VESICARE 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 lower urinary tract dysfunction (off-label in some settings).

Dosage & Administration

Dosing by Condition

Overactive bladder (OAB): 5 mg orally once daily initially; may increase to 10 mg once daily if needed and well tolerated; maximum 10 mg/day.

Initial Dose

5 mg once daily (10 mg once daily may be used as starting dose if clinically indicated)

Maintenance Dose

5-10 mg once daily

Maximum Dose

10 mg once daily.

Children's Dosage

Tablets not approved for pediatric use

Dose Adjustment Notes

Do not exceed 5 mg daily in patients with severe renal impairment (CrCl <30 mL/min), moderate hepatic impairment (Child-Pugh B), or those taking potent CYP3A4 inhibitors. Contraindicated in severe hepatic impairment (Child-Pugh C)

How to Take

Swallow the tablet whole with water; do not crush or chew; may be taken with or without food; take once daily at about the same time each day.

Side Effects

Common Side Effects

Dry mouth, constipation, blurred vision, urinary tract infection, dyspepsia, nausea, abdominal pain.

Side Effect Frequency

Very common (>10%): Dry mouth, constipation. Common (1-10%): Blurred vision, nausea, dyspepsia, urinary tract infection, dry eyes. Uncommon (<1%): Urinary retention, QT prolongation, angioedema, hallucinations

Safety & Warnings

Contraindications

Contraindicated in: urinary retention; gastric retention; uncontrolled narrow‑angle glaucoma; hypersensitivity to solifenacin or excipients.

Warnings & Precautions

Use caution in: bladder outflow obstruction (risk urinary retention); decreased GI motility/obstructive GI disorders (risk severe constipation/ileus); controlled narrow‑angle glaucoma; renal impairment and hepatic impairment (dose limits/avoid with strong CYP3A4 inhibitors); patients with congenital/acquired QT prolongation, electrolyte abnormalities, bradyarrhythmias, or taking QT‑prolonging drugs; monitor for CNS effects (somnolence, confusion, hallucinations), especially in older adults.

Age Restriction

Not indicated/approved for overactive bladder in patients <18 years (adult use).

Driving Warning

Can cause blurred vision and drowsiness; use caution when driving or operating machinery until effects known

Drug Interactions

Drug Interactions

Clinically important interactions: strong CYP3A4 inhibitors (e.g., ketoconazole/itraconazole/ritonavir/clarithromycin) ↑ solifenacin exposure (dose limit/avoid in significant renal/hepatic impairment); CYP3A4 inducers (e.g., rifampin/carbamazepine/phenytoin/St John’s wort) may ↓ effect; other anticholinergics ↑ additive anticholinergic burden; QT‑prolonging drugs and conditions increase torsades risk in susceptible patients.

Interaction Severity

MAJOR: Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) increase solifenacin exposure-avoid or limit solifenacin to 5 mg/day when co-administered; additive QT-prolongation risk with other QT-prolonging drugs in at-risk patients. MODERATE: Other anticholinergics (additive anticholinergic effects/urinary retention/constipation); CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St John’s wort) may reduce efficacy. MINOR: No consistent clinically meaningful interaction with metformin is generally expected.

Food Interaction

No clinically significant food restriction; may be taken with or without food.

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Tablets not approved for pediatric use

Elderly

Standard adult dosing; no routine dose adjustment required, but use with caution due to increased anticholinergic sensitivity in elderly patients

Kidney Impairment

CrCl ≥30 mL/min: No adjustment needed. CrCl <30 mL/min: Do not exceed 5 mg once daily.

Liver Impairment

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

Storage & Patient Advice

Missed Dose

If a dose is missed, take it as soon as remembered unless it is close to the next dose; otherwise skip the missed dose and resume the regular schedule-do not take two doses in the same day.

Stopping the Medicine

No taper is required; it can be stopped, but advise patients to consult the prescriber and expect OAB symptoms may recur.

Overdose

Overdose typically causes pronounced anticholinergic toxicity (e.g., mydriasis/blurred vision, dry mouth, tachycardia, agitation/confusion/hallucinations, urinary retention, decreased GI motility/ileus; possible QT prolongation); management is urgent medical evaluation with supportive care, consider activated charcoal if early, ECG monitoring, and specialist-directed use of physostigmine for severe central anticholinergic syndrome when appropriate.

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 sugar-free gum/candy, adequate fluids, and fiber; avoid driving/operating machinery until effects on vision/drowsiness are known; seek care for inability to urinate, severe constipation/abdominal pain, palpitations, or eye pain/acute vision changes; review all medicines for interactions (especially strong CYP3A4 inhibitors and other anticholinergics).

Monitoring Requirements

Monitor for anticholinergic adverse effects (dry mouth, constipation, blurred vision, cognitive effects-especially in older adults) and for urinary retention; consider ECG/QT risk assessment in patients with risk factors or on QT-prolonging drugs.

Pharmacology

Mechanism of Action

Competitive muscarinic receptor antagonist (relatively M3-selective) that reduces acetylcholine-mediated detrusor smooth muscle contractions, improving urgency, frequency, and urge incontinence.

Onset of Action

Symptom improvement may begin within 1-2 weeks; maximal/steady benefit is often assessed by ~4 weeks.

Duration of Effect

Approximately 24 hours per dose (once-daily dosing); symptom improvement is typically noticed within 1-2 weeks, with maximal benefit often by ~4 weeks.

Half-Life

Approximately 45-68 hours.

Bioavailability

Approximately 90%

Metabolism

Hepatic metabolism primarily via CYP3A4 (minor contribution from CYP2D6), with formation of multiple metabolites including 4R-hydroxy-solifenacin and N-oxide metabolites; the 4R-hydroxy metabolite has pharmacologic activity but overall clinical effect is mainly from parent solifenacin.

Excretion

Approximately 70% recovered in urine and ~23% in feces (as metabolites and some unchanged drug).

Protein Binding

Approximately 98% (primarily to alpha1-acid glycoprotein)

Product Information

Available Dosage Forms

Film-coated tablet

Composition per Dose

Each film-coated tablet: 10 mg solifenacin succinate

Generic Availability

Yes

Urological Condition

Overactive Bladder

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