SOTALOL HYDROCHLORIDE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Epic Pharma, LLC

INN (국제 이름):

SOTALOL HYDROCHLORIDE

구성:

SOTALOL HYDROCHLORIDE 80 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Sotalol hydrochloride tablets (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 hydrochloride tablets (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 hydrochloride tablets (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 hydrochloride tablets (AF) are 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, 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 hydrochloride tablets (AF) are 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.

제품 요약:

Sotalol hydrochloride tablets USP (AF), 80 mg are white, capsule-shaped tablets, debossed “ Є ” to the left of bisect and “121” to the right of bisect on one side and plain on the other side, available in bottles of 100 and 1000. Sotalol hydrochloride tablets USP (AF), 120 mg are white, capsule-shaped tablets, debossed “ Є ” to the left of bisect and “122” to the right of bisect on one side and plain on the other side, available in bottles of 100 and 1000. Sotalol hydrochloride tablets USP (AF), 160 mg are white, capsule-shaped tablets, debossed “ Є ” to the left of bisect and “123” to the right of bisect on one side and plain on the other side, available in bottles of 100 and 1000. Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure as required.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE TABLET
EPIC PHARMA, LLC
----------
SOTALOL HYDROCHLORIDE TABLETS, USP (AF)
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).
DESCRIPTION
Sotalol hydrochloride tablets, USP (AF) 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, 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:
pregelatinized starch, microcrystalline cellulose, lactose
monohydrate, colloidal silicon
dioxide, stearic acid, and magnesium stearate.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Sotalol hydrochloride has both beta-adrenoreceptor blocking (Vaughan
Williams Class I