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Ranexa
Generic Name: Ranolazine
Drug Category: Antianginal
Litigation Alert Level: Low
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 5 years.
| Approved Uses |
|
Indicated for the treatment of chronic angina. RANEXA may be used with beta-blockers, nitrates, calcium channel blockers, antiplatelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers. Ranolazine blocks IKr and prolongs the QTc interval in a dose-related manner. Acute renal failure has been observed in some patients with severe renal impairment (creatinine clearance [CrCL] <30 mL/min) while taking RANEXA. Monitor renal function after initiation and periodically in patients with moderate to severe renal impairment (CrCL <60 mL/min) for increases in serum creatinine accompanied by an increase in BUN. RANEXA is contraindicated in patients:
Limit the dose of RANEXA to 500 mg twice daily in patients on moderate CYP3A inhibitors, including diltiazem, verapamil, erythromycin, fluconazole, and grapefruit juice or grapefruit-containing products. Concomitant use of ranolazine and P-gp inhibitors, such as cyclosporine, may result in increases in ranolazine concentrations. Titrate ranolazine based on clinical response in patients concomitantly treated with predominant P-gp inhibitors such as cyclosporine. Do not use ranolazine with CYP3A inducers such as rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John’s wort. Limit the dose of simvastatin in patients on any dose of ranolazine to 20 mg once daily, when ranolazine is co-administered. Dose adjustment of other sensitive CYP3A substrates (e.g., lovastatin) and CYP3A substrates with a narrow therapeutic range (e.g., cyclosporine, tacrolimus, sirolimus) may be required as ranolazine may increase plasma concentrations of these drugs. Concomitant use of ranolazine and digoxin results in increased exposure to digoxin. The dose of digoxin may have to be adjusted. The exposure to CYP2D6 substrates, such as tricyclic antidepressants and antipsychotics, may be increased during co-administration with ranolazine, and lower doses of these drugs may be required. Concomitant use of ranolazine extended-release tablets 1000 mg twice daily and metformin results in increased plasma levels of metformin. When ranolazine extended-release tablets 1000 mg twice daily is co-administered with metformin, metformin dose should not exceed 1700 mg/day. Monitor blood glucose levels and risks associated with high exposures of metformin. Metformin exposure was not significantly increased when given with ranolazine extended-release tablets 500 mg twice daily. There are no available data on ranolazine extended-release tablets use in pregnant women to inform any drug-associated risks. Animal studies: decreased fetal weight and reduced ossification. There are no data on the presence of ranolazine in human milk, the effects on the breastfed infant, or the effects on milk production. However, ranolazine is present in rat milk. |
| Off-label Uses |
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• Use in patients under the age of 18. GoToSource • Monotherapy dosage greater than 1000 mg twice daily. GoToSource • Heart failure, acute and chronic myocardial ischemia, cardiac sodium channel gene mutations, ventricular and supraventricular arrhythmias, left ventricular diastolic dysfunction with preserved systolic function and skeletal muscle ischemia (intermittent claudication. GoToSource • Neuropathic pain. GoToSource • Early cardiotoxicity induced by antitumor drugs. GoToSource • Improvement of glycemic control. GoToSource • Timothy syndrome. GoToSource |
| Adverse Events |
|
Asthenia (weakness), constipation, syncope, postural hypotension (drop in blood pressure when upright position is assumed), dizziness, vertigo and abnormal vision. GoToSource Prolongation of the QTc interval and torsade de pointes. GoToSource Renal phospholipidosis. GoToSource Myopathy (disorder of skeletal muscles). GoToSource Dysarthria (speech disorder), dysmetria (lack of coordination), hallucinations and tremors. GoToSource Urinary retention. GoToSource Dyspnea on exertion. GoToSource |
| Litigation |
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No major injury lawsuits reported. |
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