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Methyldopa Tablets

Methyldopa Tablets

Methyldopa Film-Coated Tablets

Composition: Each tablet contains Methyldopa equivalent to anhydrous Methyldopa 250 mg or 500 mg, in IP or BP versions; excipients q.s.

Usage: Management of high blood pressure, including selected patients during pregnancy under medical supervision.

Category: Hypertensive / Cardiac Drugs

Therapeutic category: Centrally acting antihypertensive

Manufacturer: Healthy Life Pharma Pvt. Ltd. (as supplied; WHO-GMP certification subject to verification)

Exporter: Healthy Inc (as supplied)

SKU: Methyldopa Tablets

Product Information

Methyldopa Tablets is listed for pharmaceutical business-to-business enquiries. Exact active ingredients, formulation, strength, pack configuration and manufacturer details should be confirmed against the product label and approved technical documentation before ordering.

Description

Product Description

1. Product Introduction

Methyldopa is a centrally acting antihypertensive medicine that reduces sympathetic nervous system activity and helps lower blood pressure. It has a long history of use for hypertension in pregnancy, although the choice of treatment depends on current clinical guidelines, patient factors and local availability; it is not universally the preferred first-line option.

Healthy Life Pharma Pvt. Ltd. is identified as manufacturer and Healthy Inc as exporter in the supplied information. WHO-GMP status, manufacturing location, export markets and other commercial claims should be confirmed with current documentation.

2. Product Specifications

Product nameMethyldopa Tablets
IP 250 mgEach film-coated tablet contains Methyldopa IP equivalent to anhydrous Methyldopa 250 mg
IP 500 mgEach film-coated tablet contains Methyldopa IP equivalent to anhydrous Methyldopa 500 mg; excipients q.s.
BP 250 mgEach film-coated tablet contains Methyldopa BP equivalent to anhydrous Methyldopa 250 mg
BP 500 mgEach film-coated tablet contains Methyldopa BP equivalent to anhydrous Methyldopa 500 mg; excipients q.s.
Dosage formFilm-coated tablet
Therapeutic classCentrally acting antihypertensive
CAS number555-30-6 (methyldopa; hydrate and salt forms may have different identifiers)
Packaging and shelf lifeSubject to approved specifications and stability records; not confirmed by supplied compositions
SKUMethyldopa Tablets

3. Manufacturing Technology

Methyldopa tablet production requires control of raw-material quality, blending, compression, coating, moisture exposure and product stability. Methyldopa can undergo oxidative degradation, so formulation and packaging choices should be justified by stability studies. Specific granulation equipment, humidity limits, coating pigments and packaging barriers are not verified from the supplied information.

4. Quality Assurance

Testing should follow the applicable IP or BP monograph and approved finished-product specification, including identification, assay, content uniformity, dissolution, related substances and stability as applicable. Numerical acceptance criteria must be taken from the validated product method, not assumed across all markets.

5. Pharmacology and Clinical Use

Methyldopa is converted to an active metabolite, alpha-methylnorepinephrine, which stimulates central alpha-2 adrenergic pathways and reduces sympathetic outflow, lowering blood pressure.

Clinical use: Hypertension in selected adults and during pregnancy where a clinician considers it appropriate. Preeclampsia requires urgent obstetric assessment and broader management; methyldopa is not a stand-alone treatment for severe preeclampsia or a substitute for emergency blood-pressure control when indicated.

6. Export and Regulatory Support

Product registration and export may require CTD/ACTD dossiers, certificates of analysis, manufacturing licenses, WHO-GMP evidence, Certificates of Pharmaceutical Product and destination-country approvals. Document availability and shipping terms must be confirmed with the supplier before marketing or procurement.

7. Frequently Asked Questions

What is methyldopa used for? It is an oral prescription medicine for high blood pressure.

Can methyldopa be used in pregnancy? It has extensive historical experience in pregnancy, but the treating obstetric clinician should select and monitor therapy; no medicine is guaranteed risk-free.

Does it cause drowsiness? Yes. Sedation and dizziness can occur, particularly when starting or adjusting treatment.

Can it affect the liver or blood counts? Rare but serious hepatitis and immune-mediated hemolytic anemia have been reported. Clinicians may order liver tests and blood counts when appropriate.

8. Dosage and Administration

Adults are commonly initiated at 250 mg two or three times daily, with individualized adjustment according to blood pressure, tolerability, renal function and approved local labeling. Dosing in pregnancy must be determined by the treating clinician. Tablets are swallowed orally and may be taken with or without food. Do not change or stop prescribed treatment without clinical advice.

9. Side Effects and Precautions

Possible effects include drowsiness, dizziness, postural hypotension, headache, dry mouth and edema. Rare serious reactions include liver injury, hemolytic anemia and depression. Methyldopa is contraindicated in active hepatic disease associated with prior methyldopa therapy and should not be used with monoamine oxidase inhibitors. Review potential interactions, including iron supplements that may reduce methyldopa absorption. Seek urgent assessment for jaundice, fever with unexplained illness, severe weakness, shortness of breath or signs of severe anemia.

10. Storage Instructions

Store according to the approved pack label, protected from excessive moisture and light. Do not assign a fixed temperature limit or shelf life without validated stability and registered labeling.

Medical and regulatory note: Prescription medicine. Information is educational and does not replace an approved product label or professional advice. Certifications, product availability, packaging, shelf life and export claims require independent verification.