Страна: Індонезія
мова: індонезійська
Джерело: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
PROPAFENONE HYDROCHLORIDE
ABBOTT INDONESIA - Indonesia
PROPAFENONE HYDROCHLORIDE
150 MG
TABLET SALUT SELAPUT
DUS, 6 STRIP @ 10 TABLET SALUT SELAPUT
ABBOTT INDONESIA - Indonesia
2019-07-03
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 Прочитайте повний документ