oxybutynin (Rx)

Brand and Other Names:Ditropan XL
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 5mg

tablet, extended-release

  • 5mg
  • 10mg
  • 15mg

syrup

  • 5mg/5mL
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Overactive Bladder

Relief of symptoms (eg, urge incontinence, frequency, urgency) in patients with uninhibited neurogenic or reflex neurogenic bladder

Immediate-release: 5 mg PO twice/three times daily; not to exceed 5 mg PO four times daily

Extended-release: 5-10 mg/day PO; may be increased by 5 mg/day at weekly intervals; not to exceed 30 mg/day

Dose Modifications

Renal Impairment

  • Not studied; use caution

Hepatic Impairment

  • Not studied; use caution

Dosage Forms & Strengths

tablet

  • 5mg

tablet, extended-release

  • 5mg
  • 10mg
  • 15mg

syrup

  • 5mg/5mL
more...

Detrusor Overactivity

Bladder overactivity associated with a neurologic condition (eg, spina bifida)

≥5 years (immediate-release): 5 mg PO q12hr; may be increased to 5 mg PO q8hr

≥6 years (extended-release): 5 mg/day PO initially; may be increased by 5 mg/day at weekly intervals; not to exceed 20 mg/day

Overactive Bladder

Relief of symptoms (eg, urge incontinence, frequency, urgency) in patients with uninhibited neurogenic or reflex neurogenic bladder

Immediate-release: Initiate at lower dosage in frail elderly; 2.5 mg PO q8-12hr initially; may be increased to 5 mg q8-12hr if warranted

Extended-release: 5-10 mg PO qDay; pharmacokinetics similar to adults in elderly up to age 78 yr

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Interactions

Interaction Checker

and oxybutynin

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Dry mouth (21-71%)

            Constipation (7-15%)

            Somnolence (2-14%)

            Nausea (2-12%)

            1-10%

            Asthenia (6-10%)

            Dizziness (6-10%)

            Headache (6-10%)

            Blurred vision (6-10%)

            Dry eyes (6-10%)

            Diarrhea (6-10%)

            Nausea (6-10%)

            Pain (6-10%)

            Rhinitis (6-10%)

            <1%

            Anorexia

            Fluid retention

            Hot flush

            Dysphonia

            Dysphagia

            Frequent bowel movements

            Chest discomfort

            Thirst

            Frequency Not Defined

            Cycloplegia

            Impairment of mental alertness

            Memory impairment

            Mydriasis

            Tachycardia

            QT prolongation

            Postmarketing reports

            Hallucinations

            Confusion

            Delirium

            Urinary tract infection

            Palpitations

            Nasal congestion

            Hypertension

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            Warnings

            Contraindications

            Hypersensitivity

            Gastric or urinary obstruction or retention, paralytic ileus, severe ulcerative colitis

            Uncontrolled narrow-angle glaucoma

            Relative contraindications: Myasthenia gravis, tachycardia secondary to cardiac insufficiency or thyrotoxicosis

            Cautions

            Caution in controlled angle-closure glaucoma; mild-to-moderate ulcerative colitis, hyperthyroidism; partial obstructive uropathy; benign prostatic hyperplasia

            Caution in hepatic or renal impairment

            May increase risk of heat prostration during hot weather

            May cause memory loss

            Angioedema necessitating hospitalization and emergency medical treatment has occurred with first or subsequent doses of oral oxybutynin; if angioedema develops, oxybutynin-containing products should be discontinued and appropriate therapy promptly provided

            Caution with gastrointestinal obstructive disorders or decreased intestinal motility because of the risk of gastric retention

            May aggravate symptoms of decreased gastrointestinal motility in patients with autonomic neuropathy

            Caution with GERD and/or those taking drugs that can cause or exacerbate esophagitis (eg, bisphosphonates)

            Caution with myasthenia gravis because of decreased cholinergic activity

            Caution with other anticholinergics (antimuscarinics); may increase risk for xerostomia, constipation, headache, dizziness, and blurred vision

            Somnolence reported with oxybutynin-containing products; use caution with activities requiring mental alertness

            May aggravate Parkinson disease symptoms

            Hallucinations or confusion may occur; monitor

            May exacerbate symptoms of heart failure, hypertension, and/or cardiac arrhythmias; use with caution

            May aggravate symptoms of dementia in patients cholinesterase inhibitors; use with caution

            Use with caution in patients with hiatal hernia

            The use of the extended release formulation has been associated (rare) with symptoms of obstruction in patients with known stricture/narrowing of the GI tract

            Before using over the counter product, consider other causes of frequent urination, including early pregnancy, diabetes, and other serious conditions; contact healthcare provider if symptoms do not improve with 2 weeks of initial use

            Avoid use in patients with myasthenia gravis because of decreased cholinergic activity; if experiencing exacerbation of symptoms of myasthenia gravis, oxybutynin-containing product should be discontinued and appropriate therapy promptly provided

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            Pregnancy & Lactation

            Pregnancy

            There are no studies with topical or oral oxybutynin use in pregnant women to inform a drug associated risk for birth defects or miscarriage; no adverse developmental outcomes observed in animal reproduction studies when administered to pregnant rats and rabbits during organogenesis at approximately 50 and 1 times, respectively, the maximum human dose based on body surface area

            Lactation

            There is no information on presence of drug in human milk, effects on breastfed child, or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from the underlying maternal condition

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Exerts antispasmodic and antimuscarinic effects on smooth muscle; delays desire to void, increases bladder capacity, and decreases uninhibited contraction; decreases frequency and urgency

            Absorption

            Bioavailability: 6% (~1.5-2 times higher for extended-release)

            Onset: 30-60 min

            Peak effect: 3-6 hr

            Duration: 6-10 hr

            Peak plasma time: <1 hr (immediate-release); 12 hr (extended release)

            Peak plasma concentration: Immediate-release, 3.6 ng/mL (R-) and 7.8 ng/mL (S-); extended-release, 1 ng/mL (R-) and 1.8 ng/mL (S-)

            Distribution

            Vd: 193 L

            Metabolism

            Metabolized in liver and gut by CYP3A4; converted to active metabolite N-desethyloxybutynin (DEO) by GI metabolic pathways, which are bypassed in transdermal delivery, resulting in lower DEO ratio

            Metabolites: DEO (active)

            Elimination

            Half-life: 2-3 hr (immediate-release); 12-13 hr (extended-release)

            Excretion: Urine

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.