Powder lyophilized for preparing solution
For injection 10 mg, 50 mg, 1000 mg
Trade name: Methotrexate.
International non- proprietary name: Methotrexate.
Description: porous mass or powder of from yellow, orange to yellow- brown nonhomogenous color, hygroscopic.
Composition: each ampoule/ vial contains:
Active substance: methotrexate (in the form of methotrexate sodium)-
10 mg, 50 mg, 1000 mg.
Pharmaceutical form: lyophilized powder for solution for injection.
ATC code: L01BA01.
Indications for use:
Oncologic diseases.
Methotrexate is indicated for treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole.
In case of acute lymphoblastic leukemia, methotrexate is indicated for the prophylactics of meningeal leukemia and is used in maintenance therapy in combination with other chemotherapeutic agents.
Methotrexate is also indicated for the treatment of meningeal leukemia.
Methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous T- cell lymphoma), and lung cancer, particulary squamous cell and small cell types.
Methotrexate is also used in combination with other chemotherapeutic agents for treatment of advanced stage non- Hodgkin’s lymphoma.
Methotrexate in high doses followed by calcium folinate rescue in combination with other chemotherapeutic agents is effective in prolonging relapse – free survival in patients with non- metastatic osteosarcoma who have undergone surgical resection or amputation of the primary tumor.
Psoriasis
Methotrexate is indicated for the symptomatic control of severe, recalcitrant, disabling psoriasis in patients who do not have adequate response to other forms of therapy, but only when the diagnosis has been established, by biopsy and/or after dermatologic consultations, it is important to undiagnosed disease affecting immune responses.
Rheumatoid arthritis including polyarticular- course juvenile rheumatoid arthritis
Methotrexate is indicated in the management of selected category of adult patients with severe, active rheumatoid arthritis (ACR criteria), or children with active polyarticular – course juvenile
Rheumatoid arthritis, who have had an insufficient therapeutic response to, or are intolerant of, an adequate first- line therapy including a full dose of non- steroidal anti- inflammatory agents (NSAIDs).
Aspirin, (NSAIDs), and/or low dose steroids may be continued although the possibility of increased toxicity with concomitant use of NSAIDs including salicylates has not been fully explored.
Steroids may be reduced gradually in patients who respond to methotrexate.
Combined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine, or cytotoxic agents, has not been studied and may increase the incidence of adverse effects. Rest and physiotherapy as indicated should be continued.