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Mycamine (Micafungin Sodium) - Summary

 


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MYCAMINE SUMMARY

Mycamine®
(micafungin sodium) For Injection

MYCAMINE is a sterile, lyophilized product for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin) synthesized by a chemical modification of a fermentation product of Coleophoma empetri F-11899. Micafungin inhibits the synthesis of 1, 3-β-D-glucan, an integral component of the fungal cell wall. Each single-use vial contains 50 mg micafungin sodium, 200 mg lactose, with citric acid and/or sodium hydroxide (used for pH adjustment). MYCAMINE must be diluted with 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP (see DOSAGE AND ADMINISTRATION). Following reconstitution with 0.9% Sodium Chloride Injection, USP, the resulting pH of the solution is between 5.0-7.0.

MYCAMINE is indicated for:

  • Treatment of patients with esophageal candidiasis (see CLINICAL STUDIES, MICROBIOLOGY)
  • Prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation (see CLINICAL STUDIES, MICROBIOLOGY).

NOTE: The efficacy of MYCAMINE against infections caused by fungi other than Candida has not been established.


See all Mycamine indications & dosage >>

MYCAMINE NEWS HIGHLIGHTS

Published Studies Related to Mycamine (Micafungin)

Micafungin versus liposomal amphotericin B for pediatric patients with invasive candidiasis: substudy of a randomized double-blind trial. [2008.09]

Micafungin versus caspofungin for treatment of candidemia and other forms of invasive candidiasis. [2007.10.01]

Micafungin versus liposomal amphotericin B for candidaemia and invasive candidosis: a phase III randomised double-blind trial. [2007.05.05]

Steady-state pharmacokinetics of micafungin and voriconazole after separate and concomitant dosing in healthy adults. [2007.02]

International, open-label, noncomparative, clinical trial of micafungin alone and in combination for treatment of newly diagnosed and refractory candidemia. [2005.10]

more >>

Clinical Trials Related to Mycamine (Micafungin)

Comparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICU [Terminated]

Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for Aspergillosis [Terminated]

Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia [Completed]

Study of Micafungin in Patients With Invasive Candidiasis or Candidemia [Completed]

Trial of Two Dosing Regimens of Micafungin Versus Caspofungin for the Treatment of Esophageal Candidiasis [Completed]

more >>

Page last updated: 2008-11-02

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