Antizol (Fomepizole) - Summary

ANTIZOL SUMMARY

ANTIZOL^® (fomepizole) Injection

Antizol^® (fomepizole) Injection is a competitive inhibitor of alcohol dehydrogenase.

Antizol is indicated as an antidote for ethylene glycol (such as antifreeze) or methanol poisoning, or for use in suspected ethylene glycol or methanol ingestion, either alone or in combination with hemodialysis (see DOSAGE AND ADMINISTRATION).

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NEWS HIGHLIGHTS

Published Studies Related to Antizol (Fomepizole)

Fomepizole as an antidote for ethylene glycol poisoning. [2002.06]
CONCLUSIONS: Case reports and 1 prospective trial have shown that, in the absence of both renal dysfunction and significant metabolic acidosis, the use of fomepizole should obviate the need for hemodialysis. However, the decision to add hemodialysis in the treatment of ethylene glycol poisoning based on plasma ethylene glycol concentrations is still debatable. A randomized, controlled trial is needed to determine the exact criteria for adding hemodialysis.

Medication errors associated with the use of ethanol and fomepizole as antidotes for methanol and ethylene glycol poisoning. [2011.06]
INTRODUCTION: Little is known about medication errors which occur with the antidotes ethanol and fomepizole, used for treatment of methanol and ethylene glycol poisoning. Study objectives were to describe and compare the frequency, type, outcome and underlying causes of medication errors associated with ethanol and fomepizole... CONCLUSION: Fomepizole was less prone to medication error than ethanol. Error-related harm was most commonly due to excessive antidote dose or delayed antidote initiation.

Effect of lycopene on caspase-3 enzyme activation in liver of methanol-intoxicated rats: comparison with fomepizole. [2010.08]
Lycopene is one of the major carotenoids and is found almost exclusively in tomatoes and tomato products. This study was performed to evaluate the effect of lycopene on methanol-induced liver injury and to compare the results with those after fomepizole, which is used in treatment of methanol intoxication...

Fomepizole fails to prevent progression of acidosis in 2-butoxyethanol and ethanol coingestion. [2010.07]
CONCLUSION: Alcohol dehydrogenase inhibitors may not be adequate to prevent acidosis in significant ingestions to 2BE and extracorporeal treatments may be necessary.

Fomepizole for the treatment of pediatric ethylene and diethylene glycol, butoxyethanol, and methanol poisonings. [2010.06]
INTRODUCTION: The use and clinical efficacy of the alcohol dehydrogenase inhibitor fomepizole is well established for the treatment of ethylene glycol and methanol poisonings in adults... CONCLUSIONS: The limited data available suggest that fomepizole, using the same dosage regimen as that used for adults, is efficacious and well tolerated in pediatric patients. In many cases of pediatric ethylene glycol poisoning treated with fomepizole, hemodialysis may not be necessary despite high concentrations and the presence of metabolic acidosis.

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Clinical Trials Related to Antizol (Fomepizole)

Phase IIa Study of Fomepizole for Acetaldehyde Toxicity After Ethanol Exposure in Subjects With Altered Ethanol Metabolism [Recruiting]
This trial will evaluate if fomepizole (4-methylpyrazole)can treat symptoms associated with alcohol intolerance due to aldehyde dehydrogenase 2 (ALDH2) Deficiency, an inherited metabolic disorder. These symptoms include flushing, nausea, headache, shortness of breath and dizziness, resulting from exposure to acetaldehyde, the primary metabolite of ethanol. Long-term, serious health risks have been associated with repeated exposure to acetaldehyde, a carcinogen, among ALDH2-deficient individuals.

Phase 1 Pilot Study of 4-MP to Treat Stargardt Macular Dystrophy [Completed]
The purpose of this study is to investigate whether taking 4-methylpyrazole (4-MP, fomepizole, Antizol™) inhibits dark adaptation of the eye. In other words, we are testing if 4-MP slows the processing of vitamin A derivatives in the eye. By slowing down these processes, individuals with Stargardt disease may have better chances of saving their remaining vision. 4-MP has been shown to slow dark adaptation in animals, and is FDA approved for human use to treat individuals with methanol or ethylene glycol (antifreeze) poisoning by shutting down the body’s ability to process alcohols. This medication has an excellent safety profile and has been reported to have no short-term or long-term side effects, as long as patients refrain from any alcohol while the medication is in the body. A single dose of 4-MP remains in the body for about 12 hours, and therefore, it may inhibit dark adaptation of your eyes for up to 12 hours. Studying the effects of 4-MP may lead to effective medical treatment to save Stargardt patients’ vision, and may also have similar effects in other macular degenerative diseases.

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