Description

Oxybutynin Chloride Extended-Release (ER) Tablets (5 mg / 10 mg / 15 mg)

Healthy Inc is a specialized global supplier and exporter of advanced urological, geriatric, and smooth-muscle antispasmodic therapeutics. We provide ultra-high-purity, kinetically controlled Oxybutynin Chloride Extended-Release (ER) Tablets (5 mg / 10 mg / 15 mg), manufactured in WHO–GMP certified, high-precision modified-release oral solid dosage facilities. This “Antimuscarinic Detrusor Relaxant” is a massive-volume, highly lucrative export to urology centers, geriatric care networks, specialized incontinence clinics, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, high-compliance intervention for severe Overactive Bladder (OAB) and urinary incontinence.

Product Overview

This highly advanced Extended-Release formulation utilizes a sophisticated hydrogel polymer matrix to slowly and continuously feed a powerful anticholinergic agent into the bloodstream, silencing hyperactive bladder muscles without causing the severe, intolerable side effects associated with older therapies.

The “Bladder Calmer & Matrix-Release” Specialist:

• Mechanism 1 (The Muscarinic Receptor Blockade): In Overactive Bladder (OAB), the smooth muscle of the bladder wall (the detrusor muscle) contracts involuntarily and violently, even when the bladder is not full, causing sudden, uncontrollable urges to urinate. Oxybutynin directly binds to and blocks the M2 and M3 muscarinic receptors on this muscle. By preventing acetylcholine from stimulating these receptors, it physically paralyzes the spasms, completely relaxing the detrusor muscle and massively increasing the volume of urine the bladder can hold.
• Mechanism 2 (The Extended-Release “Dry Mouth” Solution – CRITICAL): When standard Oxybutynin is swallowed, it immediately dumps into the liver and creates massive amounts of a highly active metabolite (N-desethyloxybutynin), which is specifically responsible for extreme dry mouth and severe constipation. Our Extended-Release formulation pushes the drug past the stomach and slowly releases it deep into the intestines over 24 hours. This drastically alters the metabolism, reducing the toxic metabolite by over 50% and guaranteeing continuous, smooth bladder control with highly tolerable side effects.
• The Pediatric & Neurogenic Standard: Beyond aging populations, Oxybutynin is the primary, life-saving therapy for children and adults with neurogenic bladder dysfunction (spina bifida, spinal cord injuries), protecting their kidneys from the massive back-pressure caused by a spastic, non-compliant bladder.

Product Composition & Strength

We supply this product as a Precision-Engineered Polymeric Matrix Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips or heavy-gauge HDPE desiccant bottles to ensure the absolute chemical stability of the controlled-release hydrogel network.

*Pack Sizes: Bottles of 30 or 10×10 Alu-Alu Blisters (Optimized specifically for strict, high-compliance 30-day chronic urology dispensing regimens).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Urology Distributors, and Hospital Procurement Boards.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Hydrophilic Matrix Swelling Engineering (CRITICAL COMPLIANCE): Manufacturing an accurate 24-hour Oxybutynin ER tablet requires elite modified-release capabilities. Our facilities utilize advanced high-viscosity Hypromellose (HPMC) blending. When the patient swallows the tablet, the gastrointestinal fluids instantly interact with the polymers, forming a thick, gelatinous outer barrier. This gel barrier precisely controls the rate at which water enters the tablet and the rate at which the highly soluble Oxybutynin diffuses out, guaranteeing identical, sustained pharmacokinetic release without fatal anticholinergic toxicity.

Therapeutic Indications (Human Use)

Indicated for the targeted management of severe urological smooth-muscle dysfunction:

• Overactive Bladder (OAB): Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
• Neurogenic Bladder: Treatment of pediatric and adult patients with neurogenic detrusor overactivity associated with neurological conditions (e.g., spina bifida).

Dosage & Administration

Recommended Dosage (Strictly as per Urologist Guidelines):

• Standard Adult Dosing: Typically initiated at 5 mg once daily. Based on clinical efficacy and tolerance, the dose may be increased in 5 mg increments up to a maximum of 30 mg per day.
• Administration (THE INTACT TABLET RULE – CRITICAL): Tablets MUST be swallowed completely whole with liquids. They must never be chewed, crushed, or divided. Breaking the tablet physically destroys the ER polymer matrix, causing a massive, potentially toxic anticholinergic dose to dump into the patient’s system all at once.
• Food Independence: Can be taken with or without food.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Narrow-Angle Glaucoma (Absolute Contraindication): Oxybutynin causes the pupils to dilate (mydriasis). In patients with narrow-angle glaucoma, this will physically block the drainage of fluid from the eye, causing a massive, agonizing spike in intraocular pressure that can lead to rapid, irreversible blindness.
• Heat Prostration (Decreased Sweating): Anticholinergics aggressively shut down the body’s sweat glands. When administered in a hot environment or during heavy exercise, patients are at a massive risk of severe, fatal heat stroke (heat prostration) due to the inability to sweat.
• Gastric & Urinary Retention: Strictly contraindicated in patients with severe gastrointestinal motility disorders (like severe ulcerative colitis or paralytic ileus) and patients with severe urinary retention (e.g., severe BPH), as the drug will forcefully prevent the organs from emptying.
• Elderly Cognitive Decline: Systemic anticholinergics cross the blood-brain barrier and can cause severe confusion, hallucinations, and rapid cognitive decline in elderly or dementia patients. Extreme caution is required.

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 Modified-Release Formulations. Whether you are looking for a reliable Government Tender Supplier for incontinence clinics in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely, secure delivery of highly stable, WHO-GMP certified products.