Description

Methyldopa Tablets (250mg / 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 Methyldopa Tablets in India. Methyldopa is a classic Centrally Acting Alpha-2 Adrenergic Agonist. While newer blood pressure medicines exist, Methyldopa remains the Gold Standard and first-line treatment for Hypertension in Pregnancy (Gestational Hypertension & Preeclampsia) due to its proven long-term safety record for both the mother and the developing fetus.

We offer Contract Manufacturing (Third Party) services for this essential maternal health drug. Methyldopa is sensitive to oxidation (turning dark if exposed to air). Our WHO-GMP certified facility in Mumbai utilizes specialized Film Coating technologies and air-tight blister packing to ensure the tablets remain stable and effective. Healthy Inc manages the export logistics, supplying maternity hospitals and government health ministries across Africa, Latin America, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Stability and oxidation control are the manufacturing priorities.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Oxidation Protection: Methyldopa degrades into dark pigments (melanin-like) if exposed to oxygen and moisture. We manufacture in controlled humidity zones and use Iron Oxide Yellow in the film coating to provide a light barrier and mask any minor color changes.

  • Granulation: We use a wet granulation process optimized for compressibility, ensuring the tablet is hard enough to withstand shipping but disintegrates rapidly in the stomach for quick absorption.

  • Purity: We strictly test for the 3-O-methyl derivative impurity to ensure compliance with global standards.

• The Exporter: Healthy Inc

  • Tropicalized Packaging: We utilize Alu-PVC or PVDC Blisters which offer superior moisture resistance compared to standard PVC, ensuring the product survives in hot, humid export climates without darkening.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 20 minutes.

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

• Appearance: Strict visual inspection to reject any tablets showing signs of darkening (oxidation).

5. Why Use Methyldopa?

It is the safest choice for the unborn baby.

• Mechanism: It enters the brain and is converted into Alpha-methylnorepinephrine. This stimulates alpha-2 adrenergic receptors in the brainstem, which sends a signal to the rest of the body to reduce sympathetic outflow (relaxing blood vessels and slowing the heart rate).

• Key Indications:

  • Pregnancy-Induced Hypertension (PIH): Safe for use in all trimesters. It does not reduce blood flow to the uterus or placenta.

  • Preeclampsia: Management of high blood pressure to prevent complications during pregnancy.

  • Chronic Hypertension: Used in patients who do not respond to other drugs (though less common now due to side effects).

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 Methyldopa Tablets?

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

• Q: Is it safe for the baby?

  A: Yes. It is FDA Pregnancy Category B. It has been used for decades with no evidence of harm to the fetus.

• Q: Does it cause drowsiness?

  A: Yes. Sedation is a very common side effect, especially when starting treatment. It usually improves after a few days.

• Q: Does it affect liver function?

  A: Rarely. It can cause hepatitis or jaundice in some patients. Liver function tests (LFTs) should be monitored periodically.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Adults: Start with 250mg two or three times daily.

• Max Dose: 3000mg per day (rarely used this high).

• Administration: Swallow whole. Can be taken with or without food.

9. Side Effects and Precautions

• CNS: Sedation, drowsiness, depression, and nightmares.

• Hemolytic Anemia: Rare autoimmune reaction (positive Coombs test). Blood counts should be checked periodically.

• Liver: Risk of drug-induced hepatitis (fever, jaundice). Discontinue if liver enzymes rise.

• Fluid Retention: Can cause edema (swelling); often given with a diuretic if used for chronic hypertension (not pregnancy).

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light and moisture.