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.

     

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