Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
RANOLAZINE (UNII: A6IEZ5M406) (RANOLAZINE - UNII:A6IEZ5M406)
Viona Pharmaceuticals Inc
ORAL
PRESCRIPTION DRUG
Ranolazine extended-release tablet is indicated for the treatment of chronic angina. Ranolazine extended-release tablet 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 [seeDrug 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 2-4% and 15-20%, respectively. Data Animal Data Embryofetal toxicity studies were conducted in rats and ra
Ranolazine extended-release tablets, 500 mg are light orange colored, oval shaped, beveled edge, biconvex, film coated tablets debossed with "588" on one side and plain on other side and are supplied as follows: NDC 72578-064-14 in bottles of 60 tablets with child-resistant closure NDC 72578-064-01 in bottles of 100 tablets with child-resistant closure NDC 72578-064-05 in bottles of 500 tablets NDC 72578-064-77 in unit-dose blister cartons of 100 Tablets (10 x 10 Unit-dose) Ranolazine extended-release tablets, 1000 mg are pale yellow colored, oval shaped, beveled edge, biconvex, film coated tablets debossed with "589" on one side and plain on other side and are supplied as follows: NDC 72578-065-14 in bottles of 60 tablets with child-resistant closure NDC 72578-065-01 in bottles of 100 tablets with child-resistant closure NDC 72578-065-05 in bottles of 500 tablets NDC 72578-065-77 in unit-dose blister cartons of 100 Tablets (10 x 10 Unit-dose) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
RANOLAZINE- RANOLAZINE TABLET, EXTENDED RELEASE Viona Pharmaceuticals Inc ---------- Patient Information Ranolazine (ra NOE la zeen) extended-release tablets Dosing Strengths: 500 mg tablets 1000 mg tablets Read this Patient Information before you start taking ranolazine extended-release tablet and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. What are ranolazine extended-release tablet? Ranolazine extended-release tablet is a prescription medicine used to treat angina that keeps coming back (chronic angina). Ranolazine extended-release tablet may be used with other medicines that are used for heart problems and blood pressure control. It is not known if ranolazine extended-release tablet is safe and effective in children. Who should not take ranolazine extended-release tablet? Do not take ranolazine extended-release tablet if: • you take any of the following medicines: • for fungus infection: ketoconazole (Nizoral®), itraconazole (Sporanox®, OnmelTM) • for infection: clarithromycin (Biaxin®) • for depression: nefazodone • for HIV: nelfinavir (Viracept®), ritonavir (Norvir®), lopinavir and ritonavir (Kaletra®), indinavir (Crixivan®), saquinavir (Invirase®) • for tuberculosis (TB): rifampin (Rifadin®), rifabutin (Mycobutin®), rifapentine (Priftin®) • for seizures: phenobarbital, phenytoin (Phenytek®, Dilantin®, Dilantin125®), carbamazepine (Tegretol®) • St. John's wort (Hypericum perforatum) • you have scarring (cirrhosis) of your liver What should I tell my doctor before taking ranolazine extended-release tablet? Before you take ranolazine extended-release tablet, tell your doctor if you: • have or have a family history of a heart problem, called 'QT prolongation' or 'long QT syndrome'. • have liver problems. • have kidney problems. • are pregnant or plan to become pregnant. It is not known if ranolazine extended-release tablet will harm your unborn b Lire le document complet
RANOLAZINE- RANOLAZINE TABLET, EXTENDED RELEASE VIONA PHARMACEUTICALS INC ---------- 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 tablet is an antianginal indicated for the treatment of chronic angina. (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) 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<60 mL/min). If acute renal failure develops, discontinue ranolazine. (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 Viona Pharmaceuticals Inc. at 1-888-304-5011 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 ranolazine based on clinical response. (7.1) CYP3A substrates: Limit Lire le document complet