Oxybutynin (Lexi-Drugs)

Pronunciation

(oks i BYOO ti nin)

Brand Names: US

Ditropan XL; Gelnique; Gelnique Pump; Oxytrol; Oxytrol For Women [OTC]

Brand Names: Canada

APO-Oxybutynin; Ditropan XL; DOM-Oxybutynin; Gelnique; MYLAN-Oxybutynin [DSC]; Oxytrol; PHL-Oxybutynin [DSC]; PMS-Oxybutynin; RIVA-Oxybutynin; TEVA-Oxybutynin

Pharmacologic Category

Antispasmodic Agent, Urinary

Dosing: Adult

Overactive bladder:

Oral:

Immediate release: 5 mg 2 to 3 times daily; maximum: 5 mg 4 times daily

Extended release: Initial: 5 to 10 mg once daily, adjust dose in 5 mg increments at weekly intervals; maximum: 30 mg once daily

Topical gel: Apply contents of 1 sachet (100 mg/g) or 1 actuation of the pump (100 mg/g) once daily.

Transdermal: Apply one 3.9 mg/day patch twice weekly (every 3 to 4 days); change the patch on the same 2 days each week.

OTC labeling: Females: Apply one 3.9 mg/day patch every 4 days

Primary hyperhidrosis (off-label use): Based on limited data: Oral: Immediate release: Initial: 2.5 mg once daily; gradually titrate per effect and tolerance. Target doses of 7.5 to 10 mg/day in 2 divided doses have been studied (Schollhammer 2015; Wolosker 2012).

Dosing: Geriatric

Use with caution due to anticholinergic properties (Beers Criteria [AGS 2015]).

Oral: Immediate release: Initial: 2.5 mg 2 to 3 times daily; increase cautiously

Extended release tablets, topical gel, transdermal patch: Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); use with caution.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); use with caution.

Dosing: Pediatric

Neurogenic/Overactive bladder:

Oral:

Immediate release:

Infants and Children ≤5 years: Limited data available: 0.1 to 0.2 mg/kg/dose 2 to 3 times daily; maximum dose: 5 mg/dose (Buyse 1998a; Buyse 1998b; Ferrara 2001; Kleigman 2016); one retrospective study reported doses as high 0.2 mg/kg/dose every 6 hours (Kaefer 1999)

Children >5 years and Adolescents: Initial: 5 mg twice daily, increase as necessary up to 5 mg 3 times daily; adult maximum dose: 5 mg 4 times daily

Extended release: Children ≥6 years and Adolescents: Initial: 5 mg once daily; adjust dose as needed in 5 mg increments at weekly intervals; maximum daily dose: 20 mg/day

Intravesical: Limited data available: Infants, Children, and Adolescents: 0.2 mg/kg/dose twice daily at 8 to 12 hour intervals; maximum dose: 5 mg/dose (Amark 1998; Buyse 1998a; Buyse 1998b; Ferrara 2001)

Overactive bladder, idiopathic: Limited data available: Transdermal: Children ≥4 years and Adolescents: Apply one 3.9 mg/day patch twice weekly (every 3 to 4 days); dosing based on a retrospective study of 35 children (mean age: 8 years; range: 4 to 16 years) with idiopathic overactive bladder; most patients (97%) reported good symptom control; skin irritation at the application site was reported in 35% of patients with 20% resulting in discontinuation of therapy; no other significant side effects were reported (Gleason 2014)

Dosing: Renal Impairment: Pediatric

Oral, Transdermal: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); use with caution.

Dosing: Hepatic Impairment: Pediatric

Oral, Transdermal: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); use with caution.

Use: Labeled Indications

Overactive bladder: Treatment of symptoms associated with overactive bladder (eg, urge urinary incontinence, urgency, frequency, urinary leakage, dysuria); treatment of symptoms associated with overactive bladder due to a neurological condition (eg, spina bifida) in patients ≥6 years (extended release tablet only).

Use: Off-Label: Adult

  Primary hyperhidrosisLevel of Evidence [C]

Data from randomized, placebo-controlled trials with limited numbers of patients and of short duration suggest that oxybutynin may be beneficial for treatment of primary hyperhidrosis Ref. Additional data may be necessary to further define the role of oxybutynin in this condition.

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

American Urological Association (AUA), “Diagnosis and Treatment of Overactive Bladder (Non-neurogenic) in Adults: AUA/SUFU Guideline,” May 2014

Administration: Oral

Extended release tablets: Administer without regard to meals. Must be swallowed whole with liquid; do not crush, divide, or chew; take at approximately the same time each day.

Administration: Topical

Topical gel: For topical use only. Apply to clean, dry, intact skin on abdomen, thighs, or upper arms/shoulders. Rotate application sites; do not apply to the same site on consecutive days. Wash hands after use. Cover treated area with clothing after gel has dried to prevent transfer of medication to others. Do not bathe, shower, or swim until 1 hour after gel applied. Do not apply to recently shaved skin.

Pump: Prior to initial use, prime pump several times (≥ 4 times) until gel begins to come out; after gel is observed, fully depress the pump one more time and discard gel dispensed from pump during priming. One full depression of the pump provides one dose; discard after 30 doses.

Administration: Other

Transdermal: Apply to clean, dry, smooth (fold-free) skin on abdomen, hip, or buttock; do not apply to areas treated with oils, lotions, or powders. Do not apply to areas with cuts, scrapes, or other irritation (ie, rashes). Do not cut the patch. Apply each system at a new site (avoid reapplication to same site within 7 days). Contact with water while bathing, swimming, showering, or exercising will not change the effect; however, rubbing of the patch area should be avoided during these activities. Patch should be worn under clothing; do not expose to sunlight.

Administration: Pediatric

Oral: May be administered with or without food. Extended release tablets must be swallowed whole with liquid; do not chew, divide, or crush; take at approximately the same time each day.

Transdermal: Apply to clean dry intact skin on the abdomen, hip, or buttock. Rotate site of application with each administration and avoid application to the same site within 7 days. Wear patch under clothing; do not expose to sunlight.

Intravesical: Immediately prior to administration crush the appropriate number of immediate release tablets based on dose and dissolve in sterile water or saline to a final concentration of 5 mg/mL (Kennelly 2010); administer directly into the bladder after emptying via catheter (Buyse 1998a; Buyse 1998b)

Dietary Considerations

Food causes a slight delay in the absorption of the oral solution and bioavailability is increased by ~25%. Absorption of the extended release tablet is not affected by food. May be taken without regard to meals.

Storage/Stability

Immediate release tablet and syrup: Store at 20°C to 25°C (68°F to 77°F). Protect from light.

Extended release tablet: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from moisture and humidity.

Topical gel: Store at 20°C to 25°C (68°C to 77°F). Protect from moisture and humidity. Keep away from open flame. Do not store outside the sealed pouch or pump dispenser; apply immediately after removal from the protective pouch or once contents expelled from pump dispenser. Discard used sachets such that accidental application or ingestion by children, pets, or others are avoided.

Transdermal patch: Store at 20°C to 25°C (68°F to 77°F). Protect from moisture and humidity. Do not store outside the sealed pouch; apply immediately after removal from the protective pouch. Discard used patches such that accidental application or ingestion by children, pets, or others is avoided.

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 blurred vision, diarrhea, nausea, anxiety, insomnia, application site redness, or dry mouth. Have patient report immediately to prescriber signs of a urinary tract infection (hematuria, burning or painful urination, polyuria, fever, lower abdominal pain, or pelvic pain), severe dizziness, passing out, confusion, hallucinations, agitation, severe fatigue, mood changes, lack of sweat, severe headache, seizures, urinary retention, tachycardia, abnormal heartbeat, fast breathing, severe constipation, severe abdominal pain, muscle weakness, severe itching, or severe skin irritation (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:
  Geriatric Patients: High-Risk Medication:
  Other safety concerns:
Contraindications

Hypersensitivity to oxybutynin or any component of the formulation; patients with or at risk for uncontrolled narrow-angle glaucoma, urinary retention, gastric retention or conditions with severely decreased GI motility.

OTC labeling: When used for self-medication, do not use if you have pain or burning when urinating, blood in urine, unexplained lower back or side pain, cloudy or foul-smelling urine; in males; age <18 years; only experience accidental urine loss when cough, sneeze, or laugh; diagnosis of urinary or gastric retention; glaucoma; hypersensitivity to oxybutynin.

Canadian labeling: Additional contraindications (not in US labeling): Severe GI conditions; myasthenia gravis.

Warnings/Precautions

Concerns related to adverse effects:

• Angioedema/hypersensitivity reactions: May cause hypersensitivity, including anaphylaxis and angioedema. Cases of angioedema involving the face, lips, tongue, and/or larynx have been reported with oral oxybutynin; some cases have occurred after a single dose. Discontinue immediately if tongue, hypopharynx, or larynx is involved; promptly initiate appropriate management.

• CNS effects: Anticholinergics may cause agitation, confusion, drowsiness, dizziness, hallucinations, headache, somnolence, and/or blurred vision, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). Dose reduction or discontinuation should be considered if CNS effects occur.

• Heat prostration: May increase the risk of heat prostration.

Disease-related concerns:

• Bladder flow obstruction: Use with caution in patients with bladder flow obstruction; may increase the risk of urinary retention.

• Cardiovascular disease: Use with caution in patients with CAD, heart failure, hypertension, and/or cardiac arrhythmias; may exacerbate condition.

• Dementia: Use with caution in patients with dementia treated with cholinesterase inhibitors; may aggravate symptoms of disease.

• GI disorders: Use with caution in patients with decreased GI motility or GI obstructive disorders; may increase the risk of gastric retention. Use with caution in patients with ulcerative colitis, intestinal atony, pyloric stenosis, gastroesophageal reflux, or with medications that may cause or exacerbate esophagitis (eg, bisphosphonates). In patients with ulcerative colitis, use may decrease gastric motility to the point of increasing the risk of paralytic ileus or toxic megacolon.

• Glaucoma: Use with caution in patients with treated angle-closure glaucoma; may exacerbate condition; use is contraindicated with uncontrolled narrow-angle glaucoma.

• Hepatic impairment: Use with caution in patients with hepatic impairment (limited experience).

• Hiatal hernia: Use with caution in patients with hiatal hernia.

• Hyperthyroidism: Use with caution in patients with hyperthyroidism; may exacerbate condition.

• Myasthenia gravis: Avoid use in patients with myasthenia gravis; may exacerbate condition. Discontinue therapy if signs/symptoms occur.

• Neuropathy: Use with caution in patients with autonomic neuropathy; may aggravate symptoms of decreased GI motility.

• Parkinson disease: Use with caution in patients with Parkinson disease; may aggravate symptoms of disease.

• Prostatic hyperplasia/urinary stricture: Use with caution in patients with prostatic hyperplasia and/or urinary stricture; may cause urinary retention.

• Renal impairment: Use with caution in patients with renal impairment (limited experience).

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.

Dosage form specific issues:

• Extended release formulation: The extended release formulation consists of drug within a nondeformable matrix; following drug release/absorption, the matrix/shell is expelled in the stool. The use of nondeformable products in patients with known stricture/narrowing of the GI tract has been associated with symptoms of obstruction (rare).

• Topical gel: To minimize transferring medication to others, cover treatment area with clothing after gel has dried. Discontinue use if skin irritation occurs. Contains ethanol; do not expose to open flame or smoking until gel has dried.

• Transdermal patch: May contain conducting metal (eg, aluminum); remove patch prior to MRI.

Other warnings/precautions:

• OTC labeling: Other causes of frequent urination (UTI, diabetes, early pregnancy, other serious conditions) may need to be considered prior to use. Patients should contact a health care provider if symptoms do not improve within 2 weeks of initial use or for new or worsening symptoms.

Geriatric Considerations

Caution should be used in the elderly due to anticholinergic activity (eg, confusion, constipation, blurred vision, and tachycardia). Start with lower doses. Transdermal dosage form may have less potential for these effects. Oxybutynin may cause memory problems in the elderly. Studies using transdermal dosage form did not reveal any differences in safety or efficacy between elderly and younger adults.

Warnings: Additional Pediatric Considerations

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

Intravesical administration of oxybutynin may be used for the treatment of neurogenic bladder in patients intolerant to or refractory to oral oxybutynin. Several studies have suggested a reduced incidence of anticholinergic side effects with intravesical administration compared to those observed with oral therapy (Buyse 1998b; Guerra 2008). However, one study showed a higher incidence of CNS side effects (eg, hallucination, drowsiness, and cognitive impairment) in children receiving intravesical oxybutynin compared to those receiving oral oxybutynin at comparable doses. It is speculated that the higher plasma concentrations associated with intravesical administration compared to oral is responsible for this effect (Ferrara 2001); closely monitor patients.

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies.

Information related to the use of oxybutynin in patients treated for neurogenic bladder during pregnancy is limited (Andretta 2018).

Breast-Feeding Considerations

It is not known if oxybutynin is present in breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Suppression of lactation has been reported.

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

As reported with oral administration, unless otherwise noted.

>10%:

Central nervous system: Dizziness (oral: 5% to 17%; topical gel: 3%), drowsiness (6% to 14%)

Gastrointestinal: Xerostomia (oral: 35% to 72%; topical gel, transdermal: 4% to 10%), constipation (oral: 9% to 15%; transdermal: 3%; topical gel: 1%), nausea (5% to 12%)

Local: Application site pruritus (transdermal: 14% to 17%; topical gel: 2%)

1% to 10%:

Cardiovascular: Decreased blood pressure (1% to <5%), edema (1% to <5%), flushing (1% to <5%), increased blood pressure (1% to <5%), palpitations (1% to <5%), peripheral edema (1% to <5%), sinus arrhythmia (1% to <5%)

Central nervous system: Headache (oral: 8%; topical gel: 2%), nervousness (7%), insomnia (3% to 6%), confusion (1% to <5%), falling (1% to <5%), flank pain (1% to <5%), pain (1% to <5%), fatigue (oral, topical gel: 2% to 3%)

Dermatologic: Macular eruption (transdermal: 3%; application site), xeroderma (2% to 3%), pruritus (oral, topical gel: 1% to 2%)

Endocrine & metabolic: Fluid retention (<5%), increased thirst (<5%), increased serum glucose (1% to <5%)

Gastrointestinal: Diarrhea (3% to 8%), dyspepsia (5% to 6%), coated tongue (1% to <5%), eructation (1% to <5%), upper abdominal pain (1% to <5%), flatulence (1% to 3%), abdominal pain (2%), dysgeusia (2%), viral gastroenteritis (topical gel: 2%), vomiting (1% to 2%), gastroesophageal reflux disease (≤1%)

Genitourinary: Urinary hesitancy (2% to 9%), urinary tract infection (oral, topical gel: 7%), urinary retention (1% to 6%), cystitis (1% to <5%), pollakiuria (1% to <5%), increased post-void residual urine volume (2% to 4%), dysuria (oral, transdermal: 2%)

Infection: Fungal infection (1% to <5%)

Local: Application site erythema (transdermal: 6% to 8%), application site reaction (topical gel: 5%), application site rash (transdermal: 3%), application site vesicles (transdermal: 3%), application site dermatitis (topical gel: 2%)

Neuromuscular & skeletal: Arthralgia (1% to <5%), back pain (1% to <5%), limb pain (1% to <5%), asthenia (1% to <5%)

Ophthalmic: Blurred vision (4% to 10%), eye irritation (1% to <5%), keratoconjunctivitis sicca (1% to <5%), visual disturbance (transdermal: 3%), xerophthalmia (3%)

Respiratory: Dry nose (2% to 5%), upper respiratory tract infection (oral, topical gel: 1% to 5%), asthma (1% to <5%), bronchitis (1% to <5%), hoarseness (1% to <5%), nasal congestion (1% to <5%), nasopharyngitis (oral, topical gel: 1% to <5%), paranasal sinus congestion (1% to <5%), pharyngolaryngeal pain (1% to <5%), sinus headache (1% to <5%), cough (2% to 3%), dry throat (2% to 3%), oropharyngeal pain (2%)

<1%, postmarketing, and/or case reports: Abnormal behavior, agitation, anaphylaxis, angioedema, anorexia, cardiac arrhythmia, chest discomfort, confusion, cycloplegia, decreased gastrointestinal motility, delirium, dizziness, drowsiness, dysphagia, facial edema, frequent bowel movements, glaucoma, hallucination, headache, hot flash, hypersensitivity reaction, hypertension, hypohidrosis, impotence, lactation insufficiency, memory impairment, mydriasis, prolonged Q-T interval on ECG, psychotic reaction, seizure, skin rash, tachycardia, urticaria, voice disorder

Metabolism/Transport Effects

Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions 

Acetylcholinesterase Inhibitors: Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Acetylcholinesterase Inhibitors may diminish the therapeutic effect of Anticholinergic Agents. Risk C: Monitor therapy

Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Alcohol (Ethyl): May enhance the CNS depressant effect of Oxybutynin. Risk C: Monitor therapy

Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

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

Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Exceptions: Cannabidiol. Risk C: Monitor therapy

Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Risk C: Monitor therapy

Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Risk X: Avoid combination

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Oxybutynin. Risk C: Monitor therapy

Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Risk X: Avoid combination

Erythromycin (Systemic): May increase the serum concentration of Oxybutynin. Risk C: Monitor therapy

Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Risk C: Monitor therapy

Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Risk C: Monitor therapy

Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Risk X: Avoid combination

Glycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Risk C: Monitor therapy

Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Risk X: Avoid combination

Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Risk C: Monitor therapy

Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Risk C: Monitor therapy

Opioid Agonists: Anticholinergic Agents may enhance the adverse/toxic effect of Opioid Agonists. Specifically, the risk for constipation and urinary retention may be increased with this combination. Risk C: Monitor therapy

Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Risk X: Avoid combination

Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Risk X: Avoid combination

Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Risk D: Consider therapy modification

Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Risk C: Monitor therapy

Revefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin. Risk X: Avoid combination

Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Risk D: Consider therapy modification

Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Risk X: Avoid combination

Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Risk C: Monitor therapy

Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Test Interactions

May suppress the wheal and flare reactions to skin test antigens.

Monitoring Parameters

Incontinence episodes, postvoid residual (PVR), anticholinergic reactions (eg, dry mouth, constipation, dizziness).

Advanced Practitioners Physical Assessment/Monitoring

Assess voiding pattern, incontinent episodes, frequency, urgency, distention, and urinary retention prior to beginning therapy and periodically throughout.

Nursing Physical Assessment/Monitoring

Assess voiding pattern, incontinent episodes, frequency, urgency, distention, and urinary retention prior to beginning therapy and periodically throughout.

Dosage Forms: US

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

Gel, Transdermal:

Gelnique: 3% (92 g [DSC]) [contains propylene glycol]

Gel, Transdermal, as chloride:

Gelnique: 10% (1 g) [contains alcohol, usp]

Gelnique Pump: 10% (30 g)

Patch Twice Weekly, Transdermal:

Oxytrol: 3.9 mg/24 hr (1 ea, 2 ea [DSC], 4 ea [DSC], 8 ea)

Oxytrol For Women: 3.9 mg/24 hr (4 ea, 8 ea)

Syrup, Oral, as chloride:

Generic: 5 mg/5 mL (473 mL)

Tablet, Oral, as chloride:

Generic: 5 mg

Tablet Extended Release 24 Hour, Oral, as chloride:

Ditropan XL: 5 mg, 10 mg, 15 mg [DSC] [contains polysorbate 80]

Generic: 5 mg, 10 mg, 15 mg

Dosage Forms: Canada

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

Gel, Transdermal, as chloride:

Gelnique: 10% (1gm, 30gm) [contains ALCOHOL, USP]

Patch Twice Weekly, Transdermal:

Oxytrol: 3.9 mg/24 hr (8ea)

Syrup, Oral, as chloride:

Generic: 5 mg/5 mL (473ml, 500ml)

Tablet, Oral:

Generic: 2.5 mg

Tablet, Oral, as chloride:

Generic: 5 mg

Tablet Extended Release 24 Hour, Oral, as chloride:

Ditropan XL: 5 mg, 10 mg [contains POLYSORBATE 80]

Anatomic Therapeutic Chemical (ATC) Classification
  • G04BD04
Generic Available (US)

May be product dependent

Pricing: US

Gel (Gelnique Pump Transdermal)

10% (per gram): $15.82

Gel (Gelnique Transdermal)

10% (per gram): $15.82

Patch, twice-weekly (Oxytrol For Women Transdermal)

3.9 mg/24 hrs (per each): $3.30

Patch, twice-weekly (Oxytrol Transdermal)

3.9 mg/24 hrs (per each): $101.98

Syrup (Oxybutynin Chloride Oral)

5 mg/5 mL (per mL): $0.11

Tablet, 24-hour (Ditropan XL Oral)

5 mg (per each): $7.63

10 mg (per each): $7.63

Tablet, 24-hour (Oxybutynin Chloride ER Oral)

5 mg (per each): $1.86 – $6.24

10 mg (per each): $1.99 – $6.24

15 mg (per each): $2.39 – $6.40

Tablets (Oxybutynin Chloride Oral)

5 mg (per each): $0.56 – $0.76

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

Direct antispasmodic effect on smooth muscle, also inhibits the action of acetylcholine on smooth muscle (exhibits 1/5 the anticholinergic activity of atropine, but has 4-10 times the antispasmodic activity); does not block effects at skeletal muscle or at autonomic ganglia; increases bladder capacity, decreases uninhibited contractions, and delays desire to void, therefore, decreases urgency and frequency

Pharmacodynamics/Kinetics

Onset of action: Oral: Immediate release: 30 to 60 minutes

Peak effect: Immediate release: 3 to 6 hours; Extended release: 3 days

Duration: Oral: Immediate release: 6 to 10 hours; Extended release: Up to 24 hours; Transdermal 96 hours

Absorption: Oral: Rapid and well absorbed; Transdermal: High

Distribution: IV: Vd: 193 L

Protein binding: >99% primarily to alpha1-acid glycoprotein

Metabolism: Hepatic via CYP3A4; Oral: High first-pass metabolism; forms active and inactive metabolites

Bioavailability: Oral: Immediate release: 6% (range: 1.6% to 10.9%)

Half-life elimination: IV: ~2 hours (parent drug), 7 to 8 hours (metabolites); Oral: Immediate release: ~2 to 3 hours; Extended release: ~13 hours; Transdermal: 64 hours

Time to peak, serum: Oral: Immediate release: ~60 minutes; Extended release: 4 to 6 hours; Transdermal: 24 to 48 hours

Excretion: Urine (<0.1% as metabolites and unchanged drug)

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse (events) related to dental treatment: Xerostomia and changes in salivation (normal salivary flow resumes upon discontinuation), and taste perversion.

Effects on Bleeding

No information available to require special precautions

Index Terms

Ditropan; Oxybutynin Chloride; Oxybutynin Hydrochloride

FDA Approval Date
November 14, 1988
References

American Geriatrics Society 2015 Beers Criteria Update Expert Panel. American Geriatrics Society 2015 updated Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2015;63(11):2227-2246. doi:10.1111/jgs.13702[PubMed 26446832]

Andretta E, Landi LM, Cianfrocca M, Manassero A, Risi O, Artuso G. Bladder management during pregnancy in women with spinal-cord injury: an observational, multicenter study [published online March 29, 2018]. Int Urogynecol J.[PubMed 29600402]

Ditropan XL (oxybutynin) [prescribing information]. Titusville, NJ: Janssen; August 2017.

Ditropan XL (oxybutynin) [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc; October 2018.

Ditropan XL (oxybutynin) [product monograph]. Toronto, Ontario, Canada: Jassen; August 2018.

Gelnique (oxybutynin) gel prescribing information]. Madison, NJ: Allergan USA, Inc; March 2019.

Gelnique (oxybutynin) [product monograph]. Markham, Ontario, Canada: Allergan Pharma; March 2017.

Katz IR, Sands LP, Bilker W, et al, “Identification of Medications That Cause Cognitive Impairment in Older People: The Case of Oxybutynin Chloride,” J Am Geriatr Soc,1998, 46(1):8-13.[PubMed 9434659]

Oxybutynin chloride solution (immediate release) [prescribing information]. Huntsville, AL: Qualitest Pharmaceuticals; March 2008

Oxybutynin chloride tablets [prescribing information]. New Castle, DE: Marlex Pharmaceuticals Inc; March 2018.

Oxytrol for Women (oxybutynin) [prescribing information]. Whippany, NJ: Bayer HealthCare LLC; received March 2016.

Oxytrol (oxybutynin) [product monograph]. Markham, Ontario, Canada: Allergan Pharma; March 2018.

Oxytrol (oxybutynin) transdermal system [prescribing information]. Irvine, CA: Allergan USA Inc; October 2017.

Schollhammer M, Brenaut E, Menard-Andivot N, et al. Oxybutynin as a treatment for generalized hyperhidrosis: a randomized, placebo-controlled trial. Br J Dermatol. 2015;173(5):1163-1168. doi: 10.1111/bjd.13973.[PubMed 26114588]

Wolosker N, de Campos JR, Kauffman P, Puech-Leão P. A randomized placebo-controlled trial of oxybutynin for the initial treatment of palmar and axillary hyperhidrosis. J Vasc Surg. 2012;55(6):1696-1700. doi: 10.1016/j.jvs.2011.12.039.[PubMed 22341836]

Brand Names: International

Ao Ning (CN); Butyn (PK); Contimax (EG); Cystrin (GB, IE); Delifon (CO); Detronin (EG); Ditropan (AE, AR, AT, AU, BE, CH, CY, CZ, ES, FI, FR, GB, GR, HN, HU, IE, IT, JO, KR, KW, LB, LU, MT, PL, PT, SE, TW); Ditropan XL (BB); Diutropan (TH); Dresplan (ES); Dridase (DE, NL); Driptane (EE, HR, LB, LV, PH, RU, UA, VN); Frenurin (BR); Gradual (UY); Inprax (MX); Kentera (AT, BE, BG, CH, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HN, HR, IE, IT, MT, NL, NO, PL, PT, RO, RU, SE, SK, TR); Kentera Patch (GB, IE); Lenditro (ZA); Lyrinel (IL, MX, TH); Lyrinel Oros SR (KR); Lyrinel XL (GB, IE); Mutum (EC); Mutum CR (EC); Nefryl (CR, DO, GT, HN, MX, NI, PA, SV); Neoxy Tape (JP); Newin (TW); Novitropan (IL); Obutin (SG); Odranal (CL); Oxurate (EG); Oxyban (TW); Oxyspas (LK); Oxytrol (AU, NZ); Pollakisu (JP); Reteven (PE, VE); Sibutin (UA); Socliden (PY); Tavor (CR, DO, GT, HN, MX, NI, PA, SV); Tropan (IN); Uricon CR (BD); Urihexal (ZA); Uroflax (PY); Uropan (TR); Uroxal (HU); Voxytane (MY)

Oxybutynin (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

(oks i BYOO ti nin)

Brand Names: US

Ditropan XL; Gelnique; Gelnique Pump; Oxytrol; Oxytrol For Women [OTC]

Brand Names: Canada

Ditropan XL; Gelnique; Oxybutyn; Oxybutynine; Oxytrol

What is this drug used for?
  • It is used to treat an overactive bladder.
  • 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 oxybutynin 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: Bowel block, glaucoma, myasthenia gravis, slow moving GI (gastrointestinal) tract, or trouble passing urine.
  • 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 or have clear eyesight until you see how this drug affects you.
  • Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
  • Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
  • Good mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help with dry mouth. See a dentist often.
  • A very bad reaction called angioedema has happened with this drug. Sometimes, this may be life-threatening. Signs may include swelling of the hands, face, lips, eyes, tongue, or throat; trouble breathing; trouble swallowing; or unusual hoarseness. Get medical help right away if you have any of these signs.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • 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.
  • Extended-release tablets:
  • Do not give this drug to a child younger than 6 years of age.
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 a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
  • Very bad dizziness or passing out.
  • Feeling confused.
  • Hallucinations (seeing or hearing things that are not there).
  • Feeling agitated.
  • Feeling very sleepy.
  • Mood changes.
  • Fever.
  • Not sweating during activities or in warm temperatures.
  • Very bad headache.
  • Seizures.
  • Trouble passing urine.
  • A fast heartbeat.
  • A heartbeat that does not feel normal.
  • Fast breathing.
  • Very bad constipation.
  • Very bad belly pain.
  • Muscle weakness.
  • Skin gel and skin patch:
  • Very bad irritation where this drug is used.
  • Very bad itching.
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:
  • Feeling sleepy.
  • Dizziness.
  • Blurred eyesight.
  • Headache.
  • Upset stomach.
  • Constipation.
  • Diarrhea.
  • Dry mouth.
  • Trouble sleeping.
  • Feeling nervous and excitable.
  • Skin gel and skin patch:
  • Irritation where this drug is used.
  • Redness.
  • Itching.
  • 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.
  • All oral products:
  • Take with or without food. Take with food if it causes an upset stomach.
  • Take this drug at the same time of day.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
  • Oral solution:
  • 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.
  • Extended-release tablets:
  • Swallow whole. Do not chew, break, or crush.
  • Take with a full glass of water.
  • You may see the tablet shell in your stool. This is normal and not a cause for concern.
  • Skin gel:
  • Put on gel at the same time of day.
  • Keep using this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • Do not take this drug by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
  • Wash your hands before and after use.
  • Wash and dry the part of the skin that the gel will be used on.
  • Put on clean, dry, healthy skin on the belly, thigh, shoulder, or upper arm.
  • Do not put near belly button.
  • Do not use on irritated skin or if you have shaved your skin lately.
  • Move the site where you put the gel each day.
  • Do not bathe, shower, or swim for 1 hour after putting on.
  • Avoid fire, flames, or smoking until the gel has dried.
  • Do not let your skin where the gel was used touch anyone else’s skin while wearing the gel. Cover the treated skin with clothes.
  • Let gel dry before covering with clothing.
  • Some products come in pumps. Some products come in packets. If you are using a pump, you will need to prime it before you use it the first time. Prime the pump as you are told in the package insert.
  • Skin patch:
  • Put patch on at the same time of day.
  • Keep using this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • Do not use patches that are cut or do not look right.
  • Take off old patch first.
  • Put patch on clean, dry, healthy skin on the buttock, belly, or hip.
  • Move the patch site with each new patch. Do not put on the same site for 7 days.
  • Do not put the patch on the waistline.
  • Do not put on skin where you have just used creams, oils, lotions, powder, or other skin products. The patch may not stick as well.
  • Avoid sunlight on treated area.
  • Do not rub the patch area during bathing, swimming, showering, or exercise.
  • If the patch loosens or falls off, press it back on. If it does not stay, apply a new patch to a different area. Keep to your normal timetable.
What do I do if I miss a dose?
  • All oral products:
  • 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.
  • Skin gel:
  • Put on 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 put on 2 doses or extra doses.
  • Skin patch:
  • Put on a missed patch as soon as you think about it after taking off the old one.
  • Keep to your normal timetable.
  • Do not put on more than 1 patch at a time.
How do I store and/or throw out this drug?
  • All products:
  • 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.
  • Skin gel:
  • Protect from heat.
  • Skin patch:
  • Store in pouch until ready for use.
  • Use right after opening.
  • 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.
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.
Oxybutynin (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

(oks i BYOO ti nin)

Brand Names: US

Ditropan XL; Gelnique; Gelnique Pump; Oxytrol; Oxytrol For Women [OTC]

Brand Names: Canada

Ditropan XL; Gelnique; Oxybutyn; Oxybutynine; Oxytrol

What is this drug used for?
  • All oral products:
  • It is used to treat an overactive bladder.
  • It may be given to your child for other reasons. Talk with the doctor.
  • Skin gel and skin patch:
  • If your child has been given this form of this drug, talk with the doctor for information about the benefits and risks. Talk with the doctor if you have questions or concerns about giving this drug to your child.
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 has any of these health problems: Bowel block, glaucoma, myasthenia gravis, slow moving GI (gastrointestinal) tract, or trouble passing urine.
  • 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.
  • Talk with your child’s doctor before giving your child other drugs and natural products that may slow your child’s actions.
  • Have your child avoid tasks or actions that call for alertness or clear eyesight 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.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • Have your child be careful in hot weather or while your child is being active. Have your child drink lots of fluids to stop fluid loss.
  • Good mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help with dry mouth. Have your child see a dentist often.
  • A very bad reaction called angioedema has happened with this drug. Sometimes, this may be life-threatening. Signs may include swelling of the hands, face, lips, eyes, tongue, or throat; trouble breathing; trouble swallowing; or unusual hoarseness. Get medical help right away if your child has any of these signs.
  • 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.
  • Extended-release tablets:
  • Do not give this drug to a child younger than 6 years of age.
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 a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
  • Very bad dizziness or passing out.
  • Feeling confused.
  • Hallucinations (seeing or hearing things that are not there).
  • Feeling agitated.
  • Feeling very sleepy.
  • Mood changes.
  • Not sweating during activities or in warm temperatures.
  • Very bad headache.
  • Seizures.
  • Trouble passing urine.
  • A fast heartbeat.
  • A heartbeat that does not feel normal.
  • Fast breathing.
  • Very bad constipation.
  • Very bad belly pain.
  • Muscle weakness.
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:
  • Feeling sleepy.
  • Dizziness.
  • Blurred eyesight.
  • Headache.
  • Upset stomach.
  • Constipation.
  • Diarrhea.
  • Dry mouth.
  • Trouble sleeping.
  • Feeling nervous and excitable.
  • 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.
  • All oral products:
  • Give this drug with or without food. Give with food if it causes an upset stomach.
  • Give this drug at the same time of day.
  • 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.
  • Have your child drink lots of noncaffeine liquids every day unless told to drink less liquid by your child’s doctor.
  • Oral solution:
  • 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.
  • Extended-release tablets:
  • Have your child swallow whole. Do not let your child chew, break, or crush.
  • Give this drug with a full glass of water.
  • You may see the tablet shell in your child’s stool. This is normal and not a cause for concern.
What do I do if my child misses a dose?
  • 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.
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.