical adhesive removers and acetone-based products, such as nail polish remover, should not be used to remove patches or adhesive. If adhesive residue remains on the skin after patch removal, use an oil-based product and gently rub area to remove adhesive. Avoid touching the sticky side of the patch. Wash hands with soap and water after handling.

Dispose of used patch by folding adhesive side onto itself, and flush down the toilet or discard in appropriate lidded container; discard unused patches that are no longer needed in the same manner; protective pouch and liner should be discarded in an appropriate lidded container. Note: Used patches contain residual drug; keep all transdermal patches out of the reach of children.

Dietary Considerations

Administer immediate release (IR) tablet (Ritalin), IR solution (Methylin), IR chewable tablet (Methylin), and sustained released tablet (Ritalin-SR) 30-45 minutes before meals. Some products may contain phenylalanine.

Storage/Stability

Capsule:

Controlled-release (Biphentin, Foquest [Canadian products]): Store at 15°C to 30°C (59°F to 86°F). Protect from moisture. After sprinkling Foquest on food, the mixture should be used immediately or within 10 minutes of mixing; discard if greater than 10 minutes after mixing.

Extended-release:

Aptensio XR: Store at 20°C to 25°C (68°F to 77°F). Protect from moisture.

Jornay PM: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from humidity.

Metadate CD: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light.

Ritalin LA: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Solution: Immediate-release (Methylin): Store at 20°C to 25°C (68°F to 77°F).

Suspension: Extended-release (Quillivant XR): Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F), before and after reconstitution. Reconstituted bottle must be used within 4 months.

Tablet:

Extended-release:

Metadate ER: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light and moisture.

Concerta: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from humidity.

Extended-release chewable (QuilliChew ER): Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Extended-release orally disintegrating (Cotempla XR-ODT): Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store in reusable travel case.

Immediate-release (Ritalin): Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light.

Immediate-release chewable (Methylin): Store at 20°C to 25°C (68°F to 77°F). Protect from light and moisture.

Sustained-release (Ritalin-SR): Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light and moisture.

Transdermal system: Daytrana: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Keep patches stored in protective pouch. Once tray is opened, use patches within 2 months; once an individual patch has been removed from the pouch and the protective liner removed, use immediately. Do not refrigerate or freeze.

Preparation for Administration: Adult

Suspension: Extended release (Quillivant XR): Prior to dispensing, reconstitute with an appropriate amount of water (refer to bottle).

Preparation for Administration: Pediatric

Oral: Extended release: Powder for oral suspension (Quillivant XR): Prior to dispensing, tap bottle until powder flows freely, reconstitute with an appropriate amount of water as specified on the bottle, insert bottle adapter, and secure cap. Shake vigorously for at least 10 seconds until suspended.

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, vomiting, rhinitis, pharyngitis, fatigue, dry mouth, weight loss, anxiety, lack of appetite, insomnia, heartburn, or abdominal pain. Have patient report immediately to prescriber signs of severe cerebrovascular disease (change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight), signs of serotonin syndrome (dizziness, severe headache, agitation, hallucinations, tachycardia, abnormal heartbeat, flushing, tremors, sweating a lot, change in balance, severe nausea, or severe diarrhea), signs of infection, signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), angina, severe dizziness, passing out, vision changes, shortness of breath, joint pain, purple patches on skin or mouth, tachycardia, bradycardia, abnormal heartbeat, severe headache, seizures, tremors, abnormal movements, sweating a lot, bruising, bleeding, severe loss of strength and energy, agitation, change in color of hands or feet from pale to blue or red, numbness or tingling of hands or feet, painful extremities, cold sensation of extremities, wounds on fingers or toes, change in amount of urine passed, urinary retention, muscle pain, muscle weakness, libido changes, priapism, skin discoloration, severe skin irritation, signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), hallucinations, mood changes, or behavioral changes (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
Contraindications

US labeling: Hypersensitivity (eg, angioedema, anaphylaxis) to methylphenidate or any component of the formulation; use during or within 14 days following MAOI therapy

Additional contraindications:

Concerta, Daytrana, Metadate CD, Methylin, Metadate ER: Marked anxiety, tension, and agitation; glaucoma; family history or diagnosis of Tourette syndrome or tics

Metadate CD: Severe hypertension, heart failure, arrhythmia, hyperthyroidism or thyrotoxicosis, recent MI or angina; concomitant use of halogenated anesthetics; patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase insufficiency

Canadian labeling: Hypersensitivity to methylphenidate or any component of the formulation; marked anxiety, tension, and agitation; glaucoma; use during or within 14 days following MAO inhibitor therapy; family history or diagnosis of Tourette syndrome or tics (excluding Concerta), thyrotoxicosis, advanced arteriosclerosis, symptomatic cardiovascular disease, or moderate to severe hypertension

Additional contraindications:

Foquest: Known hypersensitivity or idiosyncrasy to sympathomimetic amines; history of drug abuse

Ritalin and Ritalin SR: Pheochromocytoma

Warnings/Precautions

Concerns related to adverse effects:

• Cardiovascular events: CNS stimulant treatment has been associated with sudden death in children and adolescents with preexisting structural cardiac abnormalities and sudden death, stroke, and MI have been reported in adults. Consistent with other studies, a large retrospective cohort study involving 1,200,438 children, adolescents, and young adults (aged 2 to 24 years) prescribed methylphenidate, dexmethylphenidate, dextroamphetamines, amphetamine salts, pemoline, or atomoxetine found no evidence that current use of an ADHD medication increased risk for sudden cardiac death, acute MI, or stroke (Cooper 2011). Stimulants should be avoided in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, Marfan syndrome, or other serious cardiac problems. Some products are contraindicated in patients with moderate or severe hypertension, angina, heart failure, arrhythmias, or recent MI. Prior to initiating stimulant, assess medical history and family history of sudden death or ventricular arrhythmia; conduct a physical exam to assess for cardiac disease; patients should receive further evaluation if findings suggest cardiac disease, such as ECG and echocardiogram. Promptly conduct cardiac evaluation in patients who develop exertional chest pain, unexplained syncope, or any other symptoms of cardiac disease during methylphenidate treatment.

• Hypersensitivity: Hypersensitivity reactions, such as angioedema and anaphylactic reactions have been reported.

• Peripheral vasculopathy: Stimulants are associated with peripheral vasculopathy, including Raynaud phenomenon; signs/symptoms are usually mild and intermittent, and generally improve with dose reduction or discontinuation. Peripheral vasculopathy effects have been observed at different times, at therapeutic doses, and in all age groups. Digital ulceration and/or soft tissue breakdown have been observed rarely; monitor for digital changes during therapy and refer for further evaluation (eg, rheumatology) if necessary.

• Priapism: Prolonged (>4 hours), painful, and nonpainful erections, sometimes requiring surgical intervention, have been reported in pediatric and adult patients, according to the manufacturers’ labeling and a 2013 FDA warning; there are at least 22 published cases (Baytunca 2016; Bozkurt 2017; Chauhan 2016; Eiland 2014; Esnafoglu 2017; Mann 2017; Unver 2017). Priapism has been reported to develop after some time on the drug, often subsequent to an increase in dose but also during a period of drug withdrawal (drug holidays or discontinuation). Patients with certain hematological dyscrasias (eg, sickle cell disease), malignancies, perineal trauma, or concomitant use of alcohol, illicit drugs, or other medications associated with priapism may be at increased risk (Eiland 2014). Patients who develop abnormally sustained or frequent and painful erections should discontinue therapy and seek immediate medical attention. An emergent urological consultation should be obtained in severe cases. Priapism has been associated with different dosage forms and products; it is not known if rechallenge with a different formulation will risk recurrence. In patients with severe cases of priapism that were slow to resolve and/or required detumescence by aspiration, avoidance of stimulants and atomoxetine may be preferred (Eiland 2014).

• Visual disturbance: Difficulty in accommodation and blurred vision have been reported with the use of stimulants.

Disease-related concerns:

• Abuse potential: [US Boxed Warning]: CNS stimulants, including methylphenidate-containing products and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Long-term abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use because severe depression may occur. Withdrawal following long-term therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

• Cardiovascular disorders: CNS stimulants may increase heart rate and blood pressure; in pediatric patients, the observed mean increase in heart rate was 3 to 6 bpm and blood pressure was 2 to 4 mm Hg. Use with caution in patients with hypertension, heart failure, recent MI, ventricular arrhythmia, and other cardiovascular conditions that might be exacerbated by increases in blood pressure or heart rate. Some products are contraindicated in patients with severe hypertension, hyperthyroidism, or angina.

• Psychiatric disorders: Use with caution in patients with preexisting psychosis (may exacerbate symptoms of behavior and thought disorder) or bipolar disorder (may induce mixed/manic episode). New-onset psychosis or mania may occur with stimulant use. Patients should be screened for bipolar disorder and risk factors for developing a manic episode prior to treatment; consider discontinuation if psychotic or manic symptoms (eg, delusional thinking, hallucinations, mania) occur. May be associated with aggressive behavior or hostility in children (causal relationship not established); monitor for development or worsening of these behaviors. Patients with ADHD are at increased risk for suicidal ideation and suicide attempt; however, neither increased risk nor a causal relationship with methylphenidate and attempted suicide has been observed in large cohort trials (Huang 2018; Man 2017). Monitor for suicide-related behavior.

• Seizure disorder: Use with caution in patients with a history of seizure disorder; may lower seizure threshold leading to new onset or breakthrough seizure activity. Discontinue in the presence of seizures.

• Tourette syndrome/tics: Use with caution in patients with Tourette syndrome or other tic disorders. Stimulants may exacerbate tics (motor and phonic) and Tourette syndrome; however, evidence demonstrating increased tics is limited. Evaluate for tics and Tourette syndrome prior to therapy initiation; use is contraindicated with some products.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Pediatric: Use of stimulants has been associated with appetite suppression, weight loss, and slowing of growth rate; monitor growth rate, height, and weight during treatment. Treatment interruption may be necessary in patients who are not increasing in height or gaining weight as expected.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP [“Inactive” 1997]; CDC 1982); some data suggest that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

• Biphentin, Foquest [Canadian products]: Controlled-release capsules are not interchangeable with other controlled-release formulations.

• Concerta: Should not be used with preexisting severe gastrointestinal narrowing conditions, such as esophageal motility disorders, small bowel disease, “short” gut syndrome, cystic fibrosis, history of peritonitis, chronic intestinal pseudo-obstruction, or Meckel diverticulum.

• Daytrana: Transdermal system may cause dermal reactions: Chemical leukoderma and contact sensitization; in a one-year tolerability study, the majority of subjects who withdrew (7%) did so due to dermal reactions (Findling 2009). Chemical leukoderma is a persistent loss of skin pigmentation at and around the application site, as well as at distant sites from the application site, that may resemble vitiligo, especially if loss of skin pigmentation occurs at areas distant from application site; patients with a personal and/or family history of vitiligo may be at more risk; patients should monitor for signs of skin depigmentation and immediately inform their health care provider if observed; discontinue use if patient experiences chemical leukoderma; loss of skin pigmentation may continue after discontinuation. Contact sensitization is characterized by erythema plus an intense local reaction (eg, edema, papules, vesicles) that does not improve within 48 hours or spreads beyond the patch site; sensitization may subsequently manifest systemically with other routes of methylphenidate administration; if using oral methylphenidate, initiate under medical supervision and monitor closely, as some sensitized patients may not be able to take methylphenidate in any form. Avoid exposure of application site to any direct external heat sources (eg, hair dryers, heating pads, electric blankets) while wearing patch; heat may increase the rate and extent of absorption more than 2-fold and result in overdose.

• Lactose/sucrose: Some dosage forms may contain lactose or sucrose; use with caution in patients intolerant to either component (some manufacturer labels recommend avoiding use in such patients).

• Metadate CD: Concomitant use with halogenated anesthetics is contraindicated; may cause sudden elevations in blood pressure; if surgery is planned, do not administer Metadate CD on the day of surgery.

• Phenylketonuria: Some dosage forms contain phenylalanine, which can be harmful to patients with phenylketonuria (PKU). Before prescribing, consider the combined daily amount of phenylalanine from all sources.

Other warnings/precautions:

• ADHD treatment: Appropriate use: Recommended to be used as part of a comprehensive treatment program for attention deficit disorders.

Geriatric Considerations

Methylphenidate is often useful in treating medically-ill depressed elderly patients who are discouraged, withdrawn, apathetic, or disinterested in their activities. In particular, it is useful in patients who are starting a rehabilitation program but have resigned themselves to fail; these patients may not have a major depressive disorder; will not improve memory or cognitive function; use with caution in patients with dementia who may have increased agitation and confusion. In elderly patients with insomnia, this medication is considered potentially inappropriate (Beers Criteria [AGS 2015]).

Warnings: Additional Pediatric Considerations

CNS stimulant treatment has been associated with sudden death in children and adolescents with preexisting structural cardiac abnormalities; one study reported methylphenidate increased risk for arrhythmia and MI in youth without congenital heart disease (Shin 2016) and a retrospective case-control study reported an association with stimulants and sudden unexplained death in youth (Gould 2009). However, as noted in reviews (Martinez-Raga 2013, Westover 2012) several large studies have not found an association between prescription stimulants and cardiovascular events; though most retrospective studies were large (n = 55,383 to 2,131,953), some had statistical power or methodological limitations (Westover 2012). A large retrospective cohort study involving 1,200,438 children and young adults (aged 2 to 24 years) prescribed ADHD medication (methylphenidate, dexmethylphenidate, dextroamphetamines, amphetamine salts, pemoline, or atomoxetine) found no evidence that ADHD medication was associated with an increased risk of serious cardiovascular events (ie, acute MI, sudden cardiac death, stroke) in current (adjusted hazard ratio: 0.75; 95% CI: 0.31 to 1.85) or former (adjusted hazard ratio: 1.03; 95% CI: 0.57 to 1.89) users compared with nonusers, nor in current compared with former users. Results were similar with multiple alternative analyses to assess for bias or study assumptions. While point estimates of relative risks for ADHD drugs did not demonstrate increased risk, the upper limit of the 95% CI suggested a doubling of the risk could not be ruled out, although absolute magnitude of increased risk would be low. Data on any individual medication, other than methylphenidate, were too sparse for separate regression analyses (Cooper 2011). Prior to treatment with medications for ADHD, the American Heart Association and the American Academy of Pediatrics recommend that all children and adolescents diagnosed with ADHD have a thorough cardiovascular assessment, including patient and family health histories, determination of all medications used (prescribed and over-the-counter), and a physical examination focused on cardiovascular disease risk factors. An ECG is not mandatory but is reasonable to consider prior to stimulant medication therapy. Prompt evaluation and appropriate referral and testing, if warranted, should occur if any cardiac symptoms present (Vetter 2008).

Evaluation of the effect of stimulants on growth in ADHD diagnosed children <12 years receiving treatment for at least 3 years with stimulants has shown decreased height and weight changes over time compared to age matched control; height: 4.7 to 5.5 cm/year compared to 6.3 cm/year and 2.1 to 3.3 kg/year compared to 4.4 kg/year (Poulton 2016). In 5,315 pediatric patients (age range: 8 to 17 years) actively treated with stimulants (methylphenidate, dexmethylphenidate, dextroamphetamine, atomoxetine, lisdexamfetamine), significant reductions in total femoral, femoral neck, and lumbar bone mineral density (BMD) were observed compared to matched unmedicated controls (n=1,967); also reported were significantly more subjects in the stimulant-treated group with BMD measurements in the osteopenic range compared to matched controls (38.3% to 21.6%); of note, there was no data on duration of medication treatment, dosing, or therapy changes (Howard 2017). A longitudinal cohort-controlled trial reported no difference in peak height velocity and final adult height in subjects with ADHD and/or treated with stimulants (Harstad 2014).

Use with caution in preschool-age children; some clinical trials have reported higher rates of adverse events in children 3 to 5 years of age, compared with older children, and some trials have noted a greater discontinuation of therapy compared to school-age children, though adverse event reports may have been a proxy for inefficacy, rebound, or other underlying causes (Greenhill 2006; Wigal 2006). The moderate to severe adverse effect profiles in children are age-related; in preschool children, the most commonly reported adverse effects were crabbiness/irritability, emotional outbursts, difficulty falling asleep, repetitive behavior/thoughts, and decreased appetite; in school-age children, they were decreased appetite, delay of sleep onset, headache, and stomach ache (Wigal 2006).

Pregnancy Considerations

Information related to the use of methylphenidate in pregnant women with attention-deficit/hyperactivity disorder (Ornoy 2018) or narcolepsy (Calvo-Ferrandiz 2018; Maurovich-Horvat 2013; Thorpy 2013) is limited and outcome data is conflicting (Ornoy 2018). If treatment of ADHD in pregnancy is needed, methylphenidate may be considered (Larsen 2015; McAllister-Williams 2017).

Data collection to monitor pregnancy and infant outcomes following exposure to methylphenidate is ongoing. Health care providers are encouraged to enroll females exposed to methylphenidate during pregnancy in the National Pregnancy Registry for Psychostimulants at 1-866-961-2388.

Breast-Feeding Considerations

Methylphenidate is present in breast milk.

The relative infant dose (RID) of methylphenidate is 0.7% when calculated using the highest breast milk concentration located and compared to a weight-adjusted maternal dose of 52 mg/day.

In general, breastfeeding is considered acceptable when the RID of a medication is <10% (Anderson 2016; Ito 2000). However some sources note breastfeeding should only be considered if the RID is <5% for psychotropic agents (Larsen 2015).

The RID of methylphenidate was calculated using a milk concentration of 19 mcg/L, providing an absolute daily infant dose via breast milk of 2.9 mcg/kg/day. This milk concentration was obtained following maternal administration methylphenidate to three women for ADHD. Maternal doses ranged from 35 to 80 mg/day (Hackett 2006). Authors of two additional case reports calculated the RID of methylphenidate <1% (Hackett 2006; Spigset 2007). In a case report, methylphenidate was no longer detectable in breast milk 20 to 21 hours after the maternal dose following administration of the immediate release tablet (Spigset 2007).

Adverse events were not noted in three case reports (Bolea-Alamanac 2014; Hackett 2006; Spigset 2007); however, infants in two cases were older (6 months of age and 11 months of age) and exposure was limited (Hackett 2006; Spigset 2007). Long-term developmental effects have not been studied. Growth and medical development were normal in one child up to 1 year of age (Bolea-Alamanac 2014).

According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of exposure to the infant and the benefits of treatment to the mother. Monitor breastfeeding infants for adverse reactions, such as agitation, anorexia, insomnia, and reduced weight gain.

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

>10%:

Central nervous system: Insomnia (including initial insomnia; oral: 2% to 33%; transdermal: 6% to 13%), headache (2% to 22%), irritability (6% to 11%)

Gastrointestinal: Decreased appetite (2% to 26%), xerostomia (oral: 14%), nausea (2% to 13%)

1% to 10%:

Cardiovascular: Tachycardia (oral: 5%; transdermal: ≤1%), palpitations (oral: 3%; transdermal: <1%), increased blood pressure (≥2%), increased heart rate (oral: ≥2%)

Central nervous system: Emotional lability (1% to 9%), anxiety (oral: 8%), increased diastolic blood pressure (oral: 7%), tics (transdermal: 7%; oral: 2%), dizziness (2% to 7%), psychomotor agitation (oral: 5%), depressed mood (oral: 4%), nervousness (oral: 3%; transdermal: <1%), restlessness (oral: 3%), aggressive behavior (oral: 2%), agitation (oral: 2%), depression (≤2%), hypertonia (oral: 2%), lack of emotion (oral: 2%), vertigo (oral: 2%), confusion (oral: 1%), sedation (oral: 1%), tension (oral: 1%), tension headache (oral: 1%), paresthesia (≤1%)

Dermatologic: Hyperhidrosis (oral: 5%), excoriation (oral: 4%), skin rash (oral: 2%)

Endocrine & metabolic: Weight loss (2% to 9%), decreased libido (oral: 2%)

Gastrointestinal: Vomiting (2% to 10%), abdominal pain (transdermal: 5% to 7%), upper abdominal pain (oral: 6%), anorexia (2% to 5%), bruxism (oral: 2%), dyspepsia (oral: 2%), motion sickness (oral: 2%), constipation (oral: 1%)

Hematologic & oncologic: Bruise (oral: 3%)

Neuromuscular & skeletal: Back pain (oral: 3%), tremor (oral: 3%)

Ophthalmic: Blurred vision (≤2%), eye pain (oral: 2%)

Respiratory: Nasopharyngitis (oral: 3%), streptococcal pharyngitis (oral: 3%), cough (oral: 2%), upper respiratory tract infection (oral: 2%), oropharyngeal pain (oral: 1% to 2%)

Miscellaneous: Fever (oral: 2%)

Frequency not defined:

Cardiovascular: Cardiac arrhythmia, decreased blood pressure, decreased pulse, heart murmur, hypertension, increased pulse

Central nervous system: Drug abuse, drug dependence, Gilles de la Tourette syndrome (rare), hypervigilance, jitteriness, mood changes, outbursts of anger, panic attack, sleep disorder, toxic psychosis

Dermatologic: Macular eruption

Endocrine & metabolic: Growth suppression, hot flash, increased thirst

Gastrointestinal: Abdominal distress, diarrhea

Genitourinary: Erectile dysfunction

Hematologic & oncologic: Anemia, leukopenia

Hepatic: Increased serum alanine aminotransferase

Neuromuscular & skeletal: Asthenia, muscle spasm

Ophthalmic: Dry eye syndrome

Respiratory: Dyspnea, sinusitis

<1%, postmarketing, and/or case reports: Accommodation disturbance, allergic contact dermatitis, allergic contact sensitivity, alopecia, anaphylaxis, angina pectoris, angioedema, application site reaction, arthralgia, auditory hallucination, auricular edema, bradycardia, bullous skin disease, cerebral arteritis, cerebrovascular occlusion, change in libido, change in WBC count, chest discomfort, chest pain, decreased platelet count, decreased therapeutic response, diplopia, disorientation, drowsiness, dyskinesia, erythema, erythema multiforme, exfoliative dermatitis, extrasystoles, fatigue, hallucination, hepatic failure (acute), hepatic injury (severe), hyperpyrexia, hypersensitivity reaction, immune thrombocytopenia, increased liver enzymes, increased serum alkaline phosphatase, increased serum bilirubin, lethargy, leukoderma (chemical; FDA Safety Alert 2015), loss of scalp hair, mania, muscle twitching, myalgia, mydriasis, necrotizing angiitis, neuroleptic malignant syndrome, pancytopenia, peripheral vascular insufficiency, priapism, Raynaud disease, rhabdomyolysis, seizure, supraventricular tachycardia, talkativeness, thrombocytopenia, urticaria, ventricular arrhythmia (Schelleman 2012), ventricular premature contractions, visual disturbance, visual hallucination, visual impairment

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

None known.

Drug Interactions 

Acebrophylline: May enhance the stimulatory effect of CNS Stimulants. Risk X: Avoid combination

Alcohol (Ethyl): May enhance the adverse/toxic effect of Methylphenidate. Alcohol (Ethyl) may increase the serum concentration of Methylphenidate. Risk X: Avoid combination

Amifampridine: Agents With Seizure Threshold Lowering Potential may enhance the neuroexcitatory and/or seizure-potentiating effect of Amifampridine. Risk C: Monitor therapy

Antacids: May increase the absorption of Methylphenidate. Specifically, antacids may interfere with the normal release of drug from the extended-release capsules (Ritalin LA brand), which could result in both increased absorption (early) and decreased delayed absorption. Risk C: Monitor therapy

Antihypertensive Agents: Methylphenidate may diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Anti-Parkinson Agents (Dopamine Agonist): Methylphenidate may enhance the adverse/toxic effect of Anti-Parkinson Agents (Dopamine Agonist). Risk C: Monitor therapy

Antipsychotic Agents: May enhance the adverse/toxic effect of Methylphenidate. Methylphenidate may enhance the adverse/toxic effect of Antipsychotic Agents. Risk C: Monitor therapy

AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

BuPROPion: May enhance the neuroexcitatory and/or seizure-potentiating effect of Agents With Seizure Threshold Lowering Potential. Risk C: Monitor therapy

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Risk C: Monitor therapy

CloNIDine: Methylphenidate may enhance the adverse/toxic effect of CloNIDine. Risk C: Monitor therapy

Cocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Risk D: Consider therapy modification

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Risk C: Monitor therapy

Esketamine: May enhance the hypertensive effect of CNS Stimulants. Risk C: Monitor therapy

Fosphenytoin: Methylphenidate may increase the serum concentration of Fosphenytoin. Risk C: Monitor therapy

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

Histamine H2 Receptor Antagonists: May increase the absorption of Methylphenidate. Specifically, H2-antagonists may interfere with the normal release of drug from the extended-release capsules (Ritalin LA brand), which could result in both increased absorption (early) and decreased delayed absorption. Risk C: Monitor therapy

Inhalational Anesthetics: Methylphenidate may enhance the hypertensive effect of Inhalational Anesthetics. Risk X: Avoid combination

Iobenguane Radiopharmaceutical Products: CNS Stimulants may diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Risk X: Avoid combination

Ioflupane I 123: Methylphenidate may diminish the diagnostic effect of Ioflupane I 123. Risk C: Monitor therapy

Iohexol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iohexol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iohexol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Risk D: Consider therapy modification

Iomeprol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iomeprol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iomeprol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Risk D: Consider therapy modification

Iopamidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iopamidol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iopamidol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Risk D: Consider therapy modification

Monoamine Oxidase Inhibitors: May enhance the hypertensive effect of Methylphenidate. Risk X: Avoid combination

PHENobarbital: Methylphenidate may increase the serum concentration of PHENobarbital. Risk C: Monitor therapy

Phenytoin: Methylphenidate may increase the serum concentration of Phenytoin. Risk C: Monitor therapy

Primidone: Methylphenidate may increase serum concentrations of the active metabolite(s) of Primidone. Specifically, phenobarbital concentrations could become elevated. Methylphenidate may increase the serum concentration of Primidone. Risk C: Monitor therapy

Proton Pump Inhibitors: May increase the absorption of Methylphenidate. Specifically, proton pump inhibitors may interfere with the normal release of drug from the extended-release capsules (Ritalin LA brand), which could result in both increased absorption (early) and decreased delayed absorption. Risk C: Monitor therapy

Serotonin Modulators: Methylphenidate may enhance the adverse/toxic effect of Serotonin Modulators. Specifically, the risk of serotonin syndrome or serotonin toxicity may be increased. Risk C: Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy

Tricyclic Antidepressants: Methylphenidate may enhance the adverse/toxic effect of Tricyclic Antidepressants. Methylphenidate may increase the serum concentration of Tricyclic Antidepressants. Risk C: Monitor therapy

Vitamin K Antagonists (eg, warfarin): Methylphenidate may increase the serum concentration of Vitamin K Antagonists. Risk C: Monitor therapy

Food Interactions

Ethanol: Alcohol consumption increases the rate of methylphenidate release from Jornay PM (ER capsules), Metadate CD (ER capsules), Ritalin LA (ER capsules), and QuilliChew ER (ER chewable tablet), but not from Concerta (ER tablet); in vitro studies showed that an alcohol concentration of 40% resulted in 84% and 98% of the methylphenidate being released in the first hour with Metadate CD and Ritalin LA, respectively, and 97% of the methylphenidate being released in 2 hours with Jornay PM; a study involving QuilliChew ER showed that an alcohol concentration of 40% resulted in 90% of the methylphenidate being released in the first hour. Management: Avoid consuming alcohol during therapy.

Food: Food may increase oral absorption of immediate-release tablet/solution/chewable tablet. Management: Administer 30 to 45 minutes before meals.

Test Interactions

May interfere with urine detection of amphetamines/methamphetamines (false-positive).

Monitoring Parameters

Periodic CBC, differential, and platelet counts with prolonged use; blood pressure, heart rate; signs and symptoms of depression, aggression, hostility, suicidal behavior/ideation; growth rate (height and weight) in children; signs of central nervous system stimulation; signs of peripheral vasculopathy (eg, digital changes)

Transdermal: Signs of worsening erythema, blistering or edema which does not improve within 48 hours of patch removal, or spreads beyond patch site.

When used for the treatment of ADHD, thoroughly evaluate for cardiovascular risk. Monitor heart rate, blood pressure, and consider obtaining ECG prior to initiation (Vetter 2008).

Advanced Practitioners Physical Assessment/Monitoring

Obtain periodic CBC with differential and platelet count. Obtain blood pressure and heart rate. Assess for history of addiction; long-term use can result in dependence, abuse, or tolerance. Evaluate periodically for need for continued use. In children and adolescents, monitor growth pattern. Assess for changes in mood after initiation and beware of emergence of suicidal ideations. Assess for signs of peripheral vasculopathy. Perform careful cardiovascular assessment prior to initiating therapy when treating ADHD. May consider random toxicology screening to verify use of medication, if concern with possible family use/abuse of medication. Beware of requests for early refills or reports of lost prescriptions. Assess patients using transdermal patch for signs of skin erythema, blistering, or edema.

Nursing Physical Assessment/Monitoring

Check ordered labs and tests and report abnormalities. Monitor height/weight as ordered. Monitor vital signs; be aware of increased blood pressure and pulse. Monitor for changes in mood and educate patient to report any depression, aggression, hostility, or suicidal ideation. Monitor for signs of peripheral vasculopathy and educate patient to report digital changes. Monitor application site in patients using transdermal patch and educate patient to erythema, blistering, or edema.

Product Availability

Adhansia XR (methylphenidate extended-release capsules): FDA approved February 2019; availability anticipated in 2019. Information pertaining to this product within the monograph is pending revision. Consult the prescribing information for additional information.

Jornay PM (methylphenidate extended-release capsules): FDA approved August 2018; availability anticipated in the first half of 2019. Consult the prescribing information for additional information.

Controlled Substance

C-II

Dosage Forms Considerations

Aptensio XR capsules contain multi layered beads. The immediate release layer delivers approximately 40% of the methylphenidate dose, and the controlled release layer delivers approximately 60% of the methylphenidate dose.

Concerta is an osmotic controlled release formulation (OROS) of methylphenidate. The tablet has an immediate-release overcoat providing an initial dose of methylphenidate within 1 hour, and the remaining is released at a controlled rate over 5-9 hours. The overcoat covers a trilayer core. The trilayer core is composed of two layers containing the drug and excipients, and one layer of osmotic components. As water from the gastrointestinal tract enters the core, the osmotic components expand and methylphenidate is released.

Metadate CD capsules contain a mixture of immediate release and extended release beads, designed to release 30% of the dose immediately and 70% over an extended period.

Ritalin LA uses Spheroidal Oral Drug Absorption System (SODAS) design to deliver a bimodal release of medication, intended to mimic twice-daily administration of immediate-release methylphenidate. Fifty percent of the drug is delivered in immediate-release beads, and the remaining half is delivered in delayed-release beads approximately 4 hours after administration.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule Extended Release, Oral, as hydrochloride:

Metadate CD: 10 mg [DSC], 20 mg [DSC], 30 mg [DSC] [contains fd&c blue #2 (indigotine)]

Metadate CD: 40 mg [DSC]

Metadate CD: 50 mg [DSC] [contains fd&c blue #2 (indigotine)]

Metadate CD: 60 mg [DSC]

Generic: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg

Capsule Extended Release 24 Hour, Oral, as hydrochloride:

Aptensio XR: 10 mg [contains brilliant blue fcf (fd&c blue #1)]

Aptensio XR: 15 mg [contains fd&c red #40, fd&c yellow #10 (quinoline yellow)]

Aptensio XR: 20 mg [contains fd&c yellow #10 (quinoline yellow)]

Aptensio XR: 30 mg [contains brilliant blue fcf (fd&c blue #1)]

Aptensio XR: 40 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40]

Aptensio XR: 50 mg [contains fd&c yellow #10 (quinoline yellow)]

Aptensio XR: 60 mg

Ritalin LA: 10 mg, 20 mg, 30 mg, 40 mg, 60 mg [DSC]

Generic: 10 mg, 20 mg, 30 mg, 40 mg, 60 mg

Patch, Transdermal:

Daytrana: 10 mg/9 hr (1 ea, 30 ea); 15 mg/9 hr (30 ea); 20 mg/9 hr (1 ea, 30 ea); 30 mg/9 hr (30 ea)

Solution, Oral, as hydrochloride:

Methylin: 5 mg/5 mL (500 mL); 10 mg/5 mL (500 mL) [contains polyethylene glycol; grape flavor]

Generic: 5 mg/5 mL (500 mL); 10 mg/5 mL (500 mL)

Suspension Reconstituted, Oral, as hydrochloride:

Quillivant XR: 25 mg/5 mL (60 mL, 120 mL, 150 mL, 180 mL) [contains corn starch, sodium benzoate; banana flavor]

Quillivant XR: 25 mg/5 mL (60 mL [DSC], 120 mL [DSC], 150 mL [DSC], 180 mL [DSC]) [contains sodium benzoate; banana flavor]

Tablet, Oral, as hydrochloride:

Ritalin: 5 mg

Ritalin: 10 mg, 20 mg [scored]

Generic: 5 mg, 10 mg, 20 mg

Tablet Chewable, Oral, as hydrochloride:

Methylin: 2.5 mg [DSC], 5 mg [DSC] [contains aspartame; grape flavor]

Methylin: 10 mg [DSC] [scored; contains aspartame; grape flavor]

Generic: 2.5 mg, 5 mg, 10 mg

Tablet Chewable Extended Release, Oral, as hydrochloride:

QuilliChew ER: 20 mg [DSC] [contains aspartame]

QuilliChew ER: 20 mg [scored; contains aspartame]

QuilliChew ER: 30 mg [DSC] [contains aspartame]

QuilliChew ER: 30 mg [scored; contains aspartame]

QuilliChew ER: 40 mg [contains aspartame]

Tablet Extended Release, Oral, as hydrochloride:

Concerta: 18 mg, 27 mg, 36 mg, 54 mg

Metadate ER: 20 mg [additive free, color free]

Relexxii: 72 mg [contains fd&c blue #1 aluminum lake]

Generic: 10 mg, 18 mg, 20 mg, 27 mg, 36 mg, 54 mg, 72 mg

Tablet Extended Release 24 Hour, Oral, as hydrochloride:

Generic: 18 mg, 27 mg, 36 mg, 54 mg

Tablet Extended Release Disintegrating, Oral:

Cotempla XR-ODT: 8.6 mg, 17.3 mg, 25.9 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule Extended Release, Oral:

Biphentin: 15 mg [contains D&C RED #28, FD&C RED #40, FD&C YELLOW #10 ALUMINUM LAKE]

Biphentin: 80 mg [contains FD&C RED #40, FD&C YELLOW #10 (QUINOLINE YELLOW), FD&C YELLOW #6 (SUNSET YELLOW)]

Capsule Extended Release, Oral, as hydrochloride:

Biphentin: 10 mg [contains FD&C BLUE #1 ALUMINUM LAKE]

Biphentin: 20 mg [contains D&C RED 33, FD&C YELLOW #10 ALUMINUM LAKE]

Biphentin: 30 mg [contains FD&C BLUE #1 ALUMINUM LAKE]

Biphentin: 40 mg [contains D&C RED #28, FD&C BLUE #1 ALUMINUM LAKE, FD&C RED #40]

Biphentin: 50 mg [contains FD&C YELLOW #10 ALUMINUM LAKE]

Biphentin: 60 mg

Capsule Extended Release 24 Hour, Oral:

Foquest: 25 mg [contains BRILLIANT BLUE FCF (FD&C BLUE #1)]

Foquest: 35 mg [contains FD&C YELLOW #6 (SUNSET YELLOW)]

Foquest: 45 mg [contains TARTRAZINE (FD&C YELLOW #5)]

Foquest: 55 mg [contains BRILLIANT BLUE FCF (FD&C BLUE #1)]

Foquest: 70 mg, 85 mg, 100 mg

Tablet, Oral, as hydrochloride:

Ritalin: 10 mg

Ritalin: 20 mg [contains FD&C YELLOW #10 (QUINOLINE YELLOW)]

Generic: 5 mg, 10 mg, 20 mg

Tablet Extended Release, Oral, as hydrochloride:

Concerta: 18 mg, 27 mg, 36 mg, 54 mg

Ritalin SR: 20 mg

Generic: 18 mg, 20 mg, 27 mg, 36 mg, 54 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • N06BA04
Generic Available (US)

May be product dependent

Pricing: US

Capsule ER 24 Hour Therapy Pack (Aptensio XR Oral)

10 mg (per each): $9.44

15 mg (per each): $9.44

20 mg (per each): $9.44

30 mg (per each): $9.44

40 mg (per each): $9.44

50 mg (per each): $9.44

60 mg (per each): $9.44

Capsule ER 24 Hour Therapy Pack (Methylphenidate HCl ER (LA) Oral)

10 mg (per each): $10.27 – $10.74

20 mg (per each): $5.67 – $10.82

30 mg (per each): $5.80 – $11.06

40 mg (per each): $5.96 – $11.37

60 mg (per each): $12.37

Capsule ER 24 Hour Therapy Pack (Ritalin LA Oral)

10 mg (per each): $11.94

20 mg (per each): $11.94

30 mg (per each): $12.21

40 mg (per each): $12.55

Capsule, controlled release (Methylphenidate HCl ER (CD) Oral)

10 mg (per each): $5.60 – $8.42

20 mg (per each): $5.60 – $8.42

30 mg (per each): $5.60 – $8.42

40 mg (per each): $7.12 – $11.55

50 mg (per each): $9.44 – $14.19

60 mg (per each): $9.44 – $14.19

Chewable (Methylphenidate HCl Oral)

2.5 mg (per each): $3.16

5 mg (per each): $4.51

10 mg (per each): $6.43

Patch (Daytrana Transdermal)

10 mg/9 hrs (per each): $14.64

15 mg/9 hrs (per each): $14.64

20 mg/9 hrs (per each): $14.64

30 mg/9 hrs (per each): $14.64

Solution (Methylin Oral)

5 mg/5 mL (per mL): $0.17

10 mg/5 mL (per mL): $0.24

Solution (Methylphenidate HCl Oral)

5 mg/5 mL (per mL): $0.90

10 mg/5 mL (per mL): $1.29

Suspension (reconstituted) (Quillivant XR Oral)

25 mg/5 mL (per mL): $2.83

Tablet Chewable Extended Release (QuilliChew ER Oral)

20 mg (per each): $13.27

30 mg (per each): $13.27

40 mg (per each): $13.27

Tablet Extended Release Dispersible (Cotempla XR-ODT Oral)

8.6 mg (per each): $13.69

17.3 mg (per each): $13.69

25.9 mg (per each): $13.69

Tablet, 24-hour (Methylphenidate HCl ER Oral)

18 mg (per each): $6.22

27 mg (per each): $4.80 – $6.38

36 mg (per each): $4.98 – $6.58

54 mg (per each): $5.40 – $7.16

Tablet, controlled release (Concerta Oral)

18 mg (per each): $13.90

27 mg (per each): $14.25

36 mg (per each): $14.70

54 mg (per each): $16.00

Tablet, controlled release (Metadate ER Oral)

20 mg (per each): $2.17

Tablet, controlled release (Methylphenidate HCl ER Oral)

10 mg (per each): $3.60 – $7.50

18 mg (per each): $9.34 – $9.73

20 mg (per each): $3.72 – $7.75

27 mg (per each): $9.58 – $9.97

36 mg (per each): $9.88 – $10.29

54 mg (per each): $10.75 – $11.20

72 mg (per each): $22.81

Tablet, controlled release (Relexxii Oral)

72 mg (per each): $25.34

Tablets (Methylphenidate HCl Oral)

5 mg (per each): $0.54 – $0.74

10 mg (per each): $0.78 – $1.05

20 mg (per each): $1.10 – $1.51

Tablets (Ritalin Oral)

5 mg (per each): $0.79

10 mg (per each): $1.12

20 mg (per each): $1.62

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Mild CNS stimulant; blocks the reuptake of norepinephrine and dopamine into presynaptic neurons; appears to stimulate the cerebral cortex and subcortical structures similar to amphetamines

Pharmacodynamics/Kinetics

Onset of action (AAP 2011):

Children:

Oral:

Extended-release formulations (capsule [Metadate CD, Ritalin LA], tablets [Concerta]): 20 to 60 minutes

Immediate-release formulations (chewable tablet, oral solution, tablet [Methylin, Ritalin]): 20 to 60 minutes

Sustained-release tablet (Ritalin-SR): 60 to 180 minutes

Transdermal (Daytrana): 60 minutes

Adults: Oral: Controlled-release: Foquest [Canadian product]: Within 1 hour

Maximum effect: Oral: Immediate-release tablet: Within 2 hours; Sustained-release tablet: Within 4 to 7 hours

Duration of action:

Oral:

Controlled-release capsule (Foquest [Canadian product]): 16 hours

Extended-release capsule: Metadate CD, Ritalin LA: 6 to 8 hours (AAP 2011); Aptensio XR: ≤16 hours

Extended-release tablet (Concerta): 8 to 12 hours (AAP 2011; Jain 2017)

Extended-release tablet (Metadate ER): 8 hours

Immediate-release formulations (chewable tablet, oral solution, immediate-release tablet [Methylin, Ritalin]): 3 to 5 hours (AAP 2011; Jain 2017)

Sustained-release tablet (Ritalin-SR): 2 to 8 hours (AAP 2011; Jain 2017)

Transdermal (Daytrana): 11 to 12 hours (AAP 2011)

Absorption:

Oral: Readily absorbed

Controlled-release capsule:

Biphentin [Canadian product]: Food delayed initial peak slightly (~18 minutes); relative to immediate-release tablets, AUC is similar in fed or fasted state (~100%)

Foquest [Canadian product]: Food does not significantly affect AUC and Cmax

Extended-release capsule:

Aptensio XR: A high-fat meal increased Cmax (~28%) and AUC (~19%). At an alcohol concentration up to 40% there was 96% release of methylphenidate within 2 hours.

Jornay PM: Initial absorption is delayed with ≤5% of total drug available within first 10 hours after dosing. A high-fat meal at night decreased Cmax (14%) and extended the median Tmax by ~2.5 hours; a high-fat morning meal had no effect on the pharmacokinetics. At an alcohol concentration of 40%, there was an increase in the release rate of methylphenidate, resulting in 97% of the methylphenidate being released in 2 hours.

Metadate CD: A high-fat meal delayed the early peak (~1 hour), and increased Cmax (~30%) and AUC (~17%). At an alcohol concentration of 40%, there was an increase in the release rate of methylphenidate in the first hour, resulting in 84% of the methylphenidate being released.

Ritalin LA: A high-fat meal delayed absorption and peak times, but not the amount absorbed nor initial peak concentration (second peak lowered by ~25%). At an alcohol concentration of 40%, there was a 98% release of methylphenidate in the first hour.

Extended-release chewable tablet: A high-fat meal increased Cmax (~20%) and AUCinf (~4%). At an alcohol concentration of 40%, there was an increase in the release rate of methylphenidate in the first hour, resulting in 90% of the methylphenidate being released.

Extended-release orally disintegrating tablet: Cotempla XR-ODT: A high-fat meal decreased Cmax (24%) and increased AUCinf (16%) and led to an earlier peak (~0.5 hour).

Extended-release suspension: Quillivant XR: A high-fat meal led to an earlier peak (~1 hour), and increased Cmax (~28%) and AUC (~19%).

Extended-release tablet: Metadate ER: Food resulted in greater Cmax and AUC compared to fasting.

Immediate-release chewable tablet: Methylin: A high-fat meal delayed peak time (~1 hour) and increased AUC (~20%).

Immediate-release solution: Methylin: A high-fat meal delayed peak time (~1 hour), and increased Cmax (~13%) and AUC (~25%).

Immediate-release tablet: A high-fat meal, increased the AUC (25%) and Cmax (27%).

Transdermal: Absorption increased when applied to inflamed skin or exposed to heat. Absorption is continuous for 9 hours after application.

Distribution: Vdd-methylphenidate: 2.65 ± 1.11 L/kg, l-methylphenidate: 1.80 ± 0.91 L/kg

Protein binding: 10% to 33%

Metabolism: Extensive metabolism, predominately via de-esterification by carboxylesterase CES1A1 to alpha-phenyl-piperidine acetic acid (PPAA; ritalinic acid) which has little to no pharmacologic activity.

Bioavailability:

Extended-release capsule:

Aptensio XR: 102% (relative to immediate-release oral product)

Jornay PM: 73.9% (relative to immediate-release oral product)

Extended-release suspension: Quillivant XR: 95% (relative to immediate-release oral solution)

Immediate-release chewable tablets and oral solution: Bioequivalent to immediate-release tablets

Sustained-release: 105% (49% to 168%) in children and 101% (85% to 152%) in adults (relative to immediate release oral product)

Transdermal patch (Daytrana): Lower first-pass effect compared to oral administration; thus, much lower doses (on a mg/kg basis) given via the transdermal route may still produce higher AUCs, compared to the oral route

Half-life elimination:

Controlled-release capsule: Biphentin [Canadian product]: Children: 2.4 hours; Adults: 2.1 hours; Foquest [Canadian product]: Adults: 6.95 ± 3.25 hours

Extended-release capsule:

Aptensio XR: Adults: ~5 hours

Jornay PM: ~5.9 hours

Metadate CD: Adults: 6.8 hours

Ritalin LA: Children: 1.5 to 4 hours; Adults: 3 to 4.2 hours

Extended-release chewable tablets: ~5.2 hours

Extended-release orally disintegrating tablet: 4 to 4.5 hours

Extended-release suspension: Quillivant XR: Children ≥9 years, Adolescents, and Adults: ~5 hours

Extended-release tablet: Concerta: Adolescents and Adults: ~3.5 hours

Immediate-release chewable tablet: Methylin: Adults: 3 hours

Immediate-release solution: Methylin: Adults: 2.7 hours

Immediate-release tablet:

Children: 3.5 hours (1.5 to 5 hours)

Adults: 3.5 hours (1.3 to 7.7 hours)

Transdermal: Children and Adolescents 6 to 17 years: d-methylphenidate ~4 to 5 hours, l-methylphenidate 1.4 to 2.9 hours

Time to peak:

Controlled-release capsule:

Biphentin [Canadian product]: Children: Initial: ~2.5 hours; Adults: Initial: ~2 hours

Foquest [Canadian product]: Adults: Initial peak at ~1.6 hours followed by second peak at ~12.5 hours (range: 11 to 16 hours)

Extended-release capsule:

Aptensio XR: Adults: Initial: ~2 hours; Second peak: ~8 hours

Jornay PM: 14 hours

Metadate CD: Children: Initial: ~1.5 hours; Second peak: ~4.5 hours

Ritalin LA:

Children: Initial: 1 to 3 hours; Second peak: 5 to 11 hour

Adults: Initial: 1.3 to 4 hours; Second peak: 4.3 to 6.5 hours

Extended-release chewable tablet: QuilliChew ER: 5 hours (median)

Extended-release orally disintegrating tablet: Cotempla XR-ODT: ~5 hours

Extended-release suspension: Quillivant XR: Children (9 to 12 years): 4.05 hours (range: 3.98 to 6 hours); Adolescents (13 to 15 years): 2 hours (range: 1.98 to 4 hours); Adults: 4 hours (range: 1.3 to 7.3 hours)

Extended-release tablet: Concerta: Initial: ~1 hours, followed by gradually ascending concentrations over 5 to 9 hours; Mean peak: 6 to 10 hours

Immediate-release chewable tablet: Methylin: ~1 to 2 hours

Immediate-release solution: Methylin: 1 to 2 hours

Immediate-release tablet: Children: 1.9 hours (range: 0.3 to 4.4 hours); time to peak is faster after a high-fat meal as compared to without food (median Tmax: 2.5 hours versus 3 hours, respectively).

Sustained-release tablet: Children: 4.7 hours (range: 1.3 to 8.2 hours)

Transdermal: ~8 to 10 hours

Excretion: Urine (78% to 97% as metabolites and unchanged drug); Feces (1% to 3%)

Pharmacodynamics/Kinetics: Additional Considerations

Pediatric:

Extended release capsule: Ritalin LA: Time until the between peak minimum and the time until the second peak were delayed and more variable in children 10 to 12 years of age compared to adults. After a 20 mg dose, concentrations in children were approximately twice the concentrations observed in adults 18 to 35 years of age.

Extended release suspension: Quillivant XR: After a single oral dose of 60 mg plasma concentrations of methylphenidate in children (9 to 12 years of age) were approximately twice the concentrations observed in adults.

Transdermal: The Cmax and AUC of d-methylphenidate were ~50% lower in adolescents, compared to children, following either a 1-day or 7-day administration of 10 mg/9 hours.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Methylphenidate causes tachycardia, increases in blood pressure, and palpitations. Consider monitoring blood pressure prior to using local anesthetic with a vasoconstrictor. Symptoms associated with bruxism have been observed in some patients.

Effects on Bleeding

No information available to require special precautions

Index Terms

Adhansia XR; Jornay PM; Methylphenidate HCl; Methylphenidate Hydrochloride; NWP09

FDA Approval Date
December 05, 1955
References

Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319.[PubMed 11487763]

American Academy of Pediatrics. ADHD: clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics. 2011;128(5):1007-1022. doi: 10.1542/peds.2011-2654.[PubMed 22003063]

American Geriatrics Society 2012 Beers Criteria Update Expert Panel, “American Geriatrics Society Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults,” J Am Geriatr Soc, 2012, 60(4):616-31.[PubMed 22376048]

Anderson PO, Sauberan JB. Modeling drug passage into human milk. Clin Pharmacol Ther. 2016;100(1):42-52.[PubMed 27060684]

Aptensio XR (methylphenidate) extended-release capsules [prescribing information]. Greenville, NC: Patheon; April 2015.

Arnold LE, Lindsay RL, López FA, et al, “Treating Attention-Deficit/Hyperactivity Disorder With a Stimulant Transdermal Patch: The Clinical Art,” Pediatrics, 2007, 120(5):1100-6.[PubMed 17974748]

Baytunca MB, Kose S, Ozbaran B, Erermis S. Risperidone, quetiapine and chlorpromazine may have induced priapism in an adolescent. Pediatr Int. 2016;58(1):61-63.[PubMed 26542690]

Biphentin (methylphenidate) [product monograph]. Pickering, Ontario, Canada: Purdue Pharma; April 2017.

Bolea-Alamanac BM, Green A, Verma G, Maxwell P, Davies SJ. Methylphenidate use in pregnancy and lactation: a systematic review of evidence. Br J Clin Pharmacol. 2014;77(1):96-101.[PubMed 23593966]

Bond WS, “Recognition and Treatment of Attention Deficit Disorder,” Clin Pharm, 1987, 6(8):617-24.[PubMed 2891464]

Bower JE, Bak K, Berger A, et al; American Society of Clinical Oncology. Screening, assessment, and management of fatigue in adult survivors of cancer: an American Society of Clinical oncology clinical practice guideline adaptation. J Clin Oncol. 2014;32(17):1840-1850.[PubMed 24733803]

Bozkurt H, Şahin S. Olanzapine-induced priapism in a child with Asperger’s Syndrome. Balkan Med J. 2017;34(1):85-87.[PubMed 28251031]

Calvo-Ferrandiz E, Peraita-Adrados R. Narcolepsy with cataplexy and pregnancy: a case-control study. J Sleep Res. 2018;27(2):268-272. doi: 10.1111/jsr.12567.[PubMed 28568319]

Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm[PubMed 6810084]

Chauhan N, Grover S, Patidar V. Methylphenidate-induced priapism in a prepubertal boy. Indian J Psychiatry. 2016;58(4):475-476.[PubMed 28197010]

Concerta (methylphenidate) [prescribing information]. Titusville, NJ: Janssen; January 2017.

Concerta (methylphenidate) [product monograph]. Toronto, Ontario, Canada: Janssen Inc; October 2017.

Cooper WO, Habel LA, Sox CM, et al, “ADHD Drugs and Serious Cardiovascular Events in Children and Young Adults,” N Engl J Med, 2011, 365(20):1896-904.[PubMed 22043968]

Cortese S, Holtmann M, Banaschewski T, et al; European ADHD Guidelines Group. Practitioner review: current best practice in the management of adverse events during treatment with ADHD medications in children and adolescents. J Child Psychol Psychiatry. 2013;54(3):227-246. doi: 10.1111/jcpp.12036.[PubMed 23294014]

Cotempla XR-ODT (methylphenidate) [prescribing information]. Grand Prairie, TX: Neos Therapeutics Brands, LLC; June 2017.

Daytrana (methylphenidate) [prescribing information]. Miami, FL: Noven; November 2017.

Eiland LS, Bell EA, Erramouspe J. Priapism associated with the use of stimulant medications and atomoxetine for attention-deficit/hyperactivity disorder in children. Ann Pharmacother. 2014;48(10):1350-1355.[PubMed 24982313]

Esnafoglu E, Demir EY. Hallucination and priapism associated with methylphenidate usage: Two case reports. Indian J Psychiatry. 2017;59(3):386-387.[PubMed 29085103]

FDA Safety Alert. Daytrana Patch (methylphenidate). Food and Drug Administration website. http://www.fda.gov/Drugs/DrugSafety/ucm452244.htm.

Findling RL, Wigal SB, Bukstein OG, et al. Long-term tolerability of the methylphenidate transdermal system in pediatric attention-deficit/hyperactivity disorder: a multicenter, prospective, 12-month, open-label, uncontrolled, phase III extension of four clinical trials. Clin Ther. 2009;31(8):1844-1855.[PubMed 19808143]

Foquest (methylphenidate) [product monograph]. Pickering, Ontario, Canada: Purdue Pharma; December 2017.

Fratto G, Manzon L. Use of psychotropic drugs and associated dental diseases. Int J Psychiatry Med. 2014;48(3):185-197.[PubMed 25492713]

Greenhill LL, “Pharmacologic Treatment of Attention Deficit Hyperactivity Disorder,” Psychiatr Clin North Am, 1992, 15(1):1-27.[PubMed 1347936]

Habel LA, Cooper WO, Sox CM, et al, “ADHD Medications and Risk of Serious Cardiovascular Events in Young and Middle-Aged Adults,” 2011, JAMA, 306(24):2673-83.[PubMed 22161946]

Habel LA, Cooper WO, Sox CM, et al. ADHD medications and risk of serious cardiovascular events in young and middle-aged adults. JAMA. 2011;306(24):2673-83.[PubMed 22161946]

Hackett LP, Kristensen JH, Hale TW, et al, “Methylphenidate and Breast-Feeding,” Ann Pharmacother, 2006, 40(10):1890-1.[PubMed 16940409]

Hardy SE. Methylphenidate for treatment of depressive symptoms, including fatigue and apathy, in medically ill older adults and terminally ill adults. Am J Geriatr Pharmacother. 2009;7(1):34-59.[PubMed 19281939]

Homsi J, Nelson KA, Sarhill N, et al. A phase II study of methylphenidate for depression in advanced cancer. Am J Hosp Palliat Care. 2001;18(6):403-7.[PubMed 11712722]

Huang KL, Wei HT, Hsu JW, et al. Risk of suicide attempts in adolescents and young adults with attention-deficit hyperactivity disorder: a nationwide longitudinal study. Br J Psychiatry. 2018;212(4):234-238.[PubMed 29501070]

“Inactive” ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs. Pediatrics. 1997;99(2):268-278.[PubMed 9024461]

Ito S. Drug therapy for breast-feeding women. N Engl J Med. 2000;343(2):118-126.[PubMed 10891521]

Jain R, Jain S, Montano CB. Addressing diagnosis and treatment gaps in adults with attention-deficit/hyperactivity disorder. Prim Care Companion CNS Disord. 2017;19(5). pii: 17nr02153. doi: 10.4088/PCC.17nr02153.[PubMed 28906602]

Jornay PM (methylphenidate) [prescribing information]. Manatí, Puerto Rico: Patheon Puerto Rico; August 2018.

Kelly DP and Aylward GP, “Attention Deficits in School-Aged Children and Adolescents,” Pediatr Clin North Am, 1992, 39(3):487-512.[PubMed 1574355]

Kerr CW, Drake J, Milch RA, et al. Effects of methylphenidate on fatigue and depression: a randomized, double-blind, placebo-controlled trial. J Pain Symptom Manage. 2012;43(1):68-77.[PubMed 22208450]

Larsen ER, Damkier P, Pedersen LH, et al. Use of psychotropic drugs during pregnancy and breast-feeding. Acta Psychiatr Scand Suppl. 2015;(445):1-28.[PubMed 26344706]

Lavretsky H, Park S, Siddarth P, Kumar A, Reynolds CF 3rd. Methylphenidate-enhanced antidepressant response to citalopram in the elderly: a double-blind, placebo-controlled pilot trial. Am J Geriatr Psychiatry. 2006;14(2):181-185.[PubMed 16473984]

Lavretsky H, Reinlieb M, St Cyr N, Siddarth P, Ercoli LM, Senturk D. Citalopram, methylphenidate, or their combination in geriatric depression: a randomized, double-blind, placebo-controlled trial. Am J Psychiatry. 2015;172(6):561-569.[PubMed 25677354]

Lazarus LW, Moberg PJ, Langsley PR, et al, “Methylphenidate and Nortriptyline in the Treatment of Poststroke Depression: A Retrospective Comparison,” Arch Phys Med Rehabil, 1994, 75(4):403-6.[PubMed 8172499]

Mann RA, George AK. Recurrent priapism in a military veteran receiving treatment for PTSD. Mil Med. 2017;182(11):e2104-e2107.[PubMed 29087891]

Manzi S, Law T, Shannon MW, et al, “Methylphenidate Produces a False-Positive Urine Amphetamine Screen,” Pediatr Emerg Care, 2002, 18(5):401.[PubMed 12395015]

Maurovich-Horvat E, Kemlink D, Högl B, et al, “Narcolepsy and Pregnancy: A Retrospective European Evaluation of 249 Pregnancies,” J Sleep Res, 2013, doi: 10.1111/jsr.12047.[PubMed 23560595]

McAllister-Williams RH, Baldwin DS, Cantwell R, et al; endorsed by the British Association for Psychopharmacology. British Association for Psychopharmacology consensus guidance on the use of psychotropic medication preconception, in pregnancy and postpartum 2017. J Psychopharmacol. 2017;31(5):519-552. doi: 10.1177/0269881117699361.[PubMed 28440103]

Metadate CD (methylphenidate) [prescribing information]. Rochester, NY: UCB Inc; February 2015.

Metadate ER (methylphenidate) [prescribing information]. Smyrna, GA: UCB, Inc; February 2016.

Methylin chewable tablets [prescribing information]. Florham Park, NJ: Shionogi Inc; December 2013.

Methylin oral solution [prescribing information]. Florham Park, NJ: Shionogi Inc; August 2017.

Methylphenidate extended-release tablets (methylphenidate) [prescribing information]. Pine Brook, NJ: Alvogen, Inc; January 2018.

Modi NB, Lindemulder B, and Gupta SK, “ Single- and Multiple-Dose Pharmacokinetics of an Oral Once-a-day Osmotic Controlled-release OROS (Methylphenidate HCl) Formulation,” J Clin Pharmacol, 2000, 40(4):379-88.[PubMed 10761165]

Murphy TK, Lewin AB, Storch EA, Stock S; American Academy of Child and Adolescent Psychiatry (AACAP) Committee on Quality Issues (CQI). Practice Parameter for the assessment and treatment of children and adolescents with tic disorders. J Am Acad Child Adolesc Psychiatry. 2013;52(12):1341-1359.[PubMed 24290467]

Nissen SE, “ADHD and Cardiovascular Risk,” N Engl J Med, 2006, 354(14):1445-8.[PubMed 16549404]

Ornoy A. Pharmacological treatment of attention deficit hyperactivity disorder during pregnancy and lactation. Pharm Res. 2018;35(3):46. doi: 10.1007/s11095-017-2323-z.[PubMed 29411149]

Perrin JM, Friedman RA, Knilans TK; Black Box Working Group; Section on Cardiology and Cardiac Surgery. Cardiovascular monitoring and stimulant drugs for attention-deficit/hyperactivity disorder. Pediatrics. 2008;122(2):451-453.[PubMed 18676566]

Pliszka S; AACAP Work Group on Quality Issues. Practice parameter for the assessment and treatment of children and adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2007;46(7):894-921.[PubMed 17581453]

QuilliChew ER (methylphenidate) extended-release chewable tablets [prescribing information]. New York, NY: Pfizer; August 2018.

Quillivant XR (methylphenidate) [prescribing information]. New York, NY: Pfizer Inc; August 2018.

Relexxii (methylphenidate hydrochloride) extended-release tablets, USP [prescribing information]. Bridgewater, NJ: Vertical Pharmaceuticals, LLC; February 2019.

Ritalin/Ritalin SR (methylphenidate) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals; January 2019.

Ritalin LA (methylphenidate) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals; January 2019.

Ritalin/Ritalin SR (methylphenidate) [product monograph]. Dorval, Quebec, Canada: Novartis Pharmaceuticals Canada Inc; June 2017.

Schelleman H, Bilker WB, Kimmel SE, et al. Methylphenidate and risk of serious cardiovascular events in adults. Am J Psychiatry. 2012;169(2):178-185.[PubMed 22318795]

Shaywitz SE and Shaywitz BA, “Diagnosis and Management of Attention Deficit Disorder: A Pediatric Perspective,” Pediatr Clin North Am, 1984, 31(2):429-57.[PubMed 6728525]

Shin JY, Roughead EE, Park BJ, Pratt NL. Cardiovascular safety of methylphenidate among children and young people with attention-deficit/hyperactivity disorder (ADHD): nationwide self controlled case series study. BMJ. 2016;353:i2550. doi: 10.1136/bmj.i2550.[PubMed 27245699]

Spigset O, Brede WR, and Zahlsen K, “Excretion of Methylphenidate in Breast Milk,” Am J Psychiatry, 2007, 164(2):348.[PubMed 17267805]

Thorpy M, Zhao CG, and Dauvilliers Y, “Management of Narcolepsy During Pregnancy,” Sleep Med, 2013, 14(4):367-76.[PubMed 23433999]

Unver H, Memik NC, Simsek E. Priapism associated with the addition of risperidone to methylphenidate monotherapy: a case report. North Clin Istanb. 2017;4(1):85-88.[PubMed 28752150]

Vetter VL, Elia J, Erickson CH, et al; American Heart Association Council on Cardiovascular Disease in the Young Congenital Cardiac Defects Committee; American Heart Association Council on Cardiovascular Nursing. Cardiovascular monitoring of children and adolescents with heart disease receiving medications for attention deficit/hyperactivity disorder [corrected]: a scientific statement from the American Heart Association Council on Cardiovascular Disease in the Young Congenital Cardiac Defects Committee and the Council on Cardiovascular Nursing [published correction appears in Circulation. 2009;120(7):e55-e59]. Circulation. 2008;117(18):2407-2423.[PubMed 18427125]

Wallace AE, Kofoed LL and West AN, “Double-Blind, Placebo-Controlled Trial of Methylphenidate in Older, Depressed, Medically Ill Patients,” Am J Psychiatry, 1995, 152(6):929-31.[PubMed 7755127]

Weiss MD and Weiss JR, “A Guide to the Treatment of Adults With ADHD,” J Clin Psychiatry, 2004, 65(Suppl 3):27-37.[PubMed 15046533]

Wiggs KK, Chang Z, Quinn PD, et al. Attention-deficit/hyperactivity disorder medication and seizures. Neurology. 2018;90(13):e1104-e1110. doi: 10.1212/WNL.0000000000005213.[PubMed 29476037]

Wilens TE and Biederman J, “The Stimulants,” Psychiatr Clin North Am, 1992, 15(1):191-222.[PubMed 1347939]

Brand Names: International

Adaphen (ZA); Adaphen XL (ZA); Addwize (IN); Aradix Retard (CL, PE, PY); Artige (AU); Attenta (AU); Aurium (PY); Cognil (PY); Comcerta (VE); Concentra (BD); Concentra SR (BD); Concerta (AE, AR, AT, AU, BB, BE, BG, BH, BM, BR, BS, BZ, CH, CL, CN, CO, CR, CY, DE, DK, DO, EC, EE, EG, ES, FI, GR, GT, GY, HK, HN, HR, ID, IE, IL, IS, JM, JP, KW, LB, LT, LU, MT, MX, MY, NI, NL, NO, NZ, PA, PE, PH, PL, PR, PT, QA, RO, SA, SE, SG, SI, SK, SR, SV, TH, TR, TT, TW, UY, VN, ZW); Concerta LP (FR); Concerta Oros (KR); Concerta XL (GB); Delmosart (NO); Equasym (BE, CH, ES, IE); Equasym Depot (DK, NO, SE); Equasym Retard (DE); Equasym XL (GB); Inspiral (IN); Matoride XL (GB); Medikinet (BE, CH, DE, DK, EE, GB, IE, NO, PL, SE); Medikinet CR (DE); Medikinet MR (IL, SG); Medikinet Retard (KR); Medikinet XL (EE, GB); Menidated (EG); Metadate CD SR (KR); Methylin (AR); Methylphen (BD); Metidate (IE); MFD (AR); Nebapul (CL); Penid (KR); Phenida (PK); Prohiper (ID); Quasym LP (FR); Rilatine (LU); Ritalin (AE, AT, AU, BB, BF, BH, BJ, CH, CI, CL, CO, CY, CZ, DE, DK, ET, GB, GH, GM, GN, HK, ID, IE, IL, IQ, IR, IS, JO, JP, KE, KW, LB, LK, LR, LY, MA, ML, MR, MT, MU, MW, MX, MY, NE, NG, NO, NZ, OM, PE, PK, SA, SC, SD, SE, SG, SI, SL, SN, SY, TN, TW, TZ, UG, VE, YE, ZM, ZW); Ritalin LA (AU, BB, CO, HK, ID, IL, MY, PE, PT, TR); Ritalin LP (VE); Ritalin SR (NO, VE); Ritalin-SR (CH, HK, ID, MY, NZ, SG); Ritalina (AR, BR, PY, UY); Ritalina LA (BR, UY); Ritaline (BE, FR, GR); Ritaline LP (FR); Rubifen (AR, ES, LK, MY, NZ, PT, SG, TH, UY); Rubifen SR (NZ); Tradea (CR, DO, GT, HN, MX, NI, PA, SV); Tradea LP (CR, DO, GT, HN, NI, PA, SV); Xenidate XL (GB)

Methylphenidate (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(meth il FEN i date)

Brand Names: US

Aptensio XR; Concerta; Cotempla XR-ODT; Daytrana; Metadate CD [DSC]; Metadate ER; Methylin; QuilliChew ER; Quillivant XR; Relexxii; Ritalin; Ritalin LA

Brand Names: Canada

Biphentin; Concerta; Foquest; Ritalin; Ritalin SR

Warning
  • This drug has a risk of abuse and misuse. Use this drug only as you were told by your doctor. Tell your doctor if you have ever abused or been addicted to any drugs or alcohol.
What is this drug used for?
  • It is used to treat attention deficit problems with hyperactivity.
  • It is used to treat narcolepsy.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • All products:
  • If you have an allergy to methylphenidate or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Glaucoma; nervous, anxious, or tense state; or overactive thyroid.
  • If you or a family member have any of these health problems: Blood vessel disease, high blood pressure, heart structure problems or other heart problems, or Tourette’s syndrome or tics.
  • If you have ever had a stroke.
  • If you have taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for Parkinson’s disease like selegiline or rasagiline in the last 14 days. Taking this drug within 14 days of those drugs can cause very bad high blood pressure.
  • If you are taking any of these drugs: Linezolid or methylene blue.
  • All chewable products:
  • If you have trouble swallowing, talk with your doctor.
  • Long-acting tablets:
  • If you cannot swallow this product whole.
  • If you have ever had any of these health problems: Cystic fibrosis; narrowing of the GI (gastrointestinal) tract or other GI problems like bowel block, small bowel disease, short gut syndrome, or slow-moving swallowing tube (esophagus) or bowel tract; peritonitis.
  • Oral-disintegrating tablet:
  • If you are taking any of these drugs: Famotidine, omeprazole, or sodium bicarbonate.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • All products:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
  • Heart attacks, strokes, and sudden deaths have happened in adults taking this drug. Sudden deaths have also happened in children with some heart problems or heart defects. Call your doctor right away if you have a fast, slow, or abnormal heartbeat; weakness on 1 side of the body; trouble speaking or thinking; change in balance; drooping on 1 side of the face; change in eyesight; chest pain or pressure; shortness of breath; or severe dizziness or passing out.
  • You may have some heart tests before starting this drug. Talk with your doctor.
  • Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
  • This drug may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to your doctor to see if you have a greater chance of seizures while taking this drug.
  • Avoid drinking alcohol while taking this drug.
  • A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take this drug with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
  • Rarely, low blood cell counts have happened with this drug. Call your doctor right away if you have any unexplained bruising or bleeding; signs of infection like fever, chills, or sore throat; or feel very tired or weak.
  • This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
  • All chewable products:
  • If you have phenylketonuria (PKU), talk with your doctor. Some products have phenylalanine.
  • Long-acting tablets:
  • For some brands, you may see the tablet shell in your stool. For these brands, this is normal and not a cause for concern. If you have questions, talk with your doctor.
  • Tell your doctor that you use this drug if you are getting x-rays near the belly.
  • Skin patch:
  • Avoid use of heat sources (such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, heated waterbeds). Avoid long, hot baths or sunbathing. Your temperature may rise and cause too much drug to pass into your body.
  • This drug may lead to loss of skin color at or around where the patch is put on. Sometimes, this has happened at other areas. This may last even after this drug is stopped. The chance may be higher if you or someone in your family has ever had a skin problem called vitiligo. Talk with the doctor.
  • This drug may cause harm if chewed or swallowed. If this drug has been put in the mouth, call a doctor or poison control center right away.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • All products:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Joint pain.
  • Purple patches on the skin or mouth.
  • Change in eyesight.
  • Seizures.
  • Shakiness.
  • Trouble controlling body movements.
  • Sweating a lot.
  • Restlessness.
  • Change in color of hands or feet from pale to blue or red.
  • Numbness, pain, tingling, or cold feeling of the hands or feet.
  • Any sores or wounds on the fingers or toes.
  • Not able to pass urine or change in how much urine is passed.
  • Muscle pain or weakness.
  • Change in sex interest.
  • Call your doctor right away if you have a painful erection (hard penis) or an erection that lasts for longer than 4 hours. This may happen even when you are not having sex. If this is not treated right away, it may lead to lasting sex problems and you may not be able to have sex.
  • New or worse behavior and mood changes like change in thinking, anger, and hallucinations have happened with this drug. Tell your doctor if you or a family member have any mental or mood problems like low mood (depression) or bipolar illness, or if a family member has killed themselves. Call your doctor right away if you have hallucinations; change in the way you act; or signs of mood changes like low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
  • Skin patch:
  • Change in skin color.
  • Very bad skin irritation.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • All products:
  • Dizziness.
  • Feeling sleepy.
  • Dry mouth.
  • Headache.
  • Upset stomach or throwing up.
  • Weight loss.
  • Feeling nervous and excitable.
  • Not hungry.
  • Trouble sleeping.
  • Belly pain or heartburn.
  • Nose or throat irritation.
  • Skin patch:
  • Skin irritation.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • Tablets:
  • Take 30 to 45 minutes before meals.
  • If taking this drug more than 1 time a day, take the last dose of the day before 6 PM.
  • All chewable products:
  • Chew well before swallowing.
  • Take with a full glass of water.
  • Fast-release chewable tablet:
  • Take 30 to 45 minutes before meals.
  • If taking this drug more than 1 time a day, take the last dose of the day before 6 PM.
  • Extended-release chewable tablet:
  • Take in the morning.
  • Take with or without food.
  • Some products may be broken in half. If you are not sure if you can break this product in half, talk with the doctor.
  • Oral-disintegrating tablet:
  • Take in the morning.
  • Take with or without food but take the same way each time. Always take with food or always take on an empty stomach.
  • Do not push the tablet out of the foil when opening. Use dry hands to take it from the foil. Place on your tongue and let it dissolve. Water is not needed. Do not swallow it whole. Do not chew, break, or crush it.
  • Do not take this drug out of the blister pack until you are ready to take it. Take this drug right away after opening the blister pack. Do not store the removed drug for future use.
  • All liquid products:
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
  • Liquid (solution):
  • Take 30 to 45 minutes before meals.
  • If taking this drug more than 1 time a day, take the last dose of the day before 6 PM.
  • Liquid (suspension):
  • Take in the morning with or without food. Shake bottle for 10 seconds or more before taking.
  • Check to make sure the drug in the bottle is a liquid. If this drug is still a powder, do not use it. Take it back to the pharmacist.
  • Long-acting capsules (Jornay PM):
  • Take in the evening.
  • Do not take this drug in the morning.
  • Take with or without food but take the same way each time. Always take with food or always take on an empty stomach.
  • You may sprinkle contents of capsule on applesauce. Do not chew.
  • After mixing, take your dose right away. Do not store for future use.
  • All other long-acting capsules and tablets:
  • Take in the morning.
  • Some drugs may need to be taken with food or on an empty stomach. For some drugs it does not matter. Check with your pharmacist about how to take this drug.
  • Swallow whole. Do not chew, break, or crush.
  • Long-acting capsules:
  • You may sprinkle contents of capsule on applesauce. Do not chew. Swallow right away and follow with water or juice.
  • After mixing, take your dose right away. Do not store for future use.
  • Skin patch:
  • Follow how to use as you have been told by the doctor or read the package insert.
  • Do not use patches that are cut or do not look right.
  • Wash your hands before and after use.
  • Put patch on clean, dry, healthy skin on the hip. Do not put the patch on the waistline.
  • Do not put on cuts, scrapes, eczema, or damaged skin.
  • Put patch on in the morning and take off 9 hours later or as you have been told by the doctor.
  • Put the patch in a new area each time you change the patch.
  • Water from bathing, swimming, or showering can make the patch not stick well or fall off. If the patch falls off, do not touch the sticky side with your fingers.
  • If the patch falls off, put on a new one on some other part of the same hip. Take the new patch off at the normal time.
  • All products:
  • If you have been taking this drug for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if this drug stops working well. Do not take more than ordered.
  • Do not switch between different forms of this drug without first talking with the doctor.
  • Limit your use of caffeine (for example, tea, coffee, cola) and chocolate. Use with this drug may cause nervousness, shakiness, and a fast heartbeat.
  • Have your blood work checked if you are on this drug for a long time. Talk with your doctor.
  • If you are taking this drug and have high blood pressure, talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
What do I do if I miss a dose?
  • Liquid (suspension):
  • Call your doctor to find out what to do.
  • Long-acting capsules (Jornay PM):
  • Take a missed dose as soon as you think about it if you remember on the same evening you missed the dose.
  • If you do not think about the missed dose until the next morning, skip the missed dose and go back to the normal evening time.
  • Do not take 2 doses at the same time or extra doses.
  • All other oral products:
  • Use a missed dose as soon as you think about it. Do not take this drug after 6 PM.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Skin patch:
  • You may apply the patch later in the day. Then take off the patch at your normal time of day.
  • Do not put on 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • All oral products:
  • Store at room temperature.
  • Oral-disintegrating tablet:
  • Store blister packs in the plastic case that comes with this drug.
  • Liquid (suspension):
  • Throw away any part not used after 4 months.
  • Store upright with the cap on.
  • Skin patch:
  • Store at room temperature. Do not refrigerate or freeze.
  • Keep patches in the pouch. Use within 2 months of opening tray.
  • After you take off a skin patch, be sure to fold the sticky sides of the patch to each other. Throw away used patches where children and pets cannot get to them.
  • All products:
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Methylphenidate (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(meth il FEN i date)

Brand Names: US

Aptensio XR; Concerta; Cotempla XR-ODT; Daytrana; Metadate CD [DSC]; Metadate ER; Methylin; QuilliChew ER; Quillivant XR; Relexxii; Ritalin; Ritalin LA

Brand Names: Canada

Biphentin; Concerta; Foquest; Ritalin; Ritalin SR

Warning
  • This drug has a risk of abuse and misuse. Give this drug only as you were told by the doctor. Tell the doctor if your child has ever abused or been addicted to any drugs or alcohol.
What is this drug used for?
  • It is used to treat attention deficit problems with hyperactivity.
  • It is used to treat narcolepsy.
  • It may be given to your child for other reasons. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
  • All products:
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child or a family member has any of these health problems: Blood vessel disease, high blood pressure, heart structure problems or other heart problems, or Tourette’s syndrome or tics.
  • If your child has any of these health problems: Glaucoma; nervous, anxious, or tense state; or overactive thyroid.
  • If your child has ever had a stroke.
  • If your child has taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for certain other health problems in the last 14 days. Taking this drug within 14 days of those drugs can cause very bad high blood pressure.
  • If your child is taking any of these drugs: Linezolid or methylene blue.
  • All chewable products:
  • If your child has trouble swallowing, talk with the doctor.
  • Long-acting tablets:
  • If your child cannot swallow this product whole.
  • If your child has ever had any of these health problems: Cystic fibrosis; narrowing of the GI (gastrointestinal) tract or other GI problems like bowel block, small bowel disease, short gut syndrome, or slow-moving swallowing tube (esophagus) or bowel tract; peritonitis.
  • Oral-disintegrating tablet:
  • If your child is taking any of these drugs: Famotidine, omeprazole, or sodium bicarbonate.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • All products:
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
  • If your child has been taking this drug for a long time or at high doses, it may not work as well and your child may need higher doses to get the same effect. This is known as tolerance. Call the doctor if this drug stops working well. Do not give more than ordered.
  • Have your child’s blood work checked if he/she is on this drug for a long time. Talk with your child’s doctor.
  • Your child may have some heart tests before starting this drug. Talk with your child’s doctor.
  • Have your child’s blood pressure and heart rate checked often. Talk with your child’s doctor.
  • This drug may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to the doctor to see if your child has a greater chance of seizures while taking this drug.
  • Limit your child’s use of caffeine and chocolate. Use with this drug may cause nervousness, shakiness, and a fast heartbeat.
  • If your child is taking this drug and has high blood pressure, talk with the doctor before giving OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • Do not switch between different forms of this drug without first talking with the doctor.
  • This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
  • All chewable products:
  • If your child has phenylketonuria (PKU), talk with your child’s doctor. Some products have phenylalanine.
  • Long-acting tablets:
  • For some brands, you or your child may see the tablet shell in your child’s stool. For these brands, this is normal and not a cause for concern. If you have questions, talk with the doctor.
  • Tell the doctor that your child takes this drug if your child is getting x-rays near the stomach.
  • Skin patch:
  • Have your child avoid use of heat sources (such as sunlamps, tanning beds, heating pads, electric blankets, heat lamps, saunas, hot tubs, heated waterbeds). Avoid long, hot baths or sunbathing. Your child’s temperature may rise and cause too much drug to pass into your child’s body.
  • This drug may lead to loss of skin color at or around where the patch is put on. Sometimes, this has happened at other areas. This may last even after this drug is stopped. The chance may be higher if you or someone in your family has ever had a skin problem called vitiligo. Talk with the doctor.
  • This drug may cause harm if chewed or swallowed. If this drug has been put in the mouth, call a doctor or poison control center right away.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • All products:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Joint pain.
  • Purple patches on the skin or mouth.
  • Change in eyesight.
  • Seizures.
  • Shakiness.
  • Trouble controlling body movements.
  • Sweating a lot.
  • Restlessness.
  • Change in color of hands or feet from pale to blue or red.
  • Numbness, pain, tingling, or cold feeling of the hands or feet.
  • Any sores or wounds on the fingers or toes.
  • Not able to pass urine or change in how much urine is passed.
  • Muscle pain or weakness.
  • Call your child’s doctor right away if your child gets a painful erection (hard penis) or gets an erection that lasts for longer than 4 hours. If this is not treated right away, it may lead to lasting sex problems and your child may not be able to have sex in the future.
  • Sudden deaths have happened with this drug in children with some heart problems or heart defects. Stroke, heart attack, and sudden death have also happened in adults taking this drug. Call your child’s doctor right away if your child has a fast, slow, or abnormal heartbeat; weakness on 1 side of the body; trouble speaking or thinking; change in balance; drooping on 1 side of the face; change in eyesight; chest pain or pressure; shortness of breath; or severe dizziness or passing out.
  • New or worse behavior and mood changes like change in thinking, anger, and hallucinations have happened with this drug. Tell the doctor if your child or a family member has any mental or mood problems like low mood (depression) or bipolar illness, or if a family member has killed themselves. Call the doctor right away if your child has hallucinations; change in the way your child acts; or signs of mood changes like low mood (depression), thoughts of killing him/herself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
  • A very bad and sometimes deadly health problem called serotonin syndrome may happen if your child takes this drug with drugs for depression, migraines, or certain other drugs. Call the doctor right away if your child has agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
  • Rarely, low blood cell counts have happened with this drug. Call your child’s doctor right away if your child has any unexplained bruising or bleeding; signs of infection like fever, chills, or sore throat; or feels very tired or weak.
  • If your child is or may be sexually active:
  • Change in sex interest.
  • Skin patch:
  • Change in skin color.
  • Very bad skin irritation.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • All products:
  • Feeling nervous and excitable.
  • Not hungry.
  • Upset stomach or throwing up.
  • Weight loss.
  • Trouble sleeping.
  • Dizziness.
  • Feeling sleepy.
  • Dry mouth.
  • Headache.
  • Belly pain or heartburn.
  • Nose or throat irritation.
  • Skin patch:
  • Skin irritation.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • Tablets:
  • Give 30 to 45 minutes before meals.
  • If giving this drug to your child more than 1 time a day, give the last dose of the day before 6 PM.
  • All chewable products:
  • Have your child chew well before swallowing.
  • Give this drug with a full glass of water.
  • Fast-release chewable tablet:
  • Give 30 to 45 minutes before meals.
  • If giving this drug to your child more than 1 time a day, give the last dose of the day before 6 PM.
  • Extended-release chewable tablet:
  • Give in the morning.
  • Give this drug with or without food.
  • Some products may be broken in half. If you are not sure if you can break this product in half, talk with the doctor.
  • Oral-disintegrating tablet:
  • Give in the morning.
  • Give this drug with or without food but give it the same way each time. Always give with food or always give on an empty stomach.
  • Do not push the tablet out of the foil when opening. Use dry hands to take it from the foil. Place on your child’s tongue and let it dissolve. Water is not needed. Do not let your child swallow it whole. Do not let your child chew, break, or crush it.
  • Do not take this drug out of the blister pack until you are ready to give this drug to your child. Give this drug right away after opening the blister pack. Do not store the removed drug for future use.
  • All liquid products:
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
  • Liquid (solution):
  • Give 30 to 45 minutes before meals.
  • If giving this drug to your child more than 1 time a day, give the last dose of the day before 6 PM.
  • Liquid (suspension):
  • Give in the morning with or without food. Shake bottle for 10 seconds or more before giving a dose.
  • Check to make sure the drug in the bottle is a liquid. If this drug is still a powder, do not use it. Take it back to the pharmacist.
  • Long-acting capsules (Jornay PM):
  • Give in the evening.
  • Do not give this drug to your child in the morning.
  • Give this drug with or without food but give it the same way each time. Always give with food or always give on an empty stomach.
  • You may sprinkle contents of capsule on applesauce. Have your child swallow without chewing.
  • Give the mixture right away. Do not store for use at a later time.
  • All other long-acting capsules and tablets:
  • Give in the morning.
  • Some drugs may need to be given with food or on an empty stomach. For some drugs, it does not matter. Check with your pharmacist about how to give this drug to your child.
  • Have your child swallow whole. Do not let your child chew, break, or crush.
  • Long-acting capsules:
  • You may sprinkle contents of capsule on applesauce. Have your child swallow right away without chewing and follow with water or juice.
  • Give the mixture right away. Do not store for use at a later time.
  • Skin patch:
  • Follow how to use as you have been told by the doctor or read the package insert.
  • Do not use patches that are cut or do not look right.
  • Wash your hands before and after use.
  • Put patch on clean, dry, healthy skin on your child’s hip. Do not put the patch on your child’s waistline.
  • Do not put on cuts, scrapes, eczema, or damaged skin.
  • Put patch on in the morning and take off 9 hours later or as you have been told by the doctor.
  • Put the patch in a new area each time you change the patch.
  • Water from bathing, swimming, or showering can make the patch not stick well or fall off. If the patch falls off, do not touch the sticky side with your fingers.
  • If the patch falls off, put on a new one on some other part of the same hip. Take the new patch off at the normal time.
What do I do if my child misses a dose?
  • Liquid (suspension):
  • Call your child’s doctor to find out what to do.
  • Long-acting capsules (Jornay PM):
  • Give a missed dose as soon as you think about it if you remember on the same evening of your child’s missed dose.
  • If you do not think about the missed dose until the next morning, skip the missed dose and go back to the normal evening time.
  • Do not give 2 doses at the same time or extra doses.
  • All other oral products:
  • Give a missed dose as soon as you think about it. Do not give this drug after 6 PM.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
  • Skin patch:
  • You may apply the patch later in the day. Then take off the patch at your child’s normal time of day.
  • Do not put on 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • All oral products:
  • Store at room temperature.
  • Oral-disintegrating tablet:
  • Store blister packs in the plastic case that comes with this drug.
  • Liquid (suspension):
  • Throw away any part not used after 4 months.
  • Store upright with the cap on.
  • Skin patch:
  • Store at room temperature. Do not refrigerate or freeze.
  • Keep patches in the pouch. Use within 2 months of opening tray.
  • After you take off a skin patch, be sure to fold the sticky sides of the patch to each other. Throw away used patches where children and pets cannot get to them.
  • All products:
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.