Description
Spironolactone Tablets (25 mg / 500 mg / 100 mg)
Healthy Inc is a premier global supplier of specialized cardiovascular and endocrine therapies. We provide premium Spironolactone Tablets, manufactured in WHO–GMP certified facilities. As a critical potassium-sparing diuretic, this product is a cornerstone export for cardiology units, nephrology centers, and dermatology clinics across Southeast Asia, Africa, and the Middle East.
Product Overview
Spironolactone is a synthetic steroid that acts as a competitive aldosterone antagonist. Unlike loop or thiazide diuretics, it promotes the excretion of sodium and water while retaining potassium, making it essential for patients at risk of hypokalemia.
The “Aldosterone-Blocking” Specialist:
- Mechanism of Action: Spironolactone binds competitively to the mineralocorticoid receptors in the distal convoluted tubule and collecting duct. It prevents aldosterone from promoting sodium-potassium exchange, resulting in increased sodium/water excretion and potassium retention.
- Cardioprotective Benefits: In chronic heart failure (CHF), Spironolactone reduces cardiac fibrosis and remodeling, significantly lowering mortality and hospitalization rates as demonstrated in the RALES trial.
- Anti-Androgenic Activity: Due to its ability to block androgen receptors and inhibit 5-alpha reductase, it is widely utilized for Hormonal Acne, Hirsutism, and Polycystic Ovary Syndrome (PCOS) in specialized dermatological settings.
Technical & Manufacturing Specifications
Formulated for precise active ingredient stability and consistent dissolution.
| Technical Metric | Specification Standard |
|---|---|
| Active Ingredient | Spironolactone BP / USP / IP |
| Dosage Form | Film-Coated or Uncoated Tablets |
| Available Strengths | 25 mg, 50 mg, 100 mg |
| HS Code | 3004.39.12 (Steroid Hormones) / 2937.29.00 |
| Packaging | Alu-Alu Blister or PVDC/Alu (Protection against oxidation) |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from ISO 9001:2015 certified units.
- Micronization for Bioavailability: Spironolactone is practically insoluble in water. We utilize micronized API to increase the surface area, ensuring rapid absorption and bioequivalence with the innovator brand (Aldactone).
- Odor Masking Excellence: Pure Spironolactone has a characteristic mercaptan-like odor. Our tablets feature a specialized film-coating technology to mask unpleasant tastes and odors, improving long-term patient compliance.
- Content Uniformity: Utilizing high-shear granulation, we ensure exact dosing across all strengths, which is critical for the narrow titration required in renal and hepatic failure management.
Therapeutic Indications & Clinical Symptoms
- Congestive Heart Failure (CHF): Management of edema and reduction of mortality in severe heart failure.
- Hepatic Cirrhosis with Ascites: Primary diuretic choice for managing fluid accumulation in liver disease.
- Essential Hypertension: Particularly effective in resistant hypertension or primary hyperaldosteronism (Conn’s Syndrome).
- Hormonal Acne & Hirsutism: Off-label management of androgen-related skin conditions in females.
Dosage & Administration
- Dosing: Ranges from 25 mg to 200 mg daily, tailored to the specific condition and serum potassium levels.
- Administration: Best taken with food to enhance absorption and minimize gastrointestinal irritation.
- Safety Monitoring: Regular monitoring of Serum Potassium and Renal Function is mandatory to avoid hyperkalemia.
Global Export & Contract Manufacturing Services
Healthy Inc is a verified Pharmaceutical Exporter in Mumbai, catering to Specialty Hospital Chains and Ministry of Health Tenders. We offer Third Party Manufacturing for Spironolactone with full CTD Dossier and COPP support. Our logistics network ensures secure transit to Vietnam, Philippines, Nigeria, and the UAE, providing WHO-GMP quality at competitive B2B prices.
Commercial Inquiries
WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in
