SOTALOL HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvKARE, Inc.

INN (International Name):

SOTALOL HYDROCHLORIDE

Composition:

SOTALOL HYDROCHLORIDE 80 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SOTALOL HYDROCHLORIDE - SOTALOL HYDROCHLORIDE TABLET
AVKARE, INC.
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SOTALOL HYDROCHLORIDE TABLETS (AF)
80 MG, 120 MG AND 160 MG
TO MINIMIZE THE RISK OF INDUCED ARRHYTHMIA, PATIENTS INITIATED OR
RE-INITIATED ON SOTALOL
HYDROCHLORIDE TABLETS (AF) SHOULD BE PLACED FOR A MINIMUM OF THREE
DAYS (ON THEIR
MAINTENANCE DOSE) IN A FACILITY THAT CAN PROVIDE CARDIAC
RESUSCITATION, CONTINUOUS
ELECTROCARDIOGRAPHIC MONITORING AND CALCULATIONS OF CREATININE
CLEARANCE. FOR DETAILED
INSTRUCTIONS REGARDING DOSE SELECTION AND SPECIAL CAUTIONS FOR PEOPLE
WITH RENAL
IMPAIRMENT, SEE DOSAGE AND ADMINISTRATION. Sotalol is also indicated
for the
treatment of documented life-threatening ventricular arrhythmias and
is marketed under the brand
name BETAPACE (SOTALOL HYDROCHLORIDE). Sotalol hydrochloride tablets,
however, must not be
substituted for Betapace AF (sotalol hydrochloride tablets, USP (AF))
because of significant
differences in labeling (i.e. patient package insert, dosing
administration and safety information).
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 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]methanesulfonamide monohydrochloride.
The molecular formula is
C
H N O S•HCl and is represented by the following structural formula:
Each tablet for oral administration, contains 80 mg, 120 mg or 160 mg
of sotalol hydrochloride. In
addition, each tablet also contains the following inactive
ingredients: magnesium stearate and
microcrystalline cellulose.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Sotalol hydrochloride has both beta-adrenoreceptor blocking