Fomepizole injection 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 ).
From the U.S. FDA-approved label for Fomepizole. Full label: DailyMed.
Fomepizole injection 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 ).
From the U.S. FDA-approved label for Fomepizole. Full label: DailyMed.
Fomepizole can interact with polycarbonate, compromising the integrity of the syringe and/or needle component containing polycarbonate. Treatment Guidelines: If ethylene glycol or methanol poisoning is left untreated, the natural progression of the poisoning leads to accumulation of toxic metabolites, including glycolic and oxalic acids (ethylene glycol intoxication) and formic acid (methanol intoxication). These metabolites can induce metabolic acidosis, nausea/vomiting, seizures, stupor, coma, calcium oxaluria, acute tubular necrosis, blindness, and death.
Directions from the U.S. FDA-approved label — your doctor or pharmacist may advise differently.
Fomepizole should not be administered to patients with a documented serious hypersensitivity reaction to fomepizole or other pyrazoles.
Excerpt from the U.S. FDA-approved label. Talk to a pharmacist or doctor before use.
General: Fomepizole injection 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 fomepizole injection at a concentration of 25 mg/mL. Do not use polycarbonate syringes or polycarbonate-containing needles (including polycarbonate filter needles) when diluting or administering fomepizole injection. Fomepizole can interact with polycarbonate, compromising the integrity of the syringe and/or needle component containing polycarbonate.
Warnings and precautions excerpt from the U.S. FDA-approved label — not a complete list. Talk to a pharmacist or doctor before use.
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 fomepizole injection were headache (14%), nausea (11%), and dizziness, increased drowsiness, and bad taste/metallic taste (6% each).
Excerpt from the U.S. FDA-approved label — not a complete list. Talk to a pharmacist or doctor about side effects.
Conditions Store at 20° to 25°C (68° to 77°F). Discard unused portion. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. SAGENT ® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in India ©2023 Sagent Pharmaceuticals August 2023 SAGENT Pharmaceuticals ®
Storage information from the U.S. FDA-approved label.
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