FomepizoleInjection
- The first "AP" Rated preservative free generic to Antizol®*1
- Vial closure is not made with natural rubber latex
| Pack NDC# | Strength | Supplied As | Shelf Pack | Vial Opening Size | Product Info | Availability | ||
|---|---|---|---|---|---|---|---|---|
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Strength:
1 g/mL Supplied As:1.5 mL |
0517-0710-01 |
1 g/mL |
1.5 mL |
1 | 13 mm | Product Label Full Prescribing Information Safety Data Sheet | In Stock | |
Product Label Full Prescribing Information Safety Data Sheet Wholesaler Numbers
Case Information
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*Antizol® is a registered trademark of Paladin Labs Inc.
1Approved Drug Products with Therapeutic Equivalence Evaluations.
https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=A&Appl_No=078368. Accessed February 2021.
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INDICATIONS AND USAGE
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.
CONTRAINDICATIONS
Fomepizole Injection should not be administered to patients with a documented serious hypersensitivity reaction to Fomepizole Injection or other pyrazoles.
General: Fomepizole Injection should not be given undiluted or by bolus injection. Do not use polycarbonate syringes or polycarbonate-containing needs (including polycarbonate filter needles) with fomepizole injection.
Minor allergic reactions have been reported. Patients should be monitored for signs of allergic reactions.
Laboratory Tests: Monitor patient throughout the treatment.
Pregnancy: Pregnancy Category C: Fomepizole should be given to pregnant women only if clearly needed.
Nursing Mothers: Caution should be exercised when fomepizole is administered to a nursing woman.
Pediatric and Geriatric Use: Safety and effectiveness have not been established.
ADVERSE REACTIONS
The most frequent adverse events reported as drug-related or unknown relationship to study drug in those who received Fomepizole Injection were headache (14%), nausea (11%), and dizziness, increased drowsiness, and bad taste/metallic taste (6% each). Other adverse events in this population were reported in approximately 3% or fewer of those receiving fomepizole and were as follows:
Body as a Whole: Abdominal pain, fever, multiorgan system failure, pain during fomepizole injection, inflammation at injection site, lumbalgia/backache, hangover.
Cardiovascular: Sinus bradycardia/bradycardia, phlebosclerosis, tachycardia, phlebitis, shock, hypotension.
Gastrointestinal: Vomiting, diarrhea, dyspepsia, heartburn, decreased appetite, transient transaminitis.
Hemic/Lymphatic: Eosinophilia/hypereosinophilia, lymphangitis, disseminated intravascular coagulation, anemia.
Nervous: Lightheadedness, seizure, agitation, feeling drunk, facial flush, vertigo, nystagmus, anxiety, “felt strange,” decreased environmental awareness.
Respiratory: Hiccups, pharyngitis.
Skin/Appendages: Application site reaction, rash.
Special Senses: Abnormal smell, speech/visual disturbances, transient blurred vision, roar in ear.
Urogenital: Anuria.
Renal Insufficiency: The metabolites of fomepizole are excreted renally. Definitive pharmacokinetic studies have not been done to assess pharmacokinetics in patients with renal impairment.
Hepatic Insufficiency: Fomepizole is metabolized through the liver, but no definitive pharmacokinetic studies have been done in subjects with hepatic disease.
OVERDOSAGE
Fomepizole is dialyzable, and hemodialysis may be useful in treating cases of overdosage.