Methotrexate 2.5 MG Oral 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.
Mylan Pharmaceuticals Inc.
ROUND ORANGE M 14
M 14 ROUND ORANGE
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16 HOW SUPPLIED/STORAGE AND HANDLING
METHOTREXATE Tablets, USP are available containing 2.5 mg
METHOTREXATE, USP equivalent to 2.74 mg
METHOTREXATE sodium. The 2.5 mg tablets are orange, round, scored tablets debossed with M above the score and 14 below the score on one side of the tablet and blank on the other side of the tablet. They are available as follows: NDC 0378-0014-01 bottles of 100 tablets 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.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
METHOTREXATE tablets are a cytotoxic drug. Follow applicable special handling and disposal procedures. 1
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