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) of lymphosarcoma especially in childn, in advanced cases of mycosis fungoides. Alone or in combination therapy for head & neck epidermoid cancers, osteogenic sarcoma & bronchogenic carcinoma. Psoriasis & RA chemotherapy.
Dosage/Direction for Use
Trophoblastic neoplasm 15-30 mg PO or 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 orally w/ prednisolone 60 mg/m2 daily. Maintenance: 30 mg/m2 orally or 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 daily PO 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. Dosage in each schedule 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/ poor nutritional status, bone marrow depression, preexisting blood dyscrasias eg, bone marrow hypoplasia, leucopenia, thrombocytopenia or anaemia, overt or lab evidence of immunodeficiency syndromes. RA patients w/ active, infectious disease or psoriasis patients w/ serious infections; psoriasis & RA patients w/ PUD or ulcerative colitis, suffering severe renal disorders, alcoholism or hepatic disorders ie, alcoholic or other chronic liver disease. Concurrent CNS RT, concomitant acitretin. Hepatic disorders, severe renal impairment. Pregnancy & lactation.
Special Precautions
Discontinue use & institute appropriate treatment if lymphoma occurs. Potentially fatal opportunistic infections. Pulmonary toxicity ie, acute or chronic interstitial pneumonitis & pulmonary fibrosis. Bone marrow depression, anaemia, aplastic anaemia, leucopenia, neutropenia, thrombocytopenia & bleeding. Hepatotoxic at high doses. Determine hepatic function prior to & regularly during therapy. Monitor closely for pulmonary symptoms. Evaluate haematologic levels pretreatment & periodically. Avoid alcohol, concomitant use of hepatotoxins eg, leflunomide, azathioprine, retinoids, sulfasalazine; NSAIDs. Liver damage or hepatic & renal impairment.
Adverse Reactions
Ulcerative stomatitis, leucopenia, nausea, abdominal distress. Malaise, undue fatigue, chills & fever, dizziness, drowsiness, tinnitus, blurred vision, eye discomfort & decreased resistance to infection.
Drug Interactions
Increased risk of hepatotoxicity w/ other potential hepatotoxins eg, leflunomide, azathioprine, retinoids, sulfasalazine. Decreased theophylline clearance. Increased mercaptopurine plasma levels. Antagonized effects by asparaginase. Skin cancer w/ psoriasis or mycosis fungoides w/ concomitant methoxsalen & UV light. Prolonged serum conc & enhanced toxicity w/ concurrent packed RBC. Reduced immunological response to vaccines. Serious adverse effects w/ NSAIDs. Increased risk of soft tissue necrosis & osteonecrosis w/ RT.
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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