Korea United Pharma


Qualicare Pharma
Concise Prescribing Info
Acute leukemia, trophoblastic neoplasms (choriocarcinoma, hydatidiform mole), non-Hodgkin's lymphoma, Burkitt's lymphoma, mycosis fungoides, osteogenic sarcomas. Solid tumors of the breast, lungs, head & neck, bladder, cervical, ovarian & testicular carcinoma. RA & severe, uncontrolled psoriasis.
Dosage/Direction for Use
Acute lymphoblastic leukemia 15-30 mg/m2 once or twice wkly. Choriocarcinoma 15-30 mg/m2 daily for 5 days at 1-2 wk interval for 3-5 courses. Mycosis fungoides 2.5-10 mg daily. Severe psoriasis 10-25 mg once wkly. RA 7.5 mg once wkly. Burkitt's lymphoma 10-25 mg daily for 4-8 days repeated after an interval of 7-10 days.
Should be taken on an empty stomach: May be taken w/ meals to reduce GI discomfort. Avoid taking w/ milk-rich products.
Hypersensitivity. Patients w/ psoriasis or RA w/ alcoholism, alcoholic liver disease or other chronic liver disease; preexisting blood dyscrasias eg, bone marrow hypoplasia, leukopenia, thrombocytopenia & significant anemia; immunodeficiency syndromes.
Special Precautions
Kidney failure, liver impairment, diarrhea or ulcerative stomatitis, gastric ulcer or colitis ulcerativa, hematologic disorder, bone marrow depression, chickenpox, complicated infections & mental disorder. Perform blood, urine, hepatic & kidney function tests periodically. Discontinue if elements of blood counts have increased. Bleeding. Methotrexate-induced lung disease. Live vaccines. Contains tartrazine. May decrease reproductive function. Avoid pregnancy 6 mth after therapy. Women of childbearing potential. Not to be used during pregnancy & lactation. Premature, neonates & infants (≤1 yr). Elderly.
Adverse Reactions
Shock; ulcer, bleeding, stomatitis, abdominal pain, diarrhea, nausea & vomiting, anorexia, black vomit, enterocleisis; death by interstitial pneumonia, chronic interstitial occlusive pulmonary disease, pulmonary fibrosis; headache, dizziness, blurred vision, dysphagia, hemiplegia, paralysis, convulsion, coma, & arrhythmia, tension of neck, head & backache; aspermatism, ovarian insufficiency, catamenia insufficiency, infertility, abortion & fetal abnormality; anemia, leukopenia, thrombocytopenia, bleeding, septicemia & hypogammaglobulinemia; increase in GOT, GPT, AL-P, jaundice, fatty liver, sphacelism of liver tissue, hepatocirrhosis; urethral necrobiosis, crucial nephropathy, hematuria & increased BUN or creatinine; loss of consciousness, hypotension, tachycardia, paralysis, sneezing, & dyspnea, cold & sweating; photohypersensitivity, rash, urticaria, pruritus, erythematous rash, erythema, pigmentation, depigmentation, subcutaneous ecchymosis, acne, cavities, telangiectasia & incision of wounds; malaise, parotidis, blennophthalmia, cystitis, arthralgia, myalgia, diabetes, osteoporosis & accidental death.
Drug Interactions
Decreased transport function which delay elimination & action, or enhance toxicity w/ NSAIDs eg, salicylates, phenylbutazone, sulfonamides, tetracycline, chloramphenicol, phenytoin, barbiturates, aminobenzoate, propionic acid, anti-inflammatory agents, probenecid & sulfinpyrazone. Increased conc w/ sulfamethoxazole & trimethoprim. May cause leukoencephalopathy w/ radiotherapeutics.
MIMS Class
Cytotoxic Chemotherapy / Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
ATC Classification
L04AX03 - methotrexate ; Belongs to the class of other immunosuppressants.
Pterin tab 2.5 mg
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