Schedule H

Oral

• Tablets: 5 mg, 10 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

Overactive Bladder (OAB) — Urge Urinary Incontinence, Urgency, and Frequency

Parameter Details

Starting dose 5 mg orally once daily

Titration After ≥4 weeks, may increase to 10 mg once daily based on symptom response and tolerability

Usual maintenance dose 5–10 mg once daily

Maximum dose 10 mg once daily

Clinical Notes:

• Assess symptom improvement after 4–8 weeks of therapy

• Exclude underlying causes of urinary frequency (UTI, polyuria due to diabetes, excessive fluid intake) before initiating

• May take with or without food

• Full therapeutic effect may require 4–12 weeks of continuous therapy

Secondary Indications — Adults Only (Off-label)

Indication Dose Duration Remarks

Neurogenic detrusor overactivity — OFF-LABEL 5 mg once daily; may increase to 10 mg once daily if tolerated Long-term Specialist only (Neuro-urologist); international RCTs demonstrate improved bladder capacity; limited Indian data

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Not applicable — Solifenacin is NOT approved for paediatric use in India.

Secondary Indications — Paediatric (Off-label)

Indication Age Dose Duration Remarks

Neurogenic bladder dysfunction — OFF-LABEL ≥5 years 0.1–0.2 mg/kg once daily (maximum 5 mg/day) Long-term; reassess periodically Specialist only (Paediatric Urologist/Neuro-urologist); small international studies; not standard of care in India

Monitoring:

• Post-void residual urine volume

• Urinary retention symptoms

• Constipation

• Dry mouth and anticholinergic effects

⚠️ Not recommended below 5 years of age. Safety and efficacy not established in paediatric population. Use only under specialist supervision with documented justification.

50 No dose adjustment required

30–50 Maximum dose 5 mg once daily

<30 Use with caution; maximum dose 5 mg once daily

Haemodialysis Avoid — no efficacy or safety data available

• Urinary retention or significant bladder outlet obstruction with risk of retention

• Gastric retention or severe decreased gastrointestinal motility conditions

• Uncontrolled narrow-angle glaucoma

• Severe hepatic impairment (Child-Pugh C)

• Hypersensitivity to solifenacin succinate or any excipient

• Patients undergoing haemodialysis

• Pre-existing QT prolongation or concurrent use of QT-prolonging medications

• Significant bladder outlet obstruction — risk of urinary retention

• Gastrointestinal obstructive disorders, severe constipation, or history of paralytic ileus

• Controlled narrow-angle glaucoma (under ophthalmology supervision)

• Autonomic neuropathy

• Hiatus hernia with reflux oesophagitis

• Moderate renal impairment (dose limitation required)

• Moderate hepatic impairment (dose limitation required)

• Elderly with cognitive impairment — increased sensitivity to anticholinergic CNS effects

• Hot weather/fever — reduced sweating may cause hyperthermia

Parameter Details

Safety Category Limited human data; animal studies suggest potential risk

Preferred alternatives Non-pharmacological measures (bladder training, pelvic floor exercises); oxybutynin if drug therapy essential (more historical data)

When to use Only if benefit clearly outweighs risk; avoid during first trimester

Monitoring Fetal growth monitoring if used during later pregnancy

Parameter Details

Compatibility Not recommended — excretion in human milk unknown

Drug levels in milk Unknown; potential anticholinergic effects in infant

Preferred alternatives Oxybutynin (more historical data); non-pharmacological measures preferred

Infant monitoring If used, monitor infant for dry mouth, poor feeding, constipation, irritability

Parameter Recommendation

Starting dose 5 mg once daily

Titration Increase to 10 mg only if well tolerated and no cognitive adverse effects

Special considerations Increased sensitivity to anticholinergic effects; higher risk of dry mouth, constipation, confusion, and cognitive impairment; assess renal function before long-term use

Additional risks Falls risk due to dizziness; urinary retention; heat intolerance; avoid in patients with pre-existing dementia or significant cognitive impairment

Drug Mechanism Clinical Effect Recommendation

Ketoconazole Strong CYP3A4 inhibitor Significantly increased solifenacin plasma levels (up to 2-fold) Do not exceed 5 mg/day solifenacin

Itraconazole Strong CYP3A4 inhibitor Markedly increased solifenacin exposure Maximum dose 5 mg/day

Ritonavir, Cobicistat Potent CYP3A4 inhibitors Substantially increased solifenacin levels Maximum dose 5 mg/day; monitor closely

Clarithromycin Strong CYP3A4 inhibitor Increased solifenacin levels Maximum dose 5 mg/day

QT-prolonging drugs (amiodarone, sotalol, moxifloxacin, haloperidol) Additive QT prolongation Risk of torsades de pointes Avoid combination or monitor ECG closely

Other antimuscarinics (oxybutynin, tolterodine, glycopyrrolate) Additive anticholinergic effects Enhanced toxicity — dry mouth, constipation, urinary retention, confusion Avoid concurrent use unless specialist-directed

Drug Interaction Recommendation

Rifampicin Strong CYP3A4 inducer; reduced solifenacin efficacy Monitor for reduced therapeutic effect; dose increase may be needed

Phenytoin, Carbamazepine, Phenobarbital CYP3A4 inducers May reduce solifenacin levels; monitor efficacy

Tricyclic antidepressants (amitriptyline, imipramine) Additive anticholinergic and CNS effects Use with caution; monitor for enhanced adverse effects

Benzodiazepines Additive sedative/cognitive effects Monitor for excessive sedation, especially in elderly

Antihypertensives Potential additive hypotensive effect Monitor blood pressure; rare interaction

Cholinesterase inhibitors (donepezil, rivastigmine) Pharmacological antagonism Reduced efficacy of both drugs; generally avoid combination

• Dry mouth (most common; dose-related)

• Constipation

• Blurred vision

• Dyspepsia

• Nausea

• Fatigue

• Urinary tract infection

• Dry eyes

• Acute urinary retention — discontinue immediately; may require catheterisation

• QT prolongation and torsades de pointes — rare; ECG monitoring if risk factors present

• Severe constipation — may progress to faecal impaction, paralytic ileus, or bowel obstruction; discontinue if severe

• Angioedema — rare; discontinue immediately

• Anaphylaxis — rare hypersensitivity reaction; discontinue and manage appropriately

• Cognitive impairment/delirium — particularly in elderly; discontinue if significant CNS effects occur

Phase Parameters

Baseline Renal function (serum creatinine, eGFR); hepatic function (LFTs); post-void residual urine volume if obstruction suspected; ECG if QT prolongation risk factors present; cognitive assessment in elderly

After initiation (4–8 weeks) Symptom response (frequency, urgency, incontinence episodes); adverse effects assessment (dry mouth, constipation); tolerability evaluation

Long-term Periodic assessment of constipation; cognitive status in elderly; post-void residual volumes if urinary symptoms worsen; reassess continued need for therapy

• Vesicare® (Astellas)

• Soliten® (Sun Pharma)

• Solicept® (Intas)

• Solimod® (Eris)

• Solifresh® (Zydus)

• Sofenac® (Torrent)

• Urifast® (Mankind)

Note: Not included in NLEM 2022; not under NPPA price control.

• Adherence issue: Dry mouth and constipation are the most common reasons for non-adherence — proactive counselling and management (sugar-free lozenges, adequate hydration, dietary fibre) improves compliance

• Elderly caution: Use the lowest effective dose (5 mg) in elderly patients to minimise CNS anticholinergic effects; avoid in patients with dementia or significant cognitive impairment

• Accurate diagnosis: Ensure OAB diagnosis is confirmed — exclude urinary tract infections, diabetes-related polyuria, and excessive caffeine/fluid intake before initiating therapy

• Specialist referral: Reserve use in neurogenic bladder for specialists with capability for post-void residual monitoring

• Comparative efficacy: Solifenacin has comparable efficacy to tolterodine and oxybutynin but may have slightly better dry mouth profile at 5 mg dose

• Drug interactions: Always check for CYP3A4 inhibitors — dose must not exceed 5 mg/day with strong inhibitors (ketoconazole, clarithromycin)

solifenacin; overactive bladder; OAB; antimuscarinic; urge incontinence; urology; elderly caution; renal adjustment; hepatic adjustment; CYP3A4 interaction; QT prolongation; Schedule H; India

RxIndia v1.0 — 30 Apr 2025

• CDSCO approved product information

• Indian Pharmacopoeia

• AIIMS Drug Formulary

• API Textbook of Medicine

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Harrison's Principles of Internal Medicine

• International RCTs — off-label neurogenic bladder use (marked as off-label)