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Oxybutynin: Drug information

Oxybutynin: Drug information
(For additional information see "Oxybutynin: Patient drug information" and see "Oxybutynin: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Ditropan XL [DSC];
  • Gelnique;
  • Oxytrol;
  • Oxytrol For Women [OTC]
Brand Names: Canada
  • APO-Oxybutynin;
  • Ditropan XL [DSC];
  • Oxytrol [DSC];
  • PMS-Oxybutynin;
  • RIVA-Oxybutynin;
  • TEVA-Oxybutynin
Pharmacologic Category
  • Antispasmodic Agent, Urinary
Dosing: Adult
Overactive bladder

Overactive bladder (urinary urgency with or without incontinence) (alternative agent): Note: Consider use after inadequate response to or in conjunction with nonpharmacologic measures (Ref). Use of other antimuscarinic agents may be preferred to minimize adverse effects (eg, cognitive deficits) (Ref). Full benefit may not be observed until after several weeks of treatment; trial for ≥4 to 12 weeks before considering other options (Ref). Antimuscarinic agents are not recommended in patients with stress type incontinence (Ref).

Oral:

Note: ER formulations are preferred due to improved tolerability (Ref).

Extended release: Initial: 5 to 10 mg once daily; adjust dose as needed based on response and tolerability in 5 mg increments every 1 to ≥2 weeks (Ref); maximum dose: 30 mg once daily.

Immediate release: 5 mg 2 to 3 times daily; adjust dose as needed based on response and tolerability in 5 mg increments approximately every 2 weeks (Ref); maximum dose: 5 mg 4 times 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 (patient-guided therapy): Females: Apply one 3.9 mg/day patch every 4 days.

Primary focal hyperhidrosis

Primary focal hyperhidrosis (alternative agent) (off-label use): Oral:

Extended release: 5 to 10 mg once daily (Ref).

Immediate release: Initial: 2.5 mg once daily; gradually titrate as needed and tolerated; usual effective dose range: 5 to 10 mg/day in 2 divided doses (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Oral, topical, transdermal:

Altered kidney function: Mild to severe impairment: No dosage adjustment necessary (<0.1% of drug and its active metabolite eliminated in urine) (Ref); however, use with caution due to limited data in patients with altered kidney function (Ref).

Hemodialysis, intermittent (thrice weekly): Unlikely to be dialyzed (highly protein bound): No supplemental dose or dosage adjustment necessary (Ref); use with caution.

Peritoneal dialysis: Unlikely to be dialyzed (highly protein bound): No dosage adjustment necessary (Ref); 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: Older Adult

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: Pediatric

(For additional information see "Oxybutynin: Pediatric drug information")

Neurogenic/overactive bladder

Neurogenic/overactive bladder:

Oral:

Immediate release:

Weight-directed dosing:

Infants, Children, and Adolescents: Limited data available: Oral: 0.1 to 0.6 mg/kg/day in 2 to 4 divided doses; most commonly divided in 3 doses; maximum dose: 5 mg/dose (Ref).

Fixed dosing:

Children >5 years and Adolescents: Oral: Initial: 5 mg twice daily; increase as necessary up to 5 mg 3 times daily; adult maximum dose: 5 mg 4 times daily (Ref).

Extended release:

Children ≥6 years and Adolescents: Oral: Initial: 5 mg once daily; adjust dose as needed in 5 mg increments at weekly intervals; maximum daily dose: 20 mg/day (Ref).

Intravesical: Limited data available:

Infants, Children, and Adolescents: Intravesical: 0.1 to 0.9 mg/kg/day in 2 to 3 divided doses (higher daily doses are usually administered in 3 divided doses); maximum dose: 5 mg/dose (Ref).

Transdermal: Limited data available:

Children ≥4 years and Adolescents: Transdermal: Apply one 3.9 mg/day patch twice weekly (every 3 to 4 days); dosing based on 2 small pediatric studies (Ref).

Nocturnal enuresis

Nocturnal enuresis: Limited data available: Children ≥6 years and Adolescents: Immediate release: Oral: Initial: 5 mg once daily at bedtime; may increase dose by 2.5 mg/dose at 2-week intervals based on patient response to a maximum of 10 mg once daily. Use in combination with desmopressin (Ref).

Primary focal hyperhidrosis

Primary focal hyperhidrosis: Limited data available: Children ≥4 years and Adolescents: Immediate release: Oral: Initial: 2.5 mg once daily; increase by 2.5 mg/dose at 1- to 2-week intervals based on patient response and tolerability; usual effective dose range: 5 to 10 mg/day in 1 to 2 divided doses. Maximum reported daily dose: 15 mg/day (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Altered kidney function: Mild to severe impairment: Infants, Children, and Adolescents: Oral, Transdermal: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). Dosage adjustment is likely unnecessary, as <0.1% is eliminated unchanged in the urine; however, use with caution due to limited data in patients with altered kidney function (Ref).

Hemodialysis, intermittent: Unlikely to be dialyzed (highly protein bound).

Peritoneal dialysis: Unlikely to be dialyzed (highly protein bound).

Dosing: Hepatic Impairment: Pediatric

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

Adverse Reactions (Significant): Considerations
Anticholinergic effects

Anticholinergic agents, including oxybutynin, may cause reversible, dose-dependent antimuscarinic adverse effects, including, but not limited to, CNS effects (agitation, confusion, cognitive impairment, drowsiness, dizziness, hallucinations, headache), GU effects (eg, urinary retention), GI effects (eg, gastric retention, decreased gastrointestinal motility, constipation, xerostomia) ophthalmic effects (eg, blurred vision, mydriasis, xerophthalmia), cardiovascular effects (eg, tachycardia), and dermatologic effects (eg, hypohidrosis, xeroderma) in adult and pediatric patients (Ref). Exertional heat illness (risk factor anticholinergic-induced hypohidrosis) may occur, especially when patients exert themselves under high environmental temperatures/humidity. Xerostomia is the most frequent adverse reaction causing discontinuation of therapy.

When compared to other medications used for the treatment of overactive bladder (eg, anticholinergic agents, beta3 agonists), oxybutynin has been associated with a higher risk of affect/mood disorders, agitation, and balance/movement disorders (Ref).

Mechanism: Dose-related; an extension of antimuscarinic pharmacological properties.

Of note, an active metabolite, desethyloxybutynin, has pharmacological activity similar to that of oxybutynin; therefore, a route of administration which bypasses hepatic metabolism to desethyloxybutynin (eg, transdermal) may result in less antimuscarinic activity (Ref).

Onset: Varied; timing may be impacted by high doses, dose titration, or accumulation.

Risk factors:

• Conditions which may lead to accumulation (eg, older patients (Ref), patients with hepatic or renal impairment)

• Routes of administration that lead to higher serum concentrations (eg, immediate release oral formulations, intravesical administration) or higher concentrations of active metabolite (eg, oral formulations) (Ref).

• Preexisting decreased GI motility or GI obstructive disorders. In patients with ulcerative colitis, use may decrease gastric motility to the point of increasing the risk of paralytic ileus or toxic megacolon.

• Preexisting angle-closure glaucoma (use is contraindicated with uncontrolled narrow-angle glaucoma)

• Preexisting coronary artery disease, heart failure, hypertension, and/or cardiac arrhythmias

• Physical exertion in high ambient temperature and humidity may lead to exertional heat illness

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. As reported with oral administration, unless otherwise noted.

>10%:

Gastrointestinal: Constipation (oral: 9% to 15%; transdermal: 3%; topical gel: 1%) (table 1), nausea (5% to 12%), xerostomia (oral: 35% to 72%; topical gel, transdermal: 4% to 10%) (table 2)

Oxybutynin: Adverse Reaction: Constipation

Drug (Oxybutynin)

Placebo

Dose

Dosage Form

Number of Patients (Oxybutynin)

Number of Patients (Placebo)

3%

0%

Oxytrol (3.9 mg/day)

Transdermal

121

117

Oxybutynin: Adverse Reaction: Xerostomia

Drug (Oxybutynin)

Placebo

Dose

Dosage Form

Number of Patients (Oxybutynin)

Number of Patients (Placebo)

10%

8%

Oxytrol (3.9 mg/day)

Transdermal

125

132

8%

3%

Gelnique (1 g/day)

Gel

389

400

4%

2%

Oxytrol (3.9 mg/day)

Transdermal

121

117

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

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

Oxybutynin: Adverse Reaction: Dizziness

Drug (Oxybutynin)

Placebo

Dose

Dosage Form

Number of Patients (Oxybutynin)

Number of Patients (Placebo)

3%

1%

Gelnique (1 g/day)

Gel

389

400

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%), sinoatrial nodal rhythm disorder (1% to 5%)

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

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

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

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

Infection: Fungal infection (1% to 5%)

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

Nervous system: Asthenia (1% to 5%), confusion (1% to 5%), falling (1% to 5%), fatigue (oral, topical gel: 2% to 3%), headache (oral: 8%; topical gel: 2%), insomnia (3% to 6%), nervousness (7%), pain (1% to 5%)

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

Ophthalmic: Blurred vision (4% to 10%), dry eye syndrome (3%), eye irritation (1% to 5%), visual disturbance (transdermal: 3%) (table 4)

Oxybutynin: Adverse Reaction: Visual disturbance

Drug (Oxybutynin)

Placebo

Dose

Dosage Form

Number of Patients (Oxybutynin)

Number of Patients (Placebo)

3%

0%

Oxytrol (3.9 mg/day)

Transdermal

121

117

Renal: Flank pain (1% to 5%)

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

<1%:

Cardiovascular: Chest discomfort

Endocrine & metabolic: Hot flash

Gastrointestinal: Anorexia, dysphagia

Nervous system: Voice disorder

Postmarketing:

Cardiovascular: Cardiac arrhythmia (Ciftci 2013), hypertension (Armstrong 2007; Branson 2008), prolonged QT interval on ECG (Ciftci 2013; Hussain 1996), tachycardia

Dermatologic: Fixed drug eruption (lip) (Pemberton 2008), hypohidrosis (Ghaleiha 2012)

Endocrine & metabolic: Heatstroke (Adubofour 1996)

Gastrointestinal: Decreased gastrointestinal motility (Meek 2011)

Hepatic: Increased liver enzymes (Alrawashdeh 2018)

Hypersensitivity: Anaphylaxis, angioedema

Nervous system: Agitation (Lackner 2008), balance impairment (Sze 2022), delirium (Götz 2009), delusion (Sze 2022), hallucination (Götz 2009; Gulsun 2006), hypertonia (Chu 2005), memory impairment (Nye 2010), mood disorder (Sze 2022), movement disorder (Sze 2022), paresthesia (Sze 2022), psychotic reaction (Gulsun 2006), seizure (Branson 2008)

Ophthalmic: Glaucoma (Haddad 2018, Jain 2015), mydriasis

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): Transdermal: Myasthenia gravis.

Warnings/Precautions

Concerns related to adverse effects:

• Exertional heat illness: May increase the risk of this illness with intense exertion in the heat.

Disease-related concerns:

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

• 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.

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

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

Dosage form specific issues:

• ER formulation: The ER 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.

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).

Product Availability

Gelnique Pump has been discontinued in the United States for >1 year.

Dosage Forms: US

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

Gel, Transdermal, as chloride:

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

Patch Twice Weekly, Transdermal:

Oxytrol: 3.9 mg/24 hr (1 ea, 8 ea)

Oxytrol For Women: 3.9 mg/24 hr (1 ea, 4 ea, 8 ea)

Solution, Oral, as chloride:

Generic: 5 mg/5 mL (473 mL)

Tablet, Oral, as chloride:

Generic: 2.5 mg, 5 mg

Tablet Extended Release 24 Hour, Oral, as chloride:

Ditropan XL: 5 mg [DSC], 10 mg [DSC]

Generic: 5 mg, 10 mg, 15 mg

Generic Equivalent Available: US

May be product dependent

Pricing: US

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

Solution (oxyBUTYnin Chloride Oral)

5 mg/5 mL (per mL): $0.11 - $1.27

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)

2.5 mg (per each): $2.80

5 mg (per each): $0.44 - $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.

Dosage Forms: Canada

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

Patch Twice Weekly, Transdermal:

Oxytrol: 3.9 mg/24 hr ([DSC])

Solution, Oral, as chloride:

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

Tablet, Oral, as chloride:

Generic: 2.5 mg, 5 mg

Tablet Extended Release 24 Hour, Oral, as chloride:

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

Administration: Adult

Oral: ER 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.

Bariatric surgery: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. Oral solution, IR tablet, topical gel, and transdermal patch formulations are available. If safety and efficacy can be effectively monitored, no change in formulation or administration is required after bariatric surgery.

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.

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.

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 (Ref); after emptying bladder, administer directly into the bladder via catheter (Ref).

Transdermal: Apply to clean, dry, smooth (fold-free) intact 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. 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.

Use: Labeled Indications

Overactive bladder (urinary urgency with or without incontinence) (alternative agent): 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 of age (ER tablet only).

Use: Off-Label: Adult

Primary focal hyperhidrosis

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

OxyBUTYnin may be confused with oxyCODONE, OxyCONTIN, oxyMORphone

Ditropan may be confused with Detrol, diazePAM, Diprivan, dithranol

Older Adult: High-Risk Medication:

Beers Criteria: Oxybutynin is identified in the Beers Criteria as a potentially inappropriate medication in patients 65 years and older due to its strong anticholinergic properties (Beers Criteria [AGS 2023]).

Other safety concerns:

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

Metabolism/Transport Effects

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

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

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

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

Chlorprothixene: Anticholinergic Agents may enhance the anticholinergic effect of Chlorprothixene. Risk C: Monitor therapy

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

CloZAPine: Anticholinergic Agents may enhance the constipating effect of CloZAPine. Management: Consider alternatives to this combination whenever possible. If combined, monitor closely for signs and symptoms of gastrointestinal hypomotility and consider prophylactic laxative treatment. Risk D: Consider therapy modification

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. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form 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 X: Avoid combination

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

Rivastigmine: Anticholinergic Agents may diminish the therapeutic effect of Rivastigmine. Rivastigmine may diminish the therapeutic effect of Anticholinergic Agents. Management: Use of rivastigmine with an anticholinergic agent is not recommended unless clinically necessary. If the combination is necessary, monitor for reduced anticholinergic effects. Risk D: Consider therapy modification

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

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies.

Information related to the use of oxybutynin in pregnant patients treated for neurogenic bladder (Andretta 2019; Beghin 2016) or excessive sweating (Harley 2020) is limited.

Breastfeeding 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.

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.

Monitoring Parameters

Incontinence episodes, post-void residual urine volume at baseline and as clinically indicated thereafter (AUA [Lerner 2021]), anticholinergic reactions (eg, dry mouth, constipation, dizziness).

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

Pharmacokinetics (Adult Data Unless Noted)

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 alpha-1 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)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Apo-oxybutynin | Ditropan | Oxybutynin | Pms-oxybutynin;
  • (AR) Argentina: Delak | Ditropan | Ditropan ud | Oxi Q | Oxibutinina ferring | Oxibutinina Vannier | Oxitina | Oxyurin | Retebem | Retemicon | Soxsup | Urequin;
  • (AT) Austria: Detrusan | Ditropan | Oxybutynin | Oxybutynin hexal pharma;
  • (AU) Australia: Ditropan | Oxybutynin Sandoz | Oxytrol;
  • (BD) Bangladesh: Uricon;
  • (BE) Belgium: Ditropan | Driptane | Oxybutynin Ratiopharm | Oxybutynine bexal | Oxybutynine eurogenerics | Oxybutynine hcl merck-generics | Oxybutynine Sandoz;
  • (BR) Brazil: Cloridrato de Oxibutinina | Dry | Frenurin | Incontinol | Nourin | Retemic | Retemic UD;
  • (CH) Switzerland: Ditropan | Kentera;
  • (CI) Côte d'Ivoire: Xytinin;
  • (CL) Chile: Odranal | Oxiburin | Urazol | Uricont | Urocontinent;
  • (CN) China: Ao ning | Oxybutynin | Shuang miao | Yi jing;
  • (CO) Colombia: Delifon | Lyrinel | Mutum | Mutum cr | Oxibutin | Oxibutinina | Sinorin | Uropran;
  • (CZ) Czech Republic: Ditropan | Kentera | Uroxal;
  • (DE) Germany: Cystonorm | Dridase | Kentera | Oxyb | Oxybase | Oxybugamma | Oxybutin | Oxybuton | Oxybutynin | Oxybutynin al | Oxybutynin Billix | Oxybutynin hexal | Oxybutynin Maxmedic | Oxybutynin Ratiopharm | Oxybutyninhydrochlorid Sandoz | Oxymedin | Ryol | Spasyt;
  • (DO) Dominican Republic: Driptane | Reteven LP | Sutropan | Urginal | Urginal UD;
  • (EC) Ecuador: Mutum;
  • (EE) Estonia: Cystrin | Driptane;
  • (EG) Egypt: Detronin | Detrusan | Oxurate | Oxybin | Uripan;
  • (ES) Spain: Ditropan | Dresplan | Kentera;
  • (FI) Finland: Cystrin | Oksibutin sandoz | Oxybase | Oxybutynin generic | Oxybutynin mylan | Spasmoxyl;
  • (FR) France: Ditropan | Driptane | Oxybutynine | Oxybutynine accord | Oxybutynine g gam | Oxybutynine merck | Oxybutynine Ratiopharm | Oxybutynine Sandoz | Zatur;
  • (GB) United Kingdom: Contimin | Cystrin | Ditropan | Kentera | Lyrinel | Oxybutynin | Oxybutynin Accord | Oxybutynin arrow | Oxybutynin cox | Oxybutynin kent | Oxybutynin Sandoz | Promictuline | Urimin;
  • (GR) Greece: Ditropan | Lyrinel | Lyrinel XL;
  • (HK) Hong Kong: Apo-Oxybutynine | Pms-oxybutynin;
  • (HR) Croatia: Driptane;
  • (HU) Hungary: Ditropan | Huma-oxybutynin | Uroxal;
  • (IE) Ireland: Cystrin | Ditropan | Kentera | Lyrinel | Oxybutynin | Oxybutynin nicobrand | Renamel;
  • (IL) Israel: Lyrinel | Novitropan | Oxybutynin GM;
  • (IN) India: Cystran | Nocturin | Oxybutin | Oxylax | Oxyspas | Tropan;
  • (IQ) Iraq: Oxybutin;
  • (IT) Italy: Ditropan | Kentera | Lyrinel | Ossibutinina | Ossibutinina cloridrato mylan generics | Oxibutinina eg;
  • (JO) Jordan: Ditropan | Dreptageed;
  • (JP) Japan: Brocell | Cobapolas | Delaiv | Delaiv choseido | Esuomin | Fandeheede | Fandeheede yoshindo | Halarase | Halarase maruko | Halarase ohara | Harblasse | Herton | Inobase mita | Inobase tatumi | Letecrin | Lofreon | Neluos | Neoxy | Orivate sawai | Orivate yoshitomi | Oxybutynin HCL | Palnaxol | Pollakisu | Porabutin | Porabutin iwaki | Poratile | Postinin | Urgent | Volanta;
  • (KE) Kenya: Oxinus;
  • (KR) Korea, Republic of: Cystrin | Ditropan | Lailinel oros | Obutin | Obutine | Oksitin | Oxybutin | Oxynin | Oyrobin | Urinin | Urotinin | Utinin;
  • (KW) Kuwait: Apo-oxybutynin | Uripan;
  • (LB) Lebanon: Ditropan | Driptane;
  • (LT) Lithuania: Cystrin | Driptane | Lyrinel | Novitropan | Oxybutynin Accord | Oxybutynine Mylan;
  • (LU) Luxembourg: Ditropan;
  • (LV) Latvia: Cystrin | Driptane | Novitropan | Oxybutynin hydrochloride accord;
  • (MA) Morocco: Ditropan | Oxybut | Urosta;
  • (MX) Mexico: Inprax | Lyrinel | Nefryl | Tavor | Tavor cr;
  • (MY) Malaysia: Driptane | Voxytane;
  • (NL) Netherlands: Dridase | Kentera | Oxybutynine HCl | Oxybutynine Hcl A | Oxybutynine hcl cf | Oxybutynine Hcl Katwijk | Oxybutynine Hcl Merck | Oxybutynine Hcl PCH | Oxybutynine Hcl Sandoz | Oxybutynine hcl unichem;
  • (NO) Norway: Dridase | Kentera | Lyrinel XL | Oxybutynine biogaran;
  • (NZ) New Zealand: Apo-oxybutynin | Oxybutynin | Oxytrol;
  • (PE) Peru: Oxibutinina clorhidrato | Reteven | Socliden | Uricont | Uritina | Uroxivan;
  • (PH) Philippines: Driptane | Lyrinel;
  • (PK) Pakistan: Butyn | Cystrin | Oxitrin | Taivor;
  • (PL) Poland: Cystrin | Ditropan | Driptane | Kentera | Oxybutynin hydrochloride accord | Uralex;
  • (PR) Puerto Rico: Ditropan | Gelnique | Oxybutynin | Oxybutynin chloride | Oxybutynin chloride er | Oxytrol | Oxytrol for women;
  • (PT) Portugal: Ditropan | Oxibutinina;
  • (PY) Paraguay: Socliden | Uroflax | Uroflax cr;
  • (RO) Romania: Ditropan | Driptane;
  • (RU) Russian Federation: Driptane | Novitropan;
  • (SA) Saudi Arabia: Apo-oxybutynin | Ditropan | Pms-oxybutynin;
  • (SE) Sweden: Ditropan | Kentera | Oxybase | Oxybutinin accord | Oxybutynin 2care4 | Oxybutynin ebb | Oxybutynin mylan | Oxybutynin Stada;
  • (SG) Singapore: Obutin;
  • (SI) Slovenia: Ditropan;
  • (SK) Slovakia: Ditropan | Eurin | Kentera | Uroxal;
  • (TH) Thailand: Diatropan | Diutropan | Lyrinel;
  • (TN) Tunisia: Ditropan | Driptane | Oxybtan;
  • (TR) Turkey: Kentera | Uropan;
  • (TW) Taiwan: Benlate | Blasec | Clonice | Ditropan | Newin | Oablok | Oubile | Oxbu | Oxipan | Oxyban | Oxybutynin | Oxypan | Oxytynin | Par Yih | Pintylin | Repinin | Urocon | Uronin;
  • (UA) Ukraine: Dream | Drimtan-Apo | Driptan | Sibutin;
  • (UY) Uruguay: Ditropan ud | Gradual | Incontin | Oxotine | Retebem | Socliden;
  • (VE) Venezuela, Bolivarian Republic of: Reteven;
  • (ZA) South Africa: Ditropan | Lenditro | Lyrinel | Merck-oxybutynin | Micro-Oxybutynin | Oxyrest | Oxyspas | Rolab-oxybutynin | Urihexal
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