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.
|
