Black Box Warning, Indication and Important Safety Information
Sotalol can cause life threatening ventricular tachycardia associated with QT interval prolongation. To minimize the risk of drug induced arrhythmia, initiate or uptitrate intravenous sotalol in a facility that can provide continuous electrocardiographic monitoring and cardiac resuscitation [see Dosage and Administration (2.3) and Warnings and Precautions (5.1)].
Do not initiate intravenous sotalol therapy if the baseline QTc is longer than 450 ms. If the QTc prolongs to 500 ms or greater, reduce the dose or discontinue. (2.3)
Sotalol IV (sotalol hydrochloride injection) should be administered only by physicians who are experienced in the treatment of life-threatening arrhythmias, who are thoroughly familiar with the risks and benefits of sotalol therapy, and who have access to facilities adequate for monitoring the effectiveness and side effects of treatment.
Sotalol hydrochloride is contraindicated in patients with:
WARNINGS AND PRECAUTIONS
To report SUSPECTED ADVERSE REACTIONS, contact AltaThera Pharmaceuticals LLC at 1-800-524-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
To match the exposure to oral sotalol, use the same dosing frequency with intravenous administration and infuse the adjusted dose (see Table 1) over 5 hours