SOTALOL HYDROCHLORIDE- 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:

Bryant Ranch Prepack

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Oral sotalol hydrochloride is 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 (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 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 determine the response to antiarrhythmic therapy, includi

leaflet_short:

Sotalol hydrochloride; capsule-shaped bisected light-blue scored tablets, are available as follows: 80 mg strength imprinted “58/75” on one side and “V” on the reverse side available in the following configurations: 120 mg strength imprinted “58/76” on one side and “V” on the reverse side available in the following configurations: 160 mg strength imprinted “58/77” on one side and “V” on the reverse side available in the following configurations: 240 mg strength imprinted “58/78” on one side and “V” on the reverse side available in the following configurations: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Betapace AF® is a registered trademark of Berlex Laboratories.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE TABLET
BRYANT RANCH PREPACK
----------
SOTALOL HYDROCHLORIDE TABLETS, USP
RX ONLY
TO MINIMIZE THE RISK OF INDUCED ARRHYTHMIA, PATIENTS INITIATED OR
RE-INITIATED 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 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 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:
Sotalol Hydrochloride Tablets contain the following inactive
ingredients: colloidal silicon dioxide,
FD&C blue color #2 (aluminum lake, conc.), lactose monohydrate,
magnesium stearate, microcrystalline
cellulose, sodium starch glycolate, a