Description

Darifenacin Tablets 

Healthy Inc is a specialized global supplier and exporter of advanced urology, geriatrics, and targeted muscarinic-receptor therapeutics. We provide ultra-high-purity, kinetically optimized Darifenacin Hydrobromide Prolonged-Release Tablets (7.5 mg / 15 mg), manufactured in WHO–GMP certified, high-precision sustained-release oral solid dosage facilities. This “Highly Selective M3-Receptor Antagonist” is a massive-volume, high-value export to urology centers, geriatric care networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, cognitively-safe intervention for Overactive Bladder (OAB) syndrome, severe urgency, and urge incontinence.

Product Overview

This highly advanced formulation operates as a localized, highly specific paralyzer for the hyperactive bladder muscle. Unlike older drugs that blindly attack receptors throughout the entire body, Darifenacin is biochemically engineered to seek out and silence only the specific receptors responsible for bladder spasms, leaving the brain and the heart completely untouched.

The “M3-Selective & Cognitively Safe” Specialist:

• Mechanism 1 (The M3-Selective Blockade): The detrusor muscle of the bladder contracts when acetylcholine binds to M3 muscarinic receptors. In Overactive Bladder syndrome, these contractions happen uncontrollably. Darifenacin acts as a highly potent, competitive antagonist that binds selectively to these M3 receptors. This prevents acetylcholine from triggering the spasm, profoundly increasing bladder capacity and giving the patient immediate control over urinary urgency.
• Mechanism 2 (The M1 & M2 Sparing Advantage): The defining clinical superiority of Darifenacin lies in what it doesn’t do. It has a 9-fold greater affinity for M3 over M1 (brain/cognition) and a 59-fold greater affinity for M3 over M2 (heart rate). Because it spares the M1 receptors in the central nervous system, it does not cause the severe confusion, memory impairment, or hallucinations associated with older OAB drugs like Oxybutynin—making it the absolute gold standard for elderly patients.
• Mechanism 3 (Prolonged-Release Pharmacokinetics): To provide true 24-hour symptom control and prevent nighttime awakenings (nocturia), the active API is embedded in a specialized hydrophilic polymer matrix. This ensures a slow, steady drip of the drug into the bloodstream, preventing sudden plasma spikes that exacerbate side effects like dry mouth.

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.

• PR Matrix Engineering & Dose-Dumping Prevention (CRITICAL COMPLIANCE): The clinical viability of Darifenacin relies 100% on its Prolonged-Release matrix. If a generic tablet suffers from “dose-dumping,” the patient will experience massive systemic anticholinergic toxicity (blinding dry mouth and severe constipation). Our urology suites utilize elite polymer-matrix blending and rigorous 24-hour in-vitro dissolution profiling to guarantee a perfectly flat, highly predictable release curve that mimics the originator brand flawlessly.

Therapeutic Indications (Human Use)

Indicated for the targeted management of chronic lower urinary tract dysfunction:

• Overactive Bladder (OAB) Syndrome: Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequent urination in adult patients.

Dosage & Administration

Recommended Dosage (Strictly as per Urologist Guidelines):

• Standard Adult Dosing: 7.5 mg taken orally once daily. Based on clinical response and tolerability, the dose may be increased to 15 mg once daily after two weeks.
• The “Do Not Crush” Mandate (CRITICAL): Tablets MUST be swallowed completely whole with water. Chewing, crushing, or dividing the tablet instantly destroys the PR matrix, causing a massive, immediate overdose of the active API.
• Administration: Can be taken with or without food.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Urinary & Gastric Retention (Contraindications): Darifenacin heavily relaxes the bladder and slows the gut. It is strictly contraindicated in patients suffering from urinary retention (inability to empty the bladder completely) and gastric retention (severe delayed emptying of the stomach).
• Narrow-Angle Glaucoma: Like all antimuscarinics, it can dangerously increase intraocular pressure. It is contraindicated in patients with uncontrolled narrow-angle glaucoma.
• CYP3A4 Inhibitor Interaction (Toxicity Alert): Darifenacin is heavily metabolized by the liver’s CYP3A4 enzyme. Co-administration with potent CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir, Clarithromycin) will cause blood levels of Darifenacin to spike violently. Daily dose must not exceed 7.5 mg in these patients.
• Severe Constipation & Dry Mouth: The most frequent adverse events are profound dry mouth and severe constipation. Patients must be counseled to increase fluid and fiber intake to prevent dangerous fecal impaction.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Urology/Geriatric Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Antispasmodic Therapeutics, Selective Muscarinic Antagonists, and High-Precision Prolonged-Release Formulations. Whether you are looking for a reliable Government Tender Supplier for geriatric care clinics in the CIS or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.