METHOTREXATE tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Par Pharmaceutical, Inc.

INN (الاسم الدولي):

METHOTREXATE SODIUM

تركيب:

METHOTREXATE 2.5 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Methotrexate Tablets is 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 is indicated for the treatment of adults with rheumatoid arthritis. Methotrexate Tablets is indicated for the treatment of adults with severe psoriasis. Methotrexate Tablets is 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 Tab

ملخص المنتج:

Methotrexate Tablets is supplied as 2.5 mg round, convex, yellow tablets with a score line on one side (M above the score and 1 below the score) available in: 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 is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

الوضع إذن:

New Drug Application

خصائص المنتج

METHOTREXATE- METHOTREXATE TABLET
PAR PHARMACEUTICAL, 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 IS 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 IS 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 is 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 AND