Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AMIODARONE HYDROCHLORIDE
SANOFI-AVENTIS (MALAYSIA) SDN. BHD.
AMIODARONE HYDROCHLORIDE
30Tablet Tablets
SANOFI WINTHROP INDUSTRIE
1 ANNEX I QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contain Amiodarone (INN) hydrochloride ........................................... 200mg PHARMACEUTICAL FORM White, round tablets, scored and enegraved with a “heart-shaped” symbol and “200” on one face. CLINICAL PARTICULARS Therapeutic indications Cordarone is indicated only for the treatment of severe rhythm disorders, not responding to other therapy or when other treatments cannot be used: - atrial rhythm disorders (conversion of fibrillation or flutter, and maintenance of sinus rhythm following conversion) - nodal rhythm disorders - ventricular rhythm disorders (life threatening ventricular premature contractions, non- sustained ventricular tachycardia, prevention of ventricular tachycardia or ventricular fibrillation episodes. -rhythm disorders, associated with Wolf-Parkinson-White syndrome In view of its pharmaceutical properties, amiodarone is indicated in the above rhythm disorders especially when they are associated with an underlying heart disease (coronary insufficiency, heart failure). Posology and method of administration Initial treatment The usual dosage regimen is 3 tablets daily for 8 to 10 days. In some cases, higher doses have been used for initial treatment (4 to 5 tablets daily), always for short periods and under electrocardiographic monitoring. Maintenance treatment The minimum effective dose, which varies depending on the patient, should be determined, and ranges from half a tablet daily (1 tablet every 2 days) to 2 tablets daily. Pediatric population The safety and efficacy of amiodarone in children have not been established. See Sections pharmacodynamics properties and pharmacokinetics properties for currently available data. Method of administration Oral route. This product is to be used only by a registered medical practitioner with experience in cardiology 2 Contraindications This medicinal product is contraindicated in the following cases: sinus bradycardia and sinoatrial block in patients without a pacemaker; Les hele dokumentet