Description
Solifenacin Succinate Tablets (5 mg / 10 mg)
Healthy Inc is a specialized global supplier and exporter of advanced urological, geriatric, and women’s health therapeutics. We provide ultra-high-purity, kinetically stabilized Solifenacin Succinate Film-Coated Tablets (5 mg / 10 mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Selective M3 Muscarinic Receptor Antagonist” is a massive-volume, premium export to urology centers, urogynecology clinics, primary care networks, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, highly tolerable intervention for Overactive Bladder (OAB) syndrome.
Product Overview
This formulation contains Solifenacin Succinate, a modern, highly targeted antimuscarinic agent that fundamentally outperforms older bladder spasm medications by heavily prioritizing the bladder over the salivary glands and brain.
The “Selective Detrusor Relaxant” Specialist:
- Mechanism (The M3 Receptor Blockade): Overactive Bladder occurs when the detrusor muscle (the smooth muscle of the bladder wall) contracts spontaneously and violently, even when the bladder isn’t full. This causes the sudden, uncontrollable urge to urinate. Solifenacin acts as a highly selective shield, aggressively binding to the M3 muscarinic receptors on the bladder wall. This blocks the neurotransmitter acetylcholine from triggering these contractions, allowing the bladder muscle to relax, massively increasing the volume of urine the bladder can hold.
- The “M3 Selectivity” Compliance Advantage: Older OAB drugs bind indiscriminately to all muscarinic receptors in the body, causing severe, debilitating dry mouth, severe constipation, and cognitive fogginess (especially in the elderly). Solifenacin’s high selectivity for the M3 receptor specifically targets the bladder, drastically reducing the severity of dry mouth and ensuring patients actually stay on the medication long-term.
- The 24-Hour Half-Life: Unlike short-acting bladder pills that require multiple doses a day, Solifenacin boasts a prolonged 45-to-68-hour terminal half-life. A single, small tablet provides smooth, uninterrupted 24-hour protection against urinary urgency and incontinence accidents.
Product Composition & Strength
We supply this product as a Precision-Blended Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu or High-Density Alu-PVC blister strips to ensure the absolute stability of the low-dose API.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Solifenacin Succinate USP/Ph.Eur. | 5 mg | Global Standard: Starting and standard maintenance dose for Overactive Bladder; required maximum dose for patients with hepatic/renal impairment. |
| Solifenacin Succinate USP/Ph.Eur. | 10 mg | High-Dose Therapy: Maximum adult dose for severe, refractory urinary urgency and frequency. |
| Excipients | Lactose Monohydrate / Maize Starch / Hypromellose / Magnesium Stearate / Macrogol | Diluent / Binder / Premium Film-Coating (Engineered for immediate gastric dissolution and light protection) |
*Pack Sizes: 10×10 or 3×10 Blisters (Optimized specifically for 30-day chronic urology dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Urology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Urologicals/Antispasmodics) |
| CAS Number | 242478-38-2 (Solifenacin Succinate) |
| Dosage Form | Film-Coated Tablet (Immediate Release) |
| Packaging | Alu-Alu or High-Density Alu-PVC Blisters. Protects the highly sensitive micro-dose formulation from environmental humidity and light degradation across Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Protect from Light and Moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Micro-Dose Geometric Blending: Dispersing a tiny 5 mg active ingredient uniformly throughout a standard-sized tablet requires elite pharmaceutical engineering. Our facilities utilize advanced high-shear homogenizers and strict geometric dilution protocols, verified by rigorous HPLC content uniformity testing, to guarantee that every single tablet delivers the exact milligram dose, preventing toxic anticholinergic spikes or sub-therapeutic failures.
Therapeutic Indications (Human Use)
Indicated for the comprehensive management of lower urinary tract symptoms (LUTS):
- Overactive Bladder (OAB): Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
Dosage & Administration
Recommended Dosage (Strictly as per Urologist Guidelines):
- Standard Adult Dosing: The recommended dose is 5 mg once daily. If the 5 mg dose is well tolerated but efficacy is insufficient, the dose may be increased to 10 mg once daily.
- Administration: Must be swallowed whole with liquids. It can be taken with or without food.
- Renal & Hepatic Impairment (DOSE CAP): For patients with severe renal impairment (CLcr < 30 mL/min) or moderate hepatic impairment (Child-Pugh B), the dose must not exceed 5 mg daily. It is strictly contraindicated in severe hepatic impairment.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Urinary Retention (BPH Caution): Because Solifenacin relaxes the bladder muscle, it can make it difficult to empty the bladder completely. It must be used with extreme caution in men with clinically significant bladder outflow obstruction (such as severe Benign Prostatic Hyperplasia), as it can trigger acute urinary retention requiring catheterization.
- Severe Constipation & GI Motility: Antimuscarinics slow down the digestive tract. It is contraindicated in patients with gastric retention, toxic megacolon, or severe gastrointestinal conditions. Patients experiencing severe constipation must seek medical advice.
- CYP3A4 Drug Interactions: Solifenacin is heavily metabolized by the CYP3A4 liver enzyme. If a patient is taking a potent CYP3A4 inhibitor (like Ketoconazole or Ritonavir), the Solifenacin dose must not exceed 5 mg daily to prevent toxic accumulation.
- QT Prolongation Risk: High doses of Solifenacin have been associated with a prolongation of the QT interval on an ECG. It should be used with caution in patients with a known history of QT prolongation or those taking Class IA or Class III antiarrhythmic medications.
- Narrow-Angle Glaucoma: Strictly contraindicated in patients with uncontrolled narrow-angle glaucoma, as anticholinergics can dangerously spike intraocular pressure.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Urological and Geriatric Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for urology programs in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.











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