Country: United States
Language: English
Source: NLM (National Library of Medicine)
Caspofungin Acetate (UNII: VUW370O5QE) (Caspofungin - UNII:F0XDI6ZL63)
Sagent Pharmaceuticals
INTRAVENOUS
PRESCRIPTION DRUG
Caspofungin acetate for injection is indicated as empirical therapy for presumed fungal infections in febrile, neutropenic adult and pediatric patients (3 months of age and older) [see Clinical Studies (14.1, 14.5)]. Caspofungin acetate for injection is indicated for the treatment of candidemia and the following candida infections: intra-abdominal abscesses, peritonitis, and pleural space infections in adult and pediatric patients (3 months of age and older) [see Clinical Studies (14.2, 14.5)] . Limitations of Use : Caspofungin acetate for injection has not been studied in endocarditis, osteomyelitis, and meningitis due to Candida. Caspofungin acetate for injection is indicated for the treatment of esophageal candidiasis in adult and pediatric patients (3 months of age and older) [see Clinical Studies (14.3, 14.5)] . Limitations of Use : Caspofungin acetate for injection has not been approved for the treatment of oropharyngeal candidiasis (OPC). In the study that evaluated the efficacy of caspofungin in the
Caspofungin Acetate for Injection is supplied as follows: Caspofungin Acetate for Injection is a lyophilized white to off-white powder/cake for intravenous infusion in a vial with an aluminum flip off seal and plastic cap. Storage Conditions Store refrigerated between 2° and 8°C (36° and 46°F). Discard unused portion. Sterile, Nonpyrogenic, Lyophilized. The container closure is not made with natural rubber latex. There are no preservatives or bacteriostatic agents in this product.
Abbreviated New Drug Application
CASPOFUNGIN ACETATE- CASPOFUNGIN ACETATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SAGENT PHARMACEUTICALS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CASPOFUNGIN ACETATE FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CASPOFUNGIN ACETATE FOR INJECTION. CASPOFUNGIN ACETATE FOR INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2001 INDICATIONS AND USAGE Caspofungin acetate for injection is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age and older) for: Empirical therapy for presumed fungal infections in febrile, neutropenic patients. (1) Treatment of candidemia and the following _Candida_ infections: intra-abdominal abscesses, peritonitis and pleural space infections. (1) Treatment of esophageal candidiasis. (1) Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies. (1) DOSAGE AND ADMINISTRATION _Important Administration Instructions for All Patients (2.1):_ Administer by slow intravenous (IV) infusion over approximately 1 hour. Do not administer by IV bolus administration. Do not mix or co-infuse caspofungin acetate for injection with other medications. Do not use diluents containing dextrose (α-D-glucose). _Dosage in Adults [18 years of age and older] (2.2):_ Administer a single 70 mg loading dose on Day 1, followed by 50 mg once daily for all indications except esophageal candidiasis. For esophageal candidiasis, use 50 mg once daily with no loading dose. _Dosage in Pediatric Patients [3 months to 17 years of age] (2.3):_ Dosing should be based on the patient's body surface area. For all indications, administer a single 70 mg/m loading dose on Day 1, followed by 50 mg/m once daily thereafter. Maximum loading dose and daily maintenance dose should not exceed 70 mg, regardless of the patient's calculated dose. _Dosage Adjustments in Patients with Hepatic Impairment (2.4):_ Reduce dosage for adult patients with moderate hepat Read the complete document