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:

Apotex Corp.

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
APOTEX CORP.
----------
SOTALOL HYDROCHLORIDE TABLETS, USP
80 MG, 120 MG, 160 MG AND 240 MG
RX ONLY
TO MINIMIZE THE RISK OF INDUCED ARRHYTHMIA, PATIENTS INITIATED OR
REINITIATED 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, 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 tablets, USP are 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 ingredients: ma