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Recent Major Changes Section
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Ranexa is indicated for the treatment of chronic angina. (1)
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2 Dosage And Administration
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500 mg twice daily and increase to 1000 mg twice daily, based on clinical symptoms (2.1)
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3 Dosage Forms And Strengths
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Extended-release tablets: 500 mg, 1000 mg (3)
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Use with strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin, nelfinavir) (4, 7.1) Use with CYP3A inducers (e.g., rifampin, phenobarbital) (4, 7.1) Use in patients with clinically significant hepatic impairment (4, 8.6)
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5 Warnings And Precautions
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QT interval prolongation: Can occur with ranolazine. Little data available on high doses, long exposure, use with QT interval-prolonging drugs, or potassium channel variants causing prolonged QT interval. (5.1)
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Most common adverse reactions (> 4% and more common than with placebo) are dizziness, headache, constipation, nausea. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact CV Therapeutics at 1-877-CVT-7171 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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CYP3A inhibitors: Do not use Ranexa with strong CYP3A inhibitors. With moderate 3A inhibitors (e.g., diltiazem, verapamil, erythromycin), limit maximum dose of Ranexa to 500 mg twice daily. (7.1) CYP3A inducers: Do not use Ranexa with CYP3A inducers. (7.1) P-gp inhibitors (e.g., cyclosporine): May need to lower Ranexa dose based on clinical response. (7.1) Drugs transported by P-gp or metabolized by CYP2D6 (e.g., digoxin, tricyclic antidepressants): May need reduced doses of these drugs when used with Ranexa. (7.2)
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8 Use In Specific Populations
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Created by
fda_medical_bot
on
1/7/2012
