DBL Methotrexate

DBL Methotrexate

methotrexate

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
MTX
Indications/Uses
Breast cancer, gestational choriocarcinoma, patients w/ chorioadenoma destruens & hydatidiform mole. In combination w/ other chemotherapeutic agents for palliative treatment of acute leukaemias particularly acute lymphoblastic leukaemia. Burkitt's lymphoma, advanced stages III & IV lymphosarcoma especially in childn, in advanced cases of mycosis fungoides. Alone or in combination therapy for head & neck epidermoid cancers, osteogenic sarcoma & bronchogenic carcinoma. Symptomatic control of severe, recalcitrant, disabling psoriasis inadequately responsive to other treatment. Management of severe, recalcitrant, active RA in adults not responding to, or intolerant of NSAIDs & ≥1 disease modifying drugs.
Dosage/Direction for Use
Trophoblastic neoplasm 15-30 mg PO/IM for 5 days, repeat course may be given after ≥1 wk. Normally, 3-5 courses are employed. Breast carcinoma 40 mg/m2 IV on 1st & 8th days. Induction of lymphoblastic leukaemia remission 3.3 mg/m2 PO w/ prednisolone 60 mg/m2 daily. Maintenance: 30 mg/m2 PO/IM twice wkly or 2.5 mg/kg IV every 14 days. Meningeal leukaemia ≥3 yr 12 mg, 2 yr 10 mg, 1 yr 8 mg, <1 yr 6 mg administered by intrathecal inj & repeated at intervals of 2-5 days. Stage I/II Burkitt's lymphoma 10-25 mg daily PO for 4-8 days. Stage III lymphosarcoma 0.625-2.5 mg/kg daily. Mycosis fungoides 2.5-10 mg PO daily for wk/mth or 50 mg IM once wkly or 25 mg IM twice wkly. Psoriasis chemotherapy Wkly single dose schedule: 10-25 mg PO/IM/IV wkly. Max: 50 mg/wk. Divided dose schedule: 2.5 mg PO at 12-hr intervals for 3 doses or at 8-hr intervals for 4 doses wkly. Max: 30 mg/wk. Daily dose schedule: 2.5 mg PO daily for 5 days followed by rest period of at least 2 days. Max: 6.25 mg daily. RA chemotherapy Initially 7.5 mg once wkly or 2.5 mg PO in divided doses at 12-hr intervals for 3 doses as once wkly course. May be increased to 15 mg/wk after 6 wk. Max: 20 mg/wk.
Administration
Should be taken on an empty stomach: May be taken w/ meals to reduce GI discomfort. Avoid taking w/ milk-rich products.
Contraindications
Hypersensitivity. Patients w/ bone marrow depression, preexisting blood dyscrasias eg, bone marrow hypoplasia, leucopenia, thrombocytopenia or anaemia; overt or lab evidence of immunodeficiency syndromes; severe acute or chronic infections. Psoriasis patients w/ PUD or ulcerative colitis. Alcoholism or alcoholic liver disease. Concurrent use w/ live vaccines. Combination w/ retinoids eg, acitretin. Concurrent CNS RT w/ intrathecal MTX. Severe hepatic & renal impairment. Pregnancy & lactation.
Special Precautions
Discontinue use if malignant lymphomas occur. Severe, occasionally fatal, dermatological reactions eg, TEN, SJS, exfoliative dermatitis, skin ulceration/necrosis, erythema multiforme. Potentially fatal opportunistic infections; peptic ulcer, ulcerative colitis; marked bone marrow, anaemia, aplastic anaemia, leukopenia, neutropenia, thrombocytopenia, bleeding; pre-existing haematopoietic impairment; soft tissue necrosis, osteonecrosis; active infections. Patients w/ significant 3rd-space accumulation eg, pleural effusions or ascites. May trigger tumour lysis syndrome in patients w/ rapidly growing tumour. Potential for reactivation of inactive chronic infections eg, herpes zoster, TB, hepatitis B or C. Monitor renal function, ensure adequate hydration & measure serum MTX & creatinine levels during therapy. Closely monitor for neurologic & pulmonary signs & symptoms. Determine hepatic function including serum albumin & prothrombin time prior to & monitor regularly. Perform complete CBC w/ differential & platelet counts; haematocrit; urinalysis; hepatitis B or C infection testing; chest X-ray prior to, during & periodically thereafter. Folate deficiency states. Avoid exposure to sun & UV light; alcohol consumption. High-dose & prolonged use. Avoid concomitant use of PPIs. Concomitant use of hepatotoxic or haematotoxic DMARDs; folate antagonists eg, trimethoprim/sulfamethoxazole; IV cytarabine; NSAIDs; gold, penicillamine, hydroxychloroquine, sulfasalazine or cytotoxic agents; live vaccines; RT. May affect ability to drive & use machines. Hepatic & renal impairment; pre-existing liver damage. May impair fertility. Women of childbearing potential & male partners should use effective contraception during & for 6 mth after last dose. Not to be used during pregnancy & lactation. Childn. Elderly & debilitated patients.
Adverse Reactions
Bone marrow suppression, mucosal damage eg, ulcerative stomatitis, leukopenia, nausea, other GI disorders; malaise, undue fatigue, chills, fever, headache, dizziness, drowsiness, tinnitus, blurred vision, eye discomfort, decreased resistance to infections.
Drug Interactions
Enhanced nephrotoxicity w/ potentially nephrotoxic chemotherapeutic agent eg, cisplatin. Increased risk of neurologic adverse events w/ IV cytarabine. Antagonised effect by asparaginase. Increased plasma levels of mercaptopurine. Increased toxicity w/ salicylates, sulfonamides, sulfonylureas, phenylbutazone phenytoin, some antibacterials (eg, penicillins, tetracycline, chloramphenicol, pristinamycin, probenecid), PABA. Elevated & prolonged serum levels w/ NSAIDs. Severe fatal marrow suppression, aplastic anaemia, GI toxicity w/ aspirin, other salicylates, azapropazone, diclofenac, indomethacin, ketoprofen. Diminished renal tubular transport by ciprofloxacin. Increased bone marrow suppression w/ trimethoprim/sulfamethoxazole, pyrimethamine. Decreased response w/ folic acid-containing vit prep. Increased risk of hepatoxicity w/ other potentially hepatotoxic agents eg, leflunomide, sulfasalazine, alcohol. Increased risk of pancytopenia w/ leflunomide. Potentiated effect on folate metabolism w/ nitrous oxide anaesth. Induced ulcerative skin lesions w/ amiodarone. Skin cancer w/ PUVA therapy. Severe antigenic reactions, fatal infections w/ live vaccine. Decreased theophylline clearance. Bone marrow suppression & decreased folate levels w/ triamterene. Decreased clearance w/ PPIs eg, omeprazole, pantoprazole. Decreased efficacy of phenytoin. Potentiated efficacy & toxicity w/ cyclosporin. Not to be given concurrently w/ hypolipidaemic compd eh, cholestyramine. Caution w/ drugs reducing tubular secretion eg, loop diuretics, pyrazoles; other cytotoxic drugs; packed RBC.
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.
L04AX03 - methotrexate ; Belongs to the class of other immunosuppressants.
Presentation/Packing
Form
DBL Methotrexate inj 1 g/10 mL
Packing/Price
1's
Form
DBL Methotrexate inj 50 mg/2 mL
Packing/Price
1's
Form
DBL Methotrexate inj 500 mg/20 mL
Packing/Price
1's
Form
DBL Methotrexate tab 2.5 mg
Packing/Price
30's
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