Atenolol with Chlorthalidone Tablets

Description

Atenolol and Chlorthalidone Tablets

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 Atenolol and Chlorthalidone Tablets in India. This is a synergistic Antihypertensive Combination widely used for the management of Hypertension (high blood pressure) that is not adequately controlled by monotherapy. It combines the heart-rate-lowering effect of Atenolol (a cardioselective beta-blocker) with the fluid-reducing action of Chlorthalidone (a long-acting diuretic).

We offer Contract Manufacturing (Third Party) services for this effective dual-therapy formulation. Our WHO-GMP certified facility in Mumbai utilizes advanced blending technologies to ensure the precise distribution of Chlorthalidone, which is crucial for consistent blood pressure control. Healthy Inc manages the export logistics, supplying this essential cardiovascular medicine to pharmacy chains and hospitals across the Middle East, Africa, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Ensuring uniformity in a combination drug is critical.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.
  • Content Uniformity: Chlorthalidone is potent in low doses (12.5mg). We use Geometric Dilution and high-shear granulation to ensure it is evenly distributed throughout the bulk of the tablet. This prevents “hot spots” where a single tablet could cause excessive urination or hypotension.
  • Stability: Atenolol is relatively stable, but Chlorthalidone can degrade in moist conditions. We process the blend in Controlled Humidity Suites (< 40% RH) and use specific binders to ensure a hard, stable tablet.
  • Dissolution: We optimize the formulation so both drugs release at compatible rates, ensuring smooth absorption and 24-hour blood pressure control.
• The Exporter: Healthy Inc
  • Packaging: We use PVDC-coated PVC Blisters or Alu-Alu Blisters to provide a robust barrier against moisture and light. This ensures the product remains effective even in hot and humid export markets.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Assay: We simultaneously quantify both Atenolol and Chlorthalidone using validated HPLC methods to ensure 100% label claim.
• Dissolution: We test the release profile to confirm that >80% of both drugs release within 30-45 minutes.
• Related Substances: We strictly monitor for degradation impurities to ensure safety over the 3-year shelf life.

5. Why Use Atenolol + Chlorthalidone?

It targets two key mechanisms of high blood pressure.

• Mechanism:
  • Atenolol: Blocks beta-1 receptors in the heart, slowing down the heart rate and reducing the force of contraction. This lowers the workload on the heart.
  • Chlorthalidone: A thiazide-like diuretic that prevents the kidneys from reabsorbing salt and water. This increases urine output, reducing blood volume and arterial pressure.
• Key Indications:
  • Hypertension: Specifically for patients who need multiple drugs to reach their BP goal.
  • Advantage: Chlorthalidone has a longer duration of action (48-72 hours) compared to Hydrochlorothiazide, providing smoother, gap-free BP control.

6. Export and Regulatory Support

• 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 Atenolol Chlorthalidone Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

Q: Is Chlorthalidone better than Hydrochlorothiazide (HCTZ)?
A: Clinical evidence (like the ALLHAT trial) suggests Chlorthalidone is superior at reducing cardiovascular events because it works for a full 24 hours, whereas HCTZ wears off sooner.

Q: Can I stop taking this suddenly?
A: No. Stopping a beta-blocker (Atenolol) abruptly can cause “rebound hypertension,” chest pain, or even a heart attack. Taper off under medical supervision.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: One tablet daily, usually in the morning.
• Timing: Take in the morning to avoid needing to wake up at night to urinate (due to the diuretic).
• Administration: Swallow whole with water. Can be taken with food.

9. Side Effects and Precautions

• Common Side Effects: Dizziness, fatigue, cold hands/feet (Atenolol effect), and increased urination.
• Electrolytes: Chlorthalidone can lower potassium levels (hypokalemia). Periodic blood tests are recommended.
• Contraindications: Asthma (beta-blockers can cause bronchospasm), severe bradycardia (slow heart rate), or anuria (kidney failure).

10. Storage Instructions

• Store below 25°C in a dry place.
• Protect from light and moisture.