Kraj: Malezja
Język: angielski
Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DIGOXIN
Aspen Medical Products Malaysia Sdn Bhd
DIGOXIN
300 Tablet Tablets
ASPEN BAD OLDESLOE GMBH
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ 1 LANOXIN TABLETS / PG TABLETS Digoxin (250mcg, PG 62.5mcg) WHAT IS IN THE LEAFLET 1. What Lanoxin Tablet is used for 2. How Lanoxin Tablet works 3. Before you use Lanoxin Tablet 4. How to use Lanoxin Tablet 5. While you are using it 6. Side effects 7. Storage and Disposal of Lanoxin Tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT LANOXIN TABLET IS USED FOR Lanoxin Tablet is used to treat arrhythmias and heart failure. An arrhythmia is an irregularity in the heartbeat, which causes the heart to skip a beat, beat irregularly or beat at the wrong speed. HOW LANOXIN TABLET WORKS Lanoxin Tablet contains the active ingredient digoxin which belongs to a group of medicines called cardiac glycosides. Lanoxin Tablet works by correcting irregular heartbeats to a normal rhythm and strengthens the force of the heartbeat, which is why it is useful in heart failure. BEFORE YOU USE LANOXIN TABLET - _When you must not use it _ You must not take Lanoxin Tablet if you are allergic to digoxin, to other cardiac glycosides or to any of the other ingredients in this medicine. Lanoxin Tablet must not be used in patients with certain heart problems. Your doctor will have checked your medical history before treating you with this medicine. If you have any concerns you should discuss these with your doctor. - _Before you start to use it _ If you are pregnant or are intending to become pregnant or breastfeeding you must discuss this with your doctor. Your doctor will discuss the possible risks and benefits involved. - _Taking other medicines _ You MUST tell your doctor or pharmacist about all the medicines you are taking, even those which you have bought for yourself without a doctor's prescription, including herbal remedies such as St John's wort and vitamins. Digoxin interacts with lots of different medicines. The other medicines that you may be taking may increase or decrease the effect of Lanoxin Tablet. This can cause Lanoxin Przeczytaj cały dokument
1 LANOXIN QUALITATIVE AND QUANTITATIVE COMPOSITION Lanoxin Tablets contain the active ingredient Digoxin in 62.5 micrograms or 250 micrograms. PHARMACEUTICAL FORM Lanoxin PG Tablets are blue, round, biconvex tablets, debossed “DO6” on the one side and plain on the other side. Each tablet contains 62.5mcg (0.0625mg) of Digoxin BP. Lanoxin Tablets 250mcg are white, round, biconvex tablets, bisected and debossed “DO25” on the same side and plain on the other side. Each tablet contains 250mcg (0.250mg) of Digoxin BP. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS CARDIAC FAILURE Digoxin is indicated in the management of chronic cardiac failure where the dominant problem is systolic dysfunction. Its therapeutic benefit is greatest in those patients with ventricular dilatation. Digoxin is specifically indicated where cardiac failure is accompanied by atrial fibrillation. SUPRAVENTRICULAR ARRHYTHMIAS Digoxin is indicated in the management of certain supraventricular arrhythmias, particularly chronic atrial flutter and fibrillation. POSOLOGY AND METHOD OF ADMINISTRATION The dose of digoxin for each patient has to be tailored individually according to age, lean body weight and renal function. Suggested doses are intended only as an initial guide. The difference in bioavailability between injectable digoxin and oral formulations must be considered when changing from one dosage form to another. For example if patients are switched from oral to the intravenous formulation the dosage should be reduced by approximately 33%. 2 MONITORING The serum concentration of digoxin can be determined by radioimmunoassay. Blood should be taken 6 hours or more after the last dose of digoxin. There are no rigid guidelines as to the range of serum concentrations that are most efficacious. Several _post hoc_ analyses of heart failure patients in the Digitalis Investigation Group trial demonstrated that at low serum digoxin concentrations (0.5 – 0.9 ng/mL), the use of digoxin was associated with reductions in mortality and hospitalizati Przeczytaj cały dokument