Description

Frusemide Tablets (20mg / 40mg / 500mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Frusemide (Furosemide) Tablets in India. Frusemide is a potent Loop Diuretic, often referred to as a “High-Ceiling Diuretic” because its effect increases dose-dependently and it remains effective even in patients with reduced kidney function. It is the first-line emergency and maintenance treatment for Edema (fluid overload) associated with Heart Failure, Cirrhosis, and Renal Disease, as well as for the management of Hypertension.

We offer Contract Manufacturing (Third Party) services for this critical care medicine. Frusemide is practically insoluble in water and sensitive to light. Our WHO-GMP certified facility in Mumbai utilizes advanced Micronization techniques to ensure rapid dissolution and onset of action (critical for relieving breathlessness in heart failure). Healthy Inc manages the export logistics, supplying hospitals, dialysis centers, and pharmacy chains across the UK, Australia, Africa, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Fast action for fluid relief.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Micronized API: To ensure the tablet works within 30-60 minutes, we use micronized Frusemide API. This increases the surface area, allowing for rapid dissolution in the stomach, which is vital for patients suffering from acute pulmonary edema.

  • High-Dose Capability: We are one of the few manufacturers capable of producing 500mg Tablets. These are specialized “Rescue Doses” used strictly in hospital settings for patients with severe Chronic Kidney Disease (CKD) or Oliguria who do not respond to standard doses.

  • Light Stability: Frusemide degrades and turns yellow/brown upon exposure to light. We process it in amber-lit zones and recommend opaque blistering (Alu-PVC or Alu-Alu) for maximum stability.

• The Exporter: Healthy Inc

  • Flexible Pack Sizes: We offer standard 10-tablet blisters for retail hypertension management and large 1000-count jars for hospital wards treating chronic heart failure.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 30 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Related Substances: We strictly monitor for degradation products (like 4-chloro-5-sulfamoylanthranilic acid) to ensure safety.

5. Why Use Frusemide?

The most powerful way to remove excess water.

• Mechanism: It acts on the Thick Ascending Limb of the Loop of Henle in the kidney nephron. It inhibits the Na+-K+-2Cl- cotransporter (NKCC2). This prevents the body from reabsorbing salt (Sodium/Chloride), causing massive amounts of salt and water to be flushed out in the urine.

• Key Indications:

  • Edema: Reduces swelling in legs (peripheral edema) and fluid in the lungs (pulmonary edema) caused by Heart Failure.

  • Hypertension: Used when other diuretics (like Hydrochlorothiazide) are not strong enough or if kidney function is poor.

  • Renal Failure: Helps maintain urine output in failing kidneys.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Frusemide Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Is it Lasix?

  A: Lasix is the brand name (Sanofi). We manufacture the Generic Equivalent (Furosemide/Frusemide), which works exactly the same way.

• Q: Will I need to use the bathroom often?

  A: Yes. The drug works by making you urinate. You should take it in the morning (or at least 4 hours before sleep) so you do not have to wake up at night.

• Q: Does it affect potassium?

  A: Yes. It is a strong “Potassium-Wasting” diuretic. You may need to take Potassium supplements or eat bananas/oranges to prevent muscle cramps.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Edema (Adults): 20mg to 80mg daily. Can be titrated up to 600mg in severe cases (hospital only).

• Hypertension: 40mg twice daily.

• Renal Failure: High doses (250mg – 500mg) used cautiously under specialist supervision.

• Administration: Swallow with water. Best taken on an empty stomach for consistent absorption, but can be taken with food.

9. Side Effects and Precautions

• Electrolytes: Severe Hypokalemia (low potassium), Hyponatremia (low sodium), and Dehydration. Monitor bloodwork regularly.

• Ototoxicity: High doses (especially injected rapidly or high-dose tablets) can cause temporary or permanent hearing loss/tinnitus.

• Hypotension: Can cause a sudden drop in blood pressure. Stand up slowly.

• Sulfa Allergy: Structurally similar to sulfonamides; use with caution in allergic patients.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light. Discard if tablets turn yellow.