Antimuscarinic (M3-selective) Pregnancy: No clinical data are available from women who became pregnant while taking solifenacin; animal studies do not indicate direct harmful effects but the potential risk for humans is unknown — caution should be exercised when prescribing to pregnant women. Breastfeeding: no human milk data; in mice solifenacin and/or its metabolites were excreted in milk and caused dose-dependent failure to thrive in neonatal mice, so use should be avoided during breastfeeding.

Solifenacin succinate

Brand names: Vesicare

Solifenacin succinate is an oral antimuscarinic used to treat the symptoms of overactive bladder, including urinary urgency, frequency and urge incontinence.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 5 mg solifenacin succinate once daily; if needed the dose may be increased to 10 mg once daily

Route: Oral — swallow whole with liquids; may be taken with or without food

Frequency: Once daily

Max: 10 mg once daily (limited to 5 mg once daily in severe renal impairment, moderate hepatic impairment, or with a potent CYP3A4 inhibitor)

The same regimen applies to adults including the elderly. The maximum effect of solifenacin can be determined after 4 weeks at the earliest (§4.4). Dose caps: no more than 5 mg once daily in patients with severe renal impairment (creatinine clearance ≤30 mL/min) or moderate hepatic impairment (Child-Pugh score 7 to 9); the maximum dose should be limited to 5 mg when given simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4 inhibitors (e.g. ritonavir, nelfinavir, itraconazole). No dose adjustment is necessary for mild to moderate renal impairment (creatinine clearance >30 mL/min) or mild hepatic impairment. Paediatric population: safety and efficacy in children have not yet been established — solifenacin should not be used in children. An interval of approximately one week should be allowed after stopping solifenacin before commencing other anticholinergic therapy. Source: UK SPC for Solifenacin 10 mg film-coated tablets (eMC product 10428); §4.5 was truncated at the source-fetch limit. US labelling (Glenmark, 2026-01-28) states the same 5 mg once daily starting dose increasing to 10 mg once daily.

Dose adjustments

Renal

No dose adjustment is necessary for mild to moderate renal impairment (creatinine clearance >30 mL/min). Patients with severe renal impairment (creatinine clearance ≤30 mL/min) should be treated with caution and receive no more than 5 mg once daily. Contraindicated in patients undergoing haemodialysis, and in severe renal impairment when combined with a potent CYP3A4 inhibitor.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Urinary retention
Severe gastrointestinal condition (including toxic megacolon)
Myasthenia gravis
Narrow-angle glaucoma — and patients at risk for any of these conditions
Hypersensitivity to the active substance or to any of the excipients
Patients undergoing haemodialysis
Severe hepatic impairment
Severe renal impairment or moderate hepatic impairment in patients on treatment with a potent CYP3A4 inhibitor (e.g. ketoconazole)

Side effects

Dry mouth (very common — 11% at 5 mg once daily and 22% at 10 mg once daily, versus 4% on placebo)
Constipation (common)
Nausea, dyspepsia and abdominal pain (common)
Blurred vision (common) and dry eyes (uncommon)
Urinary tract infection (common); difficulty in micturition (uncommon) and urinary retention (rare)

Interactions

Potent CYP3A4 inhibitors (ketoconazole, ritonavir, nelfinavir, itraconazole) — increase solifenacin exposure; limit the maximum dose to 5 mg once daily (§4.2/§4.5)
Other medicinal products with anticholinergic properties — may result in more pronounced therapeutic effects and undesirable effects; allow approximately one week after stopping solifenacin before starting other anticholinergic therapy
Cholinergic receptor agonists — may reduce the therapeutic effect of solifenacin
Medicinal products that stimulate gastrointestinal motility, such as metoclopramide and cisapride — solifenacin can reduce their effect
Drugs and conditions predisposing to QT prolongation (e.g. pre-existing long QT syndrome, hypokalaemia) — QT prolongation and Torsade de Pointes have been observed (§4.4)

Clinical monograph

How it works

It is a competitive antagonist at muscarinic (predominantly M3) receptors in the detrusor smooth muscle, reducing involuntary bladder contractions and increasing functional bladder capacity.

Prescribing in practice

Contraindicated in urinary retention, significant gastric outflow obstruction, untreated narrow-angle glaucoma and myasthenia gravis; use cautiously where these risks exist.
Antimuscarinic load is additive with other anticholinergic drugs, raising the risk of confusion and falls particularly in frail and elderly patients.
Dose reduction is advised in severe renal impairment and moderate hepatic impairment, and with potent CYP3A4 inhibitors.

Monitoring

Review symptom response and antimuscarinic side effects after a few weeks and assess cumulative anticholinergic burden, especially in older people.

Counselling the patient

Dry mouth, constipation and blurred vision are common; report difficulty passing urine.
Swallow tablets whole and report severe abdominal pain or marked constipation.

Evidence & guidelines

NICE guidance positions antimuscarinics such as solifenacin as a core pharmacological option for overactive bladder when conservative measures are insufficient.

Reference: NICE NG123; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Drugs

Darifenacin · Antimuscarinic (M3-selective)

Pathways