SOTALOL HYDROCHLORIDE- sotalol hydrochloride tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

PD-Rx Pharmaceuticals, Inc.

DCI (Dénomination commune internationale):

SOTALOL HYDROCHLORIDE

Composition:

SOTALOL HYDROCHLORIDE 80 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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, their 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

Descriptif du produit:

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: bottles of 30 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store in a dry place. Keep tightly closed. Avoid excessive heat. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. BETAPACE AF TM is a trademark of Bayer Healthcare. To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE TABLET
PD-RX PHARMACEUTICALS, INC.
----------
SOTALOL HYDROCHLORIDE TABLETS USP
TO MINIMIZE THE RISK OF INDUCED ARRHYTHMIA, PATIENTS INITIATED OR
REINITIATED ON SOTALOL
HYDROCHLORIDE 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 IS 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 aluminum l