METHOTREXATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Pharmaceuticals USA Inc.

INN (International Name):

METHOTREXATE

Composition:

METHOTREXATE 2.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Methotrexate tablets are 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 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

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: NDC 68382-775-60 in bottle of 36 tablets with child-resistant closure NDC 68382-775-16 in bottle of 90 tablets with child-resistant closure NDC 68382-775-01 in bottle of 100 tablets with child-resistant closure NDC 68382-775-05 in bottle of 500 tablets NDC 68382-775-10 in bottle of 1,000 tablets NDC 68382-775-77 in carton of 100 tablets (10 x 10 unit-dose) 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
ZYDUS PHARMACEUTICALS USA 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._
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).
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:
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