BETAPACE AF sotalol hydrochloride tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Bayer HealthCare Pharmaceuticals Inc.

INN (Nome Internazionale):

SOTALOL HYDROCHLORIDE

Composizione:

SOTALOL HYDROCHLORIDE 80 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

BETAPACE AF- SOTALOL HYDROCHLORIDE TABLET
BAYER HEALTHCARE PHARMACEUTICALS INC.
REFERENCE LABEL SET ID: 66DD794C-74C7-4512-8206-430BA79B7879
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BETAPACE AF
(SOTALOL HCI)
TO MINIMIZE THE RISK OF INDUCED ARRHYTHMIA, PATIENTS INITIATED OR
RE-INITIATED ON BETAPACE
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
. Betapace however,
should not be substituted for Betapace AF because of significant
differences in labeling (i.e.
patient package insert, dosing administration and safety information).
Rx only
DESCRIPTION
Betapace AF, (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, 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]methanesulfonamide monohydrochloride.
The molecular formula is
C
H N O S•HCl and is represented by the following structural formula:
Betapace AF tablets contain the following inactive ingredients:
microcrystalline cellulose, lactose,
starch, stearic acid, magnesium stearate, and colloidal silicon
dioxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Betapace AF (sotalol hydrochloride) has both beta-adrenoreceptor
blocking (Vaughan Williams Class
II) and cardiac action potential duration prolongation (Vaughan
Williams C