| SOLIFENACIN SUCCINATE
Classifications: anticholinergic; antimuscarinic; antispasmodic; Therapeutic: antispasmodic
Pregnancy Category: C
5 mg, 10 mg tablets
Solifenacin is a selective muscarinic antagonist that depresses both voluntary and involuntary bladder contractions caused
by detrusor overactivity.
Solifenacin improves the volume of urine per void and reduces the frequency of incontinent and urgency episodes.
Treatment of overactive bladder (OAB) with symptoms of urinary incontinence, urgency, and frequency.
Hypersensitivity to solifenacin or any component of its formulations; severe hepatic impairment; gastric retention; uncontrolled
narrow-angle glaucoma; urinary retention; toxic megacolon; GI obstruction; ileus; GERD; pregnancy (category C), lactation.
Bladder outflow obstruction; concurrent use of ketoconazole or other potent CYP3A4 inhibitors; obstructive disorders; decreased
GI motility; hepatic impairment; history of QT prolongation or concurrent use of medications known to prolong the QT interval;
controlled narrow-angle glaucoma; renal impairment; renal disease; renal failure; mild to moderate hepatic impairment; older
Route & Dosage
Adult: PO 5 mg once daily; may be increased to 10 mg once daily if tolerated (max of 5 mg/d if taking drugs that inhibit CYP3A4see
If moderate hepatic impairment, does not exceed 5 mg/d. If severe hepatic impairment, do not use.
Clcr <30 mL/min: max dose 5 mg/d
- Tablets should be swallowed whole.
- Store at 1530° C (5986° F).
Adverse Effects (≥1%)Body as a Whole:
Hypertension. GI: Dry mouth, constipation ,
nausea, vomiting, dyspepsia, upper abdominal pain. Respiratory:
Cough. Special Senses:
Blurred vision, dry eyes. Urogenital:
Urinary tract infection, urinary retention.
InteractionsDrug: cyp3a4 inhibitors
(e.g., clarithromycin, delavirdine, diltiazem, efavirenz, erythromycin, fluconazole, fluvoxamine, itraconazole, nefazodone, norfloxacin,
omeprazole, protease inhibitors
, quinine, verapamil, troleandomycin, voriconazole, zafirlukast
) may increase levels and toxicity (max dose 5 mg/d); amantadine, amoxapine, bupropion, clozapine, cyclobenzaprine, diphenhydramine, disopyramide, maprotiline, olanzapine, orphenadrine, phenothiazines, tricyclic antidepressants
have additive anticholinergic adverse effects. Food: Grapefruit juice
may increase solifenacin levels and toxicity.
90% absorbed from GI tract. Peak:
38 h. Metabolism:
Extensively metabolized in the liver by CYP3A4. Elimination:
Primarily in urine, 22% in feces. Half-Life:
Assessment & Drug Effects
- Monitor ECG in patients with a known history of QT prolongation or patients taking medications that prolong the QT interval.
Patient & Family Education
- Stop taking this drug and report to physician if urinary retention occurs.
- Report promptly any of the following: blurred vision or difficulty focusing vision, palpitations, confusion, or severe dizziness.
- Report to physician problems with bowel elimination, especially constipation lasting ≥3
- Exercise caution in hot environments, as the risk of heat prostration increases with this drug.