Voriconazole (Voriconazole)

Trade Name : Voriconazole

Mylan Pharmaceuticals Inc.

TABLET, FILM COATED

Strength 50 mg/1

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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Disclaimer

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 (Voriconazole) which is also known as Voriconazole and Manufactured by Mylan Pharmaceuticals Inc.. It is available in strength of 50 mg/1 per ml. Read more

Voriconazole (Voriconazole) 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

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About GNH

No data

Indications and Usage ()u00a0u00a0u00a0u00a0u00a01/2019
Dosage and Administration ()u00a0u00a0u00a0u00a0u00a0u00a01/2019
Contraindications ()u00a0u00a0u00a0u00a0u00a0u00a01/2019
Warnings and Precautions ()u00a0u00a0u00a0u00a0u00a0u00a01/2019

Voriconazole tablets are an azole antifungal indicated for the treatment of adults and pediatric patients aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight with:

Candida
Scedosporium apiospermum n- Fusarium n- Fusarium solani

u00a0

Voriconazole Tablets are available containing 50 mg or 200 mg of voriconazole, USP.

u2022
Tablets:
3

No data

4n- 7
4n- 7

No data

Hepatic Toxicity:
Arrhythmias and QT Prolongation:
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
Visual Disturbances n
Serious Exfoliative Cutaneous Reactions n
Photosensitivity n
Renal Toxicity n
u00a0

u2022
Adult Patients:
6

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.
u00a0
u00a0

4n- 7
4n- 7
2.3n- 2.7n- 7

u00a0
u00a0
Additional pediatric use information is approved for PF PRISM C.V.u2019s VFENDu00a0(voriconazole). However, due to PF PRISM C.V.u2019s marketing exclusivity rights, this drug product is not labeled with that information.

u2022
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.

Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration. The structural formula is:
Voriconazole is designated chemically as (2,3)-2-(2, 4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1-1, 2, 4-triazol-1-yl)butan-2-ol with a molecular formula of CHFNO and a molecular weight of 349.31.
Voriconazole, USP drug substance is a white to off-white powder.
Voriconazole tablets contain 50 mg or 200 mg of voriconazole. The inactive ingredients include croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch (corn), titanium dioxide and triacetin.

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/m basis. 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/m basis. 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 ().
Embryo-Fetal Toxicity:

This Patient Information has been approved by the U.S. Food and Drug Administration.
Manufactured for:n n Morgantown, WV 26505 U.S.A.
Manufactured by:n n Hyderabad u2013 500 096, Indian
75068634
Revised: 1/2020MX:VORIC:R10

NDC 0378-1626-93
Voriconazolen- Tabletsn- 50 mg
Rx onlyu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a030 Tablets
Each film-coated tablet contains:Voriconazole, USPu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a050 mg
Usual Dosage:
Keep this and all medication out ofn- the reach of children.
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See n- USP Controlled Room Temperature.]
Manufactured for:n n Morgantown, WV 26505 U.S.A.
Made in India
Mylan.com
RMX1626H6
Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
Keep container tightly closed.
Code No.: MH/DRUGS/25/NKD/89

NDC 0378-1640-93
Voriconazolen- Tabletsn- 200 mg
Rx onlyu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a030 Tablets
Each film-coated tablet contains:Voriconazole, USPu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0200 mg
Usual Dosage:
Keep this and all medication out ofn- the reach of children.
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See n- USP Controlled Room Temperature.]
Manufactured for:n n Morgantown, WV 26505 U.S.A.
Made in India
Mylan.com
RMX1640H6
Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
Keep container tightly closed.
Code No.: MH/DRUGS/25/NKD/89

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Voriconazole (Voriconazole)

Trade Name : Voriconazole

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Voriconazole (Voriconazole)

Trade Name : Voriconazole

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?