Description
Furosemide & Spironolactone Film-Coated Tablets (20 mg / 50 mg)
Healthy Inc is a specialized global supplier and exporter of advanced cardiovascular, nephrology, and hepatic-support therapeutics. We provide ultra-high-purity, kinetically synchronized Furosemide & Spironolactone Film-Coated Tablets (20 mg / 50 mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Synergistic Loop & Potassium-Sparing Diuretic FDC” is a massive-volume, highly critical export to cardiology centers, liver transplant step-down units, internal medicine networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated intervention for refractory edema associated with Congestive Heart Failure (CHF), Liver Cirrhosis (Ascites), and severe Nephrotic Syndrome.
Product Overview
This highly advanced formulation operates as a coordinated, dual-front biochemical assault on fluid overload. It forces the kidneys to rapidly excrete massive volumes of trapped water and sodium while simultaneously deploying a chemical shield to prevent the lethal depletion of essential cardiac electrolytes.
The “Aldosterone Blockade & Potassium-Sparing” Specialist:
- Mechanism 1 (The Flash-Flood Loop Blockade – Furosemide): Furosemide is a tremendously powerful loop diuretic. It violently blocks the Na+/K+/2Cl- symporter in the thick ascending limb of the loop of Henle in the kidneys. This paralyzes the kidney’s ability to reabsorb sodium, causing a massive, rapid “flash flood” of sodium and water out of the body through the urine, rapidly clearing fluid from waterlogged lungs and swollen extremities.
- Mechanism 2 (The Aldosterone Antagonist – Spironolactone): In heart failure and liver cirrhosis, the body panics and produces massive amounts of the hormone Aldosterone, which causes severe fluid retention and cardiac fibrosis (scarring). Spironolactone directly and aggressively blocks the aldosterone receptors in the distal convoluted tubule and collecting ducts. This forces further sodium excretion while simultaneously preventing the structural scarring of the heart and liver.
- The “Electrolyte Shield” Synergy: Furosemide’s greatest danger is that it flushes out massive amounts of Potassium, leading to hypokalemia and sudden cardiac arrest. Spironolactone actively forces the kidneys to retain Potassium. By combining them in this exact 20mg/50mg ratio, the FDC perfectly balances the body’s electrolytes, allowing for massive fluid clearance without triggering fatal arrhythmias.
Product Composition & Strength
We supply this product as a Precision-Blended, High-Density Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-PVC or Alu-Alu blister strips to ensure the absolute chemical stability of both active pharmaceutical ingredients.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Furosemide USP/Ph.Eur. | 20 mg | The Loop Diuretic (Fluid Clearance): Rapidly eliminates severe fluid buildup (edema) from the lungs, abdomen, and peripheral tissues. |
| Spironolactone USP/Ph.Eur. | 50 mg | The Potassium-Sparing Shield: Blocks aldosterone, prevents toxic cardiac fibrosis, and heavily protects the patient against lethal hypokalemia. |
| Excipients | Microcrystalline Cellulose / Lactose Monohydrate / Sodium Starch Glycolate / Povidone K-30 / Magnesium Stearate / Premium Polymeric Film | Diluent / Binder / Superdisintegrant / Slipper-Coating (Engineered utilizing advanced wet-granulation to ensure both the rapid-acting Furosemide and the slower-acting Spironolactone dissolve at precise, synchronized rates to guarantee the electrolyte-sparing synergy) |
*Pack Sizes: 10×10 Blisters (Optimized specifically for strict chronic cardiology and hepatology dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Cardiology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Cardiology/Diuretics) |
| CAS Numbers | 54-31-9 (Furosemide) / 52-01-7 (Spironolactone) |
| Dosage Form | Film-Coated Tablet (Immediate Gastric Release) |
| Packaging | High-Density Alu-PVC or Alu-Alu Blisters. Protects the formulation from environmental humidity across Zone IVb tropical climates. (Note: Film coating is heavily utilized to mask the characteristic, slightly sulfurous/peppermint odor of Spironolactone). |
| Storage | Store strictly below 30°C in a dry place. Protect heavily from Light. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Dual-Matrix Dissolution & Odor-Masking (CRITICAL COMPLIANCE): Furosemide is highly sensitive to light, and Spironolactone possesses a strong, inherently unpleasant odor that can cause immediate patient non-compliance. Our cardiology suites utilize advanced film-coating polymers to completely seal the tablet, creating an absolute barrier against UV degradation while perfectly masking the taste and smell. Furthermore, rigorous HPLC dissolution testing guarantees that the two APIs enter the bloodstream at the exact ratios required to maintain the delicate potassium balance.
Therapeutic Indications (Human Use)
Indicated for the targeted, highly specialized management of severe fluid overload and hyperaldosteronism:
- Congestive Heart Failure (CHF): Management of severe pulmonary edema and peripheral swelling in patients requiring aggressive diuresis without risking fatal hypokalemia.
- Liver Cirrhosis with Ascites: The absolute gold-standard oral therapy for draining massive fluid accumulation in the abdominal cavity caused by hepatic failure.
- Resistant Edema & Nephrotic Syndrome: Management of severe fluid retention that does not respond to single-agent diuretic therapy.
Dosage & Administration
Recommended Dosage (Strictly as per Cardiologist / Hepatologist Guidelines):
- Standard Adult Dosing: Typically 1 to 4 tablets daily, highly dependent on the severity of the edema and the patient’s baseline electrolyte panel.
- Administration (The “Morning” Rule): MUST be taken in the morning. Taking this massive diuretic combination in the evening will force the patient to urinate constantly throughout the night, completely destroying their sleep architecture.
- Food Intake: Can be taken with meals to minimize gastrointestinal upset.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Electrolyte Imbalance Paradox (Hypo/Hyperkalemia): While the FDC is designed to balance potassium, it can swing in either direction depending on patient diet and renal function. Regular serum potassium and creatinine monitoring is absolutely mandatory to prevent cardiac arrest.
- Severe Gynecomastia (Spironolactone): Spironolactone acts as a mild anti-androgen. Prolonged use in men frequently causes painful, enlarged breast tissue (gynecomastia) and impotence. Patients must be warned of this cosmetic and endocrine side effect.
- Profound Hypotension & Dehydration: Aggressive diuresis can rapidly drain the patient’s intravascular volume, leading to catastrophic drops in blood pressure, fainting, and acute kidney injury.
- Sulfa Allergy (Furosemide): Furosemide is a sulfonamide derivative. Patients with severe, life-threatening sulfa allergies may experience catastrophic anaphylaxis or severe skin reactions (SJS).
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Cardiology/Hepatology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Diuretics, Synergistic FDCs, and Cardiovascular Formulations. Whether you are looking for a reliable Government Tender Supplier for liver transplant wards in Africa or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.
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