Tables 2.5 mg and 5 mg
Trade name: Methotrexate.
International nonproprietary name: Methotrexate.
Description: biconvex, yellow film – coated tables.
Composition: each tablet contains:
Active substance: methotrexate – 2.5 mg or 5 mg.
Excipients: lactose monohydrate, povidone, calcium stearate, potato starch, coating: opadry ll color; composition: opadry ll yellow: polyvinyl alcohol – part. hydrolyzed, macrogol / polyethylene glycol, quinoline yellow aluminum lake (E-104), sunny sunset yellow FCF aluminum lake (E-110), talc, titanium dioxide, iron oxide yellow (E-172).
Pharmaceutical forms: film – coated tablet.
Pharmaceutical group: Anticancer drugs. Antimetabolites.
ATC code: L01BA01.
Indications for use:
Lympho- and myeloblastic leukosis, neuroleukemia, myelomatosis, trophoblastomas (uterine chorioepithelioma, cystic mole, incl. invasive mole), esophageal cancer, epidermoid cancer of head and neck, cancer of urinary bladder, cancer of lung, liver cancer, breast cancer, renal carcinoma, cancer of ureters, prostate cancer, cervical cancer, cancer of vulva, ovarian cancer, testicular cancer, Hodgkin’s and non- Hodgkin’s lymphoma (incl. Burkitt’s lymphoma), mycosis fungoides (local treatment), non- metastatic osteogenic sarcoma.
Rheumatoid arthritis (incl. Felty’s syndrome), steroid –dependent bronchial asthma (if glucocorticoids are contraindicated), Crohn’s disease, chronic nonspecific ulcerative colitis, lichen ruber planus, psoriasis, psoriatic arthritis, Reiter’s syndrome, Sezary syndrome, disseminated sclerosis.