Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
AMIODARONE HYDROCHLORIDE
AVENTIS PHARMA - Indonesia
AMIODARONE HYDROCHLORIDE
200 MG
TABLET
DUS, 3 BLISTER @ 10 TABLET
AVENTIS PHARMA - Indonesia
2021-10-21
BASED ON AMIODARONE-CCDSV12 –CCDSV19 + CCDS V20 + CCDS V21 + EU SMPC + REMOVE FR MAH INFORMATION + ADDITION OF HALAL LOGO CORDARONE AMIODARONE HCL 200 MG QUALITATIVE AND QUANTITATIVE COMPOSITION: Each tablet contains: Amiodarone (NN) hydrochloride ……….… 200 mg Excipient: include lactose PHARMACEUTICAL FORM Tablet of 200 mg Amiodarone PHARMACOLOGICAL PROPERTIES _ANTI ARRHYTHMIC PROPERTIES : _ - Reduced sinus automaticity leading to bradycardia unresponsive to atropine administration. - Non-competitive alpha and beta adrenergic inhibition. - Slowing in sino-atrial, atrial and nodal conduction, _ which is increased in proportion to _ _rhythm rapidity _ - No change in intra ventricular conduction. - Increased in refractory period and decrease of myocardial excitability at the atrial, nodal and ventricular levels. - Slowing in conduction and prolongation of refractory periods in accessory atrioventricular pathways. _OTHER PROPERTIES: _ - Moderate drop in peripheral resistance and decrease in heart rate leading to a reduction of oxygen intake. - Increase of coronary output due to a direct effect on myocardial arteries smooth muscle. - Maintenance of cardiac output due to a decrease in aortic pressure and peripheral resistance. OTHERS - No significant negative inotropic effect. PHARMACOKINETICS PROPERTIES Amiodarone has a slow transit and a high affinity to tissues. Oral bioavailability has varied between 30 and 80% along with individual patients (mean value around 50%). Following single administration, peak plasma concentrations are DISETUJUI OLEH BPOM: 05/10/2021 EREG100022VR12100078 BASED ON AMIODARONE-CCDSV12 –CCDSV19 + CCDS V20 + CCDS V21 + EU SMPC + REMOVE FR MAH INFORMATION + ADDITION OF HALAL LOGO reached after 3 to 7 hours. Therapeutic effects are usually obtained after one week (from a few days to two weeks), according to the loading dose. Amiodarone has a long half-life including considerable inter-patient variability (from 20 to 100 days). During the first days of therapy, the drug accumulate Baca dokumen lengkapnya