CORDARONE

국가: 인도네시아

언어: 인도네시아어

출처: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

유효 성분:

AMIODARONE HYDROCHLORIDE

제공처:

AVENTIS PHARMA - Indonesia

INN (International Name):

AMIODARONE HYDROCHLORIDE

복용량:

200 MG

약제 형태:

TABLET

패키지 단위:

DUS, 3 BLISTER @ 10 TABLET

Manufactured by:

AVENTIS PHARMA - Indonesia

승인 날짜:

2021-10-21

제품 특성 요약

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