SOTALOL HYDROCHLORIDE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Physicians Total Care, Inc.

INN (국제 이름):

SOTALOL HYDROCHLORIDE

구성:

SOTALOL HYDROCHLORIDE 80 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 (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 tablet USP 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 d

제품 요약:

Sotalol Hydrochloride Tablets USP for oral administration are available as follows: 80 mg: Blue, capsule shaped tablets, debossed “E 171” on one side and bisected on the reverse side and supplied as: NDC 54868-4435-0 bottles of 30 NDC 54868-4435-1 bottles of 60 NDC 54868-4435-3 bottles of 90 NDC 54868-4435-2 bottles of 100 120 mg: Blue, capsule shaped tablets, debossed “E 170” on one side and bisected on the reverse side and supplied as: NDC 54868-5614-1 bottles of 20 NDC 54868-5614-0 bottles of 60 160 mg: Blue, capsule shaped tablets, debossed “E 177” on one side and bisected on the reverse side and supplied as: NDC 54868-5549-1 bottles of 20 NDC 54868-5549-0 bottles of 60 To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Sandoz Inc. Princeton, NJ 08540 OS7554 REV. 02/10 MF0171REV02/10 MG #18481 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

SOTALOL HYDROCHLORIDE - SOTALOL HYDROCHLORIDE TABLET
PHYSICIANS TOTAL CARE, INC.
----------
SOTALOL HYDROCHLORIDE TABLETS USP
TO MINIMIZE THE RISK OF INDUCED ARRHYTHMIA, PATIENTS INITIATED OR
RE-INITIATED ON SOTALOL
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 USP 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
USP 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 USP 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:
Each sotalol hydrochloride tablet USP, for oral administration,
contains 80 mg, 120 mg, 160 mg or 240
mg of sotalol hydrochloride. Each tablet also contains the following
inactive ingredients: colloidal
silicon dioxide, FD&C blue No. 1 alumin