SOTALOL HYDROCHLORIDE AF- sotalol hydrochloride tables af tablet SOTALOL HYDROCHLORIDE AF- sotalol hydrochloride tablets af tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bayshore Pharmaceuticals LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 significant differences in labeling (i.e., patient package insert, dosing administration and safety information). Sotalol AF is contraindicated in patients with sinus bradycardia (<50 bpm during waking hours), sick sinus syndrome or second and third degree AV block (unless a functioning pacemaker is present), congenital or acquired long QT syndromes, baseline QT interval >450 msec, cardiogenic shock, uncontrolled heart failure, hypokalemia (<4 meq/L), creatinine clearance <40 mL/min, bronchial asthma and previous evidence of hypersensitivity to sotalol. The safety and effectiveness of Sotalol AF in children have not been established. However, the Class III electrophysiologic and beta-blocking effects, the pharmacokinetics, and the relationship between the effects (QTc interval and resting heart rate) and drug concentrations have been evaluated in children aged between 3 days and 12 years old. (See CLINICAL PHARMACOLOGY .)

Product summary:

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 76385-125-01 in bottle of 100 and NDC 76385-125-50 in bottle of 500 120 mg strength, NDC 76385-126-01 in bottle of 100 and NDC 76385-126-50 in bottle of 500 160 mg strength, NDC 76385-127-01 in bottle of 100 and NDC 76385-127-50 in bottle of 500 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 Beximco Pharmaceuticals USA Inc. at 877-372-6093 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for Beximco Pharmaceuticals USA Inc. 4110 Regal Oaks Drive, P.O. Box 1060, Suwanee, GA 30024, USA Distributed by: Bayshore Pharmaceuticals LLC Short Hills, NJ 07078 Betapace is a registered trademark of Bayer Healthcare Inc. 3020007209     060119

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SOTALOL HYDROCHLORIDE AF- SOTALOL HYDROCHLORIDE TABLES AF TABLET
BAYSHORE PHARMACEUTICALS LLC
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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 acid,
magnesium stearate and colloidal silicon dioxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Sotalol AF has both beta-ad