Description

Losartan Potassium & Hydrochlorothiazide Tablets

(50mg/12.5mg | 100mg/25mg)

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 Losartan Potassium and Hydrochlorothiazide Tablets in India. This is a powerful Fixed-Dose Combination (FDC) antihypertensive therapy. It combines Losartan (an Angiotensin II Receptor Blocker – ARB) with Hydrochlorothiazide (a Thiazide Diuretic). This dual-action formula is the “Gold Standard” for treating patients whose blood pressure is not adequately controlled by Losartan alone, providing a synergistic effect that significantly lowers blood pressure and reduces the risk of stroke.

We offer Contract Manufacturing (Third Party) services for this high-volume cardiovascular product. Losartan is hygroscopic (absorbs moisture), and recent global regulations require strict control over nitrosamine impurities. Our WHO-GMP certified facility in Mumbai utilizes low-humidity manufacturing suites and Advanced Impurity Screening to ensure our product is safe, stable, and compliant with the latest USFDA and EMA safety standards. Healthy Inc manages the export logistics, supplying cardiology centers and pharmacy chains across the USA, Europe, and the CIS region.

2. Product Specifications

3. Manufacturing Technology

The synergy of science and safety.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Nitrosamine-Free Promise: Due to global concerns about “Sartans,” we source API only from certified vendors with proven Nitrosamine-Free synthesis routes. We strictly test every batch to guarantee no genotoxic impurities are present.

  • Moisture Defense: Losartan turns into a sticky “gum” if exposed to moisture. We manufacture in dehumidified zones (< 20% RH) and pack in Alu-Alu Cold Form Blisters or bottles with high-capacity silica gel canisters to ensure the tablet stays crisp and effective.

  • Content Uniformity: Hydrochlorothiazide is a potent low-dose diuretic. We use Geometric Dilution and automated mixing to ensure it is perfectly distributed, preventing “hot spots” that could cause excessive urination or electrolyte imbalance.

• The Exporter: Healthy Inc

  • Calendar Packs: We design “Reminder Packaging” (marked Mon-Sun) to improve adherence, as missing doses can lead to dangerous “Rebound Hypertension.”

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles for both drugs simultaneously to ensure immediate bioavailability.

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

• Safety Testing: Rigorous screening for Nitrosamines (NDMA, NDEA) and organic volatile impurities.

5. Why Use Losartan + HCTZ?

The “Dual Attack” on High Blood Pressure.

• Mechanism:

  1. Losartan (The Vasodilator): Blocks the hormone Angiotensin II, which normally tightens blood vessels. By blocking it, vessels relax and widen, lowering pressure.

  2. Hydrochlorothiazide (The Diuretic): Acts on the kidneys to remove excess Salt (Sodium) and Water from the body. This reduces blood volume.

  • Synergy: The diuretic activates the renin-angiotensin system, making the ARB (Losartan) even more effective than it would be alone.

• Key Indications:

  • Hypertension: For patients not controlled on monotherapy.

  • Stroke Risk Reduction: Specifically indicated to reduce the risk of stroke in patients with hypertension and Left Ventricular Hypertrophy (LVH).

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 Losartan HCTZ Tablets?

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

• Q: Is it Hyzaar?

  A: Hyzaar is the brand name (Merck). We manufacture the Generic Equivalent (Losartan + HCTZ), which is bioequivalent.

• Q: Why combine them?

  A: Better Control. Combining two drugs with different mechanisms lowers blood pressure more effectively than doubling the dose of just one drug, often with fewer side effects.

• Q: Will I urinate more?

  A: Yes. Hydrochlorothiazide is a “water pill.” You will urinate more frequently, especially in the first few weeks. It is best to take it in the morning.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Hypertension: One tablet daily. (Start with 50/12.5mg, increase to 100/25mg if needed after 3 weeks).

• Administration: Take once daily. Can be taken with or without food. Take in the morning to avoid night-time urination.

9. Side Effects and Precautions

• Metabolic: Hypokalemia (low potassium – caused by HCTZ), Hyperkalemia (high potassium – caused by Losartan). These usually balance out, but monitoring is needed.

• Gastrointestinal: Nausea, dizziness, lightheadedness (orthostatic hypotension).

• Renal: Monitor kidney function (Creatinine) and electrolytes regularly.

• Contraindications: Pregnancy (Black Box Warning) – causes fetal harm. Anuria (kidney failure). Sulfonamide allergy.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep tightly closed. (Highly Sensitive to Moisture).