Fesoterodine Fumarate 4 mg, 8 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 4 mg, 8 mg

Reference Brands: Toviaz (USA/EU)

Category: Urology

Fesoterodine fumarate 4 mg and 8 mg prolonged-release tablets, a once-daily antimuscarinic for overactive bladder, for importers, distributors, hospital pharmacies and urology tenders.

Product Description:

Fesoterodine fumarate is an antimuscarinic medicine for the overactive bladder. It is a prodrug that plasma esterases quickly convert to 5-hydroxymethyl tolterodine, the active metabolite also formed from tolterodine. This blocks muscarinic receptors in the detrusor muscle, damping involuntary contractions so the bladder holds more. The 4 mg and 8 mg tablets here are prolonged-release, releasing the drug evenly over 24 hours for one dose a day. They are swallowed whole, not chewed, split or crushed.

It is used mainly in adults with urgency, frequency and urge incontinence. Treatment starts at 4 mg once daily, with or without food, rising to 8 mg if needed. The dose stays at 4 mg in severe kidney impairment or with strong CYP3A4 inhibitors such as clarithromycin, and severe liver impairment rules it out. Dry mouth and constipation are common. It is contraindicated in urinary or gastric retention, uncontrolled narrow-angle glaucoma and myasthenia gravis. Pharmacists watch total anticholinergic burden in older patients.

Sourcing notes. Fesoterodine is prescription-only. A generic must match the reference prolonged-release tablet, so ask for multi-point dissolution profiles and bioequivalence data with the CTD or ACTD dossier. The tablets need protection from moisture; reference packs use aluminium blisters or bottles with desiccant. Ask for zone IVb stability data for hot, humid markets. Request a batch CoA, GMP certificate and CoPP, and specify strength, pack size and registration market in your enquiry.