Label Changes for:

Rifadin (rifampin capsules USP), and Rifadin (rifampin for injection USP) IV

November 2010

Changes have been made to the CONTRAINDICATIONS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2010

 

 

CONTRAINDICATIONS

  • Rifampin is contraindicated in patients who are also receiving ritonavir-boosted saquinavir due to an increased risk of severe hepatocellular toxicity.
  • Rifampin is contraindicated in patients who are also receiving atazanavir, darunavir, fosamprenavir, saquinavir, or tipranavir due to the potential of rifampin to substantially decrease plasma concentrations of these antiviral drugs, which may result in loss of antiviral efficacy and/or development of viral resistance.

 

PRECAUTIONS

General
  • Rifadin should be used with caution in patients with a history of diabetes mellitus, as diabetes management may be more difficult.
Drug Interactions
  • Enzyme Induction: Healthy subjects who received rifampin 600 mg once daily concomitantly with saquinavir 1000 mg/ritonavir 100 mg twice daily (ritonavir-boosted saquinavir) developed severe hepatocellular toxicity. Therefore, concomitant use of these medications is contraindicated.
  • Rifampin has been reported to substantially decrease the plasma concentrations of the following antiviral drugs: atazanavir, darunavir, fosamprenavir, saquinavir, and tipranavir. These antiviral drugs must not be co-administered with rifampin.
  • Rifampin has been reported to accelerate the metabolism of the following drugs: …digitoxin…

 

ADVERSE REACTIONS

Hepatic
  • Transient abnormalities in liver function tests (e.g., elevations in serum bilirubin, BSP, alkaline phosphatase, serum transaminases) have been observed.
Central Nervous System
  • Muscular weakness
     
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