Country: Afrika Selatan
Bahasa: Inggeris
Sumber: South African Health Products Regulatory Authority (SAHPRA)
Roussel
RYTHMODAN 100 mg CAPSULES RYTHMODAN 150 mg CAPSULES RYTHMODAN RETARD TABLETS RYTHMODAN INJECTION 50 mg/5 mL SCHEDULING STATUS S4 PROPRIETARY NAME (and dosage form) RYTHMODAN 100 mg CAPSULES RYTHMODAN 150 mg CAPSULES RYTHMODAN RETARD TABLETS RYTHMODAN INJECTION 50 mg/5 mL COMPOSITION Oral: Disopyramide 100 mg; Disopyramide 150 mg Retard: Each tablet contains 322,5 mg disopyramide phosphate equivalent to 250 mg of the base in a sustained release formulation. i.v.: Each 5 ml ampoule contains 64,4 mg disopyramide phosphate equivalent to 50 mg disopyramide. Benzyl alcohol 1%. PHARMACOLOGICAL CLASSIFICATION A. 6.2 cardiac depressants. PHARMACOLOGICAL ACTION Rythmodan slows conduction in the myocardium and in the Purkinje system. Clinically a variable effect is found on the A-V node. Usage has confirmed the characteristic electrocardiographic findings found in animals of widening of the QRS complex and prolongation of the QT interval. Rythmodan is negatively inotropic and possesses anti-cholinergic properties. Cardiac output and blood pressure are usually little affected. INDICATIONS Prevention and treatment of the following arrhythmias: 1. Unifocal and multifocal premature ventricular contractions. 2. Premature atrial contractions. 3. Paroxysmal atrial tachycardia. Rythmodan may be used in the following conditions when complicated by the above arrhythmias. 1. During or after surgical procedures e.g. cardiac catheterization. 2. Following the use of digitalis or similar glycosides. CONTRA-INDICATIONS Rythmodan is contra-indicated in the presence of complete heart block. The drug should be used with caution in patients with partial heart block and in patients being concurrently treated with a potent diuretic which could give rise to hypokalaemia, which may reduce patient response to Rythmodan and increase Baca dokumen lengkap