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Cardiologynovember NOVEMBER - DECEMBER 2010 VOL. 39 NO. 7 CardiologyA MEMBER PUBLICATION OF THE AMERICAN COLLEGE OF CARDIOLOGY LASERS PRINTED AT PRINTED LASERS 100% Giant Creative Strategy Output @ 100% x 9.75"h Live: 14.5"w x 10.5"h 15.75"w Trim: x 11.125"h Bleed: 16.75"w Colors: 4C + GILRX5236 A-SIZE SPREAD InIn cchronichronic anginaangina Take a broader view PRINT live/trim_DO NOT Ranexa is FDA approved as a fi rst-line agent for treatment of patients with chronic angina Established effi cacy in a 12-week clinical trial — Clinical trial endpoints included angina frequency, exercise duration, nitroglycerin use, time to ischemia (1-mm ST-segment depression), and time to angina1 Hemodynamic neutrality — In controlled clinical trials, Ranexa caused minimal changes in mean heart rate (< 2 bpm) and systolic blood pressure (< 3 mm Hg)2 — No dose adjustment is required in patients with heart failure or diabetes2 Established safety and tolerability Redefi ne your treatment landscape www.Ranexa.comwww.Ranexa.com Indication — Taking inducers of CYP3A (eg, rifampin, rifabutin, Adverse Reactions Drug Interactions Ranexa is indicated for the treatment of chronic angina. rifapentin, phenobarbital, phenytoin, carbamazepine, The most common adverse reactions (> 4% and Do not use Ranexa with CYP3A inducers or strong and St John’s wort) Ranexa may be used with beta-blockers, nitrates, more common than with placebo) during treatment CYP3A inhibitors (see Contraindications); modify calcium channel blockers, anti-platelet therapy, lipid- — With clinically signifi cant hepatic impairment with Ranexa were dizziness, headache, constipation, the dose of Ranexa with moderate CYP3A inhibitors and nausea. (see Dosage and Administration). lowering therapy, ACE inhibitors, and angiotensin Warnings and Precautions receptor blockers. P-gp inhibitors (eg, cyclosporine): may need to lower Ranexa blocks IKr and prolongs the QTc interval in a Dosage and Administration the dose of Ranexa based on clinical response. dose-related manner. IMPORTANT SAFETY INFORMATION Begin treatment with 500 mg twice daily and Doses of drugs transported by P-gp (eg, digoxin) or Contraindications Clinical experience did not show an increased risk of increase to the maximum recommended dose of metabolized by CYP2D6 (eg, tricyclic antidepressants proarrhythmia or sudden death. 1000 mg twice daily, based on clinical symptoms. and antipsychotics) may need to be reduced. Ranexa is contraindicated in patients: There is little experience with high doses (> 1000 mg Limit the dose of Ranexa to 500 mg twice daily — Taking strong inhibitors of CYP3A (eg, ketoconazole, in patients on moderate CYP3A inhibitors (eg, 1. Chaitman BR, Pepine CJ, Parker JO, et al. Effects of ranolazine with atenolol, amlodipine, twice daily) or exposure, other QT-prolonging drugs, or diltiazem on exercise tolerance and angina frequency in patients with severe chronic itraconazole, clarithromycin, nefazodone, nelfi navir, or potassium channel variants resulting in a long diltiazem, verapamil, aprepitant, erythromycin, angina: a randomized controlled trial. JAMA. 2004;291:309-316. 2. Ranexa (ranolazine ritonavir, indinavir, and saquinavir) QT interval. fl uconazole, and grapefruit juice or grapefruit- extended-release tablets) [package insert]. Palo Alto, CA; Sept 2009. containing products). Ranexa is a registered US trademark of Gilead, Palo Alto, Inc. Please see brief summary of prescribing information on adjacent page. © 2010 Gilead Sciences, Inc. RAN4509 2/10 M16754_1b_A_Spd.indd 03.22.2010 133 linescreen G16754c01B_300ucr.tif jn LASERS PRINTED AT PRINTED LASERS 100% Giant Creative Strategy Output @ 100% x 9.75"h Live: 14.5"w x 10.5"h 15.75"w Trim: x 11.125"h Bleed: 16.75"w Colors: 4C + GILRX5236 A-SIZE SPREAD InIn cchronichronic anginaangina Take a broader view PRINT live/trim_DO NOT Ranexa is FDA approved as a fi rst-line agent for treatment of patients with chronic angina Established effi cacy in a 12-week clinical trial — Clinical trial endpoints included angina frequency, exercise duration, nitroglycerin use, time to ischemia (1-mm ST-segment depression), and time to angina1 Hemodynamic neutrality — In controlled clinical trials, Ranexa caused minimal changes in mean heart rate (< 2 bpm) and systolic blood pressure (< 3 mm Hg)2 — No dose adjustment is required in patients with heart failure or diabetes2 Established safety and tolerability Redefi ne your treatment landscape www.Ranexa.comwww.Ranexa.com Indication — Taking inducers of CYP3A (eg, rifampin, rifabutin, Adverse Reactions Drug Interactions Ranexa is indicated for the treatment of chronic angina. rifapentin, phenobarbital, phenytoin, carbamazepine, The most common adverse reactions (> 4% and Do not use Ranexa with CYP3A inducers or strong and St John’s wort) Ranexa may be used with beta-blockers, nitrates, more common than with placebo) during treatment CYP3A inhibitors (see Contraindications); modify calcium channel blockers, anti-platelet therapy, lipid- — With clinically signifi cant hepatic impairment with Ranexa were dizziness, headache, constipation, the dose of Ranexa with moderate CYP3A inhibitors and nausea. (see Dosage and Administration). lowering therapy, ACE inhibitors, and angiotensin Warnings and Precautions receptor blockers. P-gp inhibitors (eg, cyclosporine): may need to lower Ranexa blocks IKr and prolongs the QTc interval in a Dosage and Administration the dose of Ranexa based on clinical response. dose-related manner. IMPORTANT SAFETY INFORMATION Begin treatment with 500 mg twice daily and Doses of drugs transported by P-gp (eg, digoxin) or Contraindications Clinical experience did not show an increased risk of increase to the maximum recommended dose of metabolized by CYP2D6 (eg, tricyclic antidepressants proarrhythmia or sudden death. 1000 mg twice daily, based on clinical symptoms. and antipsychotics) may need to be reduced. Ranexa is contraindicated in patients: There is little experience with high doses (> 1000 mg Limit the dose of Ranexa to 500 mg twice daily — Taking strong inhibitors of CYP3A (eg, ketoconazole, in patients on moderate CYP3A inhibitors (eg, 1. Chaitman BR, Pepine CJ, Parker JO, et al. Effects of ranolazine with atenolol, amlodipine, twice daily) or exposure, other QT-prolonging drugs, or diltiazem on exercise tolerance and angina frequency in patients with severe chronic itraconazole, clarithromycin, nefazodone, nelfi navir, or potassium channel variants resulting in a long diltiazem, verapamil, aprepitant, erythromycin, angina: a randomized controlled trial. JAMA. 2004;291:309-316. 2. Ranexa (ranolazine ritonavir, indinavir, and saquinavir) QT interval. fl uconazole, and grapefruit juice or grapefruit- extended-release tablets) [package insert]. Palo Alto, CA; Sept 2009. containing products). Ranexa is a registered US trademark of Gilead, Palo Alto, Inc. Please see brief summary of prescribing information on adjacent page. © 2010 Gilead Sciences, Inc. RAN4509 2/10 M16754_1b_A_Spd.indd 03.22.2010 133 linescreen G16754c01B_300ucr.tif jn LA 100% S ER In controlled clinical trials of angina patients, the most frequently S The pharmacokinetics of diltiazem is not affected by ranolazine in PR reported treatment-emergent adverse reactions (> 4% and more healthy volunteers receiving diltiazem 60 mg three times daily and common on Ranexa than on placebo) were dizziness (6.2%), head- I Ranexa 1000 mg twice daily. NTED AT ache (5.5%), constipation (4.5%), and nausea (4.4%). Dizziness may be dose-related. In open-label, long-term treatment studies, a similar Drugs Transported by P-gp Ranexa (1000 mg twice daily) causes a 1.5-fold elevation of digoxin adverse reaction profi le was observed. plasma concentrations. The dose of digoxin may have to be adjusted. The following additional adverse reactions occurred at an incidence of 0.5 to 2.0% in patients treated with Ranexa and were more Drugs Metabolized by CYP2D6 frequent than the incidence observed in placebo-treated patients: Ranolazine or its metabolites partially inhibit CYP2D6. There are no studies of concomitant use of Ranexa with other drugs metabolized Giant Creative Strategy Output @ 100% Live: 7"w x 9.75"h x 10.5"h 7.875"w Trim: Bleed: n/a Cardiac Disorders – bradycardia, palpitations Colors: K + PI GILRX5236-A-SIZE by CYP2D6, such as tricyclic antidepressants and antipsychotics, Ear and Labyrinth Disorders – tinnitus, vertigo but lower doses of CYP2D6 substrates may be required. Gastrointestinal Disorders – abdominal pain, dry mouth, vomiting 8. USE IN SPECIFIC POPULATIONS General Disorders and Administrative Site Adverse Events – peripheral edema 8.1 Pregnancy—Pregnancy Category C: In animal studies, Brief Summary of ranolazine at exposures 1.5 (rabbit) to 2 (rat) times the usual human Respiratory, Thoracic, and Mediastinal Disorders – dyspnea exposure caused maternal toxicity and misshapen sternebrae and PRINT live/trim_DO NOT Prescribing Information Vascular Disorders – hypotension, orthostatic hypotension reduced ossifi cation in offspring. These doses in rats and rabbits Other (< 0.5%) but potentially medically important adverse reactions were associated with an increased maternal mortality rate. There These highlights do not include all the information needed to use observed more frequently with Ranexa than placebo treatment in all are no adequate well-controlled studies in pregnant women. Ranexa safely and effectively. See full prescribing information for controlled studies included: angioedema, renal failure, eosinophilia, Ranexa should be used during pregnancy only
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