Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
SOTALOL HYDROCHLORIDE (UNII: HEC37C70XX) (SOTALOL - UNII:A6D97U294I)
Bayer HealthCare Pharmaceuticals Inc.
SOTALOL HYDROCHLORIDE
SOTALOL HYDROCHLORIDE 80 mg
PRESCRIPTION DRUG
New Drug Application
BETAPACE- SOTALOL HYDROCHLORIDE TABLET BAYER HEALTHCARE PHARMACEUTICALS INC. ---------- BETAPACE (S OTALOLHCL) To minimize the risk of induced arrhythmia, patients initiated or reinitiated on Betapace 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 . Betapace 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. RX ONLY DESCRIPTION Betapace (sotalol hydrochloride) 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 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]methane-sulfonamide monohydrochloride. The molecular formula is C H N O S·HCl and is represented by the following structural formula: Betapace Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose, starch, stearic acid, magnesium stearate, colloidal silicon dioxide, and FD&C blue color #2 (aluminum lake, conc.). CLINICAL PHARMACOLOGY MECHANISM OF ACTION Betapace (sotalol hydroc Przeczytaj cały dokument