SOTALOL HYDROCHLORIDE tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

SOTALOL HYDROCHLORIDE (UNII: HEC37C70XX) (SOTALOL - UNII:A6D97U294I)

متاح من:

Avera McKennan Hospital

INN (الاسم الدولي):

SOTALOL HYDROCHLORIDE

تركيب:

SOTALOL HYDROCHLORIDE 120 mg

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE TABLET
AVERA MCKENNAN HOSPITAL
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SOTALOL HYDROCHLORIDE TABLETS USP
TO MINIMIZE THE RISK OF INDUCED ARRHYTHMIA, PATIENTS INITIATED OR
REINITIATED ON SOTALOL
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 IS 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 tablets USP are an antiarrhythmic drug with
Class II (beta-adrenoreceptor
blocking) and Class III (cardiac action potential duration
prolongation) properties. They are supplied as
a light blue, oval-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 formua is C
H N O S•HCl and is represented by the following structural formula:
Sotalol hydrochloride tablets USP contain the following inactive
ingredients: corn starch, lactose
monohydrate, magnesium stearate, povidone, and FD&C Blue No. 2.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Sotalol hydrochloride has both beta-adrenoreceptor blocking (Vaughan
Willia