RANEXA® (ranolazine)
Brief summary of full Prescribing Information.
Please see full Prescribing Information. Rx Only.
INDICATIONS AND USAGE:
RANEXA® is indicated for the treatment of chronic angina. RANEXA may be used with betablockers, nitrates, calcium channel blockers, anti-platelet therapy, lipid-lowering therapy, ACE
inhibitors, and angiotensin receptor blockers.
DOSAGE AND ADMINISTRATION:
Adult Dosage: Initiate RANEXA dosing at 500 mg twice daily and increase to 1000 mg twice
daily, as needed, based on clinical symptoms. Take RANEXA with or without meals. Swallow
RANEXA tablets whole; do not crush, break, or chew. The maximum recommended daily dose of
RANEXA is 1000 mg twice daily. If a dose of RANEXA is missed, take the prescribed dose at the
next scheduled time; do not double the next dose.
Dose Modification: Dose adjustments may be needed when RANEXA is taken in combination
with certain other drugs. Limit the maximum dose of RANEXA to 500 mg twice daily in patients
on moderate CYP3A inhibitors such as diltiazem, verapamil, and erythromycin. Use of P-gp
inhibitors, such as cyclosporine, may increase exposure to RANEXA. Titrate RANEXA based on
clinical response.
CONTRAINDICATIONS:
RANEXA is contraindicated in patients:
• Taking strong inhibitors of CYP3A
• Taking inducers of CYP3A
• With liver cirrhosis
WARNINGS AND PRECAUTIONS
QT Interval Prolongation: Ranolazine blocks IKr and prolongs the QTc interval in a doserelated manner. Clinical experience in an acute coronary syndrome population did not show an
increased risk of proarrhythmia or sudden death. However, there is little experience with high
doses (> 1000 mg twice daily) or exposure, other QT-prolonging drugs, potassium channel
variants resulting in a long QT interval, in patients with a family history of (or congenital) long QT
syndrome, or in patients with known acquired QT interval prolongation.
Renal Failure
Acute renal failure has been observed in some patients with severe renal impairment (creatinine
clearance [CrCL] < 30 mL/min) while taking RANEXA. If acute renal failure develops (e.g.,
marked increase in serum creatinine associated with an increase in blood urea nitrogen
[BUN]), discontinue RANEXA and treat appropriately. 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.
ADVERSE REACTIONS
Adverse Reactions from Clinical Trials Experience: Because clinical trials are conducted
under widely varying conditions, adverse reaction rates observed in the c Ɩ