Voriconazole 10 mg/mL
Voriconazole · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Xellia Pharmaceuticals USA LLC
Voriconazole is a injection, powder, lyophilized, for solution containing voriconazole at 10 mg/mL, taken intravenous. Manufactured by Xellia Pharmaceuticals USA LLC.
Key Facts
- Brand Name
- Voriconazole
- Generic Name
- Voriconazole
- NDC Code (Product)
70594-067- Manufacturer
- Xellia Pharmaceuticals USA LLC
- Strength
- 10 mg/mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA208562
- Drug Class
- Azole Antifungal [EPC]
- Marketing Start
- 08/24/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Voriconazole tablets are an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with: Invasive aspergillosis ( 1.1 ) Candidemia in non-neutropenics and other deep tissue Candida infections ( 1.2 ) Esophageal candidiasis ( 1.3 ) Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani , in patients intolerant of, or refractory to, other therapy ( 1.4 ) 1.1 Invasive Aspergillosis Voriconazole tablets are 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 [see Clinical Studies ( 14.1 , 14.5 ) and Microbiology ( 12.4 )]. 1.2 Candidemia in Non-neutropenic Patients and Other Deep Tissue Candida Infections Voriconazole tablets are 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: dissemi…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Dosage in Adults ( 2.3 ) Infection Maintenance Dose Oral tablets Oral suspension Invasive Aspergillosis 200 mg every 12 hours 5 mL every 12 hours Candidemia in nonneutropenics and other deep tissue Candida infections 200 mg every 12 hours 5 mL every 12 hours Scedosporiosis and Fusariosis 200 mg every 12 hours 5 mL every 12 hours Esophageal Candidiasis 200 mg every 12 hours 5 mL 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-Pugh Class A and B) ( 2.5 ) Renal Impairment: Avoid intravenous administration in adult patients with moderate to severe renal impairment (creatinine clearance <50 mL/min) ( 2.6 ) Dosage in Pediatric Patients 2 years of age and older ( 2.4 ) For pediatric patients 2 to less than 12 years of age and 12 to 14 years of age weighing less than 50 kg see Table below. Infection Maintenance Dose Oral tablets Oral suspension Invasive Aspergillosis 9 mg/kg every 12 hours (maximum dose of 350 mg every 12 hours) 0.225 mL/kg every 12 hours [maximum dose of 8.75 mL (350 mg…
Contraindications
4 CONTRAINDICATIONS Voriconazole tablets are contraindicated in patients with known hypersensitivity to voriconazole or its excipients [see Warnings and Precautions ( 5.5 ) and Adverse Reactions ( 6.1 , 6.2 )]. There is no information regarding cross-sensitivity between voriconazole and other azole antifungal agents. Refer to the prescribing information for other azole antifungal agents. Concomittant use of voriconazole with the interacting drugs described and listed below in this section are a guide and not considered a comprehensive list of all possible drugs that may be contraindicated with voriconazole tablets. 1. Concomitant use of voriconazole is contraindicated with drugs that are highly dependent on CYP3A4 for metabolism, and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions [see Drug Interactions ( 7 )]: Eplerenone Ergot alkaloids (e.g., ergotamine, dihydroergotamine) Finerenone Ivabradine Lurasidone Naloxegol Pimozide Quinidine Rifabutin [see Clinical Pharmacology ( 12.3 )] Sirolimus [see Clinical Pharmacology ( 12.3 )] Tolvaptan Venetoclax: Coadministration at initiation and during the ramp-up phase is contraindicated …
Drug Interactions
7 DRUG INTERACTIONS Voriconazole is metabolized by cytochrome P450 isoenzymes, CYP2C19, CYP2C9, and CYP3A4. Therefore, inhibitors or inducers of these isoenzymes may increase or decrease voriconazole plasma concentrations, respectively. Voriconazole is a strong inhibitor of CYP3A4, and also inhibits CYP2C19 and CYP2C9. Therefore, voriconazole may increase the plasma concentrations of substances metabolized by these CYP450 isoenzymes. Tables 10 and Table 11 provide listings of clinically significant drug interactions, including contraindicated drugs [see Contraindications ( 4 )]. Drugs listed in Table 10 and Table 11 are a guide and not considered a comprehensive list of all possible drugs and herbal products that are contraindicated or may interact with voriconazole. Table 10:Effect of Other Drugs on Voriconazole Pharmacokinetics [see Clinical Pharmacology ( 12.3 )] Drug/Drug Class (Mechanism of Interaction by the Drug) Voriconazole Plasma Exposure (C max and AUC τ after 200 mg every 12 hours) Prevention or Management Recommendations * Results based on in vivo clinical studies generally following repeat oral dosing with 200 mg every 12 hours voriconazole to healthy subjects ** Resu…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Hepatic Toxicity [see Warnings and Precautions ( 5.1 )] Arrhythmias and QT Prolongation [see Warnings and Precautions ( 5.2 )] Visual Disturbances [see Warnings and Precautions ( 5.4 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.5 )] Photosensitivity [see Warnings and Precautions ( 5.6 )] Renal Toxicity [see Warnings and Precautions ( 5.7 )] Adult Patients: The most common adverse reactions (incidence ≥2%) were visual disturbances, fever, nausea, rash, vomiting, chills, headache, liver function test abnormal, tachycardia, hallucinations ( 6 ) Pediatric Patients: The most common adverse reactions (incidence ≥ 5%) were visual disturbances, pyrexia, vomiting, epistaxis, nausea, rash, abdominal pain, diarrhea, hypertension, hypokalemia, cough, headache, thrombocytopenia, ALT abnormal, hypotension, peripheral edema, hyperglycemia, tachycardia, dyspnea, hypocalcemia, hypophosphatemia, LFT abnormal, mucosal inflammation, photophobia, abdominal distention, constipation, dizziness, hallucinations, hemoptysis, hypoalbuminemia, hypomagnesemia, renal impairment, upper …
Frequently Asked Questions
What is Voriconazole used for?
Voriconazole contains Voriconazole. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is Voriconazole a controlled substance?
Voriconazole is not classified as a controlled substance by the DEA.
What is the generic name for Voriconazole?
The generic name for Voriconazole is Voriconazole. There are 4 other brand versions of Voriconazole.
What is the NDC code for Voriconazole 10 mg/mL?
The NDC (National Drug Code) for Voriconazole 10 mg/mL is 70594-067, listed by Xellia Pharmaceuticals USA LLC.