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VORICONAZOLE Tablets, Oral Suspension (GREENSTONE LLC)

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VORICONAZOLE Tablets, Oral Suspension (GREENSTONE LLC) Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

1.1 Invasive Aspergillosis

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

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2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions for Use in All Patients

Administer Voriconazole Tablets or Oral Suspension at least one hour...

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3 DOSAGE FORMS AND STRENGTHS

Tablets

Voriconazole 50 mg tablets; white, film-coated, round, debossed with "Pfizer" on one side and "VOR50...

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4 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...
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5 WARNINGS AND PRECAUTIONS

5.1 Hepatic Toxicity

In clinical trials, there have been uncommon cases of serious hepatic reactions during treatment with voriconazole (...

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6 ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in the labeling:

Hepatic Toxicity [see

6.1 Clinical Trials Experience

Because...

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7 DRUG INTERACTIONS

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...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Voriconazole can cause...

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10 OVERDOSAGE

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...

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11 DESCRIPTION

Voriconazole, an azole antifungal agent is available as film-coated tablets for oral administration and as a powder for oral suspension. The structural formula is:

...
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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Voriconazole is an antifungal drug [see

12.2 Pharmacodynamics

...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Two-year carcinogenicity studies were conducted in rats and mice. Rats were given...

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14 CLINICAL STUDIES

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 Aspergillus...

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16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Tablets

Voriconazole 50 mg...

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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Embryo-Fetal...

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INSTRUCTIONS FOR USE
(voriconazole)
for oral suspension

Read this Instructions for Use before you start taking voriconazole and each time you get a refill. There may be new information. This information does not...

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This product's labeling may have been updated. For the most recent prescribing information, please visit www.greenstonellc.com.

...

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