SOTALOL HYDROCHLORIDE tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Aphena Pharma Solutions - Tennessee, LLC

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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. Vario

leaflet_short:

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 100 and 500 ( NDC 60429-748-01) and (NDC 60429-748-05) respectively. Sotalol Hydrochloride Tablets, USP 120 mg are available for oral administration as white to off-white capsule shaped, scored tablets, imprinted “APO” on one side and “SOT” bisect “120” on the other side; supplied in bottles of 100 ( NDC 60429-749-01 ). Sotalol Hydrochloride Tablets, USP 160 mg are available for oral administration as white to off-white capsule shaped, scored tablets, imprinted “APO” on one side and “SOT” bisect “160” on the other side; supplied in bottles of 100 ( NDC 60429-750-01 ). Sotalol Hydrochloride Tablets, USP 240 mg are available for oral administration as white to off-white capsule shaped, scored tablets, imprinted “APO” on one side and “SOT” bisect “240” on the other side; supplied in bottles of 100 ( NDC 60429-751-01 ). Store at 20° to 25°C (68° to 77°F); excursions permitted to 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, 120 mg, 160 mg and 240 mg Manufactured by: Manufactured for: Marketed/Packaged by: Apotex Inc. Apotex Corp. GSMS, Inc. Toronto, Ontario Weston, Florida Camarillo, CA Canada M9L 1T9 33326 93010 Revised: February 2012 Rev. 2

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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SOTALOL HYDROCHLORIDE TABLETS, USP 80 MG, 120 MG, 160 MG AND 240 MG
TO MINIMIZE THE RISK OF INDUCED ARRHYTHMIA, PATIENTS INITIATED OR
RE-INITIATED ON SOTALOL
HYDROCHLORIDE TABLETS, USP 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 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
0
S•HCl and is represented by the following structural formula:
Each tablet, for oral administration, contains 80 mg, 120 mg, 160 mg
or 240 mg of sotalol
hydrochloride. In addition, each tablet also contains the following
inactive ing