VORICONAZOLE injection, powder, lyophilized, for solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

VORICONAZOLE (UNII: JFU09I87TR) (VORICONAZOLE - UNII:JFU09I87TR)

Saatavilla:

Zydus Pharmaceuticals USA Inc.

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Voriconazole for injection is indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive apergillosis (IA). In clinical trials, the majority of isolates recovered were Aspergillus fumigatus . There was a small number of cases of culture-proven disease due to species of Aspergillus other than A. fumigatus [see Clinical Studies (14.1) 14.5 and Microbiology (12.4) ]. Voriconazole for injection is indicated in adults and pediatric patients (2 years of age and older) for the treatment of candidemia in non-neutropenic patients and the following Candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds [see Clinical Studies (14.2, 14.5) and Microbiology (12.4) ]. Voriconazole for injection is indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal candidiasis (EC) in adults and pediatric patients 2 years of age and older [see Clinical Studies (14.3, 14.5) and Microbiology (1

Tuoteyhteenveto:

Powder for Solution for Injection Voriconazole for injection is supplied in a single dose vial as a sterile lyophilized powder equivalent to 200 mg voriconazole and 3,200 mg sulfobutyl ether beta-cyclodextrin sodium (SBECD). This container closure is not made with natural rubber latex. Voriconazole for injection unreconstituted vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Voriconazole for injection is a single dose unpreserved sterile lyophile. From a microbiological point of view, following reconstitution of the lyophile with water for injection, the reconstituted solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2° to 8°C (36° to 46°F). Chemical and physical in-use stability has been demonstrated for 24 hours at 2° to 8°C (36° to 46°F). This medicinal product is for single use only and any unused solution should be discarded. Only clear solutions without particles should be used [see Dosage and Administration (2.1) ].

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

VORICONAZOLE - VORICONAZOLE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
ZYDUS PHARMACEUTICALS USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VORICONAZOLE FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
VORICONAZOLE FOR
INJECTION.
VORICONAZOLE FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2002
RECENT MAJOR CHANGES
Indications and Usage (1)
1/2019
Dosage and Administration (2)
1/2019
Contraindications (4)
1/2019
Warnings and Precautions (5)
1/2019
INDICATIONS AND USAGE
Voriconazole for injection is an azole antifungal indicated for the
treatment of adults and pediatric patients
2 years of age and older with:
Invasive aspergillosis (1.1)
Candidemia in non-neutropenics and other deep tissue Candida
infections (1.2)
Esophageal candidiasis (1.3)
Serious fungal infections caused by _Scedosporium apiospermum _and
_Fusarium _species including
_Fusarium solani_ , in patients intolerant of, or refractory to, other
therapy (1.4)
DOSAGE AND ADMINISTRATION
DOSAGE IN ADULTS (2.3)
INFECTION
LOADING DOSE
MAINTENANCE DOSE
INTRAVENOUS
INTRAVENOUS
ORAL
INVASIVE ASPERGILLOSIS
6 mg/kg every 12 hours
for the
first 24 hours
4 mg/kg every 12 hours
200 mg every 12
hours
CANDIDEMIA IN
NONNEUTROPENICS AND OTHER
DEEP
TISSUE _CANDIDA_
INFECTIONS
3 to 4 mg/kg every 12
hours
200 mg every 12
hours
SCEDOSPORIOSIS AND
FUSARIOSIS
4 mg/kg every 12 hours
200 mg every 12
hours
ESOPHAGEAL CANDIDIASIS
Not Evaluated
not evaluated
200 mg every 12
hours
Adult patients weighing less than 40 kg: oral maintenance dose 100 or
150 mg every 12 hours
_Hepatic Impairment_ : Use half the maintenance dose in adult patients
with mild to moderate hepatic
impairment (Child-Pugh Class A and B) (2.5)
_Renal Impairment_ : Avoid intravenous administration in adult
patients with moderate to severe renal
impairment (creatinine clearance <50 mL/min) (2.6)
Dosage in Pediatric Patients 2 years of age and older (2.4)
For pediatric patients 2 to less than 12 years