Description

Acetazolamide Tablets (250mg)

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 Acetazolamide Tablets in India. Acetazolamide is a potent Carbonic Anhydrase Inhibitor used primarily to treat Glaucoma (by reducing intraocular pressure), Altitude Sickness (preventing Acute Mountain Sickness), and as an adjuvant in Epilepsy and congestive heart failure (for edema).

We offer Contract Manufacturing (Third Party) services for this specialized diuretic agent. Acetazolamide is a diuretic that works by a unique mechanism involving bicarbonate excretion. Our WHO-GMP certified facility in Mumbai ensures precise formulation to guarantee consistent bioavailability and therapeutic efficacy. Healthy Inc manages the export logistics, supplying ophthalmology clinics, travel medicine suppliers, and hospitals across South America, Nepal (Himalayan regions), and Africa.

2. Product Specifications

3. Manufacturing Technology

Managing pressure with precision.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Dissolution Control: Acetazolamide is slightly soluble in water. We utilize Micronized API and specific wetting agents to ensure rapid disintegration and dissolution in the stomach, which is crucial for acute altitude sickness relief or rapid intraocular pressure reduction.

  • Scored Tablet: Our 250mg tablets are deeply scored to facilitate accurate dose splitting (e.g., 125mg), which is often required for pediatric patients or during the tapering phase of treatment.

  • Purity Standards: We strictly control synthesis by-products to meet the tight USP limits, ensuring a safe product for long-term use in glaucoma patients.

• The Exporter: Healthy Inc

  • Travel Medicine Packs: We are experienced in supplying smaller blister packs tailored for “Travel Kits” sold to trekkers and mountaineers for altitude sickness prevention.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

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

• Dissolution: We test release profiles to ensure >75% of the drug releases within 45 minutes (0.1N HCl).

• Related Substances: We strictly monitor for degradation products to ensure stability.

5. Why Use Acetazolamide?

Lowering pressure, helping you breathe high up.

• Mechanism: Acetazolamide inhibits the enzyme Carbonic Anhydrase in the kidneys and eyes.

  • In Eyes: It reduces the production of aqueous humor (fluid inside the eye), lowering eye pressure.

  • At Altitude: It increases the excretion of bicarbonate in urine, making the blood slightly acidic (metabolic acidosis). This stimulates the respiratory center to breathe deeper and faster, increasing oxygen levels in the blood to prevent mountain sickness.

• Key Indications:

  • Glaucoma: Open-angle glaucoma (adjunct) and acute angle-closure glaucoma (pre-surgery).

  • Altitude Sickness: Prophylaxis and treatment of Acute Mountain Sickness (AMS).

  • Edema: Drug-induced edema or heart failure (adjunct).

  • Epilepsy: Centrencephalic epilepsies (adjunct).

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 Acetazolamide Tablets?

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

• Q: Is it Diamox?

  A: Diamox is the brand name. We manufacture the Generic Equivalent (Acetazolamide).

• Q: Does it contain Sulfa?

  A: Yes. Acetazolamide is a sulfonamide derivative. Patients with severe sulfa allergies should avoid it or use it with extreme caution.

• Q: Why do my fingers tingle?

  A: Paresthesia (tingling in fingers/toes) is a very common and harmless side effect caused by the electrolyte changes. It stops when you stop the drug.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Glaucoma: 250mg to 1000mg per day (divided doses).

• Altitude Sickness: 125mg to 250mg twice daily. Start 24 hours before ascent.

• Edema: 250mg to 375mg once daily in the morning.

• Administration: Take with food to reduce stomach upset.

9. Side Effects and Precautions

• Sensory: Paresthesia (tingling/numbness in extremities), taste alteration (carbonated drinks taste flat/metallic).

• Metabolic: Metabolic Acidosis, Hypokalemia (low potassium).

• Renal: Kidney stones (crystalluria). Drink plenty of water.

• Contraindications: Severe kidney/liver disease, Sulfa allergy, Adrenal insufficiency.

• Pregnancy: Avoid in first trimester.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.