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Pharmacologic class: Anticholinergic
Therapeutic class: Renal and genitourinary agent
Pregnancy risk category C
Antagonizes muscarinic receptors, reducing urinary bladder smooth-muscle contractions
Tablets: 5 mg, 10 mg
Indications and dosages
➣ Overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency
Adults: 5 mg P.O. daily initially; may increase to 10 mg P.O. daily if well tolerated
• Moderate hepatic impairment
• Severe renal impairment
• Concurrent use of potent CYP3A4 inhibitors (such as ketoconazole)
• Hypersensitivity to drug or its components
• Urinary retention
• Gastric retention
• Uncontrolled angle-closure glaucoma
Use cautiously in:
• hepatic or renal impairment, bladder outflow obstruction, decreased GI motility, GI obstructive disorder, controlled angle-closure glaucoma, congenital or acquired QT interval prolongation
• increased risk of urinary retention or heat prostration
• pregnant or breastfeeding patients
• children (safety and efficacy not established).
• Give with liquids, with or without food. Make sure patient swallows tablet whole.
CNS: dizziness, depression, fatigue, asthenia
EENT: dry eyes, blurred vision, dry throat, pharyngitis
GI: nausea, vomiting, constipation, upper abdominal pain, dyspepsia, dry mouth
GU: urinary tract infection, urinary retention
Skin: dry skin, rash, pruritus
Other: influenza, leg or foot edema
Drug-drug. Anticholinergics: increased frequency or severity of adverse reactions
CYP3A4 inhibitors (such as ketoconazole): increased solifenacin blood level
• Monitor GI, renal, and hepatic function frequently.
• Monitor patient for ophthalmic disorders, especially angle-closure glaucoma. If present, stop drug until condition stabilizes.
• Instruct patient to take drug with liquids, with or without food, and to swallow tablet whole.
• Advise patient to contact prescriber if severe abdominal pain or constipation lasting 3 or more days occurs.
• Caution patient to avoid driving and other hazardous activities until drug effects are known.
• Advise patient of risk for heat prostration; describe symptoms.
• Instruct patient to consult prescriber before taking over-the-counter products such as antihistamines because these may increase risk of side effects.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs mentioned above.