Interactions : אינטראקציות

7        DRUG INTERACTIONS
Drug-drug interaction studies were conducted in patients with normal renal function. Patients with impaired renal function may have increased concentrations of ganciclovir and the coadministered drug following concomitant administration of CYMEVENE 500 MG and drugs excreted by the same pathway as ganciclovir. Therefore, these patients should be closely monitored for toxicity of ganciclovir and the coadministered drug.
Established and other potentially significant drug interactions conducted with ganciclovir are listed in Table 6 [see Clinical Pharmacology (12.3)].
Table 6. Established and Other Potentially Significant Drug Interactions with Ganciclovir Name of the Concomitant Drug           Change in the Concentration of           Clinical Comment Ganciclovir or Concomitant Drug
Imipenem-cilastatin                    Unknown                                  Coadministration with imipenem- cilastatin is not recommended because generalized seizures have been reported in patients who received ganciclovir and imipenem- cilastatin.
Ciclosporin or amphotericin B          Unknown                                  Monitor renal function when CYMEVENE 500 MG is coadministered with ciclosporin or amphotericin B because of potential increase in serum creatinine [see
Warnings and Precautions (5.2)].
Mycophenolate mofetil (MMF)            ↔ Ganciclovir (in patients with          Based on increased risk, patients normal renal function)                   should be monitored for
↔ MMF (in patients with normal           hematological and renal toxicity.
renal function)



Name of the Concomitant Drug          Change in the Concentration of            Clinical Comment Ganciclovir or Concomitant Drug
Other drugs associated with            Unknown                                  Because of potential for higher myelosuppresion or nephrotoxicity                                               toxicity, coadministration with (e.g., dapsone, doxorubicin,                                                    CYMEVENE 500 MG should be flucytosine, hydroxyurea,                                                       considered only if the potential pentamidine, tacrolimus,                                                        benefits are judged to outweigh the trimethoprim/ sulfamethoxazole,                                                 risks.
vinblastine, vincristine and zidovudine)
Didanosine                            ↔ Ganciclovir                             Patients should be closely monitored ↑ Didanosine                              for didanosine toxicity (e.g., pancreatitis).
Probenecid                            ↑ Ganciclovir                             CYMEVENE 500 MG dose may need to be reduced. Monitor for evidence of ganciclovir toxicity.