Description

Mirabegron Extended-Release Tablets (25 mg / 50 mg)

Healthy Inc is a specialized global supplier and exporter of advanced urological, geriatric-support, and modified-release therapeutics. We provide ultra-high-purity, kinetically controlled Mirabegron Extended-Release (ER) Film-Coated Tablets (25 mg / 50 mg), manufactured in WHO–GMP certified, high-precision extended-release oral solid dosage facilities. This “Beta-3 Adrenergic Agonist” is an ultra-high-value, highly lucrative export to urology centers, specialized geriatric clinics, retail pharmacy networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, premium intervention for Overactive Bladder (OAB) syndrome with symptoms of urge urinary incontinence, urgency, and frequency.

Product Overview

This highly advanced formulation utilizes a completely novel mechanism of action, fundamentally separating itself from the debilitating side-effect profiles of traditional antimuscarinic OAB therapies. It actively expands the bladder’s capacity while completely sparing the patient’s cognitive and gastrointestinal function.

The “Beta-3 Detrusor Relaxation & Anti-Dementia” Specialist:

• Mechanism 1 (The Beta-3 Adrenergic Activation): Overactive Bladder is caused by the detrusor muscle violently and unpredictably contracting even when the bladder is not full. Mirabegron aggressively targets and activates Beta-3 adrenergic receptors located directly on the detrusor muscle. This activation causes the muscle to actively relax during the storage phase. By increasing the physical capacity of the bladder, it drastically reduces the sudden, desperate urge to urinate and the frequency of restroom visits.
• Mechanism 2 (The “Non-Anticholinergic” Paradigm Shift): Older OAB drugs work by blocking acetylcholine. Unfortunately, acetylcholine is also required for producing saliva, moving the bowels, and forming memories in the brain. Because Mirabegron does not block acetylcholine, patients experience profound relief from urinary incontinence with zero drug-induced dry mouth, zero constipation, and zero risk of drug-induced cognitive decline—making it the absolute gold standard for elderly patients.
• The 24-Hour ER Kinetic Shield (CRITICAL): Mirabegron must be released into the bloodstream at a slow, steady trickle. Our advanced Extended-Release formulation utilizes a complex swellable polymer matrix that paces the drug’s absorption over 24 hours. This ensures constant bladder relaxation while preventing the sharp blood plasma spikes that can trigger dangerous cardiovascular side effects.

Product Composition & Strength

We supply this product as a Precision-Blended, Hydrophilic Matrix ER Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute physical stability of the extended-release polymers.

*Pack Sizes: 10×10 Alu-Alu Blisters or Bottles of 30 (Optimized specifically for strict 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.

• Polymeric Matrix Engineering & Anti-Dose-Dumping (CRITICAL COMPLIANCE): The cardiovascular safety of Mirabegron is entirely dependent on its release rate. If manufactured poorly, the tablet can “dose dump” its entire 50mg payload into the stomach at once, causing a violent spike in the patient’s heart rate and blood pressure. Our facilities utilize advanced high-shear granulation to embed the Mirabegron into a precise Polyethylene Oxide / HPMC matrix. This guarantees a flawless, 24-hour pharmacokinetic dissolution curve, delivering maximum urological efficacy while ensuring absolute cardiovascular safety.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized management of urinary tract dysfunction:

• Overactive Bladder (OAB): Treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency.
• Alternative to Antimuscarinics: The primary treatment pathway for patients who cannot tolerate the severe dry mouth, constipation, or cognitive risks associated with older therapies like Oxybutynin, Tolterodine, or Solifenacin.

Dosage & Administration

Recommended Dosage (Strictly as per Urologist Guidelines):

• Standard Adult Dosing: 25 mg taken orally once daily. Based on individual patient efficacy and tolerability, the dose may be increased to 50 mg once daily after 4 to 8 weeks.
• Administration (THE INTACT RULE – FATAL WARNING): The tablet MUST be swallowed completely whole with water. It must never be crushed, broken, or chewed. Destroying the ER matrix will cause an immediate, dangerous spike in blood plasma levels.
• Food Interaction: Can be taken with or without food.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Severe Uncontrolled Hypertension (Absolute Contraindication): Mirabegron can increase blood pressure and heart rate. It is strictly contraindicated in patients with severe uncontrolled hypertension (systolic BP ≥ 180 mm Hg and/or diastolic BP ≥ 110 mm Hg). Blood pressure must be monitored periodically, especially in hypertensive patients.
• Urinary Retention Risk: Must be administered with extreme caution in patients with clinically significant bladder outlet obstruction (like severe BPH) or those taking antimuscarinic medications, due to the risk of acute urinary retention.
• CYP2D6 Drug Interactions: Mirabegron is a moderate inhibitor of the CYP2D6 liver enzyme. It will significantly spike the blood levels of other drugs metabolized by this pathway, particularly narrow-therapeutic-index drugs like Flecainide or Propafenone, and Beta-Blockers like Metoprolol.

Global Export & Contract Manufacturing Services

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