RANOLAZINE tablet, film coated, extended release

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

RANOLAZINE (UNII: A6IEZ5M406) (RANOLAZINE - UNII:A6IEZ5M406)

Disponible depuis:

Ascend Laboratories, LLC

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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

Descriptif du produit:

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).

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

RANOLAZINE - RANOLAZINE TABLET, FILM COATED, EXTENDED RELEASE
ASCEND LABORATORIES, LLC
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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