Aspruzyo Sprinkle

ASPRUZYO Sprinkle is indicated for the treatment of chronic angina.

ASPRUZYO Sprinkle may be used with beta-blockers, nitrates, calcium channel blockers, anti‑platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers.

500 mg orally twice daily and increase to 1000 mg orally twice daily, based on clinical symptoms (2.1)

ASPRUZYO Sprinkle (ranolazine) is supplied as unit-dose sachets containing 500 or 1000 mg of white to off-white, coated, extended-release granules.

There are no available data on ranolazine use in pregnant women to inform any drug‑associated risks. Studies in rats and rabbits showed no evidence of fetal harm at exposures 4 times the maximum recommended human dose (MRHD)

In the U.S. general population, the estimated background risk of major birth defects and of miscarriage of clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Embryofetal toxicity studies were conducted in rats and rabbits orally administered ranolazine during organogenesis. In rats, decreased fetal weight and reduced ossification were observed at doses (corresponding to 4-fold the AUC for the MRHD) that caused maternal weight loss. No adverse fetal effects were observed in either species exposed (AUC) to ranolazine at exposures (AUC) equal to the MRHD.

• QT interval prolongation: Can occur with ranolazine. Little information available on high doses, long exposure, use with QT interval‑ prolonging drugs, potassium channel variants causing prolonged QT interval, in patients with a family history of (or congenital) long QT syndrome, or in patients with known acquired QT interval prolongation. (5.1)
• Renal failure: Monitor renal function after initiation and periodically in patients with moderate to severe renal impairment (CrCL <60 mL/min). If acute renal failure develops, discontinue ASPRUZYO Sprinkle. (5.2)