G-Methotrexate - Tablet Methotrexate - 2.5mg 1 Tablet(s) / Tablet Gonoshasthaya Pharmaceuticals Ltd. Introduction: G-Methotrexate is a medicine used to treat rheumatoid arthritis where it can prevent further joint damage. It is also used to treat severe forms of a skin disease called psoriasis by killing cells in the skin which are growing too quickly. G-Methotrexate may be used alone or in combination with other medicines. You should take it exactly as your doctor has advised. Taking it too much can cause very serious side effects. It may take several weeks or months for you to see or feel the benefits but do not stop taking it unless your doctor tells you to. You... Uses of G-Methotrexate: Rheumatoid arthritisPsoriasis Side effects of G-Methotrexate: Abdominal painIndigestionLoss of appetiteNauseaVomitingTirednessMouth sore How to use G-Methotrexate: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. G-Methotrexate may be taken with or without food, but it is better to take it at a fixed time. How G-Methotrexate works: G-Methotrexate is an immunosuppressant. In rheumatoid arthritis, it works by decreasing the activity of the body's immune system. This decreases swelling, reduces pain and stiffness, and improves function. In psoriasis, it works by slowing down the rapid growth of skin cells. Indication: Burkitt's lymphoma, Choriocarcinoma, Mycosis fungoides, Crohn's disease, Psoriasis, Osteosarcoma, Breast cancer, lymphosarcoma, Acute lymphoblastic leukaemia, Rheumatoid arthritis Administration: Should be taken on an empty stomach. Best taken on an empty stomach. May be taken w/ meals to reduce GI discomfort. Avoid taking w/ milk-rich products. IV/IM Preparation Reconstitute with D5W or NS: 20-mg vial, up to 25 mg/mL; 1-g vial, up to 50 mg/mL May dilute further for IV infusion IV/IM Administration Administer by IM, IV push, or IV infusion Regular IV given with no more than 25 mg/mL IV push: Administered at 10 mg/min IV infusion (usually >100 mg): Administered over 30 minutes to 4 hours, or according to institutional protocol High-dose therapy (uses 1-g vial): Administered... Adult Dose: Adult: PO Burkitt's lymphoma 10-25 mg/day for 4-8 days, repeat after 7-10 days. Choriocarcinoma 15-30 mg/day for 5 days, repeat after an interval of at least 1 wk for 3-5 courses. Mycosis fungoides 2.5-10 mg/day to induce remission. Rheumatoid arthritis 7.5 mg once wkly, adjust if needed. Up to 20 mg/wk. Crohn's disease 12.5-22.5 mg once wkly for up to 1 yr. PO/IV/IM Psoriasis 10-25 mg once wkly, adjust subsequent doses if needed. IV Osteosarcoma 12-15 g/m2 as infusion, followed by folinic acid. Breast cancer 10-60 mg/m2 often w/ cyclophosphamide and fluorouracil. Advanced lymphosarcoma Up to 30 mg/kg, followed by... Child Dose: Polyarticular Juvenile Idiopathic Arthritis Initial: 10 mg/m² PO/IM/SC qWeek Meningeal Leukemia 3 years: 12 mg IT every 2-5 days Renal Dose: Renal impairment: CrCl (ml/min) Dosage Recommendation 61-80 75% of dose 51-60 70% of dose 10-50 30-50% of dose <10 Avoid use Intermittent hemodialysis: 50% of dose at normal dosing interval Continuous renal replacement therapy: 50% of dose at normal dosing interval Contraindication: Severe renal or hepatic impairment, pre-existing profound bone marrow suppression in patients with psoriasis or rheumatoid arthritis, alcoholic liver disease, AIDS, pre-existing blood dyscrasias, pregnancy (in patients with psoriasis or rheumatoid arthritis), breast-feeding. Mode of Action: Methotrexate is a folic acid antagonist that inhibits DNA synthesis. It irreversibly binds to dihydrofolate reductase, inhibiting the formation of reduced folates, and thymidylate synthetase, resulting in inhibition of purine and thymidylic acid synthesis. Precaution: Hepatic or renal impairment, bone marrow depression, elderly, neonates. Ulcerative disorders of the GI tract. Monitor haematological, renal and hepatic function, and GI toxicity regularly. Lactation: Drug excreted in breast milk; do not nurse Side Effect: >10% Arachnoiditis with intrathecal administration,Subacute toxicity with intrathecal administration (paralysis of extremities, cranial nerve palsy, seizure or coma),Demyelinating encephalopathy with cranial irradiation or other systemic chemotherapy,Reddening of skin,Hyperuricemia,Ulcerative stomatitis,Glossitis,Gingivitis,Nausea and vomiting,Diarrhea,Anorexia,Intestinal perforation,Mucositis (dose-dependent),Leukopenia,Thrombocytopenia,Renal failure,Azotemia,Nephropathy,Pharyngitis 1-10% Alopecia,Photosensitivity,Rash,Abdominal distress,Malaise,Fatigue,Chills, fever,Decreased resistance to infection,Gastrointestinal hemorrhage,Myelosuppression,Disorders of lung, interstitial pneumonia (acute, chronic),Atrophy of liver, cirrhosis, hepatic fibrosis or necrosis, elevated liver function tests, hepatic failure Potentially Fatal: Pulmonary reactions (e.g. interstitial lung disease); neurotoxicity (e.g. leukoencephalopathy, paresis, demyelination) with intrathecal use; foetal deaths. Interaction: Decreased effectiveness with folic acid and its derivatives. Potentially Fatal: Increased toxicity with NSAIDs and salicylates; probenecid; some penicillins; aminoglycosides neomycin and paromomycin; sulfonamides such as sulfafurazole and sulfamethoxazole; co-trimoxazole or trimethoprim; nephrotoxic agents (e.g. cisplatin); ciclosporin; etretinate. Synergistic enhancement of effects with fluorouracil. Increased bioavailability of mercaptopurine. Reduces serum-valproate concentrations. Reduced serum concentrations with colestyramine. Increased serum concentrations with omeprazole.