SOTALOL HYDROCHLORIDE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Aphena Pharma Solutions - Tennessee, LLC

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Sotalol hydrochloride tablets, USP (AF) are 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. Because sotalol hydrochloride tablets, USP (AF) can cause life-threatening ventricular arrhythmias, it should be reserved for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB whose AFIB/AFL that is easily reversed (by Valsalva maneuver, for example) should usually not be given sotalol hydrochloride tablets, USP (AF) (see WARNINGS ). In general, antiarrhythmic therapy for AFIB/AFL aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see CLINICAL STUDIES ). 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

제품 요약:

Sotalol hydrochloride tablets, USP (AF) 80 mg are available for oral administration as white to off-white, capsule shaped, scored tablets, imprinted "APO" on one side and "AF" bisect "80" on the other side; supplied in bottles of 100 (NDC 60505-0222-1) and bottles of 1,000 (NDC 60505-0222-2). Sotalol hydrochloride tablets, USP (AF) 120 mg are available for oral administration as white to off-white, capsule shaped, scored tablets, imprinted "APO" on one side and "AF" bisect "120" on the other side; supplied in bottles of 100 (NDC 60505-0223-1) and bottles of 1,000 (NDC 60505-0223-2). Sotalol hydrochloride tablets, USP (AF) 160 mg are available for oral administration as white to off-white, capsule shaped, scored tablets, imprinted "APO" on one side and "AF" bisect "160" on the other side; supplied in bottles of 100 (NDC 60505-0224-1) and bottles of 1,000 (NDC 60505-0224-2). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. APOTEX INC. SOTALOL HYDROCHLORIDE TABLETS, USP (AF) 80 mg, 120 mg and 160 mg Manufactured by          Manufactured for Apotex Inc.                  Apotex Corp. Toronto, Ontario          Weston, Florida Canada M9L 1T9         33326 Revised: July 2015 Rev. 2

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
SOTALOL HYDROCHLORIDE TABLETS, USP (AF)
80 MG, 120 MG AND 160 MG
RX ONLY
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]methane-sulfonamide 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 hydrochlor