Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
RANOLAZINE (UNII: A6IEZ5M406) (RANOLAZINE - UNII:A6IEZ5M406)
Ascend Laboratories, LLC
ORAL
PRESCRIPTION DRUG
Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers. Ranolazine is contraindicated in patients: • Taking strong inhibitors of CYP3A [see Drug Interactions (7.1)] • Taking inducers of CYP3A [see Drug Interactions (7.1)] • With liver cirrhosis [see Use in Specific Populations (8.6)] Risk Summary 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) (see Data) . 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. Data Animal Data Embryofetal toxicity studies
Ranolazine is supplied as extended-release tablets in the following strengths: Ranolazine extended-release tablets are available in: Store ranolazine tablets at 25°C (77°F) with excursions permitted to 15° to 30°C (59° to 86°F).
Abbreviated New Drug Application
RANOLAZINE - RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE ASCEND LABORATORIES, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE RANOLAZINE EXTENDED- RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RANOLAZINE EXTENDED-RELEASE TABLETS. RANOLAZINE EXTENDED-RELEASE TABLETS FOR ORAL USE INITIAL U.S. APPROVAL: 2006 INDICATIONS AND USAGE Ranolazine extended-release tablets are an antianginal indicated for the treatment of chronic angina. (1) (1) DOSAGE AND ADMINISTRATION 500 mg twice daily and increase to 1000 mg twice daily, based on clinical symptoms (2.1) DOSAGE FORMS AND STRENGTHS Extended-release tablets: 500 mg, 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 data 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 less than 60 mL/min). If acute renal failure develops, discontinue ranolazine. (5.2) ADVERSE REACTIONS Most common adverse reactions (greater than 4% and more common than with placebo) are dizziness, headache, constipation, nausea. (6.1) To report SUSPECTED ADVERSE REACTIONS,contact Ascend Laboratories,LLC at 1-877-ASC-RX01 (877- 272-7901) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Moderate CYP3A inhibitors (e.g., diltiazem, verapamil, erythromycin): Limit ranolazine to 500 mg twice daily. (7.1) P-gp inhibitors (e.g., cyclosporine): Ranolazine exposure increased.Titrate rano Прочитать полный документ