Methotrexate Injection B.P.


 
COMPOSITION
Each ml contains :
Methotexate B.P. 25 mg.
Methyl Paraben B.P. 0.08 % w/v.
Propyl Paraben B.P. 0.02 % w/v.
(As preservatives)
Water for Injection B.P. q.s.

STORAGE
Store in a cool place. Protect from light.

PRESENTATION
25 mg / ml - 2 ml vial

ACTIONS
It inhibits the hydrogenetation of folic acid and prevents its participation in the synthesis of purines and nucleic acids. It also inhibits antibody synthesis.

INDICATIONS
Acute lymphoblastic leukemia, choriocarcinoma. It may be used alone or in combination with other anticancer agents in the management of breast cancer, particularly squamous cell and small cell types, advanced stage non-hodgkin's lymphoma, mycosis, fungoids, osterogenic sarcoma. It is also useful in treatment of psoriasis.

CONTRAINDICATIONS
severe renal or hepatic disorders, pre-existing blood dyscrasias, pregnancy, hypersensitivity to this drug.

WARNINGS
Methotrexate injection should not be administered intrathecally.

PREGNANCY
Methotrexate is contraindicated in pregnancy.

ADVERSE REACTIONS
Neurotoxicity, hepatotoxicity, hematological toxicity, renal function impairement, gastrointestinal toxicity, dermatological toxicity, allergic reactions, ocular toxicity, cough, dyspnoea, malaise, osteoporosis, anaphylaxis, reversible oligospermia, vasculitis have been observed.

DRUG INTERACTIONS
Folic acid and its derivatives may increase the effectiveness of Methotrexate. The effects of Methotrexate may be enhanced by concurrent administration of aminobenzoic acid, some antibacterials, many anti-inflammatory agents, diuretics and phenytoin. Fatal toxicity has occurred in patients given NSAIDS, hepatotoxic or nephrotoxic agents concurrently with Methotrexate.

OVERDOSAGE
leucovorin calcium (Folinic acid) should be administered as soon as possible.

DOSAGE AND ADMINISTRATION
Acute lymphoblastic leukemia: Methotrexate IM in maintenance dosage of 20-30 mg / m2 twice weekly is recommended. Alternatively 2.5 mg / kg IV every 14 days.
Choricarcinoma: 15-30 mg daily for 5 days.
In palliation of inoperable solid tumors: 25-30 mg weekly by IV injections.

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