METHOTREXATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METHOTREXATE (UNII: YL5FZ2Y5U1) (METHOTREXATE - UNII:YL5FZ2Y5U1)

Available from:

Major Pharmaceuticals

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: 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 pregnant woman. There are no animal data that meet current standards for nonclinical developmental toxicity studies. Advise pregnant women with neoplastic diseases of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recogni

Product summary:

Methotrexate tablets, USP are yellow, round, uncoated tablets, with debossing "L2" on one side and scoring on other side. They are supplied as follows: Cartons of 20 tablets ( 10 tablets per blister pack x 2), NDC 0904-7141-10 Storage: Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light Methotrexate tablets are a cytotoxic drug. Follow applicable special handling and disposal procedures1 .

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHOTREXATE- METHOTREXATE TABLET
MAJOR PHARMACEUTICALS
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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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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 are a dihydrofolate reductase inhibitor indicated
for the:
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DOSAGE AND ADMINISTRATION
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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
arth