METHOTREXATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METHOTREXATE SODIUM (UNII: 3IG1E710ZN) (METHOTREXATE - UNII:YL5FZ2Y5U1)

Available from:

Alvogen Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHOTREXATE- METHOTREXATE TABLET
ALVOGEN INC.
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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._
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INDICATIONS AND USAGE
Methotrexate tablets are a dihydrofolate reductase inhibitor indicated
for the:
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DOSAGE AND ADMINISTRATION
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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