BETAPACE 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- SOTALOL HYDROCHLORIDE TABLET
BAYER HEALTHCARE PHARMACEUTICALS INC.
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BETAPACE
(S OTALOLHCL)
To minimize the risk of induced arrhythmia, patients initiated or
reinitiated on Betapace
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 . Betapace 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.
RX ONLY
DESCRIPTION
Betapace
(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:
Betapace Tablets contain the following inactive ingredients:
microcrystalline cellulose, lactose, starch,
stearic acid, magnesium stearate, colloidal silicon dioxide, and FD&C
blue color #2 (aluminum lake,
conc.).
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Betapace (sotalol hydroc