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Anidulafungin
Aug 21, 06 FDA ApprovalsERAXIS® (Pfizer) is an echinocandin antifungal.
DOSING INFORMATION: For the treatment of candidemia or candida infections (intra-abdominal abscess and peritonitis), the recommended dose is a single 200 milligram (mg) loading dose intravenously (IV) followed by 100 mg IV every day thereafter. The treatment duration should be at least 14 days after the last positive culture while taking into consideration the patient’s clinical response. For the treatment of esophageal candidiasis, the recommended dose is a single 100 mg loading dose IV followed by 50 mg IV every day thereafter. The minimum treatment duration is 14 days and for at least 7 days following resolution of symptoms while taking into consideration the patient’s clinical response.
PHARMACOKINETICS: The volume of distribution is 30 to 50 liters. Protein binding is 84%. Is not a substrate, inducer, or inhibitor of the cytochrome P450 isoenzymes. It is not metabolized. Anidulafungin undergoes slow chemical degradation (lacks antifungal activity) and is subsequently excreted in the feces. The half-life is 43 to 50 hours.
CAUTIONS: Significant hepatic dysfunction, worsening hepatic failure, hepatitis, or clinically significant hepatic abnormalities have occurred. Other serious events include hypokalemia and deep vein thrombosis. Diarrhea occurred with an incidence of 3.1%. Histamine-related symptoms (rash, urticaria, flushing, pruritus, dyspnea, and hypotension) has occurred but is infrequent when the infusion rate does not exceed 1.1 milligrams/minute.
FDA APPROVED INDICATIONS: Anidulafungin is approved for the treatment of candidemia, other forms of candida infections (intra-abdominal abscess and peritonitis), and esophageal candidiasis.
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