Solifenacin is a cholinergic muscarinic antagonist sold in the U.S. under 3 brand and generic names, for overactive urinary bladder and urge urinary incontinence. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Vesicare (application NDA021518). Other solifenacin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
5 mg tablet taken orally once daily, and if well tolerated may be increased to 10 mg once daily. ( 2.1 ) • Do not exceed the 5 mg dose of VESIcare in patients with: o Severe renal impairment creatinine clearance < 30 mL/min/1.73 m 2 . ( 2.2 , 8.6 ) o Moderate hepatic impairment (Child-Pugh B). VESIcare is not recommended in patients with severe hepatic impairment (Child-Pugh C). ( 2.3 , 8.7 ) o Concomitant use of strong CYP3A4 inhibitors. ( 2.4 , 7.1 ) 2.1 Dosing Information The recommended oral dose of VESIcare is 5 mg once daily. If the 5 mg dose is well tolerated, the dose may be increased to 10 mg once daily. VESIcare should be taken with water and swallowed whole. VESIcare can be administered with or without food. 2.2 Dosing Recommendations in Patients with Renal Impairment Do not exceed 5 mg once daily in patients with severe renal impairment (CL cr < 30 mL/min/1.73 m 2 ) [see Use in Specific Populations ( 8.6 )] . 2.3 Dosing Recommendations in Patients with Hepatic Impairment Do not exceed 5 mg once daily in patients with moderate hepatic impairment (Child-Pugh B). Do not use VESIcare in patients with severe hepatic impairment (Child-Pugh C) [see Use in Specific Populations ( 8.7 )] . 2.4 Dosing Recommendations in Patients Taking CYP3A4 Inhibitors Do not exceed 5 mg once daily when VESIcare is administered with strong CYP3A4 inhibitors such…
The most common adverse reactions (> 4% in VESIcare-treated patients and > placebo-treated patients) were dry mouth and constipation at both 5 mg and 10 mg doses; and urinary tract infection and blurred vision at the 10 mg dose. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. at 1-800-727-7003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, 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 practice. VESIcare has been evaluated for safety in 1811 adult patients in four randomized, placebo-controlled trials (Studies 1-4) [see Clinical Studies ( 14 )] . Expected adverse reactions of antimuscarinic agents are dry mouth, constipation, blurred vision (accommodation abnormalities), urinary retention, and dry eyes. The incidence of dry mouth and constipation in patients treated with VESIcare was higher in the 10 mg dose group compared to the 5 mg dose group. In the four 12-week double-blind clinical trials, severe fecal impaction, colonic obstruction, and intestinal obstruction were reported in one patient each, all in the VESIcare 10 mg group. Angioneurotic edema was reported in one patient taking VESIcare 5 mg.…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Tablet | Generic | $5 | View → | |
| 2 | 72/100 | Prescription | Suspension | Generic |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| AP28 | 5 mg | yellow | round | — |
| U;329 | 10 mg | pink | round | — |
| AP29 | 10 mg | yellow | round | — |
| G;51 | 5 mg | yellow | round | — |
| 150 | 5 mg | yellow | round | — |
| 151 | 10 mg | pink |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Icare is contraindicated in patients: • With urinary retention [see Warnings and Precautions ( 5.2 )] , • With gastric retention [see Warnings and Precautions ( 5.3 )] , • With uncontrolled narrow-angle glaucoma [see Warnings and Precautions ( 5.5 )] , and • Who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in VESIcare. Reported adverse reactions have included anaphylaxis and angioedema [see Adverse Reactions ( 6.2 )] . • Urinary retention. ( 4 , 5.2 ) • Gastric retention. ( 4 , 5.3 ) • Uncontrolled narrow-angle glaucoma. ( 4 , 5.5 ) • Hypersensitivity to this product or any of its components. ( 4 , 5.1 , 6.2 )
Inhibitors : Do not exceed the 5 mg dose of VESIcare with concomitant use of strong CYP3A4 inhibitors. ( 7.1 ) 7.1 Strong CYP3A4 Inhibitors Solifenacin is a substrate of CYP3A4. Concomitant use of ketoconazole, a strong CYP3A4 inhibitor, significantly increased the exposure of solifenacin [see Clinical Pharmacology ( 12.3 )] . The dosage of VESIcare greater than 5 mg once daily is not recommended when concomitantly used with strong CYP3A4 inhibitors [see Dosage and Administration ( 2.4 )] .
| $5 |
| View → |
| 3 | 70/100 | Prescription | Tablet | Generic | $5 | View → |
| round |
| — |
| G;52 | 10 mg | pink | round | — |
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