CORDARONE

Country: Indoneżja

Lingwa: Indoneżjan

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

Ingredjent attiv:

AMIODARONE HYDROCHLORIDE

Disponibbli minn:

AVENTIS PHARMA - Indonesia

INN (Isem Internazzjonali):

AMIODARONE HYDROCHLORIDE

Dożaġġ:

50 MG

Għamla farmaċewtika:

CAIRAN INJEKSI

Unitajiet fil-pakkett:

DUS, 6 AMPUL @ 3 ML

Manifatturat minn:

SANOFI WINTHROP INDUSTRIE - France

Data ta 'l-awtorizzazzjoni:

2019-08-04

Karatteristiċi tal-prodott

BASED ON AMIODARONE-CCDSV12 –CCDSV19 + CCDSV21 + EU SMPC
CORDARONE

AMIODARONE HCL
150 MG / 3 ML
RANCANGAN LEAFLET
QUALITATIVE AND QUANTITATIVE COMPOSITION :
per ml /Inj.
Amiodarone (INN) hydrochloride
......................................................................................................
50 mg
Excipient: polysorbate 80, benzyl alcohol, Water for injection
preparation q.s …………...1 ml
PHARMACEUTICAL FORM
Ampoules containing 3 ml of solution for injection.
CLINICAL PARTICULARS
_THERAPEUTIC INDICATIONS _
Serious rhythm disorders when the oral route is not appropriate,
namely
-
atrial rhythm disorders, with rapid ventricular rhythm;
-
Wolf-Parkinson-White syndrome tachycardia;
-
documented symptomatic and disabling ventricular rhythm disorders.
PHARMACOLOGICAL PROPERTIES
_PHARMACODYNAMIC PROPERTIES _
Antiarrhythmic properties
-
Prolongs phase 3 of the cardiac cell action potential without
modifying its height or
ascension rate (Vaughan Williams class III). Phase 3 of the action
potential is prolonged
by slowing the potassium current, without modifying the sodium or
calcium current;
-
Bradycardiac effect by reducing sinus code automatically. This effect
is not antagonized
by atropine;
-
Non competitive alpha-and beta-adrenergic effect;
-
Slowed sinoatrial, atrial and nodal conduction, which is more
pronounced the more rapid
the rhythm;
-
No change in ventricular conduction.
-
Prolonged refractory periods and reduced myocardial excitability on
atrial, nodal and
ventricular levels;
-
Slowed conduction and prolonged refractory periods in the
atrioventricular accessory
channels.
-
No negative inotropic effect
DISETUJUI OLEH BPOM: 31/08/2021
EREG10002212100101
BASED ON AMIODARONE-CCDSV12 –CCDSV19 + CCDSV21 + EU SMPC
_PHARMACOKINETICS PROPERTIES _
The amiodarone injected diminishes very rapidly in the blood as the
tissues become
impregnated and drug flows to the receptor sites: the effects reach a
maximum after
approximately 15 minutes and decrease over a period of 4 hours.
Amiodarone is mainly