Description
Tamsulosin & Dutasteride Capsules
Healthy Inc is a specialized global supplier and exporter of advanced urological and geriatric care therapeutics. We provide high-purity Tamsulosin (0.4 mg) & Dutasteride (0.5 mg) Capsules, manufactured in WHO–GMP certified, highly specialized advanced pelletization facilities. This “Dual-Action BPH Therapy” is a massive-volume, ultra-premium export to urology centers, surgical hospitals, and government health ministries in Africa, LATAM, and Southeast Asia, serving as the definitive, disease-modifying intervention for severe Benign Prostatic Hyperplasia (BPH) and the prevention of acute urinary retention.
Product Overview
This advanced formulation combines two highly synergistic urological agents: Tamsulosin Hydrochloride (a uro-selective alpha-1 adrenoceptor antagonist) and Dutasteride (a potent, dual 5-alpha-reductase inhibitor).
The “Complete Prostate Shrinkage & Relief” Specialist:
- Mechanism 1 (Tamsulosin – Immediate Symptom Relief): Tamsulosin binds selectively to the alpha-1A receptors in the prostate and bladder neck. By blocking these receptors, it instantly relaxes the smooth muscle, drastically reducing urethral resistance and providing rapid, day-one relief from painful urinary retention, hesitancy, and weak stream.
- Mechanism 2 (Dutasteride – Disease Modification): While Tamsulosin treats the symptom, Dutasteride treats the disease. It aggressively inhibits both Type I and Type II 5-alpha-reductase enzymes, completely shutting down the conversion of testosterone into dihydrotestosterone (DHT). Because DHT is the primary hormone driving prostate growth, plummeting DHT levels cause the hypertrophied prostate tissue to undergo apoptosis (cell death), physically shrinking the prostate gland over 3 to 6 months.
- The Synergistic Clinical Advantage: Monotherapy often fails in severe BPH. This combination provides immediate symptomatic relief (via Tamsulosin) while simultaneously working long-term to shrink the prostate (via Dutasteride), drastically reducing the patient’s risk of requiring highly invasive transurethral resection of the prostate (TURP) surgery.
Product Composition & Strength
We supply this product as a highly advanced Hard Gelatin Capsule containing both Modified-Release Tamsulosin Pellets and Dutasteride, packed strictly in high-barrier Alu-Alu blister strips.
| Active Ingredient | Strength & Format | Release Profile Function |
|---|---|---|
| Tamsulosin Hydrochloride USP/BP | 0.4 mg (Modified-Release Pellets) | Alpha-1 blocker for immediate, 24-hour smooth muscle relaxation. |
| Dutasteride BP/Ph.Eur. | 0.5 mg (Isolated Matrix/Softgel) | 5-ARI for profound DHT suppression and long-term prostate shrinkage. |
| Excipients | Methacrylic Acid Copolymer / Butylated Hydroxytoluene | MR Polymer Coating / Potent Antioxidant Stabilizer |
*Pack Sizes: 10×10 Alu-Alu Blisters or 10×15 Alu-Alu Blisters (optimized for 30-day monthly urology dispensing cycles).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Urology Distributors.
| HS Code | 3004.90.99 (Medicaments containing other active substances) |
| CAS Numbers | 106133-20-4 (Tamsulosin) / 164656-23-9 (Dutasteride) |
| Dosage Form | Hard Gelatin Capsule containing advanced multi-particulate system |
| Packaging | Alu-Alu Blisters (CRITICAL). Absolute protection against light and moisture is required to prevent degradation of the highly sensitive Dutasteride API and the Tamsulosin MR polymers. |
| Storage | Store strictly below 25°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.
- Advanced Chemical Isolation Technology: Dutasteride is highly lipophilic, while Tamsulosin requires a strict pH-dependent release matrix. Combining them requires elite-level pharmaceutical engineering. Our capsules utilize an advanced multi-particulate isolation system (often employing a “Capsule-in-Capsule” or strictly segregated pellet coating technology) to guarantee absolutely zero cross-reactivity between the APIs over the product’s 24-month shelf life.
- Teratogenic API Containment: Dutasteride is highly teratogenic. It is manufactured and encapsulated within dedicated, negative-pressure isolator suites featuring heavy HEPA filtration to guarantee the absolute safety of facility operators and eliminate any risk of cross-contamination with other drug lines.
Therapeutic Indications (Human Use)
Indicated for the comprehensive management of symptomatic Benign Prostatic Hyperplasia (BPH) in men with an enlarged prostate:
- Symptom Management: Immediate and sustained treatment of moderate to severe symptoms of BPH.
- Disease Progression Halt: Drastically reduces the risk of acute urinary retention (AUR) and the necessity for BPH-related surgery (e.g., TURP).
Dosage & Administration
Recommended Dosage (Strictly as per Urologist):
- Administration (TIMING): Taken orally, once daily, approximately 30 minutes after the same meal each day. Consistent timing relative to food intake is mandatory to prevent dangerous spikes in Tamsulosin bioavailability.
- Swallowing Protocol (CRITICAL): The capsule MUST be swallowed whole. It must not be crushed, chewed, or opened. Destroying the capsule will cause immediate Tamsulosin dose-dumping (causing cardiovascular collapse) and expose the patient/handler to highly toxic Dutasteride powder.
Safety Warnings (CRITICAL):
- BLACK BOX EQUIVALENT (Teratogenicity – Handling Risk): Dutasteride is absorbed through the skin and causes catastrophic abnormalities to the external genitalia of a male fetus. Women who are pregnant or may become pregnant MUST NOT handle crushed, leaking, or opened capsules under any circumstances.
- Intraoperative Floppy Iris Syndrome (IFIS): Tamsulosin paralyzes the dilator muscle of the iris. Patients must inform their ophthalmologist that they are taking this medication prior to undergoing cataract surgery to prevent severe ocular complications.
- Orthostatic Hypotension: The alpha-blocking component can cause a sudden drop in blood pressure upon standing up, leading to dizziness or fainting, particularly during the first few days of therapy.
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 Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Urological Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government procurement 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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