VORICONAZOLE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Novel Laboratories, Inc.

INN (International Name):

VORICONAZOLE

Composition:

VORICONAZOLE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 known hypers

Product summary:

Voriconazole 50 mg tablets: White, film-coated, round shaped, debossed with "V above 5" on one side and plain on the reverse. Bottles of 30 (NDC 40032-088-03) Bottles 0f 500 (NDC 40032-088-05) Cartons of 30 (3×10) Unit-dose Tablets (NDC 40032-088-31) Voriconazole 200 mg tablets: White, film-coated, capsule shaped, debossed with "V2" on one side and plain on the reverse. Bottles of 30 (NDC 40032-089-03) Bottles 0f 500 (NDC 40032-089-05) Cartons of 30 (3×10) Unit-dose Tablets (NDC 40032-089-31) Voriconazole Tablets should be stored at 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VORICONAZOLE- VORICONAZOLE TABLET, FILM COATED
NOVEL LABORATORIES, 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 is an azole antifungal drug indicated for use in the
treatment of:
Invasive aspergillosis (1.1)
Candidemia (non-neutropenics) 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)
INFECTION
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 NON-
NEUTROPENICS AND OTHER
DEEP TISSUE _CANDIDA_
INFECTIONS
3-4 mg/kg q 12h
200 mg q12h
SCEDOSPORIOSIS AND
FUSARIOSIS
4 mg/kg q 12h
ESOPHAGEALCANDIDIASIS
Not evaluated
not evaluated
Adult patients weighing less than 40 kg: oral maintenance dose 100 mg
or 150 mg q12 hours
DOSAGE FORMS AND STRENGTHS
_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 _(including optic neuritis and papilledema):
Mon