"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Mycamine is highly protein bound and, therefore, is not dialyzable. No cases of Mycamine overdosage have been reported. Repeated daily doses up to 8 mg/kg (maximum total dose of 896 mg) in adult patients, up to 6 mg/kg in pediatric patients 4 months of age and older, and up to 10 mg/kg in pediatric patients less than 4 months of age have been administered in clinical trials with no reported dose-limiting toxicity. The minimum lethal dose of Mycamine is 125 mg/kg in rats, equivalent to 8 times the recommended highest adult clinical dose (150 mg) and approximately 7 times the highest pediatric clinical dose (3 mg/kg), based on body surface area comparisons.
Mycamine is contraindicated in persons with known hypersensitivity to micafungin, any component of Mycamine, or other echinocandins.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/26/2013
Additional Mycamine Information
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