URILAX 5MG TAB

Indications

Approved Uses

Overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency

Off-Label Uses

Neurogenic detrusor overactivity/neurogenic overactive bladder (off-label in some settings).

Dosage & Administration

Dosing by Condition

Overactive bladder: 5 mg orally once daily; may increase to 10 mg once daily if needed and tolerated. Maximum 5 mg once daily in severe renal impairment (CrCl <30 mL/min), moderate hepatic impairment (Child-Pugh B), or when used with strong CYP3A4 inhibitors.

Initial Dose

5mg once daily.

Maintenance Dose

5mg once daily (up to 10mg once daily if tolerated and needed

Maximum Dose

5mg once daily (for this exact 5mg formulation; general max 10mg once daily

Children's Dosage

Not approved for children under 18 years for overactive bladder. An oral suspension is available for neurogenic detrusor overactivity in children aged 2 years and older, with dosing based on weight.

Dose Adjustment Notes

For patients with severe renal impairment (CrCl < 30 mL/min), moderate hepatic impairment (Child-Pugh B), or those taking strong CYP3A4 inhibitors, the dose should not exceed 5mg daily. Not recommended for patients with severe hepatic impairment (Child-Pugh C).

How to Take

Swallow the film-coated tablet whole with water; may be taken with or without food; take once daily at the same time each day.

Side Effects

Common Side Effects

Dry mouth, constipation, blurred vision, dry eyes, dyspepsia, nausea, urinary tract infection

Safety & Warnings

Contraindications

Urinary retention; gastric retention; uncontrolled narrow‑angle glaucoma; hypersensitivity to solifenacin/excipients; severe hepatic impairment; severe renal impairment (CrCl ≤30 mL/min) when used with a potent CYP3A4 inhibitor (e.g., ketoconazole).

Warnings & Precautions

Use caution in bladder outflow obstruction/urinary retention risk; decreased GI motility/constipation, GI obstructive disorders, or reflux/hiatus hernia; controlled narrow‑angle glaucoma; renal impairment and moderate hepatic impairment; QT prolongation risk factors (congenital/acquired QT prolongation, electrolyte disturbances, concomitant QT‑prolonging drugs); monitor for angioedema and CNS anticholinergic effects (somnolence, confusion), especially in older adults.

Age Restriction

Not approved/recommended for patients <18 years (pediatric safety/efficacy not established for OAB).

Drug Interactions

Drug Interactions

Strong CYP3A4 inhibitors (e.g., ketoconazole/itraconazole/ritonavir/clarithromycin) increase levels-do not exceed 5 mg/day and avoid if CrCl ≤30 mL/min; CYP3A4 inducers (e.g., rifampin/carbamazepine/phenytoin) may reduce effect; other anticholinergics increase anticholinergic adverse effects; caution with QT‑prolonging drugs and in patients with QT risk factors.

Interaction Severity

MAJOR: Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) - increased solifenacin exposure; QT-prolonging drugs in high-risk patients - additive QT prolongation/torsades risk. MODERATE: Other anticholinergics - additive anticholinergic effects/urinary retention; CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St John’s wort) - reduced efficacy. MINOR/variable: Digoxin (small PK change; usually not clinically significant).

Food Interaction

No clinically significant food restriction; may be taken with or without food. Avoid/limit grapefruit juice with strong CYP3A4 inhibition potential.

Special Populations

Children

Not approved for children under 18 years for overactive bladder. An oral suspension is available for neurogenic detrusor overactivity in children aged 2 years and older, with dosing based on weight.

Elderly

Standard adult dosing (5mg once daily); no routine dose adjustment required, but monitor closely for anticholinergic CNS effects including confusion and cognitive impairment

Kidney Impairment

CrCl >30 mL/min: no adjustment; CrCl ≤30 mL/min: maximum 5 mg once daily; if CrCl ≤30 mL/min and a strong CYP3A4 inhibitor is required, avoid/contraindicated.

Liver Impairment

Mild (Child-Pugh A): No adjustment needed. Moderate (Child-Pugh B): Do not exceed 5mg once daily. Severe (Child-Pugh C): Not recommended.

Storage & Patient Advice

Overdose

Expected toxicity is severe anticholinergic syndrome (mydriasis/blurred vision, dry mouth, tachycardia, agitation/hallucinations, urinary retention, ileus/constipation); management is urgent medical evaluation with supportive care, consider activated charcoal if early, and physostigmine may be used in severe central anticholinergic toxicity under specialist supervision.

Monitoring Requirements

Monitor clinical response and anticholinergic adverse effects (dry mouth, constipation, blurred vision, cognitive effects), and assess for urinary retention; consider ECG/QT risk assessment in patients with risk factors or on QT-prolonging drugs; monitor renal/hepatic function when impairment is present or suspected for dose-limiting decisions.

Pharmacology

Mechanism of Action

Competitive muscarinic receptor antagonist (predominantly M3) in the bladder, reducing acetylcholine-mediated detrusor contractions and increasing functional bladder capacity to reduce urgency, frequency, and urge incontinence.

Onset of Action

Within a few hours (peak effect ~3-8 hours); symptom improvement may take several days to weeks.

Duration of Effect

24 hours

Half-Life

Approximately 45-68 hours.

Bioavailability

Approximately 90%.

Metabolism

Extensively hepatic metabolism primarily via CYP3A4 to multiple metabolites (including 4R-hydroxy solifenacin among others).

Excretion

Approximately 69% excreted in urine and ~23% in feces (as parent drug and metabolites).

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: 5mg solifenacin succinate

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Urological Condition

Overactive Bladder

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