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methotrexate tablet

1 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 ) 1.1 Neoplastic Diseases 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. 1.2 rheumatoid arthritis Methotrexate tablets are indicated for the treatment of adults with rheumatoid arthritis. 1.3 Polyarticular Juvenile Idiopathic Arthritis Methotrexate tablets are indicated for the treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). 1.4 Psoriasis Methotrexate tablets are indicated for the treatment of adults with severe psoriasis.

amneal pharmaceuticals ny llc


4 years ago ROUND YELLOW A 1 methotrexate tablet

ROUND YELLOW A 1

16 HOW SUPPLIED/STORAGE AND HANDLING

METHOTREXATE Tablets USP, 2.5 mg , are supplied as round, biconvex, yellow tablets, scored in half on one side, engraved with “A” above the score and “1” below. They are available as follows: Bottles of 36: NDC 69238-1423-6 Bottles of 100: NDC 69238-1423-1 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

METHOTREXATE tablets, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1


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