CASPOFUNGIN ACETATE injection, powder, lyophilized, for solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Sandoz 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,

Povzetek izdelek:

How Supplied Caspofungin acetate for injection 50 mg is a white to off-white lyophilized cake or powder for intravenous infusion supplied in single-dose vials with a green flip-off cap. Caspofungin acetate for injection 70 mg is a white to off-white lyophilized cake or powder for intravenous infusion supplied in single-dose vials with a blue flip-off cap. 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, POWDER,
LYOPHILIZED,
FOR SOLUTION
SANDOZ 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
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 hepatic imp