Betapace AF
BETAPACE AF™
(sotalol HCl)
| To minimize the risk of induced arrhythmia, patients initiated or re-initiated on BETAPACE 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® . BETAPACE® however, should not be substituted for BETAPACE AF™ because of significant differences in labeling (i.e. patient package insert, dosing administration and safety information). |
DRUG DESCRIPTION
BETAPACE AF™, (sotalol hydrochloride), is an antiarrhythmic drug with Class I (beta-adrenoreceptor blocking) and Class I (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]methane- sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S HCl and is represented by the following structural formula:
BETAPACE AF™ tablets contain the following inactive ingredients: microcrystalline cellulose, lactose, starch, stearic acid, magnesium stearate, and colloidal silicon dioxide.
Generic Name: Sotalol Hcl
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Betapace AF
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