RYTMONORM

Country: Индонезија

Језик: Индонежански

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

Активни састојак:

PROPAFENONE HYDROCHLORIDE

Доступно од:

ABBOTT INDONESIA - Indonesia

INN (Међународно име):

PROPAFENONE HYDROCHLORIDE

Дозирање:

150 MG

Фармацеутски облик:

TABLET SALUT SELAPUT

Јединице у пакету:

DUS, 6 STRIP @ 10 TABLET SALUT SELAPUT

Произведен од:

ABBOTT INDONESIA - Indonesia

Датум одобрења:

2019-07-03

Карактеристике производа

Page 1 of 9
RYTMONORM
RDCCDS00348V10.0
RYTMONORM
®
PROPAFENONE HCL
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film coated tablet of Rytmonorm contains 150 mg of propafenone
hydrochloride.
TRADE NAMES
Rytmonorm
®
DESCRIPTION
Propafenone hydrochloride is a class 1c antiarrhythmic drug with some
structural similarities to beta-
blocking agents.
It is a white or colorless crystalline powder with a very bitter
taste. It is slightly soluble in water (20°C),
chloroform and ethanol. Its chemical name is
2’-{2-hydroxy-3-(propylamino)-propoxy]-3-
phenylpropiophenone hydrochloride and its chemical formula is C
21
H
27
NO
3
.HCl. Its molecular weight is
377.92.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
In patients without structural heart disease Propafenone hydrochloride
is indicated to prolong the time to
recurrence of:

Paroxysmal Atrial Fibrillation/ Flutter (PAF) associated with
disabling symptoms.

Paroxysmal Supraventricular Tachycardia (PSVT) associated with
disabling symptoms.
The use of Propafenone in patients with chronic Atrial Fibrillation
has not been evaluated. It should not
be used to control ventricular rate during atrial fibrillation.

Documented ventricular arrhythmias such as sustained ventricular
tachycardia, that in judgement
of the physician are life threatening. Because the pro arrhythmic
effects of Rytmonorm; its use
with lesser ventricular arrhythmias is not recommended. Even if
patients are symptomatic and
any use of the drug should be reserved for patients in whom, in the
opinion of the physician, the
potential benefits outweigh the risks.
Initiation of Rytmonorm treatment, as with other anti-arrhythmics used
to treat life-threatening ventricular
arrhythmias, should be carried out in the hospital.
POSOLOGY AND METHOD OF ADMINISTRATION
The individual maintenance dose should be determined under
cardiological surveillance, ECG checks (1
st
and 2
nd
day of treatment and at the end of dose adjustment). If the QRS phase
is prolonged by more than
20% or the rate-dependent QT interval cha