VESICARE 5/MG FC TAB 30/FC TAB

Indications

Approved Uses

Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults., Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 2 years and older.

Off-Label Uses

Neurogenic detrusor overactivity/neurogenic overactive bladder (e.g., spinal cord injury, multiple sclerosis) is used off-label in some settings.

Dosage & Administration

Dosing by Condition

Overactive bladder (adults): 5 mg orally once daily; may increase to 10 mg once daily if needed and tolerated. Dose limit: do not exceed 5 mg once daily in severe renal impairment (CrCl <30 mL/min) or moderate hepatic impairment (Child-Pugh B); avoid in severe hepatic impairment (Child-Pugh C).

Initial Dose

5 mg once daily.

Maintenance Dose

5 mg to 10 mg once daily.

Maximum Dose

10 mg once daily.

Children's Dosage

Not approved for use in children for overactive bladder. Approved as an oral suspension for neurogenic detrusor overactivity in children ≥2 years, with dosing based on body weight.

Dose Adjustment Notes

Do not exceed 5 mg daily in severe renal impairment (CrCl <30 mL/min) or moderate hepatic impairment (Child-Pugh B); contraindicated in severe hepatic impairment (Child-Pugh C); dose reduction required when used with potent CYP3A4 inhibitors

How to Take

Swallow the film-coated tablet whole with water; may be taken with or without food; do not crush or chew.

Side Effects

Common Side Effects

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

Side Effect Frequency

Very common (>10%): dry mouth, constipation. Common (1-10%): blurred vision, nausea, dyspepsia. Uncommon (0.1-1%): dry eyes, urinary tract infection, fatigue, dizziness.

Safety & Warnings

Contraindications

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

Warnings & Precautions

Use caution with bladder outflow obstruction/urinary retention risk; decreased GI motility/constipation or GI obstruction; controlled narrow‑angle glaucoma; renal or hepatic impairment (dose limits); risk factors for QT prolongation (congenital QT, electrolyte abnormalities, concomitant QT‑prolonging drugs); CNS anticholinergic effects (somnolence, confusion, hallucinations-especially elderly); heat prostration in hot environments.

Age Restriction

Not approved for pediatric use (<18 years) for this tablet product.

Driving Warning

Can cause blurred vision and drowsiness; patients should be advised that solifenacin may cause blurred vision and somnolence. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that solifenacin does not adversely affect them

Drug Interactions

Drug Interactions

Strong CYP3A4 inhibitors (e.g., ketoconazole/itraconazole/ritonavir/clarithromycin): increase exposure-do not exceed 5 mg/day and avoid in severe renal impairment or moderate hepatic impairment; CYP3A4 inducers (e.g., rifampin/carbamazepine/phenytoin/St John’s wort): may reduce effect; other anticholinergics: additive anticholinergic toxicity; QT‑prolonging drugs/conditions: additive QT risk in susceptible patients.

Interaction Severity

MAJOR: Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir/clarithromycin) increase solifenacin exposure-limit solifenacin to 5 mg/day; additive QT-prolongation risk with other QT-prolonging drugs in at-risk patients. MODERATE: Other anticholinergics (additive anticholinergic effects/urinary retention); CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) may reduce efficacy.

Food Interaction

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

Special Populations

Children

Not approved for use in children for overactive bladder. Approved as an oral suspension for neurogenic detrusor overactivity in children ≥2 years, with dosing based on body weight.

Elderly

Standard adult dosing (5 mg once daily); use with caution due to increased risk of anticholinergic side effects including cognitive impairment, confusion, and urinary retention; no routine dose reduction required based on age alone

Kidney Impairment

CrCl ≥30 mL/min: no adjustment; CrCl <30 mL/min: max 5 mg once daily; CrCl <30 mL/min with strong CYP3A4 inhibitor: contraindicated/avoid.

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 the next dose at the usual time the next day; do not take two doses in the same day.

Stopping the Medicine

Can be stopped without taper; advise patient to consult prescriber and expect OAB symptoms may return.

Overdose

Symptoms: pronounced anticholinergic toxicity (mydriasis/blurred vision, tachycardia, agitation/delirium/hallucinations, dry skin/mucosa, hyperthermia, urinary retention, ileus/constipation); Management: urgent medical care, supportive treatment, consider activated charcoal if early, monitor ECG/QT, and physostigmine may be considered for severe central anticholinergic syndrome under specialist supervision.

Patient Counseling

Take once daily at the same time; with or without food; swallow whole (do not crush/chew). Common effects: dry mouth/constipation/blurred vision-use sugar-free gum/candy, fluids and fiber; seek care for inability to urinate, severe constipation, palpitations, confusion. Avoid driving until effects known; avoid overheating/heat exposure due to reduced sweating; review all medicines for interactions (especially strong CYP3A4 inhibitors and QT-prolonging drugs).

Monitoring Requirements

No routine labs for most patients; monitor clinically for urinary retention and anticholinergic adverse effects (dry mouth, constipation, blurred vision, cognitive effects). Consider ECG/QT-risk assessment in patients with risk factors or on QT-prolonging drugs; assess renal/hepatic function when impairment is known/suspected to ensure appropriate dose limits.

Pharmacology

Mechanism of Action

Competitive muscarinic receptor antagonist (relatively M3-selective) that reduces acetylcholine-mediated detrusor contractions, increasing bladder capacity and reducing urgency/frequency/urge incontinence.

Duration of Effect

Approximately 24 hours (once-daily dosing).

Half-Life

Terminal half-life approximately 45-68 hours.

Bioavailability

Approximately 90%.

Metabolism

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

Excretion

Elimination is via urine and feces; approximately ~69% recovered in urine and ~23% in feces (as parent drug and metabolites).

Protein Binding

Approximately 98% (primarily bound to α1-acid glycoprotein).

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: 5 mg solifenacin succinate

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Urological Condition

Overactive Bladder

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