Product image of Metotab (Methotrexate Disodium) supplied by GNH India

Metotab

Active Ingredient:
Methotrexate Disodium
Origin:
EU

Metotab (Methotrexate Disodium)

Methotrexate, the active ingredient in Metotab, is an antimetabolite (folate antagonist) presented as an oral dosage form for systemic use. It is employed to treat certain cancers, autoimmune disorders, and severe skin conditions in adult patients. The drug works by interfering with DNA synthesis, which helps control abnormal cell growth and immune system activity. Metotab is marketed in the European Union and is available by prescription only, reflecting its potent pharmacological profile. It is supplied under strict Good Distribution Practice standards to ensure product integrity throughout the supply chain.

GNH India supplies Metotab as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Medac Gesellschaft Für Klinische Spezialpräparate Mbh (Wedel)

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Indications & Clinical Uses

Methotrexate is used in several disease categories where rapid cell proliferation or immune activation is a key feature.

  • Rheumatoid arthritis: reduces joint inflammation and slows disease progression.
  • Psoriasis: decreases skin cell turnover, improving plaque severity.
  • Acute lymphoblastic leukemia: inhibits malignant lymphoblast proliferation, supporting remission.
  • Non-Hodgkin lymphoma: impedes tumor growth, enhancing chemotherapy effectiveness.
  • Breast cancer: used as part of combination regimens to limit tumor cell replication.
  • Ectopic pregnancy: terminates trophoblastic tissue, preventing further implantation.

How It Works

  • Methotrexate is a folate antagonist that competitively inhibits dihydrofolate reductase, blocking the conversion of dihydrofolate to tetrahydrofolate. This prevents synthesis of purine nucleotides and thymidylate, essential for DNA, RNA and protein production, thereby reducing proliferation of rapidly dividing cells such as malignant lymphocytes, cancer cells, and activated immune cells.

Side Effects

Methotrexate may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Nausea or vomiting.
  • Fatigue and weakness.
  • Mouth sores (stomatitis).
  • Elevated liver enzymes.
  • Low white blood cell count (leukopenia).
  • Hair thinning or loss.

Serious or Rare Side Effects

  • Severe liver injury or fibrosis.
  • Pulmonary toxicity (interstitial pneumonitis).
  • Bone marrow failure leading to pancytopenia.

Precautions & Warnings

When prescribing methotrexate, clinicians should observe several safety measures to minimize risks.

  • Renal function: assess baseline creatinine and adjust dose in impairment.
  • Hepatic monitoring: perform regular liver function tests during therapy.
  • Hematologic surveillance: check complete blood count before each cycle.
  • Contraception: ensure effective contraception for both sexes due to teratogenicity.
  • Pregnancy and lactation: contraindicated in pregnancy (Category X) and not recommended while breastfeeding.
  • Store at ambient temperature: keep below 25°C in original container, protect from moisture and light.

Avoid Interactions

Methotrexate interacts with several medicines that can alter its efficacy or increase toxicity.

Major Interactions (Avoid)

  • Non‑steroidal anti‑inflammatory drugs (NSAIDs): may increase methotrexate toxicity.
  • Proton pump inhibitors (e.g., omeprazole): can raise serum methotrexate levels.
  • Trimethoprim‑sulfamethoxazole: enhances risk of bone marrow suppression.

Moderate Interactions (Monitor Closely)

  • Penicillins (high‑dose): may reduce methotrexate clearance.
  • Live vaccines: risk of infection due to immunosuppression.
  • Alcohol: potentiates hepatic toxicity.

Frequently Asked Questions

Metotab, containing methotrexate, is indicated for rheumatoid arthritis, psoriasis, acute lymphoblastic leukemia, non‑Hodgkin lymphoma, certain breast cancer regimens, and ectopic pregnancy. In each case the drug helps control abnormal cell growth or immune system activity that drives disease progression.

Methotrexate blocks the enzyme dihydrofolate reductase, preventing the formation of tetrahydrofolate, a key cofactor for making purine nucleotides and thymidylate. Without these building blocks, DNA, RNA and protein synthesis are reduced, limiting the proliferation of rapidly dividing cells such as cancer cells and activated immune cells.

The dose of Metotab is individualized by the prescribing clinician based on the specific indication, patient weight, renal and hepatic function, and treatment response. No universal dosing schedule is provided here; the prescriber will set the appropriate regimen for each patient.

Methotrexate is classified as pregnancy category X because it is teratogenic and can cause fetal malformations or loss. It is also not recommended while breastfeeding, as it may be excreted in milk and affect the infant. Effective contraception is required for both men and women of reproductive potential.

To request Metotab, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain needs) and the necessary import documentation.

Compared with biologic agents that target specific cytokines, methotrexate offers a broad‑acting, oral option that is less costly but requires careful monitoring for toxicity. Within antimetabolites, methotrexate is distinguished by its folate‑antagonist mechanism, making it effective for both oncologic and autoimmune indications, whereas agents like 5‑fluorouracil are more cancer‑specific.

Metotab should be stored at ambient temperature, preferably below 25 °C. Keep the tablets in the original blister or container, protect them from moisture and direct sunlight, and ensure the packaging remains tightly closed until use.

Metotab is taken orally with a full glass of water, usually on an empty stomach to improve absorption. The prescriber may advise specific timing relative to meals or other medications. Patients should follow the exact schedule provided and not alter the dose without medical guidance.

The most critical adverse effects include severe liver injury or fibrosis, bone‑marrow suppression leading to pancytopenia, and pulmonary toxicity such as interstitial pneumonitis. Early detection through regular laboratory monitoring and prompt reporting of symptoms like persistent cough, jaundice, or unusual bruising is essential.

Metotab is contraindicated in pregnant or breastfeeding individuals, patients with severe renal or hepatic impairment, and those with known hypersensitivity to methotrexate or its excipients. Caution is also advised for patients with active infections, uncontrolled diabetes, or a history of pulmonary disease.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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