Voriconazoledrug info

voriconazole 40 MG/ML Oral Suspension

What it is used for

Voriconazole for oral suspension is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: Invasive aspergillosis Candidemia in non-neutropenics and other deep tissue Candida infections Esophageal candidiasis Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy

1.1 Invasive

Aspergillosis Voriconazole for oral suspension is indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive aspergillosis (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.

1.2 Candidemia in

Non-Neutropenic Patients and Other Deep Tissue Candida Infections Voriconazole for oral suspension 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.

1.3 Esophageal

Candidiasis Voriconazole for oral suspension is indicated in adults and pediatric patients (2 years of age and older) for the treatment of esophageal candidiasis (EC).

1.4 Scedosporiosis and

Fusariosis Voriconazole for oral suspension is indicated for the treatment of serious fungal infections caused by Scedosporium apiospermum (asexual form of Pseudallescheria boydii ) and Fusarium spp. including Fusarium solani, in adults and pediatric patients (2 years of age and older) intolerant of, or refractory to, other therapy. 1.5 Usage 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.

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective September 9, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.

Description

Voriconazole, an azole antifungal agent is available as a powder for oral suspension.

The structural formula is: Voriconazole is designated chemically as (2R,3S)-2-(2,4- difluorophenyl) -3- (5-fluoro- 4- pyrimidinyl)-1-(1 H -1,2,4-triazol-1-yl)-2butanol with an empirical formula of C 16 H 14 F 3 N 5 O and a molecular weight of 349.3. Voriconazole, USP drug substance is a white to light-colored powder. Voriconazole for Oral Suspension is a white to off-white powder providing a white to off-white, orange-flavored suspension when reconstituted. Bottles containing 45 grams powder for oral suspension, which contain 3 g of voriconazole, are intended for reconstitution with water to produce a suspension containing 40 mg/mL voriconazole, USP. The inactive ingredients include anhydrous citric acid, colloidal silicon dioxide, orange flavor, sodium benzoate, sodium citrate dihydrate, sucrose, titanium dioxide, and xanthan gum. chemical structure

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