देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
methotrexate sodium (UNII: 3IG1E710ZN) (methotrexate - UNII:YL5FZ2Y5U1)
Rebel Distributors Corp
methotrexate sodium
methotrexate 2.5 mg
ORAL
PRESCRIPTION DRUG
Methotrexate tablets are indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. Methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides, (cutaneous T cell lymphoma), and lung cancer, particularly squamous cell and small cell types. Methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-Hodgkin’s lymphomas. Methotrexate tablets are indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation . It is important to ensure that a psoriasis “flare” is not due to an undiagnosed concomitant disease affecting immune responses. Methotrexate tablets are indicated in the management of selected adults with severe
Methotrexate Tablets, USP contain an amount of methotrexate sodium equivalent to 2.5 mg of methotrexate. Dispense with a child-resistant closure in a well-closed container as defined in the USP. Store at controlled room temperature 15°-30°C (59°-86°F) [See USP]. Protect from light.
Abbreviated New Drug Application
METHOTREXATE- METHOTREXATE SODIUM TABLET REBEL DISTRIBUTORS CORP ---------- METHOTREXATE TABLETS, USP RX ONLY REVISED MARCH 2002 1005720109 WARNINGS: 1.Methotrexate has been reported to cause fetal death and/or congenital anomalies. Therefore, it is not recommended for women of childbearing potential unless there is clear medical evidence that the benefits can be expected to outweigh the considered risks. Pregnant women with psoriasis or rheumatoid arthritis should not receive methotrexate. (See CONTRAINDICATIONS.) 2.Methotrexate elimination is reduced in patients with impaired renal function, ascites, or pleural effusions. Such patients require especially careful monitoring for toxicity, and require dose reduction or, in some cases, discontinuation of methotrexate administration. 3.Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia and gastrointestinal toxicity have been reported with concomitant administration of methotrexate (usually in high dosage) along with some nonsteroidal anti-inflammatory drugs (NSAIDs). (See PRECAUTIONS, Drug Interactions.) 4.Methotrexate causes hepatotoxicity, fibrosis and cirrhosis, but generally only after prolonged use. Acutely, liver enzyme elevations are frequently seen. These are usually transient and asymptomatic, and also do not appear predictive of subsequent hepatic disease. Liver biopsy after sustained use often shows histologic changes, and fibrosis and cirrhosis have been reported; these latter lesions may not be preceded by symptoms or abnormal liver function tests in the psoriasis population. For this reason, periodic liver biopsies are usually recommended for psoriatic patients who are under long-term treatment. Persistent abnormalities in liver function tests may precede appearance of fibrosis or cirrhosis in the rheumatoid arthritis population. (See PRECAUTIONS, Organ System Toxicity, Hepatic.) 5.Methotrexate-induced lung disease is a potentially dangerous lesion, which may occur acutely at any time during therapy and which has been report पूरा दस्तावेज़ पढ़ें