Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AMIODARONE HYDROCHLORIDE
UNIMED SDN BHD
AMIODARONE HYDROCHLORIDE
100Tablet Tablets
Troikaa Pharmaceuticals Ltd
EURYTHMIC TABLETS 200MG Amiodarone Hydrochloride 200mg 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What EURYTHMIC Tablet is used for 2. How EURYTHMIC Tablet works 3. Before you use EURYTHMIC Tablet 4. How to use EURYTHMIC Tablet 5. While you are using it 6. Side effects 7. Storage and Disposal of EURYTHMIC Tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT EURYTHMIC TABLET IS USED FOR EURYTHMIC tablet is indicated only for the treatment of severe heart rhythm disorders, not responding to other therapy or when other treatment cannot be used: • Treat uneven heartbeats • Treat other types of fast or uneven heartbeats known as ‘ atrial flutter’ or ‘atrial fibrillation’ • Treat fast heartbeats which may happen suddenly and may be uneven. • Treat an illness called Wolff- Parkinson-White Syndrome. This is where your heart beats unusually fast. HOW EURYTHMIC TABLET WORKS EURYTHMIC tablet contains the active ingredient Amiodarone Hydrochloride which belongs to the group of medicines called anti-arrhythmics. Eurythmic works by controlling the uneven beating of your heart (called ‘arrhythmias’). Taking the tablet helps your heartbeat to return to normal. BEFORE YOU USE EURYTHMIC TABLET_ _ _When you must not use it _ Do not take EURYTHMIC tablet if: • You are allergic (hypersensitive) to iodine, amiodarone or any of the other ingredients of this medicine. • Signs of allergic reaction include: a rash, swallowing or breathing problem, swelling of your lips, face, throat or tongue • You have a slower than usual heartbeat (called ‘sino-atrial’ heart block. • You have any other problem with your heartbeat and do not have a pacemaker fitted. • You have ever had thyroid problem. Your doctor should test your thyroid before giving you this medicine. • If you’re pregnant or breast-feeding. • You are taking any other medicines that may include heart rhythm disturbances Do not use this medicin Přečtěte si celý dokument
FRONT AMIODARONE HYDROCHLORIDE BP 200 mg. Pharmacodynamics: There is no well-established relationship of plasma concentration to effectiveness, but it does appear that concentrations much below 1 mg/L are often ineffective and that levels above 2.5 mg/L are generally not needed. Some observations have suggested a plasma concentration, dose, or dose/duration relationship for side effects such as pulmonary fibrosis, liver-enzyme elevations, corneal deposits and facial pigmentation, peripheral neuropathy, gastrointestinal and central nervous system effects. White to off white colored, round, flat, uncoated beveled edge and having break line on one side of tablet. Pharmacodynamics Electrophysiology / Mechanism of Action: The antiarrhythmic effect of amiodarone may be due to at least two major properties: DESCRIPTION: 2. Noncompetitive α - and β -adrenergic inhibition. Amiodarone prolongs the duration of the action potential of all cardiac fibers while causing minimal reduction of dV/dt (maximal upstroke velocity of the action potential). The refractory period is prolonged in all cardiac tissues without influencing resting membrane potential, except in automatic cells where the slope of the prepotential is reduced, generally reducing automaticity. These electrophysiologic effects are reflected in a decreased sinus rate of 15 to 20%, increased PR and QT intervals of about 10%, the development of U-waves, and changes in T-wave contour. These changes should not require discontinuation of amiodarone as they are evidence of its pharmacological action, although amiodarone can cause marked sinus bradycardia or sinus arrest and heart block. On rare occasions, QT prolongation has been associated with worsening of arrhythmia. Hemodynamics: After intravenous administration, amiodarone relaxes vascular smooth muscle, reduces peripheral vascular resistance (afterload), and slightly increases cardiac index. After oral dosing, amiodarone produces no significant change in left ventricular ejection fraction (LVEF), even in patients Přečtěte si celý dokument