Metoxate

Metoxate

methotrexate

Manufacturer:

Ildong Pharm

Distributor:

International Apex
Concise Prescribing Info
Contents
Methotrexate
Indications/Uses
Acute lymphocytic leukemia, meningeal leukemia prophylaxis, Non-Hodgkin's lymphomas, osteogenic sarcoma, adjuvant & in advanced disease of breast cancer, metastatic or recurrent head & neck cancer, choriocarcinoma & similar trophoblastic diseases, & advanced cancer of urinary bladder.
Dosage/Direction for Use
Conventional low dose therapy 15-50 mg/m2 in single dose. Intermediate dose therapy 100-1,000 mg/m2 in a single dose. Advanced squamous epithelial & bladder cancer Up to 100-200 mg/m2. High dose therapy Several malignant diseases, including malignant lymphoma, acute lymphatic leukemia, osteogenic sarcoma & metastatic choriocarcinoma ≥1,000 mg/m2 over 24-hr period. Begin folinic acid administration w/ 10-15 mg (6-12 mg/m2) 12-24 hr after starting methotrexate treatment.
Contraindications
Alcohol abuse; preexisting blood dyscrasias eg, bone marrow hypoplasia, leukopenia, thrombocytopenia, or significant anemia; serious acute or chronic infections eg, TB & HIV; ulcers of the oral cavity & known active GI ulcer disease. Concurrent vaccination w/ live vaccine. Severe liver & renal (CrCl <20 mL/min) impairment. Pregnancy & lactation.
Special Precautions
Use only in life-threatening neoplastic diseases due to risk of severe toxic reactions. Not recommended in women of childbearing potential. Affects spermatogenesis & oogenesis during treatment (may be reversible on discontinuation). Fetal death &/or congenital malformations.
Adverse Reactions
Bone marrow depression, leucopenia, thrombocytopenia, anemia; mouth ulcer, GI disturbances, stomatitis, diarrhea; acute/chronic liver damage, hepatic fibrosis & cirrhosis. Renal failure & tubular necrosis after high doses, pulmonary reactions including life-threatening interstitial lung disease, skin reactions (sometimes severe), alopecia, & ocular irritation; leukoencephalopathy, paresis, demyelination. Intrathecal: Arachnoiditis, an acute syndrome of headache, nuchal rigidity, back pain, & fever.
Drug Interactions
Reduced excretion (increased risk of toxicity) w/ ciprofloxacin. Elevated & prolonged serum levels w/ NSAIDs. Reduced tubular section w/ NSAIDs prep & salicylates. Increased risk of pancytopenia w/ leflunomide. Diminished renal tubular transport w/ probenecid. Reduced renal clearance w/ penicillins. May decrease intestinal absorption or interfere w/ the enterohepatic circulation by inhibiting bowel flora & metabolism by bacteria w/ oral antibiotics eg, tetracycline, chloramphenicol & non-absorbable broad-spectrum antiobiotics. Increased myelosuppression w/ trimethoprim/sulfamethoxazole (isolated cases). Increased renal toxicity w/ potentially nephrotic chemotherapeutic agents (eg, cisplatin). Increased risk of soft tissue necrosis & osteonecrosis w/ radiotherapy. Increased risk of severe neurological side effects w/ cytarabine. Hepatoxicity w/ drugs w/ known hepatotoxic effect (eg, leflunomide, azathioprine, sulfasalazine, retinoids). Reduced theophylline clearance. Increased mercaptopurine plasma content. Increased toxicity w/ other highly bound drugs eg, salicylates, phenylbutazone, phenytoin & sulfonamides. Increased levels w/ furosemide. Reduced response & increased toxicity w/ vit prep containing folic acid or its derivatives. Elevated & prolonged plasma levels w/ proton pump inhibitors.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01BA01 - methotrexate ; Belongs to the class of antimetabolites, folic acid analogues. Used in the treatment of cancer.
Presentation/Packing
Form
Metoxate soln for inj 25 mg/mL
Packing/Price
2 mL x 1's
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