Drug Catalog - Product Detail
RANOLAZINE 500MG ER TABLETS 500
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 45963-0418-50 | ACTAVIS | 500 | 500MG | TABLET |
PACKAGE FILES
Generic Name
RANOLAZINE
Substance Name
RANOLAZINE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA208862
Description
11 DESCRIPTION Ranolazine is available as a film-coated, non-scored, extended-release tablet for oral administration. Ranolazine is a racemic mixture, chemically described as 1-piperazineacetamide, N -(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (±)-. It has a molecular formula of C 24 H 33 N 3 O 4 , a molecular weight of 427.54 g/mole, and the following structural formula: Ranolazine is a white to off-white solid. Ranolazine is soluble in dichloromethane and methanol; sparingly soluble in tetrahydrofuran, ethanol, acetonitrile, and acetone; slightly soluble in ethyl acetate, isopropanol, toluene, and ethyl ether; and very slightly soluble in water. Ranolazine extended-release tablets contain 500 mg or 1,000 mg of ranolazine and the following inactive ingredients: black iron oxide, hypromellose 2910, magnesium stearate, methacrylic acid copolymer (Type C), microcrystalline cellulose, sodium hydroxide, polyethylene glycol 3350, polyvinyl alcohol, talc and titanium dioxide. The 1,000 mg tablets also contain red iron oxide and yellow iron oxide. 1
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Ranolazine extended-release tablets are supplied as follows: 500 mg - Each gray, oval shaped, film-coated tablet debossed with and 418 on one side and plain on the other side contains 500 mg of ranolazine. Tablets are supplied in bottles of 60 tablets (NDC 45963-418-06). 1,000 mg - Each pink, oval shaped, film-coated tablet debossed with and 419 on one side and plain on the other side contains 1,000 mg of ranolazine. Tablets are supplied in bottles of 60 tablets (NDC 45963-419-06). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. 1 1
Indications & Usage
1 INDICATIONS AND USAGE 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 extended-release tablets are an antianginal indicated for the treatment of chronic angina. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION 500 mg twice daily and increase to 1,000 mg twice daily, based on clinical symptoms ( 2.1 ) 2.1 Dosing Information Initiate ranolazine extended-release tablets dosing at 500 mg twice daily and increase to 1,000 mg twice daily, as needed, based on clinical symptoms. Take ranolazine extended-release tablets with or without meals. Swallow ranolazine extended-release tablets whole; do not crush, break, or chew. The maximum recommended daily dose of ranolazine extended-release tablets is 1,000 mg twice daily. If a dose of ranolazine extended-release tablets are missed, take the prescribed dose at the next scheduled time; do not double the next dose. 2.2 Dose Modification Dose adjustments may be needed when ranolazine extended-release tablets are taken in combination with certain other drugs [see Drug Interactions (7.1) ] . Limit the maximum dose of ranolazine extended-release tablets to 500 mg twice daily in patients on moderate CYP3A inhibitors such as diltiazem, verapamil, and erythromycin. Use of ranolazine extended-release tablets with strong CYP3A inhibitors is contraindicated [see Contraindications (4) , Drug Interactions (7.1) ] . Use of P-gp inhibitors, such as cyclosporine, may increase exposure to ranolazine extended-release tablets. Titrate ranolazine extended-release tablets based on clinical response [see Drug Interactions (7.1) ] .