InjectionInjection
Schedule H (Prescription Required)Cytotoxic Chemotherapy FormulationsCode: 2603

Methotrexate Injection 50mg/2ml

Generic Formulation:Methotrexate Injection IP 50mg/2ml
Pack Size:2ml Ampoule

MRP Under Process

Official PMBI MRP is being updated for catalog code 2603.

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Clinical Overview

Methotrexate Injection (25mg/ml, 50mg/2ml) is an antifolate antimetabolite on the WHO Model List of Essential Medicines. It competitively and irreversibly inhibits dihydrofolate reductase (DHFR), halting the conversion of dihydrofolate to tetrahydrofolate (FH4) and blocking de novo synthesis of thymidylate and purine nucleotides essential for DNA and RNA synthesis. Indicated for acute lymphoblastic leukemia (ALL), osteosarcoma, choriocarcinoma, breast cancer, head and neck carcinomas, non-Hodgkin lymphoma, and severe recalcitrant psoriasis/rheumatoid arthritis.

Active Pharmaceutical Ingredients

AI-assistedClinical summary synthesized from pharmacopoeial references (CDSCO, WHO EML, IP/BP/USP). Not clinician-reviewed. Drug code 2603.Report inaccuracy

Usage Guidelines

Administer intramuscularly, intravenously, intra-arterially, or intrathecally according to validated clinical oncological protocols. High-dose methotrexate (HDMTX) protocols (>500 mg/m²) REQUIRE vigorous urinary alkalinization (urine pH >= 7.0 with sodium bicarbonate) and mandatory Leucovorin (folinic acid) rescue starting 24 hours post-infusion until serum MTX falls below 0.05-0.1 micromolar.

General Administration Advice: Adhere strictly to the prescribed dosage, frequency, and treatment course. For oral medications, swallow with sufficient water. Never stop antibiotics, psychiatric medications, or antihypertensives abruptly without clinical direction.

Possible Side Effects

Common: Bone marrow suppression (leukopenia, thrombocytopenia), ulcerative stomatitis, nausea, transaminase elevation, alopecia. Rare/Severe: Acute tubular necrosis / renal failure, acute hepatotoxicity / cirrhosis, severe pulmonary toxicity (pneumonitis), Stevens-Johnson syndrome, and toxic epidermal necrolysis.

*Note: Individual physiological responses vary. While many patients experience few or no side effects, notify your treating physician if adverse reactions persist or if hypersensitivity (angioedema, skin rash, dyspnea) occurs.

Precautions & Warnings

Black Box Warning: Strict weekly dosing for non-oncologic indications (daily dosing is potentially fatal). Black Box Warning: Renal and hepatic toxicity; HDMTX requires mandatory leucovorin rescue and urine alkalinization. Contraindicated in pregnancy (potent teratogen/abortifacient), severe renal impairment, and preexisting bone marrow depression.

Schedule H (Prescription Required)

This medication is scheduled under statutory drug regulatory frameworks (CDSCO / Drugs & Cosmetics Rules). Dispensing requires a valid medical prescription from a registered medical practitioner. Self-medication or unsupervised dosage adjustment carries significant clinical risks.

Medical Disclaimer: Statutory Clinical Disclaimer: The information provided is for educational and price-transparency purposes only and does not constitute medical advice, oncological diagnosis, or chemotherapy protocol guidance. Cancer therapies require specialized administration under the direct supervision of a registered medical oncologist in an accredited healthcare facility.