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Selective M3 muscarinic receptor antagonist Pregnancy: No clinical data in women who became pregnant while taking solifenacin; potential risk for humans unknown — caution should be exercised when prescribing to pregnant women. Use should be avoided during breastfeeding.

Solifenacin

Brand names: Vesicare

Solifenacin is an antimuscarinic used for the symptoms of overactive bladder (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
Route: Oral (swallow whole with liquid; with or without food)
Frequency: Once daily
Max: 10 mg once daily (5 mg once daily in severe renal impairment, moderate hepatic impairment, or with potent CYP3A4 inhibitors)
§4.2: adults including the elderly — recommended dose 5 mg once daily; if needed the dose may be increased to 10 mg once daily. Paediatric: safety and efficacy in children have not been established, so solifenacin should not be used in children (no per-kg regimen stated — paedDose null). Hepatic impairment: no adjustment in mild impairment; moderate impairment (Child-Pugh 7–9) treat with caution and give no more than 5 mg once daily; severe hepatic impairment is contraindicated. Potent CYP3A4 inhibitors: limit the maximum dose to 5 mg when given with ketoconazole or therapeutic doses of other potent CYP3A4 inhibitors (e.g. ritonavir, nelfinavir, itraconazole). §4.4: the maximum effect can be determined after 4 weeks at the earliest.

Dose adjustments

Renal

No dose adjustment for mild to moderate renal impairment (creatinine clearance > 30 ml/min). Severe renal impairment (creatinine clearance ≤ 30 ml/min): treat with caution and give no more than 5 mg once daily. Contraindicated in patients undergoing haemodialysis.

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.

US labelling (FDA)

Reference — US labelling, may differ from UK

• 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 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 ). 2.1 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. Solifenacin …

Source: US FDA prescribing information (openFDA / DailyMed), label dated 2026-01-28. Accessed 2026-06-12. US dosing and indications can differ from UK practice — use UK sources for prescribing decisions.

Contraindications

  • Urinary retention
  • Severe gastrointestinal condition (including toxic megacolon)
  • Myasthenia gravis
  • Narrow angle glaucoma — and patients at risk for 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 treated with a potent CYP3A4 inhibitor (e.g. ketoconazole)

Side effects

  • Dry mouth (very common; 11% at 5 mg, 22% at 10 mg)
  • Constipation
  • Nausea, dyspepsia and abdominal pain
  • Blurred vision
  • Urinary tract infection
  • Somnolence and dry eyes

Interactions

  • Other medicinal products with anticholinergic properties — more pronounced therapeutic and undesirable effects; allow about one week after stopping solifenacin before starting other anticholinergic therapy
  • Cholinergic receptor agonists — may reduce the therapeutic effect of solifenacin
  • Metoclopramide and cisapride — solifenacin can reduce the effect of medicines that stimulate GI motility
  • Potent CYP3A4 inhibitors (ketoconazole, ritonavir, nelfinavir, itraconazole) — limit solifenacin to a maximum of 5 mg once daily

Clinical monograph

How it works

It blocks muscarinic (mainly M3) receptors in the bladder, reducing detrusor overactivity.

Prescribing in practice

  • Antimuscarinic effects (dry mouth, constipation, blurred vision, and — importantly in older people — confusion and falls) limit it; weigh the overall anticholinergic burden.
  • Avoid in narrow-angle glaucoma, significant urinary retention or gastrointestinal obstruction.
  • It can prolong the QT interval.

Monitoring

Review symptom benefit and anticholinergic adverse effects, particularly cognition in older patients.

Counselling the patient

  • Dry mouth and constipation are common.
  • Report difficulty passing urine or new confusion.
  • It may take a few weeks for full benefit.

Evidence & guidelines

An antimuscarinic option for overactive bladder (NICE NG123), mindful of anticholinergic burden in older people.

Reference: NICE NG123; EAU Incontinence Guidelines; 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).

Related

Curated clinical cross-links plus same-class fallbacks.

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