Product image of Metotrexato Accord (Methotrexate) supplied by GNH India

Metotrexato Accord

Active Ingredient:
Methotrexate
Origin:
EU

Metotrexato Accord (Methotrexate)

Methotrexate, the active ingredient in Metotrexato Accord, is an antimetabolite (folate antagonist) presented as a sterile injectable for intra‑arterial, intramuscular, or intravenous use. It is employed to treat autoimmune disorders and several malignancies in adult and pediatric patients.
GNH India supplies Metotrexato Accord as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

Manufacturer / TM Owner

Accord Healthcare S.L.U.

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Indications & Clinical Uses

Methotrexate acts on rapidly dividing cells and immune pathways, making it useful across several disease families.

  • Rheumatoid arthritis: reduces joint inflammation and slows disease progression.
  • Psoriasis: decreases skin plaque formation and severity.
  • Acute lymphoblastic leukemia: induces remission by inhibiting leukemic cell proliferation.
  • Non‑Hodgkin lymphoma: contributes to tumor control as part of combination chemotherapy.
  • Breast cancer: used in adjuvant regimens to limit tumor growth.

How It Works

  • Methotrexate inhibits dihydrofolate reductase, leading to depletion of tetrahydrofolate cofactors required for thymidylate and purine synthesis. This impairs DNA, RNA and protein production, thereby suppressing the replication of rapidly dividing cells and modulating immune cell activity.

Side Effects

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

Common Side Effects

  • Nausea and vomiting: gastrointestinal upset often occurring shortly after administration.
  • Fatigue: persistent tiredness that may affect daily activities.
  • Elevated liver enzymes: mild hepatic irritation detectable on blood tests.
  • Mouth sores: ulceration of oral mucosa causing discomfort.

Serious or Rare Side Effects

  • Bone marrow suppression: pancytopenia leading to infection or bleeding risk.
  • Pulmonary toxicity: interstitial pneumonitis presenting with cough and dyspnea.
  • Severe hepatic injury: fibrosis or cirrhosis with prolonged use.

Precautions & Warnings

Methotrexate requires careful monitoring and patient education to minimise risks.

  • Monitor blood counts: regular CBC testing is required to detect marrow suppression.
  • Assess liver function: periodic liver enzyme tests help identify hepatotoxicity early.
  • Evaluate renal function: dose adjustments may be needed for impaired clearance.
  • Avoid pregnancy: effective contraception is mandatory for both sexes during treatment and for a defined period after cessation.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze.

Avoid Interactions

Methotrexate interacts with several drug classes, necessitating vigilance.

Major Interactions (Avoid)

  • Non‑steroidal anti‑inflammatory drugs (NSAIDs): can increase methotrexate toxicity by reducing renal clearance.
  • Proton pump inhibitors (PPIs): may elevate serum methotrexate levels, heightening adverse effects.

Moderate Interactions (Monitor Closely)

  • Trimethoprim‑sulfamethoxazole: can potentiate bone marrow suppression.
  • Azathioprine or other immunosuppressants: may enhance immunosuppressive effects.
  • Live vaccines: risk of infection due to compromised immunity.

Frequently Asked Questions

Metotrexato Accord, containing methotrexate, is indicated for rheumatoid arthritis, psoriasis, acute lymphoblastic leukemia, non‑Hodgkin lymphoma and certain breast cancer treatment protocols. It works by targeting rapidly dividing cells and modulating immune responses, helping to control disease activity in these conditions.

Methotrexate blocks the enzyme dihydrofolate reductase, which is essential for producing tetrahydrofolate. This cofactor is required for synthesising DNA, RNA and proteins. By limiting these building blocks, methotrexate hampers the growth of rapidly dividing cells and reduces inflammatory immune activity.

The specific dose of Metotrexato Accord is determined by the prescribing clinician based on the patient’s condition, weight, renal function and treatment goals. Healthcare professionals calculate the appropriate regimen and adjust it as needed during therapy.

Methotrexate is classified as contraindicated in pregnancy because it can cause fetal malformations and miscarriage. Women of child‑bearing potential must use effective contraception during treatment and for a period after stopping the drug. Breastfeeding is also discouraged, as methotrexate can be excreted in milk.

To place an order, 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 cold‑chain if needed) and import documentation.

Metotrexato Accord is a methotrexate formulation meeting EU quality standards and is supplied as a sterile injectable. Compared with oral tablets, the injectable route offers predictable bioavailability and is often preferred for rapid disease control or when oral absorption is unreliable. Efficacy is comparable across approved methotrexate brands when used at equivalent doses.

Metotrexato Accord should be stored refrigerated at 2‑8 °C, protected from light, and must not be frozen or shaken. Keep the vials in their original packaging until use and discard any solution that appears discoloured or cloudy.

The product is supplied as a sterile solution for intra‑arterial, intramuscular or intravenous injection. Administration is performed by qualified healthcare professionals in a clinical setting, following aseptic technique and the dosing instructions provided by the prescriber.

Serious risks include bone‑marrow suppression leading to pancytopenia, severe hepatic injury such as fibrosis or cirrhosis, and pulmonary toxicity presenting as interstitial pneumonitis. Patients should be monitored regularly for blood counts, liver enzymes and respiratory symptoms to detect these complications early.

Methotrexate is contraindicated in patients with known hypersensitivity to the drug, severe renal impairment, active uncontrolled infections, and in women who are pregnant or planning pregnancy without effective contraception. Caution is also advised for individuals with pre‑existing liver disease or significant pulmonary disorders.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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