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2, 3 When added to a regimen of maximal dose amlodipine, ranolazine significantly reduced the frequency of angina episodes per week compared with placebo (2.9 versus 3.3, respectively) and weekly nitroglycerine uses (2.0 versus 2.7, respectively). Patients with persistent angina who were given ranolazine in addition to another treatment experienced fewer episodes of angina attacks per week compared with patients given placebo (3.3 versus 4.3, respectively) and required fewer nitroglycerin doses per week (2.7 versus 3.6, respectively).
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Ranolazine primarily has been studied in patients who continue to be symptomatic despite pharmacotherapy with other anti-anginal medications, such as beta blockers or calcium antagonists. Small, reversible elevations in serum creatinine and blood urea nitrogen levels have been reported, but no evidence of renal toxicity was observed. 2 Dizziness, headache, and constipation were infrequently reported. In controlled studies of patients with angina, approximately 6 percent of those receiving ranolazine discontinued treatment because of side effects compared with 3 percent of those receiving placebo. It is not known whether it is distributed in breast milk.
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Food and Drug Administration pregnancy category C drug. Potential drug-drug and drug-food interactions should be evaluated before starting ranolazine or when adding any therapy. Ranolazine should not be used in patients taking any medication that also prolongs the QT interval or inhibits the CYP3A enzyme system this includes numerous medications. Ranolazine also has been reported to increase blood pressure by approximately 15 mm Hg in patients with severe renal impairment. The manufacturer does not state when the drug should be discontinued if QT interval prolongation occurs, only that modest QT prolongation (four to six milliseconds) is associated with torsades de pointes arrhythmia. It is contraindicated in patients with preexisting QT prolongation, including congenital long QT syndrome, uncorrected hypokalemia, and hepatic impairment. Ranolazine prolongs the QTc interval in a dose-related manner, particularly in persons with mild, moderate, or severe hepatic dysfunction.