Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Warfarin sodium
Teva UK Ltd
B01AA03
Warfarin sodium
1mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02080200; GTIN: 5017007390510 5017007390121
• antibiotics such as amoxicillin, levofloxacin and tetracycline • allopurinol (for gout) • capecitabine, erlotinib, tamoxifen (for types of cancer) • disulfiram (for alcohol dependence) • ketoconazole, fluconazole, itraconazole (for fungal infections) • omeprazole (for stomach ulcers) • propafenone, amiodarone, quinidine (for heart disorders) • methylphenidate (for attention deficit disorder) • zafirlukast (for asthma) • bezafibrate, ciprofibrate, fenofibrate, gemfibrozil (to reduce high blood fats) • statins such as fluvastatin to lower cholesterol (but this does not include pravastatin) • erythromycin, sulfamethoxazole, metronidazole (for bacterial infections) • orlistat (for obesity). MEDICINES WHICH DECREASE THE EFFECT OF WARFARIN: TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING: • barbiturates (sedatives) • primidone, phenytoin, carbamazepine (to treat epilepsy) • griseofulvin (for fungal infections) • oral contraceptives (the ’Pill’) • rifampicin (for tuberculosis) • azathioprine (for inflammatory bowel disease and rheumatoid arthritis and to prevent organ rejection) • sucralfate (for stomach ulcers) • colestyramine (for lowering cholesterol). MEDICINES WHICH HAVE VARYING EFFECTS ON WARFARIN: TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING: • corticosteroids (for inflammation and many other diseases) • nevirapine, ritonavir (for HIV infection). PREGNANCY AND BREAST-FEEDING Do not take this medicine if you are pregnant, may become pregnant or have had a baby within the last 48 hours. See your doctor straight away if you get pregnant whilst taking this medicine. Warfarin is unlikely to harm your baby during breast-feeding, if taken at the correct dose. DRIVING AND USING MACHINES Warfarin has no known effect on the ability to drive or operate machines. IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS • If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. HOW TO TAKE Always tak Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Warfarin 1 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Warfarin Sodium 1 mg Excipient with known effect: Each tablet contains 96.67 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Brown tablet (diameter 8 mm) with WFN above and 1 below a breakline on one side and twin triangle on reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of systemic embolism in rheumatic heart disease and atrial fibrillation. Prophylaxis and treatment of venous thrombosis and pulmonary embolism. Transient cerebral ischaemic attacks. Prophylaxis of thromboembolism after insertion of prosthetic heart valve. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS Whenever possible, base-line prothrombin time should be determined before the initial dose is given. An initial loading dose for warfarin is usually 10mg daily for adults, tailored to individual requirements for the desired degree of anticoagulant effect. The maintenance dose is usually started after 48 hours and depends upon the prothrombin time - reported as international normalised ratio (INR). Currently recommended ranges of therapeutic anticoagulation are the following: Prophylaxis of deep-vein thrombosis including surgery in high risk patients: INR 2- 2.5 Prophylaxis in hip surgery and fractured femur operations, treatment of deep vein thrombosis, pulmonary and systemic embolism, prevention of venous thrombo- embolism in myocardial infarction, transient ischaemic attacks, mitral stenosis with embolism, tissue prosthetic heart valves: INR 2-3 Recurrent deep-vein thrombosis and pulmonary embolism, mechanical prosthetic heart valves, arterial disease including myocardial infarction: INR 3-4.5 The daily maintenance dose, taken at the same time each day, is usually between 3 mg and 9 mg. In the early days of treatment, INR should be determined daily or on alternative days, then, depending on response, determ Baca dokumen lengkapnya