Pterin Injection

Pterin Injection

methotrexate

Manufacturer:

Korea United Pharma

Distributor:

Qualimed
Concise Prescribing Info
Contents
Methotrexate
Indications/Uses
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 IM 15-30 mg/m2 once or twice wkly. IV Alternately, 2.5 mg/kg every 14 days. Choriocarcinoma IM 15-30 mg/m2 daily for 5 days at 1-2 wk interval for 3-5 courses. IM Alternately, 0.25-1 mg/kg up to a max of 60 mg every 48 hr for 4 doses followed by folinic acid rescue & repeated at intervals of 7 days. Mycosis fungoides IM 50 mg as a single dose wkly. Severe psoriasis IV/IM 10-25 mg once wkly. Meningogenic leukemia in childn 12 mg/m2 or 15 mg (about 0.4-0.5 mg/kg) intrathecal once or twice wkly. Osteogenic sarcoma 12-15 mg/m2 IV infusion followed by folinic acid.
Contraindications
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. 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
L01BA01 - methotrexate ; Belongs to the class of antimetabolites, folic acid analogues. Used in the treatment of cancer.
Presentation/Packing
Form
Pterin Injection soln for inj 25 mg/mL
Packing/Price
2 mL x 10 × 1's
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