Sotalol injection description: Difference between revisions
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== | ==Description== | ||
Sotalol hydrochloride for injection is an aqueous formulation of sotalol hydrochloride for intravenous use. Sotalol is an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. | |||
Intravenous sotalol is supplied as a sterile, clear solution in a 10 mL vial, for intravenous administration after dilution. Each vial contains 150 mg racemic sotalol hydrochloride in sodium acetate buffer. The sotalol hydrochloride concentration of the formulation is 15 mg/mL. Each mL contains 2.9 mg glacial acetic acid in water for injection as an inactive ingredient. The pH of the injection is adjusted with sodium hydroxide to be between 6.0 and 7.0. 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 | |||
<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = SOTALOL HYDROCHLORIDE INJECTION [BIONICHE PHARMA USA LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2afe7385-2441-4e22-b63e-ab8614b275df | publisher = | date = | accessdate = }}</ref> | d,l- N -[4-[1-hydroxy-2-[(1-methylethyl)amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12 H20 N2O3S•HCl and is represented by the following structural formula:<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = SOTALOL HYDROCHLORIDE INJECTION [BIONICHE PHARMA USA LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2afe7385-2441-4e22-b63e-ab8614b275df | publisher = | date = | accessdate = }}</ref> | ||
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==References== | ==References== | ||
Revision as of 06:19, 10 February 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Description
Sotalol hydrochloride for injection is an aqueous formulation of sotalol hydrochloride for intravenous use. Sotalol is an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties.
Intravenous sotalol is supplied as a sterile, clear solution in a 10 mL vial, for intravenous administration after dilution. Each vial contains 150 mg racemic sotalol hydrochloride in sodium acetate buffer. The sotalol hydrochloride concentration of the formulation is 15 mg/mL. Each mL contains 2.9 mg glacial acetic acid in water for injection as an inactive ingredient. The pH of the injection is adjusted with sodium hydroxide to be between 6.0 and 7.0. 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 C12 H20 N2O3S•HCl and is represented by the following structural formula:[1]
References
Adapted from the FDA Package Insert.