SOTALOL HYDROCHLORIDE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Adı):

SOTALOL HYDROCHLORIDE

Kompozisyon:

SOTALOL HYDROCHLORIDE 80 mg

Reçete türü:

PRESCRIPTION DRUG

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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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,