SOTALOL HYDROCHLORIDE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Proficient Rx LP

INN (International Adı):

SOTALOL HYDROCHLORIDE

Kompozisyon:

SOTALOL HYDROCHLORIDE 80 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Sotalol hydrochloride tablets, USP are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. Because of the proarrhythmic effects of sotalol hydrochloride tablets, USP (see WARNINGS ), including a 1.5 to 2% rate of Torsade de Pointes or new VT/VF in patients with either NSVT or supraventricular arrhythmias, its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of sotalol hydrochloride treatment or increasing doses, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. The response to treatment should then be evaluated by a suitable method (e.g., PES or Holter monitoring) prior to continuing the patient on chronic therapy. Various approaches have been used to determi

Ürün özeti:

Sotalol Hydrochloride Tablets, USP 80 mg are available for oral administration as white to off-white capsule shaped, scored tablets, imprinted “APO” on one side and “SO” bisect “80” on the other side; supplied in bottles of 30 (NDC 63187-804-30), bottles of 60 (NDC 63187-804-60) and bottles of 90 (63187-804-90). Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container [see USP].  Betapace AF® is a trademark of Berlex. APOTEX INC. SOTALOL HYDROCHLORIDE TABLETS, USP 80 mg Manufactured by Manufactured for Repackaged by Apotex Inc. Apotex Corp. Proficient Rx LP Toronto, Ontario Weston, Florida Thousand Oaks, CA 91320 Canada M9L 1T9 33326 Revised: April 2015 Rev. 3

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE TABLET
PROFICIENT RX LP
----------
SOTALOL HYDROCHLORIDE TABLETS, USP
80 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 of sotalol
hydrochloride. In addition,
each tablet also contains the following inactive ingredients:
magnesium stearate and
microcrystalline cellulose.