Label Changes for:

Videx (didanosine) pediatric powder and Videx EC capsules

June 2009

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2009

CONTRAINDICATIONS

Allopurinol
  • Coadministration of didanosine and allopurinol is contraindicated because systemic exposures of didanosine are increased, which may increase didanosine-associated toxicity.
Ribavirin
  • Coadministration of didanosine and ribavirin is contraindicated because exposures of the active metabolite of didanosine (dideoxyadenosine 5’-triphosphate) are increased. Fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in patients receiving both didanosine and ribavirin.
PRECAUTION/Drug Interactions

updated to provide information regarding drug-drug interactions with ganciclovir and methadone

  • Do not coadminister methadone with Videx pediatric powder due to significant decreases in didanosine concentrations. If coadministration of methadone and didanosine is necessary, the recommended formulation of didanosine is Videx EC. Patients should be closely monitored for adequate clinical response when Videx EC is coadministered with methadone, including monitoring for changes in HIV RNA viral load.
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