RANOLAZINE tablet, extended release

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Viona Pharmaceuticals Inc

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

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].

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

RANOLAZINE- RANOLAZINE TABLET, EXTENDED RELEASE
Viona Pharmaceuticals Inc
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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

Produktets egenskaber

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