Finished product reference
Voriconazole
Injection, Powder, for Solution · Parenteral · 200 mg
- List code
- 6383
- Pharmacologic class
- Azole Antifungal
What it is and how it works
Mechanism of Action Voriconazole is an antifungal drug .
Mechanism class: Cytochrome P450 3A4 Inhibitors · Cytochrome P450 2C19 Inhibitors · Cytochrome P450 2C9 Inhibitors
Indications
Voriconazole for injection 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 Invasive Aspergillosis Voriconazole for injection 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 .
Dosage and administration (summary)
Dosage in Adults Infection Loading dose Maintenance Dose Intravenous infusion Intravenous infusion Oral Invasive Aspergillosis 6 mg/kg every 12 hours for the first 24 hours 4 mg/kg every 12 hours 200 mg every 12 hours Candidemia in nonneutropenics and other deep tissue Candida infections 3 to 4 mg/kg every 12 hours 200 mg every 12 hours Scedosporiosis and Fusariosis 4 mg/kg every 12 hours 200 mg every 12 hours Esophageal Candidiasis Not Evaluated Not Evaluated 200 mg every 12 hours Adult patients weighing less than 40 kg: oral maintenance dose 100 mg or 150 mg every 12 hours Hepatic Impairment: Use half the maintenance dose in adult patients with mild to moderate hepatic impairment (Child-Pu…
Contraindications
Voriconazole is contraindicated in patients with known hypersensitivity to voriconazole or its excipients. There is no information regarding cross-sensitivity between voriconazole and other azole antifungal agents. Caution should be used when prescribing voriconazole to patients with hypersensitivity to other azoles.
Warnings and precautions
Hepatic Toxicity : Serious hepatic reactions reported. Evaluate liver function tests at start of and during voriconazole therapy Arrhythmias and QT Prolongation : Correct potassium, magnesium and calcium prior to use; caution patients with proarrhythmic conditions Infusion Related Reactions (including anaphylaxis) : Stop the infusion Visual Disturbances (including optic neuritis and papilledema): Monitor visual function if treatment continues beyond 28 days Severe Cutaneous Adverse Reactions : Discontinue for exfoliative cutaneous reactions Photosensitivity : Avoid sunlight due to risk of phot…
Pregnancy
Pregnancy Risk Summary Voriconazole can cause fetal harm when administered to a pregnant woman. There are no available data on the use of voriconazole in pregnant women. In animal reproduction studies, oral voriconazole was associated with fetal malformations in rats and fetal toxicity in rabbits.
Storage and supply
Storage Voriconazole for injection unreconstituted vials should be stored at 20° to 25°C (68° to 77°F) . 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.
Source: Voriconazole (Voriconazole) — US FDA prescribing information, 2024-02-02, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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