SOTALOL HYDROCHLORIDE tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Bryant Ranch Prepack

INN (nemzetközi neve):

SOTALOL HYDROCHLORIDE

Összetétel:

SOTALOL HYDROCHLORIDE 80 mg

Recept típusa:

PRESCRIPTION DRUG

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE TABLET
BRYANT RANCH PREPACK
----------
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:
Sotalol Hydrochloride Tablets contain the following inactive
ingredients: colloidal silicon dioxide,
FD&C blue color #2 (aluminum lake, conc.), lactose monohydrate,
magnesium stearate, microcrystalline
cellulose, sodium starch glycolate, a