Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
METHOTREXATE SODIUM (UNII: 3IG1E710ZN) (METHOTREXATE - UNII:YL5FZ2Y5U1)
Alvogen Inc.
ORAL
PRESCRIPTION DRUG
Methotrexate tablets are indicated for the: Methotrexate tablets are indicated for the treatment of adults with rheumatoid arthritis. Methotrexate tablets are indicated for the treatment of pediatric patients with polyarticular Juvenile Idiopathic Arthritis (pJIA). Methotrexate tablets are indicated for the treatment of adults with severe psoriasis. Methotrexate tablets are 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 tablets are contraindicated in pregnant women with non-neoplastic diseases [see Contraindications (4)]. Based on published reports and its mechanism of action [see Clinical Pharmacology (12.1)] , methotrexate can cause embryo-fetal toxicity and fetal death when administered to a preg
Methotrexate Tablets, USP is supplied as 2.5 mg round, yellow tablets, scored on one side, imprinted with “LP” above the score and “22” below, and blank on the other side. It is available as: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. 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, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
Abbreviated New Drug Application
METHOTREXATE- METHOTREXATE TABLET ALVOGEN 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._ • • • INDICATIONS AND USAGE Methotrexate tablets are a dihydrofolate reductase inhibitor indicated for the: • • • • • • DOSAGE AND ADMINISTRATION • • • • • • • • DOSAGE FORMS AND STRENGTHS Tablets: 2.5 mg (3) CONTRAINDICATIONS METHOTREXATE TABLETS CAN CAUSE EMBRYO-FETAL TOXICITY, INCLUDING FETAL DEATH. FOR NON-NEOPLASTIC DISEASES, METHOTREXATE TABLETS ARE 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 ARE 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). 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) Instruct patients and caregivers to ta Lees het volledige document