País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
METHOTREXATE SODIUM (UNII: 3IG1E710ZN) (METHOTREXATE - UNII:YL5FZ2Y5U1)
Teva Parenteral Medicines, Inc.
METHOTREXATE SODIUM
METHOTREXATE 25 mg in 1 mL
INTRA-ARTERIAL
PRESCRIPTION DRUG
Methotrexate Injection is indicated for the treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy regimen. Methotrexate Injection is indicated for the prophylaxis and treatment of meningeal leukemia in adult and pediatric patients. Methotrexate Injection is indicated for the treatment of adults and pediatric patients with Non-Hodgkin lymphoma. Methotrexate Injection is indicated for the treatment of adults and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen. Methotrexate Injection is indicated for the treatment of adults with breast cancer as part of a combination chemotherapy regimen. Methotrexate Injection is indicated for the treatment of adults with squamous cell carcinoma of the head and neck as a single-agent. Methotrexate Injection is indicated for the treatment of adults with gestational trophoblastic neoplasia (GTN) as part of a combination chemotherapy regimen. Methotrexate Injection is indicated for
How Supplied Parenteral: Methotrexate Injection, USP, Isotonic Liquid, Preservative Free, Single Dose Vials. Each 25 mg/mL, 2 mL, 10 mL, and 40 mL vials contain methotrexate sodium equivalent to 50 mg, 250 mg, and 1 g methotrexate, USP respectively. Contents NDC Package 50 mg, 2 mL Vial 0703-3671 -01 Individually packaged 250 mg, 10 mL Vial 0703-3675 -01 Individually packaged 1 g, 40 mL Vial 0703-3678 -01 Individually packaged Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. Methotrexate Injection, USP is a hazardous drug. Follow applicable special handling and disposal procedures.
Abbreviated New Drug Application
METHOTREXATE- METHOTREXATE INJECTION, SOLUTION TEVA PARENTERAL MEDICINES, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE METHOTREXATE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR METHOTREXATE INJECTION. METHOTREXATE INJECTION, FOR INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, OR INTRATHECAL USE INITIAL U.S. APPROVAL: 1953 WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, BENZYL ALCOHOL TOXICITY, AND OTHER SERIOUS ADVERSE REACTIONS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ METHOTREXATE INJECTION CAN CAUSE EMBRYO-FETAL TOXICITY, INCLUDING FETAL DEATH. USE IN NON-NEOPLASTIC DISEASES IS CONTRAINDICATED DURING PREGNANCY. ADVISE FEMALES AND MALES OF REPRODUCTIVE POTENTIAL TO USE EFFECTIVE CONTRACEPTION DURING AND AFTER TREATMENT WITH METHOTREXATE INJECTION. (4, 5.1, 8.1, 8.3) METHOTREXATE INJECTION IS CONTRAINDICATED IN PATIENTS WITH A HISTORY OF SEVERE HYPERSENSITIVITY REACTIONS TO METHOTREXATE, INCLUDING ANAPHYLAXIS. (4, 5.2). FORMULATIONS WITH BENZYL ALCOHOL CAN CAUSE SEVERE CENTRAL NERVOUS TOXICITY OR METABOLIC ACIDOSIS. USE ONLY PRESERVATIVE-FREE METHOTREXATE INJECTION FOR TREATMENT OF NEONATES OR LOW-BIRTH WEIGHT INFANTS, AND FOR INTRATHECAL USE. DO NOT USE BENZYL ALCOHOL-CONTAINING FORMULATIONS FOR HIGH-DOSE REGIMENS UNLESS IMMEDIATE TREATMENT IS REQUIRED AND PRESERVATIVE-FREE FORMULATIONS ARE NOT AVAILABLE. (2.1, 5.3) OTHER SERIOUS ADVERSE REACTIONS, INCLUDING DEATH, HAVE BEEN REPORTED WITH METHOTREXATE. CLOSELY MONITOR FOR INFECTIONS AND ADVERSE REACTIONS OF THE BONE MARROW, KIDNEYS, LIVER, NERVOUS SYSTEM, GASTROINTESTINAL TRACT, LUNGS, AND SKIN. WITHHOLD OR DISCONTINUE METHOTREXATE INJECTION AS APPROPRIATE. (5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 5.10, 5.11) RECENT MAJOR CHANGES Boxed Warning 3/2021 Indications and Usage (1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.10) 3/2021 Dosage and Administration (2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 2.10, 2.11, 2.12) 3/2021 Warnings and Precautions Leia o documento completo