Oxybutynin (oral)

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Oxybutynin (oral)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

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Black Box Warning

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Overview

Oxybutynin (oral) is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • DITROPAN XL® (oxybutynin chloride) is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
  • DITROPAN XL® is also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).

Dosage

  • The recommended starting dose of DITROPAN XL® is 5 or 10 mg once daily at approximately the same time each day. Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 30 mg/day). In general, dosage adjustment may proceed at approximately weekly intervals.

DOSAGE FORMS AND STRENGTHS

  • DITROPAN XL® extended-release tablets are available as 5, 10 and 15 mg tablets for oral use:
  • 5 mg: Pale yellow, round, tablet with "5 XL" printed on one side with black ink.
  • 10 mg: Pink, round, tablet with "10 XL" printed on one side with black ink.
  • 15 mg: Gray, round, tablet with "15 XL" printed on one side with black ink.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Oxybutynin (oral) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Oxybutynin (oral) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Oxybutynin (oral) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Oxybutynin (oral) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Oxybutynin (oral) in pediatric patients.

Contraindications

  • DITROPAN XL® is contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma.

Warnings

ConditionName:
See full prescribing information for complete Boxed Warning.
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  • Content

Angioedema

  • Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. In some cases, angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, oxybutynin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.

Central Nervous System Effects

  • Oxybutynin is associated with anticholinergic central nervous system (CNS) effects. A variety of CNS anticholinergic effects have been reported, including hallucinations, agitation, confusion and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly in the first few months after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how DITROPAN XL® affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.
  • DITROPAN XL® should be used with caution in patients with preexisting dementia treated with cholinesterase inhibitors due to the risk of aggravation of symptoms.
  • DITROPAN XL® should be used with caution in patients with Parkinson's disease due to the risk of aggravation of symptoms.

Worsening of Symptoms of Myasthenia Gravis

  • DITROPAN XL® should be used with caution in patients with myasthenia gravis due to the risk of aggravation of symptoms.

Worsening of Symptoms of Decreased Gastrointestinal Motility in Patients with Autonomic Neuropathy

  • DITROPAN XL® should be used with caution in patients with autonomic neuropathy due to the risk of aggravation of symptoms of decreased gastrointestinal motility.

Urinary Retention

  • DITROPAN XL® should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.

Gastrointestinal Adverse Reactions

  • DITROPAN XL® should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention.
  • DITROPAN XL®, like other anticholinergic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis and intestinal atony.
  • DITROPAN XL® should be used with caution in patients who have gastroesophageal reflux and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis.
  • As with any other nondeformable material, caution should be used when administering DITROPAN XL® to patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic). There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of other drugs in nondeformable controlled-release formulations.

Adverse Reactions

Clinical Trials Experience

  • Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
  • The safety and efficacy of DITROPAN XL® (5 to 30 mg/day) was evaluated in 774 adult subjects who participated in five double-blind, controlled clinical trials. In four of the five studies, Ditropan IR (5 to 20 mg/day in 199 subjects) was an active comparator. Adverse reactions reported by ≥ 1% of subjects are shown in Table 1.
This image is provided by the National Library of Medicine.
  • The discontinuation rate due to adverse reactions was 4.4% with DITROPAN XL® compared to 0% with Ditropan IR. The most frequent adverse reaction causing discontinuation of study medication was dry mouth (0.7%).
  • The following adverse reactions were reported by <1% of DITROPAN XL®-treated patients and at a higher incidence than placebo in clinical trials:
  • Respiratory, thoracic and mediastinal disorders: dysphonia;
  • Gastrointestinal Disorders: dysphagia, frequent bowel movements;

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Oxybutynin (oral) in the drug label.

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Drug Interactions

There is limited information regarding Oxybutynin (oral) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Oxybutynin (oral) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Oxybutynin (oral) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Oxybutynin (oral) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Oxybutynin (oral) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Oxybutynin (oral) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Oxybutynin (oral) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Oxybutynin (oral) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Oxybutynin (oral) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Oxybutynin (oral) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Oxybutynin (oral) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Oxybutynin (oral) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Oxybutynin (oral) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral

Monitoring

There is limited information regarding Monitoring of Oxybutynin (oral) in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Oxybutynin (oral) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Oxybutynin (oral) in the drug label.

Pharmacology

There is limited information regarding Oxybutynin (oral) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Oxybutynin (oral)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Oxybutynin (oral) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Oxybutynin (oral) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Oxybutynin (oral) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Oxybutynin (oral) in the drug label.

How Supplied

Storage

There is limited information regarding Oxybutynin (oral) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Oxybutynin (oral) in the drug label.

Precautions with Alcohol

  • Alcohol-Oxybutynin (oral) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • DITROPAN XL®[1]

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ "oxybutynin chloride tablet, extended release".
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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