Product image of Methotrexat Stada (Methotrexate) supplied by GNH India

Methotrexat Stada

Active Ingredient:
Methotrexate
Origin:
EU

Methotrexat Stada (Methotrexate)

Methotrexate, the active ingredient in Methotrexat Stada, is an antimetabolite (folate antagonist) presented as an injectable solution for intramuscular or subcutaneous use. It is employed to treat autoimmune disorders, certain cancers, and specific gestational conditions in adult patients.

GNH India supplies Methotrexat Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide. The company adheres to stringent quality standards and provides regulatory support for global distribution.

Manufacturer / TM Owner

Stadapharm Gmbh

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Indications & Clinical Uses

Methotrexate is used across several disease families, primarily autoimmune disorders, malignancies, and gestational trophoblastic conditions.

  • Rheumatoid arthritis: reduces joint inflammation and disease progression.
  • Psoriasis: slows skin cell proliferation and improves plaque appearance.
  • Acute lymphoblastic leukemia: interferes with malignant cell replication to achieve remission.
  • Non‑Hodgkin lymphoma: inhibits tumor growth and induces apoptosis.
  • Ectopic pregnancy: terminates trophoblastic tissue to avoid surgical intervention.
  • Gestational trophoblastic disease: promotes resolution of abnormal placental growth.

How It Works

  • Methotrexate inhibits dihydrofolate reductase, preventing the conversion of dihydrofolate to tetrahydrofolate. This blockade reduces the synthesis of purines and pyrimidines, leading to impaired DNA, RNA, and protein production. The resulting antiproliferative effect limits rapidly dividing cells, while its anti‑inflammatory action stems from increased extracellular adenosine, which dampens immune cell activation.

Side Effects

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

Common Side Effects

  • Nausea and vomiting: gastrointestinal upset common after injection.
  • Fatigue: persistent tiredness reported by many patients.
  • Oral mucositis: painful sores or ulceration in the mouth.
  • Elevated liver enzymes: mild transaminitis detectable on labs.
  • Cytopenias: reduced white blood cells or platelets.
  • Alopecia: temporary hair thinning or loss.

Serious or Rare Side Effects

  • Severe liver toxicity: potential for fibrosis or cirrhosis.
  • Pulmonary fibrosis: interstitial lung disease with dyspnea.
  • Life‑threatening infection: due to bone‑marrow suppression.
  • Bone‑marrow aplasia: profound pancytopenia.
  • Renal failure: acute kidney injury from precipitation.
  • Anaphylactic reaction: rare but possible hypersensitivity.

Precautions & Warnings

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

  • Pregnancy: contraindicated (Category X); avoid use in pregnant or planning patients.
  • Renal function: assess baseline creatinine; adjust or avoid if severe impairment.
  • Hepatic function: monitor transaminases regularly; avoid in active liver disease.
  • Hematologic monitoring: perform complete blood counts before and during therapy.
  • Infection risk: screen for latent infections and defer use in active infections.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Methotrexate interacts with several medicines; some require avoidance while others need close monitoring.

Major Interactions (Avoid)

  • NSAIDs: increase methotrexate toxicity by reducing renal clearance.
  • Penicillins (e.g., ampicillin): may potentiate bone‑marrow suppression.
  • Sulfonamides: can enhance hematologic adverse effects.
  • Live vaccines: risk of severe infection due to immunosuppression.
  • Proton pump inhibitors: may alter absorption and increase exposure.

Moderate Interactions (Monitor Closely)

  • Azathioprine: additive immunosuppression; monitor blood counts.
  • Warfarin: methotrexate may enhance anticoagulant effect; check INR.
  • Oral contraceptives: reduced efficacy; advise alternative contraception.
  • Allopurinol: may increase methotrexate levels; adjust dose if needed.
  • Trimethoprim‑sulfamethoxazole: heightened risk of myelosuppression.

Frequently Asked Questions

Methotrexat Stada is indicated for several serious conditions, including rheumatoid arthritis and psoriasis for their anti‑inflammatory effects, acute lymphoblastic leukemia and non‑Hodgkin lymphoma as part of chemotherapy regimens, and gestational trophoblastic diseases such as ectopic pregnancy and molar pregnancy where it helps resolve abnormal trophoblastic tissue.

Methotrexate blocks the enzyme dihydrofolate reductase, which is essential for converting folic acid into its active form. This inhibition reduces the synthesis of nucleotides needed for DNA and RNA production, limiting the proliferation of rapidly dividing cells. Additionally, it increases extracellular adenosine, which suppresses inflammatory pathways, providing both anticancer and immunosuppressive benefits.

The dose of Methotrexat Stada is individualized by the prescribing clinician based on the specific indication, patient weight, renal and hepatic function, and treatment response. Dosing regimens can vary widely, ranging from low weekly doses for autoimmune diseases to higher, more intensive schedules for oncologic protocols. Always follow the prescriber’s instructions.

Methotrexat Stada is classified as Pregnancy Category X, meaning it is contraindicated in pregnancy because it can cause fetal malformations and loss. It is also not recommended during breastfeeding, as it can be excreted in milk and potentially harm the infant. Women of child‑bearing potential must use effective contraception while on therapy.

To place an order, visit the product page on gnhindia.com, submit an enquiry with the required quantity, and provide your institutional or trade credentials. GNH India works with hospitals, pharmacies, and procurement teams worldwide, confirming eligibility, then responding with pricing, availability, shipping details (including cold‑chain logistics if needed), and any required import documentation.

Methotrexat Stada belongs to the antimetabolite class, similar to drugs like azathioprine or leflunomide for autoimmune diseases, and to other chemotherapy agents such as cyclophosphamide for cancers. Compared with leflunomide, methotrexate has a longer history of use in rheumatoid arthritis and may offer stronger anti‑inflammatory effects, but it also carries a higher risk of hepatic and hematologic toxicity, requiring more frequent monitoring.

Methotrexat Stada must be stored at 2‑8 °C (refrigerated). Keep the vials in their original packaging, protect them from light, and avoid freezing or shaking the solution. If the product is temporarily removed from refrigeration, it should be returned to the controlled temperature zone within the time limits specified by the manufacturer to maintain potency.

Methotrexat Stada is supplied as an injectable solution for intramuscular or subcutaneous administration. The injection is typically given once weekly, although the exact schedule is determined by the prescriber. Proper aseptic technique is essential, and the injection site should be rotated to reduce local irritation. Patients may be instructed on self‑administration after appropriate training.

The most serious risks include severe liver toxicity that can progress to fibrosis or cirrhosis, bone‑marrow suppression leading to pancytopenia, pulmonary fibrosis causing respiratory compromise, and life‑threatening infections due to immunosuppression. Renal failure and rare anaphylactic reactions are also critical concerns. Early detection through regular laboratory monitoring is essential to mitigate these risks.

Methotrexat Stada is contraindicated in pregnant women, individuals with known hypersensitivity to methotrexate or its excipients, patients with severe hepatic impairment, significant renal dysfunction, active uncontrolled infections, and those with pre‑existing pulmonary disease that could be exacerbated. Clinicians should also exercise caution in patients with a history of alcohol abuse or concurrent use of other myelosuppressive agents.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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