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Voriconazole (Vfend)

Trade Name : VFEND

Roerig

POWDER, FOR SUSPENSION

Strength 40 mg/mL

VORICONAZOLE Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Voriconazole (Vfend) which is also known as VFEND and Manufactured by Roerig. It is available in strength of 40 mg/mL per ml. Read more

Voriconazole (Vfend) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • VFEND 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 infections ()
  • Esophageal candidiasis ()
  • Serious fungal infections caused by and species including , in patients intolerant of, or refractory to, other therapy ()
  • No data
  • No data
  • Tablets
  • For Oral Suspension
  • For Injection
  • No data
  • Hypersensitivity to voriconazole or its excipients ()
  • Coadministration with cisapride, pimozide or quinidine, sirolimus due to risk of serious adverse reactions (, )
  • Coadministration with rifampin, carbamazepine, long-acting barbiturates, efavirenz, ritonavir, rifabutin, ergot alkaloids, and St. John's Wort due to risk of loss of efficacy (, )
  • No data
  • Hepatic Toxicity
  • Arrhythmias and QT Prolongation
  • Infusion Related Reactions n- (including anaphylaxis)
  • Visual Disturbances
  • Serious Exfoliative Cutaneous Reactions
  • Photosensitivity
  • Embryo-Fetal Toxicity
  • Skeletal Adverse Reactions
  • Clinically Significant Drug Interactions
  • Patients with Hereditary Galactose Intolerance, Lapp Lactase Deficiency or Glucose-Galactose Malabsorption:
  • The following serious adverse reactions are described elsewhere in the labeling:
  • Hepatic Toxicity n
  • Arrhythmias and QT Prolongation n
  • Infusion Related Reactions n
  • Visual Disturbances n
  • Serious Exfoliative Cutaneous Reactions n
  • Photosensitivity n
  • Renal Toxicity n
  • To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Adult Patients
  • Pediatric Patients
  • Voriconazole is metabolized by, and inhibits the activity of, cytochrome P450 isoenzymes, CYP2C19, CYP2C9, and CYP3A4. Inhibitors or inducers of these isoenzymes may increase or decrease voriconazole plasma concentrations, respectively, and there is potential for voriconazole to increase the plasma concentrations of substances metabolized by these CYP450 isoenzymes.
  • Tables 10 and 11 provide the clinically significant interactions between voriconazole and other medical products.
  • CYP3A4, CYP2C9, and CYP2C19 inhibitors and inducers: Adjust VFEND dosage and monitor for adverse reactions or lack of efficacy (, )
  • VFEND may increase the concentrations and activity of drugs that are CYP3A4, CYP2C9 and CYP2C19 substrates. Reduce dosage of these other drugs and monitor for adverse reactions (, )
  • Phenytoin or Efavirenz: With co-administration, increase maintenance oral and intravenous dosage of VFEND (, , )
  • No data
  • Pediatrics
  • 8.4
  • In clinical trials, there were three cases of accidental overdose. All occurred in pediatric patients who received up to five times the recommended intravenous dose of voriconazole. A single adverse event of photophobia of 10 minutes duration was reported.
  • There is no known antidote to voriconazole.
  • Voriconazole is hemodialyzed with clearance of 121 mL/min. The intravenous vehicle, SBECD, is hemodialyzed with clearance of 55 mL/min. In an overdose, hemodialysis may assist in the removal of voriconazole and SBECD from the body.
  • VFEND (voriconazole), an azole antifungal agent is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration, and 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-(1-1,2,4-triazol-1-yl)-2-butanol with an empirical formula of CHFNO and a molecular weight of 349.3.
  • Voriconazole drug substance is a white to light-colored powder.
  • VFEND I.V. is a white lyophilized powder containing nominally 200 mg voriconazole and 3200 mg sulfobutyl ether beta-cyclodextrin sodium in a 30 mL Type I clear glass vial.
  • VFEND I.V. is intended for administration by intravenous infusion. It is a single-dose, unpreserved product. Vials containing 200 mg lyophilized voriconazole are intended for reconstitution with Water for Injection to produce a solution containing 10 mg/mL VFEND and 160 mg/mL of sulfobutyl ether beta-cyclodextrin sodium. The resultant solution is further diluted prior to administration as an intravenous infusion .
  • VFEND Tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include croscarmellose sodium, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, and a coating containing hypromellose, lactose monohydrate, titanium dioxide, and triacetin.
  • VFEND 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 are intended for reconstitution with water to produce a suspension containing 40 mg/mL voriconazole. The inactive ingredients include anhydrous citric acid, colloidal silicon dioxide, natural orange flavor, sodium benzoate, sodium citrate dihydrate, sucrose, titanium dioxide, and xanthan gum.
  • No data
  • Two-year carcinogenicity studies were conducted in rats and mice. Rats were given oral doses of 6, 18 or 50 mg/kg voriconazole, or 0.2, 0.6, or 1.6 times the RMD on a mg/mbasis. Hepatocellular adenomas were detected in females at 50 mg/kg and hepatocellular carcinomas were found in males at 6 and 50 mg/kg. Mice were given oral doses of 10, 30 or 100 mg/kg voriconazole, or 0.1, 0.4, or 1.4 times the RMD on a mg/mbasis. In mice, hepatocellular adenomas were detected in males and females and hepatocellular carcinomas were detected in males at 1.4 times the RMD of voriconazole.
  • Voriconazole demonstrated clastogenic activity (mostly chromosome breaks) in human lymphocyte cultures . Voriconazole was not genotoxic in the Ames assay, CHO HGPRT assay, the mouse micronucleus assay or the DNA repair test (Unscheduled DNA Synthesis assay).
  • Voriconazole administration induced no impairment of male or female fertility in rats dosed at 50 mg/kg, or 1.6 times the RMD.
  • Voriconazole, administered orally or parenterally, has been evaluated as primary or salvage therapy in 520 patients aged 12 years and older with infections caused by spp., spp., and spp.
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Embryo-Fetal Toxicity
  • This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.
  • LAB-0271-37.0
  • LAB-0311-14.0
  • Revised: January 2019
  • Read this Instructions for Use before you start taking VFEND and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
  • Important information
  • Each pack contains:
  • How to prepare the bottle and take VFEND:
  • Rinse the oral dispenser after each use.
  • How should I store VFEND oral suspension?
  • This Instructions for Use has been approved by the U.S. Food and Drug Administration.
  • This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.
  • LAB-1348-1.0Revised: 04/2019
  • Pfizer
  • Vfend
  • 50 mg
  • Tablets
  • 30 TabletsRx only
  • Pfizer
  • Vfend
  • 200 mg
  • Tablets
  • 30 TabletsRx only
  • NDC 0049-3190-28
  • Vfend I.V.
  • 200 mg*
  • No LatexNo Preservatives
  • Sterile Single Use VialFor I.V. Infusion Only
  • Pfizer Injectablesn- Rx only
  • NDC 0049-3190-28n n
  • 1 VialVfend I.V.
  • 200 mg*
  • No LatexNo Preservatives
  • Sterile Single Use VialFor I.V. Infusion Only
  • Pfizer Injectables
  • Pfizer
  • NDC 0049-3160-44
  • Vfend
  • 40 mg/mL*
  • for oral suspension
  • ORANGE FLAVORED
  • 75 mL (when reconstituted)Rx only
  • Pfizer
  • NDC 0049-3160-44
  • Vfend
  • 40 mg/mL*
  • for oral suspension
  • ORANGE FLAVORED
  • Oral Dispenser Included
  • Important: Read assembly instructionscarefully before dispensing.Contains Small Parts -Keep out of reach of children.
  • 75 mL (when reconstituted)Rx only

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