Pays: Singapour
Langue: anglais
Source: HSA (Health Sciences Authority)
PROPAFENONE HCl
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
C01BC03
150 mg
TABLET, FILM COATED
PROPAFENONE HCl 150 mg
ORAL
Prescription Only
Benta Lyon
ACTIVE
1988-04-26
Updated 23-Jun-2014 Rytmonorm ® 150 mg · Rytmonorm ® 300 mg 1. NAME OF THE MEDICINAL PRODUCT Rytmonorm ® tablet 150mg Rytmonorm ® tablet 300mg 2. QUALITATIVE AND QUANTITATIVECOMPOSITION One Rytmonorm ® tablet 150 mg contains 150 mg propafenone hydrochloride. One Rytmonorm ® tablet 300 mg contains 300 mg propafenone hydrochloride. 3. PHARMACEUTICAL FORM White to off white film coated tablets, biconvex. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Symptomatic supraventricular tachyarrhythmias warranting treatment, such as AV junctional tachycardias, supraventricular tachycardias in patients with WPW syndrome or paroxysmal atrial fibrillation. Serious symptomatic ventricular tachyarrhythmias if life-threatening or necessitating treatment in the judgement of the physician. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION The individual maintenance dose should be determined under cardiological surveillance including ECG monitoring and repeated blood pressure control (stabilization phase) unless otherwise prescribed by the physician. For initial and maintenance treatment a daily dose of 450-600 mg divided in two or three doses per day (one 150 mg Rytmonorm coated tablet three times daily or up to one 300 mg Rytmonorm coated tablet twice daily) is recommended. Occasionally an increase of the daily dose to 900 mg may be necessary (one 300 mg Rytmonorm coated tablet three times daily or two 150 mg Rytmonorm coated tablets three times daily). These data apply to patients with a body weight of about 70 kg. The daily doses should be reduced accordingly for patients with a lower body weight. Dose increases should not be attempted until the patient has been receiving treatment for three to four days. This daily dose should be exceeded only in exceptional circumstances and unde Lire le document complet
Updated 21 May 2020 Rytmonorm ® 150 mg 1. NAME OF THE MEDICINAL PRODUCT Rytmonorm ® tablet 150mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One Rytmonorm ® tablet 150 mg contains 150 mg propafenone hydrochloride. 3. PHARMACEUTICAL FORM White to off white film coated tablets, biconvex. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Symptomatic supraventricular tachyarrhythmias warranting treatment, such as AV junctional tachycardias, supraventricular tachycardias in patients with WPW syndrome or paroxysmal atrial fibrillation. Serious symptomatic ventricular tachyarrhythmias if life-threatening or necessitating treatment in the judgement of the physician. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION The individual maintenance dose should be determined under cardiological surveillance including ECG monitoring and repeated blood pressure control (stabilization phase) unless otherwise prescribed by the physician. For initial and maintenance treatment a daily dose of 450-600 mg divided in two or three doses per day (one 150 mg Rytmonorm coated tablet three times daily) is recommended. Occasionally an increase of the daily dose to 900 mg may be necessary (two 150 mg Rytmonorm coated tablets three times daily). These data apply to patients with a body weight of about 70 kg. The daily doses should be reduced accordingly for patients with a lower body weight. Dose increases should not be attempted until the patient has been receiving treatment for three to four days. This daily dose should be exceeded only in exceptional circumstances and under strict cardiological control. In those patients in whom significant widening of the QRS complex, prolonging of the PR interval or second or third degree AV block occurs, a dose reduction should be considered. Particularly in the elderly and in patients with marked previous myocardial damage (relevant impairment of left ventricular function or structural myocardial disease), the first dose increase should take place after 5 to 8 days of therapy. When prescribing propafenone Lire le document complet