Dosing & Uses
Dosage Forms & Strengths
Indicated for overactive bladder with urge incontinence, urgency, and frequency
4 mg/day PO; may increase to 8 mg/day
Renal Impairment, severe (CrCl <30 mL/min): do not exceed dose >4 mg/day
Coadministration with potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, clarithromycin): Not to exceed 4 mg/day
CrCl <30 mL/min: Not to exceed dose 4 mg/day
CrCl≥30 mL/min: Dose adjustment not necessary
Mild to mederate: Dose adjustment not necessary
Severe hepatic impairment (Child-Pugh C): Not recommended
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Dry mouth (18-34%)
Abdominal pain (1%)
Urinary retention (1%)
Upper respiratory tract infection (2-3%)
Dry throat (1-2%)
General disorders and administrative site conditions: Hypersensitivity reactions, including angioedema with airway obstruction, face edema
Central nervous system disorders: Dizziness, headache, somnolence
Skin and subcutaneous tissue disorders: Urticaria, pruritus
Hypersensitivity to drug or ingredients
Urinary or gastric retention
Uncontrolled narrow-angle glaucoma
Concomitant strong CYP3A4 inhibitors: Not to exceed 4 mg/day recommended; if coadministered with weak/moderate inhibitors, may increase to 8 mg/day carefully
Controlled narrow-angle glaucoma, bladder outflow obstruction, GI obstruction, reduced hepatic/renal function, and autonomic neuropathy
Angioedema of the face, lips, tongue, and/or larynx reported; in some cases angioedema occurred after the first dose
Anticholinergic CNS effects (eg, headache, dizziness, somnolence) reported; advise patients not to drive or operate heavy machinery until they adjust to therapy
Caution with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction, bladder flow obstruction
Heat prostration may occur in the presence of increased environmental temperature
Pregnancy & Lactation
Pregnancy Category: C
Lactation: Not known wehther excreted in breast milk; not recommended
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.
Mechanism of Action
Competitive muscarinic receptor antagonist; inhibition of receptors in the bladder prevent symptoms of urgency and frequency
Protein Bound: 50%
Vd: 169 L (5-HMT active metabolite)
Rapidly hydrolyzed to active metabolite, and THEN by liver CYP3A4 and CYP2D6 to inactive metabolites
Half-Life: 7 hr
Excretion: Urine (70%); feces (7%)
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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.
|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.|
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Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.