VORICONAZOLE- voriconazole tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

APPCO PHARMA LLC

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 hypersensitiv

Product summary:

Tablets VORICONAZOLE 50 mg tablets ; white, round shaped, biconvex, film coated tablets with ‘APP 332’ debossed on one side and plain on other side. Bottles of 30 (NDC 55801-332-01) VORICONAZOLE 200 mg tablets ; white, oval shaped, biconvex, film coated tablets with ‘APP 333’ debossed on one side and plain on other side. Bottles of 30 (NDC 55801-333-01) VORICONAZOLE Tablets should be stored at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VORICONAZOLE- VORICONAZOLE TABLET
APPCO PHARMA LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VORICONAZOLE SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR VORICONAZOLE.
VORICONAZOLE TABLETS FOR ORAL USE. INITIAL U.S. APPROVAL: 2002
RECENT MAJOR CHANGES
Contraindications, Efavirenz 400 mg q24h or higher (4)
2/2014
Warnings and Precautions, Hepatic Toxicity (5.2)
2/2015
Warnings and Precautions, Arrhythmias/QT Prolongation (5.6) 2/2015
Warnings and Precautions, Dermatological Reactions (5.13)
2/2015
INDICATIONS AND USAGE
VORICONAZOLE is an azole antifungal drug 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 DOSING (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
3-4 mg/kg
q12h
200 mg q12h
SCEDOSPORIOSIS AND FUSARIOSIS
4 mg/kg
q12h
200 mg q12h
ESOPHAGEAL
CANDIDIASIS
Not
Evaluate d
Not
Evaluate d
200 mg q12h
Adult patients weighing less than 40 kg: oral maintenance dose 100 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 Interactio