URILAX 10/MG FC TAB 30/FC TAB

Indications

Approved Uses

Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Off-Label Uses

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

Dosage & Administration

Dosing by Condition

Overactive Bladder: Initial 5mg once daily; may increase to 10mg once daily if tolerated and needed; Maximum 10mg once daily

Initial Dose

5mg once daily (may be increased to 10mg once daily if clinically appropriate

Maintenance Dose

5mg to 10mg once daily.

Maximum Dose

10mg once daily.

Children's Dosage

Not approved for use in children

Dose Adjustment Notes

Do not exceed 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; avoid use in 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, urinary tract infection, dyspepsia, nausea, abdominal pain, dizziness, dry eyes.

Side Effect Frequency

Very common (≥10%): dry mouth. Common (1-10%): constipation, nausea, dyspepsia. Uncommon (0.1-1%): blurred vision. Rare/very rare (post‑marketing): urinary retention, urinary tract infection, QT prolongation, angioedema/anaphylaxis, hallucinations/confusion, rash.

Safety & Warnings

Contraindications

Contraindicated in: urinary retention; gastric retention; uncontrolled narrow‑angle glaucoma; hypersensitivity to solifenacin or excipients; severe hepatic impairment (Child‑Pugh C); severe renal impairment (CrCl <30 mL/min) when used with a potent CYP3A4 inhibitor.

Warnings & Precautions

Use caution in: bladder outflow obstruction (risk urinary retention); GI obstructive disorders or decreased GI motility (incl. severe constipation); controlled narrow‑angle glaucoma; renal impairment and moderate hepatic impairment; patients with congenital/acquired QT prolongation, electrolyte disturbances (e.g., hypokalemia), bradycardia, or concomitant QT‑prolonging drugs; counsel to stop and seek care if angioedema occurs.

Age Restriction

Not approved/recommended for use in children and adolescents (<18 years).

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Clinically important interactions: strong CYP3A4 inhibitors (e.g., ketoconazole/itraconazole/ritonavir/clarithromycin) increase solifenacin exposure (limit dose to 5 mg and avoid if severe renal impairment); CYP3A4 inducers (e.g., rifampicin/carbamazepine/phenytoin/St John’s wort) may reduce efficacy; additive effects with other anticholinergics; caution with QT‑prolonging drugs in at‑risk patients.

Interaction Severity

MAJOR: Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir) increase solifenacin exposure-limit dose to 5 mg/day and monitor anticholinergic/QT risk. MODERATE: Other anticholinergics (additive anticholinergic effects); QT-prolonging drugs (additive QT prolongation risk, especially in predisposed patients). MODERATE: Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin) may reduce efficacy.

Food Interaction

No restriction.

Special Populations

Pregnancy

Consult Doctor

Children

Not approved for use in children

Elderly

Standard adult dosing (5-10mg once daily); no routine dose adjustment required, but use with caution due to increased sensitivity to anticholinergic effects

Kidney Impairment

CrCl ≥30 mL/min: no adjustment; CrCl <30 mL/min: do not exceed 5 mg once daily; CrCl <30 mL/min with a potent CYP3A4 inhibitor: avoid/contraindicated.

Liver Impairment

Mild hepatic impairment (Child‑Pugh A): no adjustment; Moderate (Child‑Pugh B): do not exceed 5 mg once daily; Severe (Child‑Pugh C): contraindicated.

Storage & Patient Advice

Missed Dose

If a dose is missed, take it as soon as remembered the same day; if it is almost time for the next dose, skip the missed dose and resume the next day-do not take two doses in one day.

Stopping the Medicine

No taper is required; it can be stopped, but patients should consult the prescriber because symptoms commonly recur and ongoing need should be reassessed periodically.

Overdose

Overdose may cause pronounced anticholinergic toxicity (e.g., mydriasis/blurred vision, dry mouth, tachycardia, agitation/confusion/hallucinations, urinary retention, severe constipation/ileus) and may affect QT; management is urgent supportive care with ECG monitoring, consider activated charcoal if early, and treat severe central anticholinergic syndrome with physostigmine only under specialist/toxicology supervision.

Patient Counseling

Take once daily at the same time with or without food; swallow whole (do not crush/chew). Common effects include dry mouth and constipation-use fluids/fiber and consider sugar-free gum/candy for dry mouth. Use caution with driving if blurred vision/dizziness occurs; avoid combining with other anticholinergics unless advised. Seek care for inability to urinate, severe constipation/abdominal pain, palpitations/syncope, or signs of allergy (facial/throat swelling).

Monitoring Requirements

No routine lab monitoring is required for most patients; clinically monitor for urinary retention, constipation, dry mouth, blurred vision/cognitive effects, and consider ECG/QT risk assessment in susceptible patients; reassess benefit/tolerability periodically (e.g., within 4-12 weeks after initiation and then at intervals).

Pharmacology

Mechanism of Action

Competitive muscarinic receptor antagonist with preferential M3 activity that inhibits acetylcholine-mediated detrusor contractions, increasing bladder capacity and reducing urgency, frequency, and urge incontinence.

Onset of Action

Antimuscarinic effect begins within a few hours after a dose; clinically meaningful symptom improvement is typically seen within 1-2 weeks, with maximal benefit by ~4 weeks.

Duration of Effect

Antimuscarinic effect begins within a few hours after a dose; clinically meaningful symptom improvement is typically seen within 1-2 weeks, with maximal benefit by ~4 weeks.

Half-Life

The elimination half life of solifenacin ranges from 33-85 hours

Bioavailability

After oral administration of VESIcare to healthy volunteers, peak plasma levels (Cmax) of solifenacin are reached within 3 to 8 hours after administration

Metabolism

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

Excretion

Approximately 69% recovered in urine and ~23% in feces (over ~26 days).

Protein Binding

Approximately 98% protein bound, mainly to α1-acid glycoprotein.

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: 10mg solifenacin succinate

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Urological Condition

Overactive Bladder

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