Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
SOTALOL HYDROCHLORIDE (UNII: HEC37C70XX) (SOTALOL - UNII:A6D97U294I)
Aphena Pharma Solutions - Tennessee, LLC
ORAL
PRESCRIPTION DRUG
Sotalol hydrochloride tablets, USP are 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 hydrochloride tablets, USP (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 hydrochloride 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. Vario
Sotalol Hydrochloride Tablets, USP 80 mg are available for oral administration as white to off-white capsule shaped, scored tablets, imprinted “APO” on one side and “SO” bisect “80” on the other side; supplied in bottles of 100 and 500 ( NDC 60429-748-01) and (NDC 60429-748-05) respectively. Sotalol Hydrochloride Tablets, USP 120 mg are available for oral administration as white to off-white capsule shaped, scored tablets, imprinted “APO” on one side and “SOT” bisect “120” on the other side; supplied in bottles of 100 ( NDC 60429-749-01 ). Sotalol Hydrochloride Tablets, USP 160 mg are available for oral administration as white to off-white capsule shaped, scored tablets, imprinted “APO” on one side and “SOT” bisect “160” on the other side; supplied in bottles of 100 ( NDC 60429-750-01 ). Sotalol Hydrochloride Tablets, USP 240 mg are available for oral administration as white to off-white capsule shaped, scored tablets, imprinted “APO” on one side and “SOT” bisect “240” on the other side; supplied in bottles of 100 ( NDC 60429-751-01 ). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container [see USP]. Betapace AF ® is a trademark of Berlex. APOTEX INC. SOTALOL HYDROCHLORIDE TABLETS, USP 80 mg, 120 mg, 160 mg and 240 mg Manufactured by: Manufactured for: Marketed/Packaged by: Apotex Inc. Apotex Corp. GSMS, Inc. Toronto, Ontario Weston, Florida Camarillo, CA Canada M9L 1T9 33326 93010 Revised: February 2012 Rev. 2
Abbreviated New Drug Application
SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE TABLET APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- SOTALOL HYDROCHLORIDE TABLETS, USP 80 MG, 120 MG, 160 MG AND 240 MG TO MINIMIZE THE RISK OF INDUCED ARRHYTHMIA, PATIENTS INITIATED OR RE-INITIATED ON SOTALOL HYDROCHLORIDE TABLETS, USP 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, USP 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 white to off-white, capsule-shaped, scored 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 0 S•HCl and is represented by the following structural formula: Each tablet, for oral administration, contains 80 mg, 120 mg, 160 mg or 240 mg of sotalol hydrochloride. In addition, each tablet also contains the following inactive ing Les hele dokumentet