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FLUCONAZOLE DEMOGEN (Demogen Australia Pty Ltd trading as DEMOGEN Pharmaceuticals)

Product name
FLUCONAZOLE DEMOGEN
Sponsor
Demogen Australia Pty Ltd trading as DEMOGEN Pharmaceuticals
Date registered
Evaluation commenced
Decision date
Approval time
121 (255 working days)
Active ingredients
fluconazole
Registration type
New generic medicine
Indication

FLUCONAZOLE DEMOGEN IV is indicated for the same conditions in adults and children. but should be used only when fluconazole cannot be administered orally*.

FLUCONAZOLE DEMOGEN is indicated for:

  • Treatment of cryptococcal meningitis in patients who are unable to tolerate amphotericin B.

NOTE: Data suggest that the clinical efficacy of fluconazole is lower than that of amphotericin B in the treatment of the acute phase of cryptococcal meningitis.

  • Maintenance therapy to prevent relapse of cryptococcal meningitis in patients with AIDS.
  • Treatment of oropharyngeal and oesophageal candidiasis in AIDS and other immunosuppressed patients.
  • Secondary prophylaxis of oropharyngeal candidiasis in patients with HIV infection.
  • Serious and life-threatening Candida infections in patients who are unable to tolerate amphotericin B.

NOTE: It remains to be shown that fluconazole is as effective as amphotericin B in the treatment of serious and life-threatening Candida infections. Until such data are available, amphotericin B remains the drug of choice.

*oral fluconazole is available from other brands.