Antizol Safety Information
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Antizol should not be given undiluted or by bolus injection. Venous irritation and phlebosclerosis were noted in two of six normal volunteers given bolus injections (over 5 minutes) of Antizol at a concentration of 25 mg/ml.
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Antizol may be safely administered while awaiting laboratory confirmation of suspected ethylene glycol and methanol poisonings.
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The most frequent adverse events reported as drug-related or unknown relationship to study drug in the 78 patients and 63 normal volunteers who received Antizol® (fomepizole) Injection were headache (14%), nausea (11%), and dizziness, increased drowsiness, and bad taste/metallic taste (6% each). All other adverse events in this population were reported in approximately 3% or fewer of those receiving Antizol.
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Minor allergic reactions (mild rash, eosinophilia) have been reported in a few patients receiving Antizol (see ADVERSE REACTIONS section of the package insert). Therefore, patients should be monitored for signs of allergic reactions.
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Antizol treatment is well-tolerated during prolonged administration.
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Antizol does not worsen central nervous system depression or cause hypoglycemia.
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The use of Antizol does not require monitoring plasma fomepizole concentrations and in select cases of ethylene glycol poisoning, Antizol may eliminate the need for hemodialysis.
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The only contraindication to the use of Antizol is a known hypersensitivity to fomepizole or other pyrazoles.
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Antizol is approved for the treatment of real or suspected ethylene glycol and methanol poisoning. Please see the full prescribing information for a complete discussion of INDICATIONS and USAGE, CONTRAINDICATIONS, PRECAUTIONS, ADVERSE REACTIONS, and OVERDOSAGE. 13