RANOLAZINE 500 mg/1
RANOLAZINE · TABLET, FILM COATED, EXTENDED RELEASE · ScieGen Pharmaceuticals, Inc
Ranolazine is a prescription tablet taken by mouth to help reduce angina symptoms in patients with heart disease. It works by improving how the heart uses energy during stress, allowing patients to exercise with less chest pain.
Key Facts
- Brand Name
- RANOLAZINE
- Generic Name
- RANOLAZINE
- NDC Code (Product)
50228-423- Manufacturer
- ScieGen Pharmaceuticals, Inc
- Strength
- 500 mg/1
- Dosage Form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA211829
- Drug Class
- Anti-anginal [EPC]
- Marketing Start
- 06/04/2019
Recall History
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Aidapak Services, LLC
Labeling:Label Mixup; RANOLAZINE ER Tablet, 500 mg may be potentially mislabeled as MELATONIN, Tablet, 3 mg, NDC 51991001406, Pedigree: AD25452_16, EXP: 5/3/2014; DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: AD70585_16, EXP: 5/29/2014; OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 00904404360, Pedigree: W002852, EXP: 6/7/2014; VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree:
Glenmark Pharmaceuticals Inc., USA
Failed Dissolution Specifications: Out of specification for dissolution.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 extended-release tablet is an antianginal indicated for the treatment of chronic angina. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 500 mg twice daily and increase to 1000 mg twice daily, based on clinical symptoms ( 2.1 ) 2.1 Dosing Information Initiate ranolazine extended-release tablet dosing at 500 mg twice daily and increase to 1000 mg twice daily, as needed, based on clinical symptoms. Take ranolazine extended-release tablet with or without meals. Swallow ranolazine extended-release tablet whole; do not crush, break, or chew. The maximum recommended daily dose of ranolazine extended-release tablet is 1000 mg twice daily. If a dose of ranolazine extended-release tablet is missed, take the prescribed dose at the next scheduled time; do not double the next dose. 2.2 Dose Adjustments in Specific Populations Dose adjustments may be needed when ranolazine extended-release tablet is taken in combination with certain other drugs [see Drug Interactions (7.1) ] . Limit the maximum dose of ranolazine extended-release tablet to 500 mg twice daily in patients on moderate CYP3A inhibitors such as diltiazem, verapamil, and erythromycin. Use of ranolazine extended-release tablet with strong CYP3A inhibitors is contraindicated [ see Contraindications (4) , Drug Interactions (7.1) ] . Use of P-g…
Contraindications
4 CONTRAINDICATIONS 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) ] 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 )
Drug Interactions
7 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 simvastatin to 20 mg when used with ranolazine. Doses of other sensitive CYP3A substrates (e.g., lovastatin) and CYP3A substrates with narrow therapeutic range (e.g., cyclosporine, tacrolimus, sirolimus) may need to be reduced with ranolazine. ( 7.2 ) OCT2 substrates: Limit the dose of metformin to 1700 mg daily when used with ranolazine 1000 mg twice daily. Doses of other OCT2 substrates may require adjusted doses. ( 7.2 ) Drugs transported by P-gp (e.g., digoxin), or drugs metabolized by CYP2D6 (e.g., tricyclic antidepressants) may need reduced doses when used with ranolazine. ( 7.2 ) 7.1 Effects of Other Drugs on Ranolazine Strong CYP3A Inhibitors Do not use ranolazine with strong CYP3A inhibitors, including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir [see Contraindications (4) , Clinical Pharmacology (12.3) ]. Moderate CYP3A Inhibitors L…
Adverse Reactions
6 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 2018 patients with chronic angina were treated with ranolazine in controlled clinical trials. Of the patients treated with ranolazine, 1026 were enrolled in three double-blind, placebo-controlled, randomized studies (CARISA, ERICA, MARISA) of up to 12 weeks' duration. In addition, upon study completion, 1251 patients received treatment with ranolazine in open-label, long-term studies; 1227 patients were exposed to ranolazine for more than 1 year, 613 patients for more than 2 years, 531 patients for more than 3 years, and 326 patients for more than 4 years. At recommended doses, about 6% of patients d…
Frequently Asked Questions
What is RANOLAZINE used for?
Ranolazine is a prescription tablet taken by mouth to help reduce angina symptoms in patients with heart disease. It works by improving how the heart uses energy during stress, allowing patients to exercise with less chest pain.
Is RANOLAZINE a controlled substance?
RANOLAZINE is not classified as a controlled substance by the DEA.
What is the generic name for RANOLAZINE?
The generic name for RANOLAZINE is RANOLAZINE. There are 8 other brand versions of RANOLAZINE.
What is the NDC code for RANOLAZINE 500 mg/1?
The NDC (National Drug Code) for RANOLAZINE 500 mg/1 is 50228-423, listed by ScieGen Pharmaceuticals, Inc.