CASPOFUNGIN ACETATE injection, powder, for solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

CASPOFUNGIN ACETATE (UNII: VUW370O5QE) (CASPOFUNGIN - UNII:F0XDI6ZL63)

Verfügbar ab:

Mylan Institutional LLC

INN (Internationale Bezeichnung):

CASPOFUNGIN ACETATE

Zusammensetzung:

CASPOFUNGIN ACETATE 5 mg in 1 mL

Verabreichungsweg:

INTRAVENOUS

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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

Produktbesonderheiten:

How Supplied Caspofungin acetate for injection 50 mg is a lyophilized white to off-white cake or powder for intravenous infusion supplied in single-dose vials with an aluminum flip off seal. NDC 67457-831-50 supplied as one single-dose vial. NDC 67457-832-70 supplied as one single-dose vial. Storage and Handling The lyophilized vials should be stored refrigerated at 2° to 8°C (36° to 46°F).

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

CASPOFUNGIN ACETATE- CASPOFUNGIN ACETATE INJECTION, POWDER, FOR
SOLUTION
MYLAN INSTITUTIONAL LLC
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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:
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DOSAGE AND ADMINISTRATION
_Important Administration Instructions for All Patients (2.1):_
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_Dosage in Adults [18 years of age and older] (2.2):_
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_Dosage in Pediatric Patients [3 months to 17 years of age] (2.3):_
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_Dosage Adjustments in Patients with Hepatic Impairment (2.4):_
Reduce dosage for adult patients with moderate hepatic impairment (35
mg once daily, with a 70 mg loading dose on Day 1
where appropriate).
_Dosage Adjustment in Patients Receiving Concomitant Inducers of
Hepatic CYP Enzymes (2.5):_
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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)
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).
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 w