Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
METHOTREXATE SODIUM (UNII: 3IG1E710ZN) (METHOTREXATE - UNII:YL5FZ2Y5U1)
Par Pharmaceutical, Inc.
METHOTREXATE SODIUM
METHOTREXATE 2.5 mg
ORAL
PRESCRIPTION DRUG
Methotrexate Tablets is indicated for the: - treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen - treatment of adults with mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen. - treatment of adults with relapsed or refractory non-Hodgkin lymphomas as part of a metronomic combination chemotherapy regimen Methotrexate Tablets is indicated for the treatment of adults with rheumatoid arthritis. Methotrexate Tablets is indicated for the treatment of adults with severe psoriasis. Methotrexate Tablets is contraindicated in: - Pregnant women receiving Methotrexate Tablets for treatment of non-neoplastic diseases [see Warnings and Precautions (5.1), and Use in Specific Populations (8.1, 8.3)] . - Patients with a history of a severe hypersensitivity reactions, including anaphylaxis, to methotrexate. [see Warnings and Precautions (5.2)] . Risk Summary Methotrexate Tab
Methotrexate Tablets is supplied as 2.5 mg round, convex, yellow tablets with a score line on one side (M above the score and 1 below the score) available in: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Methotrexate Tablets is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
New Drug Application
METHOTREXATE- METHOTREXATE TABLET PAR PHARMACEUTICAL, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE METHOTREXATE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METHOTREXATE TABLETS. METHOTREXATE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1953 WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, AND SEVERE ADVERSE REACTIONS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ METHOTREXATE TABLETS CAN CAUSE EMBRYO-FETAL TOXICITY, INCLUDING FETAL DEATH. FOR NON-NEOPLASTIC DISEASES, METHOTREXATE TABLETS IS CONTRAINDICATED IN PREGNANCY. FOR NEOPLASTIC DISEASES, ADVISE PATIENTS OF REPRODUCTIVE POTENTIAL OF THE POTENTIAL RISK TO A FETUS AND TO USE EFFECTIVE CONTRACEPTION (4, 5.1, 8.1, 8.3). METHOTREXATE TABLETS IS CONTRAINDICATED IN PATIENTS WITH A HISTORY OF SEVERE HYPERSENSITIVITY REACTIONS TO METHOTREXATE, INCLUDING ANAPHYLAXIS (4, 5.2). SERIOUS ADVERSE REACTIONS, INCLUDING DEATH, HAVE BEEN REPORTED WITH METHOTREXATE. CLOSELY MONITOR FOR ADVERSE REACTIONS OF THE BONE MARROW, GASTROINTESTINAL TRACT, LIVER, LUNGS, SKIN, AND KIDNEYS. WITHHOLD OR DISCONTINUE METHOTREXATE TABLETS AS APPROPRIATE (5.3, 5.4, 5.5, 5.6, 5.7, 5.8). RECENT MAJOR CHANGES Boxed Warning 5/2020 Indications and Usage (1) 5/2020 Dosage and Administration (2) 5/2020 Contraindications (4) 5/2020 Warnings and Precautions (5) 5/2020 INDICATIONS AND USAGE Methotrexate Tablets is a dihydrofolate reductase inhibitor indicated for the: Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen (1.1) Treatment of adults with mycosis fungoides (1.1) Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen (1.1) Treatment of adults with rheumatoid arthritis (1.2) Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) (1.3) Treatment of adults with severe psoriasis (1.4) DOSAGE AND Citiți documentul complet