Description

Hydrochlorothiazide Tablets (12.5mg / 25mg / 50mg)

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 Hydrochlorothiazide (HCTZ) Tablets in India. HCTZ is the most commonly prescribed Thiazide Diuretic (“water pill”) globally. It is the first-line treatment for mild-to-moderate Essential Hypertension and is also used to manage Edema (fluid retention) associated with congestive heart failure, hepatic cirrhosis, and corticosteroid therapy.

We offer Contract Manufacturing (Third Party) services for this high-volume essential medicine. Hydrochlorothiazide is light-sensitive and requires precise formulation to ensure consistent bioavailability. Our WHO-GMP certified facility in Mumbai utilizes high-speed tableting lines capable of producing millions of tablets daily to meet large-scale government tenders. Healthy Inc manages the export logistics, supplying national health programs and pharmacy chains across the Americas, Africa, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Consistency in every tablet.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Direct Compression: HCTZ has excellent flow properties. We use direct compression technology with specific disintegrants (like Crospovidone) to ensure rapid disintegration (< 5 minutes), allowing the drug to start working quickly.

  • Light Protection: The API degrades upon exposure to light. We use opaque blister films (Amber PVC or Alu-Alu) and light-resistant coating materials (if film-coated) to ensure stability.

  • Content Uniformity: We ensure strict blend uniformity to guarantee that every tablet, especially the low-dose 12.5mg, contains the precise amount of active ingredient.

• The Exporter: Healthy Inc

  • Cost-Effective Packs: We offer economic blister packs (10 strips of 10 tablets) and bulk jars (1000s) designed for high-volume markets where cost per dose is a critical factor.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >60% of the drug releases within 30 minutes (USP Standard).

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

• Related Substances: We strictly monitor for degradation products (like chlorothiazide) to ensure safety.

5. Why Use Hydrochlorothiazide?

It flushes out excess salt and water.

• Mechanism: It acts on the Distal Convoluted Tubule of the kidney nephron. It inhibits the Sodium-Chloride Symporter (NCC), preventing the reabsorption of sodium and chloride. This causes water to stay in the urine (osmosis) and be excreted, reducing blood volume and blood pressure.

• Key Indications:

  • Hypertension: Effective as monotherapy or combined with ACE inhibitors/ARBs/Beta-blockers.

  • Edema: Reduces swelling in ankles/legs due to heart failure or liver disease.

  • Kidney Stones: Reduces urinary calcium excretion, preventing calcium stones.

  • Diabetes Insipidus: Paradoxically reduces urine volume in this specific condition.

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 Hydrochlorothiazide Tablets?

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

• Q: Is it Microzide?

  A: Microzide is a brand name (Actavis). We manufacture the Generic Equivalent (Hydrochlorothiazide), which acts exactly the same.

• Q: Will it make me urinate a lot?

  A: Yes. That is how it works. It is best to take it in the morning so you don’t have to wake up at night to use the bathroom.

• Q: Does it affect potassium?

  A: Yes. It can lower potassium levels (Hypokalemia). Eat bananas or oranges while taking this medication.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Hypertension: 12.5mg to 25mg once daily.

• Edema: 25mg to 100mg daily (single or divided doses).

• Administration: Take in the morning with food to reduce stomach upset.

9. Side Effects and Precautions

• Electrolyte Imbalance: Hypokalemia (low potassium), Hyponatremia (low sodium), Hypercalcemia (high calcium).

• Metabolic: Can raise blood sugar (Caution in Diabetics) and Uric Acid (Risk of Gout).

• Photosensitivity: Increased risk of sunburn. Use sunscreen.

• Sulfa Allergy: Contraindicated in patients with severe sulfonamide allergy.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light and moisture.