Solifenacin Succinate

What it is and how it works

Mechanism of Action Solifenacin is a competitive muscarinic receptor antagonist. Muscarinic receptors play an important role in several major cholinergically mediated functions, including contractions of urinary bladder smooth muscle.

Indications

Solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin succinate tablets are a muscarinic antagonist indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency .

Dosage and administration (summary)

• 5 mg tablet taken orally once daily, and if well tolerated may be increased to 10 mg once daily . • Do not exceed the 5 mg dose of solifenacin succinate tablets in patients with: • Severe renal impairment creatinine clearance <30 mL/min/1.73 m 2 ( 2.2 , 8.6 ). • Moderate hepatic impairment (Child-Pugh B). Solifenacin succinate tablets are not recommended in patients with severe hepatic impairment (Child- Pugh C) ( 2.3 , 8.7 ). • Concomitant use of strong CYP3A4 inhibitors ( 2.4 , 7.1 ). Dosing Information The recommended oral dose of solifenacin succinate tablets is 5 mg once daily. If the 5 mg dose is well tolerated, the dose may be increased to 10 mg once daily.

Contraindications

Solifenacin succinate tablets are contraindicated in patients: • With urinary retention [ see Warnings and Precautions ], • With gastric retention [ see Warnings and Precautions ], • With uncontrolled narrow-angle glaucoma [ see Warnings and Precautions ], and • Who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in solifenacin succinate tablets. Reported adverse reactions have included anaphylaxis and angioedema [ see Adverse Reactions ].

Warnings and precautions

• Angioedema and Anaphylactic Reactions : Promptly discontinue solifenacin succinate and provide appropriate therapy • Urinary Retention : Solifenacin succinate is not recommended for use in patients with clinically significant bladder outlet obstruction . • Gastrointestinal Disorders : Solifenacin succinate is not recommended for use in patients with decreased gastrointestinal motility . • Central Nervous System Effects : Somnolence has been reported with solifenacin succinate . Advise patients not to drive or operate heavy machinery until they know how solifenacin succinate affects them .

Pregnancy

Pregnancy Risk Summary There are no studies with the use of solifenacin succinate in pregnant women to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes.

Storage and supply

Solifenacin Succinate Tablets are supplied as round, biconvex, film-coated tablets, available in bottles and unit-dose blister packages as follows: Each 5 mg tablet is yellow colored and debossed with ‘G’ on one side and ‘51’ on the other side and is available as follows: Bottle of 30 with child-resistant closure, NDC 68462-386-30 Bottle of 90 with…

Source: Solifenacin Succinate (Solifenacin Succinate) — US FDA prescribing information, 2026-01-28, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.