CASPOFUNGIN ACETATE injection

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Cipla USA Inc.

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 th

Povzetek izdelek:

How Supplied Caspofungin acetate for injection, 50 mg is a white to off-white powder/cake for infusion in a vial with red plastic cap. NDC 69097-365-37 supplied as one single-dose vial. Caspofungin acetate for injection, 70 mg is a white to off-white powder/cake for infusion in a vial with orange plastic cap. NDC 69097-366-37 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).

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

CASPOFUNGIN ACETATE- CASPOFUNGIN ACETATE INJECTION
CIPLA USA INC.
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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 ACATATE FOR INJECTION.
CASPOFUNGIN ACETATE FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Caspofungin acetate 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 hepatic impairment (35
mg once daily, with a 70 mg loading