VORICONAZOLE- voriconazole injection, powder, lyophilized, for solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Hainan Poly Pharm. Co., Ltd.

관리 경로:

INTRAVENOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Voriconazole is indicated for use in patients 12 years of age and older in the treatment of the following fungal infections: 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) and Clinical Pharmacology (12.4) ]. [ see Clinical Studies (14.2) and Clinical Pharmacology (12.4) ] [ see Clinical Studies (14.3) and Clinical Pharmacology (12.4) ] [ see Clinical Studies (14.4) and Clinical Pharmacology (12.4) ] Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly. - Voriconazole is contraindicated in patients with k

제품 요약:

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). Individually packaged vials of 200 mg voriconazole for injection (NDC 14335-080-01) Voriconazole for Injection unreconstituted vials should be stored at 15° – 30°C (59° – 86°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 dose only and any unused solution should be discarded. Only clear solutions without particles should be used [ see Dosage and Administration (2.1) ].

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

VORICONAZOLE- VORICONAZOLE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
HAINAN POLY PHARM. CO., LTD.
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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
INDICATIONS AND USAGE
Voriconazole for injection is an azole antifungal indicated for use in
the treatment of:
Invasive aspergillosis ( 1.1)
Candidemia (nonneutropenics) and disseminated candidiasis in skin,
abdomen, kidney, bladder wall, and wounds ( 1.2)
Esophageal candidiasis ( 1.3)
Serious 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
RECOMMENDED DOSAGE ( 2.3)
INFE C TIO N
LOADING DOSE
MAINTENANCE DOSE
IV
IV
ORAL
INVASIVE ASPERGILLOSIS
6 mg/kg q12h for the first 24
hours
4 mg/kg q12h
200 mg q12h
CANDIDEMIA IN NONNEUTROPENICS
AND OTHER DEEP TISSUE _CANDIDA_
INFE C TIO NS
3–4 mg/kg q12h
200 mg q12h
SCEDOSPORIOSIS AND FUSARIOSIS
4 mg/kg q12h
200 mg q12h
ESOPHAGEAL CANDIDIASIS
Not Evaluated
not evaluated
200 mg q12h
Adult patients weighing less than 40 kg: oral maintenance dose 100 or
150 mg q12 hours
See full prescribing information for instructions on reconstitution of
lyophilized powder for intravenous use and
important administration instructions ( 2.5)
DOSAGE FORMS AND STRENGTHS
_For Injection_: lyophilized powder containing 200 mg voriconazole and
3,200 mg of sulfobutyl ether beta-cyclodextrin
sodium (SBECD); after reconstitution 10 mg/mL of voriconazole and 160
mg/mL of SBECD ( 3)
CONTRAINDICATIONS
Hypersensitivity to voriconazole or its excipients ( 4)
Coadministration with terfenadine, astemizole, cisapride, pimozide or
quinidine, sirolimus due to risk of serious adverse
reactions ( 4, 7)
Coadministration with rifampin, carbamazepine, long-acting
barbiturates