Clinical Information
Gen. Code and Des.
83129 ranolazine ORAL PACK ER GR 1000 MG
GCN and Des.
52006 ranolazine ORAL PACK ER GR 1000 MG
Strength
1000MG ER
Dose Form
PACKET, EXTENDED RELEASE GRANULES
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
24049200 CARDIAC DRUGS, MISCELLANEOUS
Active Ingredients
11195 ranolazine 95635555
These highlights do not include all the information needed to use ASPRUZYO SPRINKLE safely and effectively. See full prescribing information for ASPRUZYO SPRINKLE.
ASPRUZYO SPRINKLETM (ranolazine) extended-release granules, for oral use
Initial U.S. Approval: 2006
INDICATIONS AND USAGE
ASPRUZYO Sprinkle is an antianginal indicated for the treatment of chronic angina. (1) (1)
DOSAGE AND ADMINISTRATION
500 mg orally twice daily and increase to 1000 mg orally twice daily, based on clinical symptoms (2.1) (2)
DOSAGE FORMS AND STRENGTHS
Extended-release granules: 500 and 1000 mg (3) (3)
CONTRAINDICATIONS
•
Strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin, nelfinavir) (4, 7.1)
•
CYP3A inducers (e.g., rifampin, phenobarbital, St. John's wort) (4, 7.1)
•
Liver cirrhosis (4, 8.6)
WARNINGS AND PRECAUTIONS
•
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)
ADVERSE REACTIONS
Most common adverse reactions (> 4% and more common than with placebo) are dizziness, headache, constipation, nausea. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
•
Moderate CYP3A inhibitors (e.g., diltiazem, verapamil, erythromycin): Limit ASPRUZYO Sprinkle to 500 mg twice daily. (7.1)
•
P-gp inhibitors (e.g., cyclosporine): Ranolazine exposure increased. Titrate ASPRUZYO Sprinkle based on clinical response. (7.1)
•
CYP3A substrates: Limit simvastatin to 20 mg when used with ASPRUZYO Sprinkle. Doses of other sensitive CYP3A substrates (e.g., lovastatin) and CYP3A substrates with narrow therapeutic range (e.g., cyclosporine, tacrolimus, sirolimus) may need to be reduced with ASPRUZYO Sprinkle. (7.2)
•
OCT2 substrates: Limit the dose of metformin to 1700 mg daily when used with ASPRUZYO Sprinkle 1000 mg twice daily. Doses of other OCT2 substrates may require adjusted doses. (7.2)
•
Drugs transported by P-gp (e.g., digoxin), or drugs metabolized by CYP2D6 (e.g., tricyclic antidepressants) may need reduced doses when used with ASPRUZYO Sprinkle. (7.2)
See 17 for PATIENT COUNSELING INFORMATION.
