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

Methotrexate Accord Healthcare

Active Ingredient:
Methotrexate
Origin:
EU

Methotrexate Accord Healthcare (Methotrexate)

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

Manufacturer / TM Owner

Accord Healthcare Ireland Limited

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Indications & Clinical Uses

Methotrexate acts on rapidly dividing cells and immune pathways, providing disease‑modifying effects across several therapeutic areas.

  • Rheumatoid arthritis: reduces joint inflammation and slows structural damage.
  • Psoriasis: diminishes skin lesions by inhibiting keratinocyte proliferation.
  • Acute lymphoblastic leukemia: eradicates malignant lymphoblasts through folate pathway blockade.
  • Osteosarcoma: impedes tumor growth by disrupting DNA synthesis.
  • Gestational trophoblastic disease: induces remission by targeting proliferative trophoblastic tissue.

How It Works

  • Methotrexate inhibits dihydrofolate reductase, preventing the conversion of dihydrofolate to tetrahydrofolate. This blockade reduces the availability of tetrahydrofolate cofactors required for purine and pyrimidine synthesis, thereby interfering with DNA, RNA and protein production in rapidly dividing cells and activated immune cells.

Side Effects

Methotrexate may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Nausea and vomiting: gastrointestinal upset occurring shortly after administration.
  • Oral ulcers: painful sores on the mucous membranes of the mouth.
  • Fatigue: persistent tiredness not relieved by rest.
  • Alopecia: temporary hair thinning or loss.

Serious or Rare Side Effects

  • Bone marrow suppression: leading to anemia, leukopenia or thrombocytopenia.
  • Severe hepatotoxicity: marked elevation of liver enzymes or fibrosis.
  • Pulmonary fibrosis: progressive scarring of lung tissue causing breathlessness.
  • Anaphylactic reaction: acute hypersensitivity requiring immediate medical intervention.

Precautions & Warnings

Prior to initiating therapy, clinicians should assess baseline laboratory values and patient risk factors.

  • Monitor blood counts: perform regular complete blood count testing to detect marrow suppression.
  • Assess liver function: check hepatic enzymes before and during treatment.
  • Evaluate renal function: adjust dosing in patients with impaired clearance.
  • Avoid use in pregnancy: teratogenic risk mandates contraception for women of child‑bearing potential.
  • Counsel on infection risk: advise patients to report fever or signs of infection promptly.
  • Store at ambient temperature: keep in original container, protect from moisture and light.

Avoid Interactions

Methotrexate's efficacy and toxicity can be altered by concomitant medicines.

Major Interactions (Avoid)

  • NSAIDs: increase methotrexate serum concentrations and risk of renal toxicity.
  • Trimethoprim‑sulfamethoxazole: synergistic myelosuppression leading to severe cytopenias.

Moderate Interactions (Monitor Closely)

  • Azathioprine: additive immunosuppression may heighten infection risk.
  • Warfarin: potentiates anticoagulant effect, requiring INR monitoring.
  • Oral contraceptives: may reduce methotrexate clearance, necessitating dose adjustment.

Frequently Asked Questions

Methotrexate Accord Healthcare is indicated for the management of rheumatoid arthritis, moderate to severe plaque psoriasis, acute lymphoblastic leukemia, osteosarcoma, and gestational trophoblastic disease. In each case, the drug works by interfering with folate metabolism, which reduces abnormal cell proliferation and modulates immune activity.

Methotrexate blocks the enzyme dihydrofolate reductase, preventing the formation of tetrahydrofolate. This cofactor is essential for synthesizing purines and pyrimidines, the building blocks of DNA and RNA. By limiting these nucleotides, methotrexate hampers the growth of rapidly dividing cells, including malignant cells and activated immune cells.

The dose of methotrexate is individualized by the prescribing clinician based on the specific indication, patient weight, renal function, and treatment response. Dosing regimens can vary widely, ranging from low weekly doses for autoimmune disease to higher, more frequent doses for oncologic protocols.

Methotrexate is classified as teratogenic and is contraindicated in pregnancy because it can cause fetal malformations and miscarriage. Women of child‑bearing potential should use effective contraception. Limited data exist for breastfeeding, and the drug is generally avoided due to potential infant exposure through 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 any required import documentation.

Methotrexate is often considered a first‑line disease‑modifying antirheumatic drug (DMARD) because of its proven efficacy, oral and injectable formulations, and cost‑effectiveness. Compared with biologic agents, it has a broader safety profile but may require more laboratory monitoring. Its mechanism differs from biologics, which target specific cytokines or cell surface receptors.

Methotrexate Accord Healthcare should be stored at ambient temperature, below 25 °C. Keep the vials in their original packaging, protect them from moisture and direct light, and avoid freezing. Ensure the storage area is dry and well‑ventilated to maintain product stability.

Methotrexate is supplied as a sterile injectable solution and can be given via intra‑arterial, intramuscular, or intravenous routes, depending on the clinical indication and dosing schedule. Administration is performed by qualified healthcare professionals under aseptic conditions, with dosage intervals typically ranging from weekly to daily in oncologic protocols.

The most serious risks include bone marrow suppression leading to severe cytopenias, hepatotoxicity that can progress to fibrosis or cirrhosis, pulmonary toxicity such as interstitial pneumonitis, and rare but life‑threatening anaphylactic reactions. Patients should be monitored regularly for laboratory abnormalities and clinical signs of toxicity.

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

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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