SOTALOL HYDROCHLORIDE AF- 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:

Marlex Pharmaceuticals Inc

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Sotalol 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 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 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 sotalol hydrochloride tablets (AF) because of significan

leaflet_short:

Sotalol Hydrochloride Tablets, USP (AF) are presented as follows: For 80 mg strength: White to off-white colored, capsule shaped, scored tablets debossed 'B107' on one side and scored on the other side. For 120 mg strength: White to off-white colored, capsule shaped, scored tablets debossed 'B108' on one side and scored on the other side. For 160 mg strength: White to off-white colored, capsule shaped, scored tablets debossed 'B109' on one side and scored on the other side. Sotalol Hydrochloride Tablets, USP (AF) are available as follows: 80 mg strength, NDC 10135-0715-01 in bottle of 100 120 mg strength, NDC 10135-0716-01 in bottle of 100 160 mg strength, NDC 10135-0717-01 in bottle of 100 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for & Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 Rev. 10/20 BS

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

SOTALOL HYDROCHLORIDE AF- SOTALOL HYDROCHLORIDE TABLET
MARLEX PHARMACEUTICALS INC
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SOTALOL HYDROCHLORIDE TABLETS - AF
SOTALOL HYDROCHLORIDE AF- SOTALOL HYDROCHLORIDE TABLES AF TABLET
MARLEX PHARMACEUTICALS, INC.
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SOTALOL HYDROCHLORIDE TABLETS, USP (AF) 80 MG, 120 MG, AND 160 MG
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 tablets). Sotalol hydrochloride tablets,
however, should
not be substituted for sotalol hydrochloride tablets (AF) because of
significant differences in
labeling (i.e., patient package insert, dosing administration and
safety information).
Rx only
DESCRIPTION
Sotalol Hydrochloride Tablets, USP (AF) 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, 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]methanesulfonamide monohydrochloride.
The molecular formula is C
H
N
O
S•HCl and is represented by the following structural formula:
Sotalol Hydrochloride Tablets, USP (AF) contain the following inactive
ingredients: microcrystalline
cellulose, lactose monohydrate, pregelatinized starch, stearic