Methox 2.5 tablet: Each film coated tablet contains Methotrexate USP equivalent to 2.5 mg Anhydrous Methotrexate. Methox 10 tablet: Each film coated tablet contains Methotrexate USP equivalent to 10 mg Anhydrous Methotrexate.
Dosage and administration:
Choriocarcinoma and similar trophoblastic diseases: Methotrexate is administered orally in doses of 15 to 30 mg daily for a five-day course. In acute lymphoblastic leukemia in children methotrexate in doses of 3.3 mg/m2 in combination with 60 mg/m2 of prednisone, given daily, produced remissions in 50% of patients treated usually within a period of 4 to 6 weeks. In Burkitt\’s tumor, Stages I-II, recommended dosage is 10 to 25 mg/day orally for 4 to 8 days. In Stage III, methotrexate is commonly given concomitantly with other antitumor agents. Treatment in all stages usually consists of several courses of the drug interposed with 7 to 10 day rest periods. Lymphosarcomas in Stage llI may respond to combined drug therapy with methotrexate given in doses of 0.625 to 2.5 mg/kg daily. In mycosis fungoides Dosage in early stages is usually 5 to 50 mg once weekly. Methotrexate has also been administered twice weekly in doses ranging from 15 to 37.5 mg in patients who have responded poorly to weekly therapy. Adult Rheumatoid Arthritis: Recommended Starting Dosage Schedules Single oral doses of 7.5 mg once weekly. Divided oral dosages of 2.5 mg at 12 hour intervals for 3 doses given as a course once weekly. Psoriasis: Recommended Starting Dose Schedules Weekly single oral, IM or IV dose schedule: 10 to 25 mg per week until adequate response is achieved. Divided oral dose schedule: 2.5 mg at 12-hour intervals for three doses. Dosages in each schedule may be gradually adjusted to achieve optimal clinical response; 30 mg/week should not ordinarily be exceeded.
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Side effect:
The most frequently reported adverse reactions include ulcerative stomatitis, leukopenia, nausea, and abdominal distress. Other frequently reported adverse effects are malaise, undue fatigue, chills and fever, dizziness and decreased resistance to infection. Other adverse reactions are gingivitis, pharyngitis, stomatitis, anorexia, nausea, vomiting, diarrhea, hematemesis, melena, gastrointestinal ulceration and bleeding, enteritis, pancreatitis. Suppressed hematopoiesis causing anemia, aplastic anemia, leukopenia and/or thrombocytopenia. Hypogammaglobulinemia has been reported rarely. pericarditis, pericardial effusion, hypotension, and thromboembolic events (including arterial thrombosis, cerebral thrombosis, deep vein thrombosis, retinal vein thrombosis, thrombophlebitis, and pulmonary embolus). headaches, drowsiness, blurred vision. Aphasia, hemiparesis, paresis and convulsions have also occurred following administration of methotrexate. Following low doses, there have been occasional reports of transient subtle cognitive dysfunction, mood alteration, unusual cranial sensations, leukoencephalopathy, or encephalopathy. There have been case reports of sometimes fatal opportunistic infections in patients receiving methotrexate therapy for neoplastic and non-neoplastic diseases. Pneumocystis carinii pneumonia was the most common infection. Other reported infections included nocardiosis; histoplasmosis, cryptococcosis, Herpes zoster, H. simplex hepatitis, and disseminated H. simplex, conjunctivitis, interstitial pneumonitis deaths have been reported, and chronic interstitial obstructive pulmonary disease has occasionally occurred, erythematous rashes, pruritus, urticaria, photosensitivity, pigmentary changes, alopecia, ecchymosis, telangiectasia, acne, furunculosis, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, skin necrosis, and exfoliative dermatitis, severe nephropathy or renal failure, azotemia, cystitis, hematuria; defective oogenesis or spermatogenesis, transient oligospermia, menstrual dysfunction, vaginal discharge and gynecomestia; infertility, abortion, fetal defects.
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