Dextroamphetamine and Amphetamine (Lexi-Drugs)

ALERT: US Boxed Warning
  Abuse potential (Adderall, Adderall XR, Mydayis):
  Cardiovascular events (Adderall, Adderall XR):
Pronunciation

(deks troe am FET a meen & am FET a meen)

Brand Names: US

Adderall; Adderall XR; Mydayis

Brand Names: Canada

Adderall XR

Pharmacologic Category

Central Nervous System Stimulant

Dosing: Adult

Note: Use lowest effective individualized dose; administer first dose as soon as awake.

ADHD: Oral:

Note: Interrupt therapy occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

Immediate release: Initial: 5 mg once or twice daily; may increase daily dose in 5 mg increments at weekly intervals until optimal response is obtained; usual dosage range: 5 to 40 mg/day in 1 to 3 divided doses. Note: Although doses greater than 40 mg/day will rarely be necessary, doses as high as 60 mg/day have been shown to be safe and effective (Spencer 2001).

Extended release:

Adderall XR: Initial: 20 mg once daily in the morning; alternatively 10 mg/day has been recommended as an initial dose (Canadian manufacturer labeling). Limited evidence suggests that doses up to 60 mg/day may provide benefit; however, the frequency and severity of adverse effects were increased with higher doses (Biederman 2005).

Conversion from immediate release to Adderall XR: Switch to Adderall XR at the same total daily dose.

Mydayis: Initial: 12.5 mg to 25 mg once daily in the morning; may increase daily dose by 12.5 mg no sooner than once weekly; maximum: 50 mg/day

Conversion from other dextroamphetamine and amphetamine formulations to Mydayis: Discontinue previous formulation and titrate using above schedule; do not substitute on a mg-per-mg basis.

Narcolepsy: Immediate release: Oral: Initial: 10 mg once daily in the morning; may increase daily dose in 10 mg increments at weekly intervals until optimal response is obtained; usual dosage range: 5 to 60 mg/day in 1 to 3 divided doses

Dosing: Geriatric

Refer to adult dosing; use with caution and start at low end of dosage range.

Dosing: Renal Impairment: Adult

Immediate release: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution; the potential exists for elimination of amphetamine to be inhibited resulting in prolonged exposure.

Hemodialysis: There are no specific dosage adjustments provided in the manufacturer’s labeling; dextroamphetamine is not dialyzable (Ermer 2016).

Extended release: Adderall XR:

Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution; the potential exists for elimination of amphetamine to be inhibited resulting in prolonged exposure.

Severe impairment (GFR 15 to <30 mL/minute/1.73 m2): 15 mg once daily in the morning.

ESRD (GFR <15 mL/minute/1.73 m2): Use is not recommended; dextroamphetamine is not dialyzable.

Mydayis:

Mild or moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling.

Severe impairment (GFR 15 to <30 mL/minute/1.73 m2): Maximum dose: 25 mg/day

ESRD (GFR <15 mL/minute/1.73 m2): Use is not recommended; dextroamphetamine is not dialyzable

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

Dosing: Pediatric

Note: Use lowest effective individualized dose; administer first dose as soon as awake; avoid late evening doses

Attention-deficit/hyperactivity disorder: Note: Extended-release products are not interchangeable on a mg-per-mg basis; use precaution to ensure appropriate product specific dosing.

Immediate-release tablets:

Children 3 to 5 years: Oral: Initial 2.5 mg once daily in the morning; increase daily dose by 2.5 mg at weekly intervals until optimal response is obtained; maximum daily dose: 40 mg/day administered in 1 to 2 divided doses per day; use intervals of 4 to 6 hours between doses. Note: Select patients may require daily dose to be given in 3 divided doses per day. Although FDA approved, current guidelines do not recommend dextroamphetamine/amphetamine use in children ≤5 years due to insufficient evidence (AAP 2011).

Children ≥6 years and Adolescents: Oral: Initial: 5 mg once or twice daily; increase daily dose by 5 mg at weekly intervals until optimal response is obtained; usual maximum daily dose: 40 mg/day administered in 1 to 2 divided doses; use intervals of 4 to 6 hours between doses; some patients weighing >50 kg may require and tolerate doses up to 60 mg/day in divided doses with frequent monitoring (AACAP [Pliszka 2007]; Dopheide 2009). Note: Some patients may require daily dose to be administered as 3 divided doses per day.

Extended-release capsules:

Adderall XR:

Initial therapy:

Children 6 to 12 years: Oral: Initial: 5 to 10 mg once daily in the morning; increase daily dose by 5 mg or 10 mg at weekly intervals until optimal response is obtained; usual maximum daily dose: 30 mg/day; some patients weighing >50 kg may require and tolerate doses up to 60 mg/day (AACAP [Pliszka 2007]; Dopheide 2009)

Adolescents 13 to 17 years: Oral: Initial: 10 mg once daily in the morning; may increase to 20 mg daily after 1 week if symptoms are not controlled; usual maximum daily dose: 20 mg/day; some patients weighing >50 kg may require and tolerate doses up to 60 mg/day with frequent monitoring (AACAP [Pliszka 2007]; Dopheide 2009)

Converting Adderall to Adderall XR:Patients taking divided doses of immediate-release Adderall tablets may be switched to extended-release Adderall XR capsule using the same total daily dose (taken once daily); titrate dose at weekly intervals to achieve optimal response.

Mydayis: Note: Do not substitute Mydayis for other amphetamine products on a mg-per-mg basis because of different amphetamine base compositions and differing pharmacokinetic profiles. Adolescents 13 to 17 years: Oral: Initial: 12.5 mg once daily in the morning; may increase by 12.5 mg increments at weekly intervals; maximum daily dose: 25 mg/day

Narcolepsy:

Children 6 to 12 years: Immediate-release tablets: Oral: Initial: 5 mg daily; increase daily dose by 5 mg at weekly intervals until optimal response is obtained; maximum daily dose: 60 mg/day given in 1 to 3 divided doses per day; use intervals of 4 to 6 hours between doses

Adolescents: Immediate-release tablets: Oral: Initial: 10 mg daily; increase daily dose by 10 mg at weekly intervals until optimal response is obtained; maximum daily dose: 60 mg/day given in 1 to 3 divided doses per day; use intervals of 4 to 6 hours between doses

Dosing: Renal Impairment: Pediatric

Immediate release: Children ≥3 years and Adolescents: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution; elimination may be decreased with renal impairment.

Extended release:

Adderall XR: Children ≥6 years and Adolescents ≤17 years:

GFR 15 to <30 mL/minute/1.73 m2: Initial dose: 5 mg once daily; maximum daily dose in children 6 to 12 years: 20 mg/day

GFR <15 mL/minute/1.73 m2: Use not recommended

Mydayis: Adolescents 13 to 17 years:

GFR 15 to <30 mL/minute/1.73 m2: Reduce maximum daily dose to 12.5 mg/day

GFR <15 mL/minute/1.73 m2: Use not recommended

Dosing: Hepatic Impairment: Pediatric

Children ≥3 years and Adolescents: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution; elimination may be decreased with hepatic impairment.

Use: Labeled Indications

Attention-deficit/hyperactivity disorder: Treatment of attention-deficit/hyperactivity disorder (ADHD) as part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect.

Narcolepsy (immediate release only): Treatment of narcolepsy.

Clinical Practice Guidelines

Also see individual agents.

Attention Deficit Hyperactivity Disorder:

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

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

National Collaborating Centre for Mental Health, “Attention Deficit Hyperactivity Disorder, NICE Guidelines,” 2009

Administration: Oral

Administer with or without food. Administer Mydayis consistently either with food or without food.

Immediate release: Administer in 1 to 3 divided doses per day with intervals of 4 to 6 hours between doses. To avoid insomnia, late evening doses should be avoided.

Extended release: To avoid insomnia, afternoon doses should be avoided. Capsule may be swallowed whole or it may be opened and the contents sprinkled on applesauce. Applesauce should be consumed immediately without chewing. Do not divide the contents of the capsule. Do not take less than one capsule per day; a single capsule should not be divided.

Administration: Pediatric

Oral:

Immediate-release tablet: Take on awakening; to avoid insomnia, last daily dose should be administered no less than 6 hours before retiring.

Extended-release capsule: Take on awakening. Avoid afternoon doses to prevent insomnia. Swallow capsule whole; do not chew or divide. May be administered with or without food; however, Mydayis should be taken in a consistent manner with regards to food. May open capsule and sprinkle contents on applesauce; consume applesauce/medication mixture immediately; do not store; do not chew sprinkled beads from capsule.

Storage/Stability

Immediate-release tablets: Store at 20°C to 25°C (68°F to 77°F); protect from light.

Extended-release capsules: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F); protect from light.

Extemporaneously Prepared

A 1 mg/mL oral suspension may be made with tablets. Crush ten 10 mg tablets in a mortar and reduce to a fine powder. Add small portions of Ora-Sweet and mix to a uniform paste; mix while adding the vehicle in equal proportions to almost 100 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add sufficient quantity of vehicle to make 100 mL. Label “shake well”. Stable 30 days at room temperature.

Justice J, Kupiec TC, Matthews P, et al, “Stability of Adderall in Extemporaneously Compounded Oral Liquids,” Am J Health Syst Pharm, 2001, 58(15):1418-21.[PubMed 11494787]

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 abdominal pain, lack of appetite, insomnia, constipation, diarrhea, dry mouth, bad taste, nausea, vomiting, loss of strength and energy, or weight loss. Have patient report immediately to prescriber signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), angina, shortness of breath, severe dizziness, passing out, tachycardia, severe anxiety, severe headache, sexual dysfunction, libido changes, abnormal heartbeat, seizures, abnormal movements, agitation, vision changes, priapism, change in color of hands or feet from pale to blue or red, burning or numbness of hands or feet, cold sensation of extremities, painful extremities, 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), wounds on fingers or toes, dark urine, urinary retention, change in amount of urine passed, painful urination, muscle pain, muscle weakness, signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), mood changes, hallucinations, 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:
Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Adderall: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM467750.pdf

Adderall XR: http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021303s032lbl.pdf#page=15

Mydayis: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022063s000lbl.pdf#page=22

Contraindications

Hypersensitivity (eg, angioedema, anaphylaxis) or idiosyncrasy to amphetamine, sympathomimetic amines or any component of the formulation; during or within 14 days following MAOI (including linezolid or methylene blue).

Documentation of allergenic cross-reactivity for amphetamines is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Immediate release, Adderall XR: Additional contraindications: Advanced arteriosclerosis; symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism; glaucoma, agitated states; history of drug abuse.

Warnings/Precautions

Concerns related to adverse effects:

• Cardiovascular events: [US Boxed Warning]: Use has been associated with serious cardiovascular events including sudden death in patients with preexisting structural cardiac abnormalities or other serious heart problems (sudden death in children and adolescents; sudden death, stroke, and MI 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. 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 stimulant treatment.

• CNS effects: Amphetamines may impair the ability to engage in potentially hazardous activities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery, driving).

• Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, and urticaria, have been observed.

• 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 seek further evaluation (eg, rheumatology) if necessary.

• Serotonin syndrome: Potentially life-threatening serotonin syndrome (SS) may occur when dextroamphetamine/amphetamine is used in combination with other serotonergic agents (eg, SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, St. John’s wort, tryptophan), agents that impair metabolism of serotonin (eg, MAOIs) or CYP2D6 inhibitors that impair metabolism of dextroamphetamine/amphetamine. Concomitant use with MAOIs is contraindicated. If concomitant use of dextroamphetamine/amphetamine with serotonergic drugs or CYP2D6 inhibitors is indicated, initiate dextroamphetamine/amphetamine at a low dose and monitor patient closely for signs and symptoms of SS. Discontinue treatment (and any concomitant serotonergic agent) immediately if signs/symptoms arise.

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

Disease-related concerns:

• 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 moderate to severe hypertension or hyperthyroidism.

• Hepatic impairment: Use with caution in patients with hepatic impairment; elimination is reduced.

• 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 (causal relationship not established); monitor for development or worsening of these behaviors.

• Renal impairment: Use with caution in patients with renal impairment; elimination is reduced.

• Seizure disorder: Limited information exists regarding stimulant use in seizure disorder. Whereas patients with attention-deficit/hyperactivity disorder (ADHD) are at an increased risk for seizure activity compared to the general population, a retrospective study using drug claims data showed that the use of stimulant medications was associated with a lower risk (Cortese 2013; Wiggs 2018). Manufacturers of some stimulants recommend discontinuing therapy if seizures occur.

• 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 (AACAP [Murphy 2013; Pliszka 2007]).

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:

• Elderly: Use caution in this age group due to CNS stimulant adverse effects.

• Pediatric: Appetite suppression may occur; particularly in children. Use of stimulants has been associated with weight loss and slowing growth rate; monitor growth rate and weight during treatment. Treatment interruption may be necessary in patients who are not increasing in height or gaining weight as expected. Pediatric patients 12 years and younger experienced high plasma exposure to Mydayis and more adverse reactions, including insomnia and decreased appetite, compared to patients 13 years and older.

Other warnings/precautions:

• Abuse/misuse/diversion: [US Boxed Warning]: Has high potential for abuse and dependence. Administration for prolonged periods may lead to drug dependence and must be avoided. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy. Use with caution in patients with history of ethanol or drug abuse. Prescriptions should be written for the smallest quantity consistent with good patient care to minimize possibility of overdose.

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

• Appropriate use: Mydayis: Medication errors, including substitution and dispensing errors, may occur, leading to possible overdosage. Do not substitute Mydayis for other amphetamine products on a mg-per-mg basis because of different amphetamine base compositions and differing pharmacokinetic profiles.

• Discontinuation of therapy: Abrupt discontinuation following high doses for prolonged periods results in extreme fatigue, mental depression, and sleep EEG changes; may also result in other symptoms of withdrawal.

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).

Use of stimulants in children has been associated with growth suppression; monitor growth; treatment interruption may be needed. Appetite suppression may occur; monitor weight during therapy, particularly in children. 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 pediatric patients 8 to 17 years actively treated with stimulants, significant reductions in total femoral, femoral neck, and lumbar bone mineral density (BMD) were observed compared to matched unmedicated cohorts; also reported were significantly more subjects in the stimulant-treated group with BMD measurements in the osteopenic range compared to matched cohorts (38.3% to 21.6%) (Howard 2017). A longitudinal cohort-controlled trial reported no different in peak height velocity and final adult height in subjects with ADHD and/or treated with stimulants (Harstad 2014).

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies. Refer to individual monographs.

Breast-Feeding Considerations

Amphetamines are present in breast milk. The manufacturer recommends that mothers taking dextroamphetamine/amphetamine refrain from breastfeeding. Refer to individual monographs

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

Frequency not always defined.

Cardiovascular: Systolic hypertension (extended release; adolescents: 12% to 35%; dose related; transient), tachycardia (extended release; adults: ≤6%), palpitations (extended release: 2% to 4%), increased blood pressure, myocardial infarction, Raynaud’s phenomenon

Central nervous system: Insomnia (extended release: 8% to 31%), headache (extended release; adults: ≤26%), emotional lability (extended release: 2% to 9%), anxiety (extended release; adults: 7% to 8%), agitation (extended release; adults: 2% to ≤8%), dizziness (extended release: 2% to 7%), irritability (6%), fatigue (extended release: 2% to 6%), drowsiness (extended release: 2% to 4%), speech disturbance (extended release: 2% to 4%), twitching (extended release: 2% to 4%), depression (3%), jitteriness (2%), aggressive behavior, dysphoria, euphoria, exacerbation of vocal tics, formication, outbursts of anger, overstimulation, paresthesia, psychosis, restlessness, talkativeness

Dermatologic: Diaphoresis (extended release: 2% to 4%), skin photosensitivity (extended release: 2% to 4%), alopecia, dermatillomania, skin rash, urticaria

Endocrine & metabolic: Weight loss (extended release: 4% to 10%), decreased libido (extended release: 2% to 4%), dysmenorrhea (extended release: 2% to 4%)

Gastrointestinal: Decreased appetite (extended release: 22% to 36%), xerostomia (extended release: 2% to 35%), abdominal pain (extended release: 11% to 14%), nausea (extended release: 2% to 8%), vomiting (extended release: 2% to 7%), diarrhea (extended release: 2% to 6%), constipation (extended release: 2% to 4%), dyspepsia (extended release: 2% to 4%), teeth clenching (extended release: ≤4%), tooth infection (extended release: ≤4%), anorexia (extended release: 2%), bruxism (2%), unpleasant taste

Genitourinary: Urinary tract infection (extended release: 5%), upper abdominal pain (adolescents: 4%), impotence (extended release: 2% to 4%), erectile dysfunction (2%), frequent erections, prolonged erections

Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction

Infection: Infection (extended release: 2% to 4%)

Neuromuscular & skeletal: Dyskinesia, rhabdomyolysis, tremor

Ophthalmic: Blurred vision, mydriasis

Respiratory: Dyspnea (extended release: 2% to 4%)

Miscellaneous: Fever (extended release: 5%), accidental injury (children and adolescents: 4%)

<1%, postmarketing, and/or case reports: Cardiomyopathy, cerebrovascular accident, exacerbation of Gilles de la Tourette’s syndrome, exacerbation of vocal tics, peripheral vascular disease, seizure, Stevens-Johnson syndrome, toxic epidermal necrolysis

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

Refer to individual components.

Drug Interactions 

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

Alkalinizing Agents: May decrease the excretion of Amphetamines. Risk D: Consider therapy modification

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

Ammonium Chloride: May decrease the serum concentration of Amphetamines. This effect is likely due to an enhanced excretion of amphetamines in the urine. Risk C: Monitor therapy

Antacids: May decrease the excretion of Amphetamines. Risk C: Monitor therapy

Antihistamines: Amphetamines may diminish the sedative effect of Antihistamines. Risk C: Monitor therapy

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

Antipsychotic Agents: May diminish the stimulatory effect of Amphetamines. Risk C: Monitor therapy

Ascorbic Acid: May decrease the serum concentration of Amphetamines. 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

Carbonic Anhydrase Inhibitors: May decrease the excretion of Amphetamines. Exceptions: Brinzolamide; Dorzolamide. 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

CYP2D6 Inhibitors (Moderate): May increase the serum concentration of Amphetamines. Risk C: Monitor therapy

CYP2D6 Inhibitors (Strong): May increase the serum concentration of Amphetamines. Risk C: Monitor therapy

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

Ethosuximide: Amphetamines may diminish the therapeutic effect of Ethosuximide. Amphetamines may decrease the serum concentration of Ethosuximide. Risk C: Monitor therapy

Gastrointestinal Acidifying Agents: May decrease the serum concentration of Amphetamines. Risk C: Monitor therapy

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

Iobenguane Radiopharmaceutical Products: Amphetamines 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

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: Amphetamines 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

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Risk D: Consider therapy modification

Lithium: May diminish the stimulatory effect of Amphetamines. Risk C: Monitor therapy

Methenamine: May decrease the serum concentration of Amphetamines. This effect is likely due to an enhanced excretion of amphetamines in the urine. Risk C: Monitor therapy

Monoamine Oxidase Inhibitors: May enhance the hypertensive effect of Amphetamines. While linezolid and tedizolid may interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors. Refer to monographs specific to those agents for details. Exceptions: Linezolid; Tedizolid. Risk X: Avoid combination

Multivitamins/Fluoride (with ADE): May decrease the serum concentration of Amphetamines. More specifically, the ascorbic acid (vitamin C) in many multivitamins may decrease amphetamine concentrations. Risk C: Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Amphetamines. Risk C: Monitor therapy

Multivitamins/Minerals (with AE, No Iron): May decrease the serum concentration of Amphetamines. Specifically, vitamin C may impair absorption of amphetamines. Risk C: Monitor therapy

Opioid Agonists: Amphetamines may enhance the analgesic effect of Opioid Agonists. Risk C: Monitor therapy

PHENobarbital: Amphetamines may decrease the serum concentration of PHENobarbital. Risk C: Monitor therapy

Phenytoin: Amphetamines may decrease the serum concentration of Phenytoin. Risk C: Monitor therapy

Proton Pump Inhibitors: May increase the absorption of Amphetamine. Risk C: Monitor therapy

Proton Pump Inhibitors: May increase the absorption of Dextroamphetamine. Specifically, the dextroamphetamine absorption rate from mixed amphetamine salt extended release (XR) capsules may be increased in the first hours after dosing. Risk C: Monitor therapy

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

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

Tricyclic Antidepressants: May enhance the stimulatory effect of Amphetamines. Tricyclic Antidepressants may also potentiate the cardiovascular effects of Amphetamines. Risk C: Monitor therapy

Urinary Acidifying Agents: May decrease the serum concentration of Amphetamines. Risk C: Monitor therapy

Food Interactions

Amphetamine serum levels may be reduced if taken with acidic food, juices, or vitamin C. Management: Monitor response when taken concurrently.

Test Interactions

May cause a significant elevation in plasma corticosteroid levels; may interfere with urinary steroid testing

Monitoring Parameters

Cardiac evaluation should be completed on any patient who develops exertional chest pain, unexplained syncope, and any symptom of cardiac disease during treatment with stimulants; behavioral changes; CNS activity; height, weight and growth parameters in children; signs of peripheral vasculopathy (eg, digital changes). Assess for risk of abuse prior to prescribing and signs of misuse, abuse, or addiction throughout treatment.

When used for the treatment of ADHD, perform a targeted cardiac history (eg, patient history of previously detected cardiac disease, palpitations, syncope, or seizures; family history of sudden death in children or young adults; hypertrophic cardiomyopathy; long QT syndrome) and physician examination including cardiac examination. Monitor heart rate and blood pressure (baseline; follow-up within 1 to 3 months and routinely at 6 to 12 month intervals thereafter unless clinically indicated with dose titration and weaning of therapy) Consider obtaining ECG prior to initiation (Perrin 2008; Vetter 2008).

Advanced Practitioners Physical Assessment/Monitoring

Monitor vital signs (heart rate, respiratory rate, blood pressure) at beginning of therapy and periodically during therapy. Monitor weight and growth (children) throughout therapy. Do a cardiac evaluation in patients with signs or symptoms of cardiac disease. Consider obtaining ECG prior to initiation in patients being treated for ADHD. Assess for signs of peripheral vasculopathy (digital changes). Assess patients for signs of drug dependency and abuse potential.

Nursing Physical Assessment/Monitoring

Monitor vital signs (heart rate, respiratory rate, blood pressure) at beginning of therapy and periodically during therapy. Monitor weight and growth (children).

Controlled Substance

C-II

Dosage Forms: US

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

Capsule, extended release, oral:

Adderall XR:

5 mg [dextroamphetamine sulfate 1.25 mg, dextroamphetamine saccharate 1.25 mg, amphetamine aspartate monohydrate 1.25 mg, amphetamine sulfate 1.25 mg (equivalent to amphetamine base 3.1 mg)]

10 mg [dextroamphetamine sulfate 2.5 mg, dextroamphetamine saccharate 2.5 mg, amphetamine aspartate monohydrate 2.5 mg, amphetamine sulfate 2.5 mg (equivalent to amphetamine base 6.3 mg)]

15 mg [dextroamphetamine sulfate 3.75 mg, dextroamphetamine saccharate 3.75 mg, amphetamine aspartate monohydrate 3.75 mg, amphetamine sulfate 3.75 mg (equivalent to amphetamine base 9.4 mg)]

20 mg [dextroamphetamine sulfate 5 mg, dextroamphetamine saccharate 5 mg, amphetamine aspartate monohydrate 5 mg, amphetamine sulfate 5 mg (equivalent to amphetamine base 12.5 mg)]

25 mg [dextroamphetamine sulfate 6.25 mg, dextroamphetamine saccharate 6.25 mg, amphetamine aspartate monohydrate 6.25 mg, amphetamine sulfate 6.25 mg (equivalent to amphetamine base 15.6 mg)]

30 mg [dextroamphetamine sulfate 7.5 mg, dextroamphetamine saccharate 7.5 mg, amphetamine aspartate monohydrate 7.5 mg, amphetamine sulfate 7.5 mg (equivalent to amphetamine base 18.8 mg)]

Mydayis:

12.5 mg [dextroamphetamine sulfate 3.125 mg, dextroamphetamine saccharate 3.125 mg, amphetamine aspartate monohydrate 3.125 mg, amphetamine sulfate 3.125 mg (equivalent to amphetamine base 7.8 mg)]

25 mg [dextroamphetamine sulfate 6.25 mg, dextroamphetamine saccharate 6.25 mg, amphetamine aspartate monohydrate 6.25 mg, amphetamine sulfate 6.25 mg (equivalent to amphetamine base 15.6 mg)]

37.5 mg [dextroamphetamine sulfate 9.375 mg, dextroamphetamine saccharate 9.375 mg, amphetamine aspartate monohydrate 9.375 mg, amphetamine sulfate 9.375 mg (equivalent to amphetamine base 23.5 mg)]

50 mg [dextroamphetamine sulfate 12.5 mg, dextroamphetamine saccharate 12.5 mg, amphetamine aspartate monohydrate 12.5 mg, amphetamine sulfate 12.5 mg (equivalent to amphetamine base 31.3 mg)]

Generic:

5 mg [dextroamphetamine sulfate 1.25 mg, dextroamphetamine saccharate 1.25 mg, amphetamine aspartate monohydrate 1.25 mg, amphetamine sulfate 1.25 mg (equivalent to amphetamine base 3.1 mg)]

10 mg [dextroamphetamine sulfate 2.5 mg, dextroamphetamine saccharate 2.5 mg, amphetamine aspartate monohydrate 2.5 mg, amphetamine sulfate 2.5 mg (equivalent to amphetamine base 6.3 mg)]

15 mg [dextroamphetamine sulfate 3.75 mg, dextroamphetamine saccharate 3.75 mg, amphetamine aspartate monohydrate 3.75 mg, amphetamine sulfate 3.75 mg (equivalent to amphetamine base 9.4 mg)]

20 mg [dextroamphetamine sulfate 5 mg, dextroamphetamine saccharate 5 mg, amphetamine aspartate monohydrate 5 mg, amphetamine sulfate 5 mg (equivalent to amphetamine base 12.5 mg)]

25 mg [dextroamphetamine sulfate 6.25 mg, dextroamphetamine saccharate 6.25 mg, amphetamine aspartate monohydrate 6.25 mg, amphetamine sulfate 6.25 mg (equivalent to amphetamine base 15.6 mg)]

30 mg [dextroamphetamine sulfate 7.5 mg, dextroamphetamine saccharate 7.5 mg, amphetamine aspartate monohydrate 7.5 mg, amphetamine sulfate 7.5 mg (equivalent to amphetamine base 18.8 mg)]

Tablet, oral:

Adderall:

5 mg [dextroamphetamine sulfate 1.25 mg, dextroamphetamine saccharate 1.25 mg, amphetamine aspartate monohydrate 1.25 mg, amphetamine sulfate 1.25 mg (equivalent to amphetamine base 3.13 mg)]

7.5 mg [dextroamphetamine sulfate 1.875 mg, dextroamphetamine saccharate 1.875 mg, amphetamine aspartate monohydrate 1.875 mg, amphetamine sulfate 1.875 mg (equivalent to amphetamine base 4.7 mg)]

10 mg [dextroamphetamine sulfate 2.5 mg, dextroamphetamine saccharate 2.5 mg, amphetamine aspartate monohydrate 2.5 mg, amphetamine sulfate 2.5 mg (equivalent to amphetamine base 6.3 mg)]

12.5 mg [dextroamphetamine sulfate 3.125 mg, dextroamphetamine saccharate 3.125 mg, amphetamine aspartate monohydrate 3.125 mg, amphetamine sulfate 3.125 mg (equivalent to amphetamine base 7.8 mg)]

15 mg [dextroamphetamine sulfate 3.75 mg, dextroamphetamine saccharate 3.75 mg, amphetamine aspartate monohydrate 3.75 mg, amphetamine sulfate 3.75 mg (equivalent to amphetamine base 9.4 mg)]

20 mg [dextroamphetamine sulfate 5 mg, dextroamphetamine saccharate 5 mg, amphetamine aspartate monohydrate 5 mg, amphetamine sulfate 5 mg (equivalent to amphetamine base 12.6 mg)]

30 mg [dextroamphetamine sulfate 7.5 mg, dextroamphetamine saccharate 7.5 mg, amphetamine aspartate monohydrate 7.5 mg, amphetamine sulfate 7.5 mg (equivalent to amphetamine base 18.8 mg)]

Generic:

5 mg [dextroamphetamine sulfate 1.25 mg, dextroamphetamine saccharate 1.25 mg, amphetamine aspartate monohydrate 1.25 mg, amphetamine sulfate 1.25 mg (equivalent to amphetamine base 3.13 mg)]

7.5 mg [dextroamphetamine sulfate 1.875 mg, dextroamphetamine saccharate 1.875 mg, amphetamine aspartate monohydrate 1.875 mg, amphetamine sulfate 1.875 mg (equivalent to amphetamine base 4.7 mg)]

10 mg [dextroamphetamine sulfate 2.5 mg, dextroamphetamine saccharate 2.5 mg, amphetamine aspartate monohydrate 2.5 mg, amphetamine sulfate 2.5 mg (equivalent to amphetamine base 6.3 mg)]

12.5 mg [dextroamphetamine sulfate 3.125 mg, dextroamphetamine saccharate 3.125 mg, amphetamine aspartate monohydrate 3.125 mg, amphetamine sulfate 3.125 mg (equivalent to amphetamine base 7.8 mg)]

15 mg [dextroamphetamine sulfate 3.75 mg, dextroamphetamine saccharate 3.75 mg, amphetamine aspartate monohydrate 3.75 mg, amphetamine sulfate 3.75 mg (equivalent to amphetamine base 9.4 mg)]

20 mg [dextroamphetamine sulfate 5 mg, dextroamphetamine saccharate 5 mg, amphetamine aspartate monohydrate 5 mg, amphetamine sulfate 5 mg (equivalent to amphetamine base 12.6 mg)]

30 mg [dextroamphetamine sulfate 7.5 mg, dextroamphetamine saccharate 7.5 mg, amphetamine aspartate monohydrate 7.5 mg, amphetamine sulfate 7.5 mg (equivalent to amphetamine base 18.8 mg)]

Generic Available (US)

Yes

Pricing: US

Capsule ER 24 Hour Therapy Pack (Adderall XR Oral)

5 mg (per each): $8.55

10 mg (per each): $8.55

15 mg (per each): $8.55

20 mg (per each): $8.55

25 mg (per each): $8.55

30 mg (per each): $8.55

Capsule ER 24 Hour Therapy Pack (Amphetamine-Dextroamphet ER Oral)

5 mg (per each): $1.67 – $7.05

10 mg (per each): $1.67 – $7.05

15 mg (per each): $1.67 – $7.05

20 mg (per each): $1.67 – $7.05

25 mg (per each): $1.67 – $7.05

30 mg (per each): $1.67 – $7.05

Capsule ER 24 Hour Therapy Pack (Mydayis Oral)

12.5 mg (per each): $10.83

25 mg (per each): $10.83

37.5 mg (per each): $10.83

50 mg (per each): $10.83

Tablets (Adderall Oral)

5 mg (per each): $8.44

7.5 mg (per each): $8.44

10 mg (per each): $8.44

12.5 mg (per each): $8.44

15 mg (per each): $8.44

20 mg (per each): $8.44

30 mg (per each): $8.44

Tablets (Amphetamine-Dextroamphetamine Oral)

5 mg (per each): $0.05 – $2.06

7.5 mg (per each): $0.11 – $2.06

10 mg (per each): $0.09 – $2.06

12.5 mg (per each): $0.15 – $2.06

15 mg (per each): $0.12 – $2.06

20 mg (per each): $0.13 – $2.06

30 mg (per each): $0.19 – $2.06

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

Amphetamines are noncatecholamine, sympathomimetic amines that promote release of catecholamines (primarily dopamine and norepinephrine) from their storage sites in the presynaptic nerve terminals. A less significant mechanism may include their ability to block the reuptake of catecholamines by competitive inhibition.

Pharmacodynamics/Kinetics

Note: The immediate-release tablets and ER capsules contain d-amphetamine and l-amphetamine salts in the ratio of 3:1.

Duration of action: Immediate-release tablet: 4 to 6 hours (Dopheide 2009); Adderall XR: 8 to 12 hours (Jain 2017); Mydayis: ≤16 hours

Absorption: Extended release: Food does not affect absorption, but prolongs Tmax of Adderall XR by 2 to 3 hours and Mydayis by 4 to 5 hours.

Half-life elimination:

Children 6 to 12 years: d-amphetamine: 9 hours; l-amphetamine: 11 hours

Adolescents 13 to 17 years: d-amphetamine: 11 hours; l-amphetamine: 13 to 14 hours

Adults: d-amphetamine: 10 hours; l-amphetamine: 13 hours

Metabolism: Hepatic oxidation via cytochrome P450 to 4-hydroxyamphetamine (active) norephedrine (active), and alpha-hydroxy-amphetamine with both active metabolites subsequently oxidized to 4-hydroxy-norephedrine. Cytochrome P450 2D6 is primarily responsible for the formation of 4-hydroxy-amphetamine.

Time to peak: Immediate release: 3 hours; Adderall XR: 7 hours; Mydayis: 7 to 10 hours (children and adolescents 6 to 17 years), 8 hours (adults)

Excretion: Urine (highly dependent on urinary pH); excreted as unchanged amphetamine (30% to 40%, may range from ~1% in alkaline urine to ~75% in acidic urine), and derivatives of alpha-hydroxyamphetamine (50%)

Pharmacodynamics/Kinetics: Additional Considerations

Pediatric: Children eliminated amphetamine faster than adults. The elimination half-life is approximately 1 hour shorter for d-amphetamine and 2 hours shorter for l-amphetamine in children than in adults. However, children had higher systemic exposure to amphetamine (Cmax and AUC) than adults for a given dose of ER capsules, which was attributed to the higher dose administered to children on a mg/kg basis compared with adults. Upon dose normalization on a mg/kg basis, children showed 30% less systemic exposure compared with adults. Patients 6 to 12 years of age experienced higher systemic exposure (72% to 79% higher Cmax and 83% higher AUC), compared with adults.

Weight: Weight is the primary determinant of apparent differences in the pharmacokinetics of d- and l-amphetamine across the age range. Systemic exposure measured by AUC and Cmax decreased with increases in body weight, while apparent oral volume of distribution, apparent oral clearance, and elimination half-life increased with increases in body weight.

Local Anesthetic/Vasoconstrictor Precautions

Use vasoconstrictor with caution in patients taking dextroamphetamine. Amphetamines enhance the sympathomimetic response of epinephrine and norepinephrine leading to potential hypertension and cardiotoxicity.

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Dextroamphetamine and amphetamine 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

Amphet Asp/Amphet/D-Amphet; Amphetamine and Dextroamphetamine; Dextroamphetam/Amphetam(Base); Dextroamphetamine/Amphetamine; Mixed Amphetamine Salts

FDA Approval Date
January 19, 1960
References

Adderall (dextroamphetamine/amphetamine) [prescribing information]. Horsham, PA: Teva Pharmaceuticals; December 2016.

Adderall XR (dextroamphetamine/amphetamine) [prescribing information]. Lexington, MA: Shire US Inc; July 2018.

American College of Obstetricians and Gynecologists (ACOG) Committee Opinion: No. 479, “Methamphetamine Abuse in Women of Reproductive Age,” Obstet Gynecol, 2011, 117(3):751-5.[PubMed 21343793]

Anderson PO, Sauberan JB. Modeling drug passage into human milk. Clin Pharmacol Ther. 2016;100(1):42-52. doi: 10.1002/cpt.377.[PubMed 27060684]

Biederman J, Spencer TJ, Wilens TE, et al; SLI381.304 study group. Long-term safety and effectiveness of mixed amphetamine salts extended release in adults with ADHD. CNS Spectr. 2005;10(12 Suppl 20):16-25.[PubMed 16344837]

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 medication in children and adolescents. J Child Psychol Psychiatry. 2013;54(3): 227-246.[PubMed 23294014]

Dopheide JA, Pliszka SR. Attention-deficit-hyperactivity disorder: an update. Pharmacotherapy. 2009;29(6):656-679.[PubMed 19476419]

Ermer J, Corcoran M, Lasseter K, Marbury T, Yan B, Martin PT. A Single-Dose, Open-Label Study of the Pharmacokinetics, Safety, and Tolerability of Lisdexamfetamine Dimesylate in Individuals With Normal and Impaired Renal Function. Ther Drug Monit. 2016;38(4):546-555.[PubMed 26926668]

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

Golub M, Costa L, Crofton K, et al, “NTP-CERHR Expert Panel Report on the Reproductive and Developmental Toxicity of Amphetamine and Methamphetamine,” Birth Defects Res B Dev Reprod Toxicol, 2005, 74(6):471-584.[PubMed 16167346]

Ilett KF, Hackett LP, Kristensen JH, Kohan R. Transfer of dexamphetamine into breast milk during treatment for attention deficit hyperactivity disorder. Br J Clin Pharmacol. 2007;63(3):371-375.[PubMed 17380592]

Ito S. Drug therapy for breast-feeding women [published correction appears in N Engl J Med. 2000;343(18):1348]. N Engl J Med. 2000;343(2):118-126.[PubMed 10891521]

Jain R, Jain S, Montano B. Addressing diagnosis and treatment gaps in adults with attention-deficit/hyperactivity disorder. Prim Care Companion CNS Disord 2017; 19(5).[PubMed 28906602]

LaGasse LL, Derauf C, Smith LM, et al. Prenatal methamphetamine exposure and childhood behavior problems at 3 and 5 years of age. Pediatrics. 2012;129(4):681-688.[PubMed 22430455]

Murphy TK, Lewin AB, Storch EA, et al. 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]

Mydayis (dextroamphetamine/amphetamine) [prescribing information]. Lexington, MA: Shire US Inc; June 2017.

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]

Spencer T, Biederman J, Wilens T, et al. Efficacy of a mixed amphetamine salts compound in adults with attention-deficit/hyperactivity disorder. Archives of General Psychiatry. 2001;58(8): 775-782.[PubMed 11483144]

Steiner E, Villén T, Hallberg M, et al, “Amphetamine Secretion in Breast Milk,” Eur J Clin Pharmacol, 1984, 27(1):123-4.[PubMed 6489423]

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. Circulation. 2008;117(18):2407-2423.[PubMed 18427125]

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]

Dextroamphetamine and Amphetamine (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

(deks troe am FET a meen & am FET a meen)

Brand Names: US

Adderall; Adderall XR; Mydayis

Brand Names: Canada

Adderall XR

Warning
  • This drug has a risk of abuse and misuse. This drug may also be habit-forming if taken for a long time. Do not take longer than you have been told by your doctor. 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. Misuse of this drug may cause heart-related side effects or even sudden death. If you have any questions, talk with your doctor.
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?
  • If you have an allergy to dextroamphetamine, amphetamine, 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 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 any of these health problems: Glaucoma; nervous, anxious, or tense state; or overactive thyroid.
  • If you have ever had any of these health problems: Drug abuse or stroke.
  • If you have kidney disease.
  • If you are taking acetazolamide.
  • If you are taking sodium bicarbonate.
  • 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.
  • If you are breast-feeding. Do not breast-feed while you take this drug.
  • 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.
  • 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.
  • This drug may be habit-forming with long-term use.
  • If you have been taking this drug for many weeks, talk with your doctor before stopping. You may want to slowly stop this drug.
  • You may have some heart tests before starting this drug. Talk with your doctor.
  • This drug may cause high blood pressure.
  • Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
  • Do not take antacids with this drug.
  • Do not switch between this product and other products that have the same drugs in them without checking with the doctor.
  • 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.
  • 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.
  • This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
  • Different brands of this drug may be for use in different ages of children. Talk with the doctor before giving this drug to a child.
  • 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.
  • Long-acting capsules (Mydayis):
  • Avoid drinking alcohol while taking this drug.
  • All other products:
  • Talk with your doctor before you drink alcohol.
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:
  • 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.
  • A fast heartbeat.
  • Very nervous and excitable.
  • Not able to get or keep an erection.
  • Change in sex interest.
  • A heartbeat that does not feel normal.
  • Seizures.
  • Trouble controlling body movements.
  • Restlessness.
  • Change in eyesight.
  • For males, erections (hard penis) that happen often or that last a long time.
  • 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.
  • Dark urine.
  • Not able to pass urine or change in how much urine is passed.
  • Pain when passing urine.
  • Muscle pain or weakness.
  • 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.
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:
  • Belly pain.
  • Feeling nervous and excitable.
  • Headache.
  • Not hungry.
  • Not able to sleep.
  • Constipation.
  • Diarrhea.
  • Dizziness.
  • Dry mouth.
  • Bad taste in your mouth.
  • Weight loss.
  • Upset stomach or throwing up.
  • Feeling tired or weak.
  • 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 with or without food.
  • Take last dose of the day at least 4 hours before bedtime.
  • Long-acting capsules (Adderall XR):
  • Take with or without food.
  • Long-acting capsules (Mydayis):
  • Take with or without food but take the same way each time. Always take with food or always take on an empty stomach.
  • All long-acting products:
  • Take in the morning.
  • Swallow whole. Do not chew, break, or crush.
  • 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 products:
  • To gain the most benefit, do not miss doses.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • 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?
  • Tablets:
  • Take a missed dose as soon as you think about it.
  • 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.
  • All long-acting products:
  • Skip the missed dose and go back to your normal time.
  • Do not take it later in the day.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • 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.
Dextroamphetamine and Amphetamine (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

(deks troe am FET a meen & am FET a meen)

Brand Names: US

Adderall; Adderall XR; Mydayis

Brand Names: Canada

Adderall XR

Warning
  • This drug has a risk of abuse and misuse. This drug may also be habit-forming if taken for a long time. Do not give to your child longer than you have been told by the doctor. 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. Misuse of this drug may cause heart-related side effects or even sudden death. If you have any questions, talk with your child’s doctor.
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?
  • 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 any of these health problems: Drug abuse or stroke.
  • If your child has kidney disease.
  • If your child is taking any of these drugs: Acetazolamide or sodium bicarbonate
  • 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.
  • If your child is breast-feeding a baby:
  • Be sure your child does not breast-feed a baby while taking this drug.
  • 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.
  • This drug may be habit-forming with long-term use.
  • If your child has been taking this drug for many weeks, talk with your child’s doctor before stopping. You may want to slowly stop this drug.
  • Your child may have some heart tests before starting this drug. Talk with your child’s doctor.
  • This drug may cause high blood pressure.
  • Have your child’s blood pressure and heart rate checked often. Talk with your child’s doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
  • Talk with the doctor before giving your child 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.
  • Do not give antacids with this drug.
  • Do not switch between this product and other products that have the same drugs in them without checking with the doctor.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
  • Different brands of this drug may be for use in different ages of children. Talk with the doctor before giving this drug to a child.
  • If your child is pregnant:
  • Tell the doctor if your child is pregnant or becomes pregnant. You will need to talk about the benefits and risks of your child using this drug while pregnant.
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:
  • 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.
  • A fast heartbeat.
  • Very nervous and excitable.
  • A heartbeat that does not feel normal.
  • Seizures.
  • Trouble controlling body movements.
  • Restlessness.
  • Change in eyesight.
  • For males, erections (hard penis) that happen often or that last a long time.
  • 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.
  • Dark urine.
  • Not able to pass urine or change in how much urine is passed.
  • Pain when passing urine.
  • Muscle pain or weakness.
  • 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.
  • If your child is or may be sexually active:
  • Not able to get or keep an erection.
  • Change in sex interest.
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:
  • Belly pain.
  • Feeling nervous and excitable.
  • Headache.
  • Not hungry.
  • Not able to sleep.
  • Constipation.
  • Diarrhea.
  • Dizziness.
  • Dry mouth.
  • Bad taste in your child’s mouth.
  • Weight loss.
  • Upset stomach or throwing up.
  • Feeling tired or weak.
  • 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 this drug with or without food.
  • Give last dose of the day at least 4 hours before bedtime.
  • Long-acting capsules (Adderall XR):
  • Give this drug with or without food.
  • Long-acting capsules (Mydayis):
  • 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.
  • All long-acting products:
  • Give in the morning.
  • Have your child swallow tablet whole. Do not let your child chew, break, or crush.
  • You may sprinkle contents of capsule on applesauce. Have your child swallow without chewing.
  • After mixing, give your child’s dose right away. Do not store for future use.
  • All products:
  • To gain the most benefit, do not miss giving your child doses.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
What do I do if my child misses a dose?
  • Tablets:
  • Give a missed dose as soon as you think about it.
  • 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.
  • All long-acting products:
  • Skip the missed dose and go back to your child’s normal time.
  • Do not give it later in the day.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • 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.