Label Changes for:
Ranexa (ranolazine) extended-release tablets
September 2010
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2011
4 CONTRAINDICATIONS
third bullet
- With liver cirrhosis [see Use in Specific Populations (8.6)]
5 WARNINGS AND PRECAUTIONS
5.1 QT Interval Prolongation
- However, there is little experience with high doses (> 1000 mg twice daily.....
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
paragraph 5 and 6 changed
6.2 Postmarketing Experience
new section added
7 DRUG INTERACTIONS
7.2 Drugs Metabolized by CYP3A
- ......to include information on dosing with simvastatin
8 USE IN SPECIFIC POPULATIONS
8.6 Use in Patients with Hepatic Impairment
- Ranexa is contraindicated in patients with liver cirrhosis.....
8.7 Use in Patients with Renal Impairment
- Compared to patients with no renal impairment.....
17 PATIENT COUNSELING INFORMATION
bullet 7
- to inform their physician if they are receiving drugs that are moderate CYP3A inhibitors (e.g., diltiazem, verapamil, erythromycin)
bullet 8
- to inform their physician if they are receiving P-gp inhibitors (e.g., cyclosporine)
bullet 10
- that Ranexa should not be used in patients with liver cirrhosis
September 2010
DRUG INTERACTIONS
Effects of Ranolazine on Other Drugs
- Drugs Metabolized by CYP2D6: Ranexa 750 mg twice daily increased the plasma concentrations of a single dose of immediate-release metoprolol (100 mg), a CYP2D6 substrate, by 1.8-fold. The exposure to other CYP2D6 substrates, such as tricyclic antidepressants and antipsychotics, may be increased during co-administration with Ranexa, and lower doses of these drugs may be required.
