VORICONAZOLE- voriconazole tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Teva Pharmaceuticals USA, Inc.

INN (שם בינלאומי):

VORICONAZOLE

הרכב:

VORICONAZOLE 50 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Voriconazole tablets are 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 tablets are contraindicated in patients wit

leaflet_short:

Voriconazole Tablets, 50 mg are available as white to off-white, round shaped, unscored, film-coated tablets, debossed with “TEVA” on one side and “5289” on the other side and packaged in bottles of 30 tablets (NDC 0093-5289-56). Voriconazole Tablets, 200 mg are available as white to off-white, oval shaped, unscored, film-coated tablets, debossed with “TEVA” on one side and “5290” on the other side and packaged in bottles of 30 tablets (NDC 0093-5290-56). Voriconazole Tablets should be stored at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

VORICONAZOLE- VORICONAZOLE TABLET, FILM COATED
TEVA PHARMACEUTICALS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VORICONAZOLE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VORICONAZOLE
TABLETS.
VORICONAZOLE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2002
INDICATIONS AND USAGE
Voriconazole tablets are 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_ INFECTIONS
3 to 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
DOSAGE FORMS AND STRENGTHS
Film-coated tablets: 50 mg, 200 mg (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, efavirenz, ritonavir, rifabutin, ergot alkaloids,
and St. John’s Wort due to risk of loss of efficacy (4, 7)
WARNINGS AND PRECAUTIONS
_Clinically Significant Drug Interactions_: Review patient’s
concomitant medications (5.1, 7)
_Hepatic Toxicity_: Serious hepatic reactions reported. Evaluate liver
function tests at start of and during voriconazole
therapy (5.2)
_Visual Disturbances