Description

Tamsulosin & Dutasteride Tablets

Healthy Inc is a specialized global supplier and exporter of advanced urological, men’s health, and hormonal therapeutics. We provide ultra-high-purity, kinetically segregated Tamsulosin Hydrochloride (0.4 mg MR) & Dutasteride (0.5 mg) Tablets, manufactured in WHO–GMP certified, strictly dedicated hormonal containment oral solid dosage facilities. This “Dual-Pathway BPH Eradication Synergy” is a highly lucrative, premium export to urology centers, geriatric care networks, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, definitive intervention for moderate-to-severe Benign Prostatic Hyperplasia (BPH) and the prevention of acute urinary retention.

Product Overview

This highly advanced Fixed-Dose Combination (FDC) perfectly synchronizes a rapid-acting, uro-selective alpha-blocker with a highly potent, disease-modifying 5-alpha-reductase inhibitor (5-ARI).

The “Shrink & Relieve” Urological Specialist:

• Mechanism 1 (The Immediate Reliever – Tamsulosin 0.4mg): Within days of starting therapy, the Modified-Release Tamsulosin component binds to alpha-1A receptors in the prostate and bladder neck. This relaxes the smooth muscle, instantly relieving the physical strangulation of the urethra and restoring strong, normal urinary flow.
• Mechanism 2 (The Disease Modifier – Dutasteride 0.5mg): The prostate gland grows rapidly when testosterone is converted into Dihydrotestosterone (DHT). Dutasteride is a potent dual inhibitor of both Type 1 and Type 2 5-alpha-reductase enzymes, almost entirely shutting down DHT production. Starved of DHT, the enlarged prostate gland actively shrinks over 3 to 6 months. This stops the disease in its tracks, drastically reducing the patient’s risk of sudden urinary blockage (Acute Urinary Retention) or the need for invasive prostate surgery (TURP).
• The FDC Compliance Advantage: Older men suffering from BPH are often burdened with “pill fatigue.” Combining the immediate symptom relief of Tamsulosin with the long-term structural cure of Dutasteride into a single, once-daily tablet guarantees unparalleled patient compliance and superior long-term urological outcomes.

Product Composition & Strength

We supply this product as a Precision-Engineered Bilayer Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant and child-resistant Alu-Alu blister strips to ensure the absolute stability of both the kinetic polymer matrix and the sensitive hormonal API.

*Pack Sizes: 10×10 or 10×15 Alu-Alu Blisters (Optimized specifically for strict 30-day chronic urology adherence 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.

• Solid-State Hormonal Containment Engineering: Traditionally, Dutasteride is manufactured as a liquid inside a soft gelatin capsule. Formulating it into a highly stable solid tablet requires elite pharmaceutical engineering, involving specialized solid-lipid extrusion or advanced carrier matrices to ensure bioavailability. Furthermore, because Dutasteride is a potent hormonal teratogen, our manufacturing is executed within strictly segregated, highly controlled hormonal blocks operating under negative pressure with multi-stage HEPA filtration to guarantee absolute operator safety and zero cross-contamination.

Therapeutic Indications (Human Use)

Indicated for the comprehensive management of severe urological disease:

• Benign Prostatic Hyperplasia (BPH): Treatment of moderate-to-severe symptoms of BPH.
• Disease Progression Prevention: Reduction in the risk of acute urinary retention (AUR) and the need for BPH-related surgery in men with an enlarged prostate.

Dosage & Administration

Recommended Dosage (Strictly as per Urologist Guidelines):

• Standard Adult Dosing: One tablet taken orally once daily.
• Administration (THE 30-MINUTE RULE): Should be taken approximately 30 minutes after the same meal each day.
• Swallowing Protocol (CRITICAL HAZARD): The tablet MUST be swallowed whole. It must never be crushed, chewed, or divided. Chewing destroys the modified-release Tamsulosin matrix (causing hypotension) and risks exposing the oral mucosa to localized hormonal toxicity from Dutasteride.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX EQUIVALENT (Teratogenicity – Handling Risk): Dutasteride prevents the conversion of testosterone to DHT, which is essential for the development of male genitalia in a fetus. Women who are pregnant or may become pregnant MUST NOT handle crushed, broken, or leaking tablets. If the active ingredient is absorbed through the skin of a pregnant woman, it will cause catastrophic birth defects in a male fetus.
• Prostate-Specific Antigen (PSA) Alteration: Dutasteride artificially lowers serum PSA levels by approximately 50% within 3 to 6 months of therapy. Urologists must establish a new baseline PSA level after 6 months to accurately screen for prostate cancer, doubling the tested value for comparison against normal ranges.
• Intraoperative Floppy Iris Syndrome (IFIS): Tamsulosin can cause IFIS during cataract surgery. Patients must inform their ophthalmologist prior to surgery.
• Sexual Dysfunction: The Dutasteride component frequently causes decreased libido, impotence (erectile dysfunction), and ejaculation disorders. Patients should be counseled on these potential quality-of-life impacts.

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 FDCs, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for geriatric care 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.