국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
SOTALOL HYDROCHLORIDE (UNII: HEC37C70XX) (SOTALOL - UNII:A6D97U294I)
Proficient Rx LP
SOTALOL HYDROCHLORIDE
SOTALOL HYDROCHLORIDE 80 mg
ORAL
PRESCRIPTION DRUG
Oral sotalol hydrochloride is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. Because of the proarrhythmic effects of sotalol (see WARNINGS ), including a 1.5 to 2% rate of torsade de pointes or new VT/VF in patients with either NSVT or supraventricular arrhythmias, its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of sotalol treatment or increasing doses, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. The response to treatment should then be evaluated by a suitable method (e.g., PES or Holter monitoring) prior to continuing the patient on chronic therapy. Various approaches have been used to determine the response to antiarrhythmic therapy, includi
Sotalol hydrochloride; capsule-shaped bisected light-blue scored tablets, are available as follows: 80 mg strength imprinted “58/75” on one side and “V” on the reverse side available in the following configurations: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Betapace AF® is a registered trademark of Berlex Laboratories.
Abbreviated New Drug Application
SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE TABLET PROFICIENT RX LP ---------- SOTALOL HYDROCHLORIDE TABLETS, USP RX ONLY TO MINIMIZE THE RISK OF INDUCED ARRHYTHMIA, PATIENTS INITIATED OR RE-INITIATED ON SOTALOL HYDROCHLORIDE TABLETS SHOULD BE PLACED FOR A MINIMUM OF THREE DAYS (ON THEIR MAINTENANCE DOSE) IN A FACILITY THAT CAN PROVIDE CARDIAC RESUSCITATION AND CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING. CREATININE CLEARANCE SHOULD BE CALCULATED PRIOR TO DOSING. FOR DETAILED INSTRUCTIONS REGARDING DOSE SELECTION AND SPECIAL CAUTIONS FOR PEOPLE WITH RENAL IMPAIRMENT, SEE DOSAGE AND ADMINISTRATION. SOTALOL IS ALSO INDICATED FOR THE MAINTENANCE OF NORMAL SINUS RHYTHM [DELAY IN TIME TO RECURRENCE OF ATRIAL FIBRILLATION/ATRIAL FLUTTER (AFIB/AFL)] IN PATIENTS WITH SYMPTOMATIC AFIB/AFL WHO ARE CURRENTLY IN SINUS RHYTHM AND IS MARKETED UNDER THE BRAND NAME BETAPACE AF . SOTALOL HYDROCHLORIDE TABLETS ARE NOT APPROVED FOR THE AFIB/AFL INDICATION AND SHOULD NOT BE SUBSTITUTED FOR BETAPACE AF BECAUSE ONLY BETAPACE AF IS DISTRIBUTED WITH A PATIENT PACKAGE INSERT THAT IS APPROPRIATE FOR PATIENTS WITH AFIB/AFL. DESCRIPTION Sotalol hydrochloride is an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. It is supplied as a light-blue, capsule- shaped tablet for oral administration. Sotalol hydrochloride is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride is d,l-_N_-[4-[1-hydroxy-2-[(1- methylethyl)amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C H N O S•HCl and is represented by the following structural formula: CLINICAL PHARMACOLOGY MECHANISM OF ACTION Sotalol hydrochloride has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. Sotalo 전체 문서 읽기