SOTALOL HYDROCHLORIDE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Avera McKennan Hospital

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
AVERA MCKENNAN HOSPITAL
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SOTALOL HYDROCHLORIDE TABLETS USP
TO MINIMIZE THE RISK OF INDUCED ARRHYTHMIA, PATIENTS INITIATED OR
REINITIATED ON SOTALOL
HYDROCHLORIDE 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 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 USP 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
USP 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 USP 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:
Each sotalol hydrochloride tablet USP, for oral administration,
contains 80 mg, 120 mg, 160 mg or 240
mg of sotalol hydrochloride. Each tablet also contains the following
inactive ingredients: colloidal
silicon dioxide, FD&C blue No. 1 aluminum lake,