Antidote
Fomepizole
The FDA lists this product in 5 strengths and forms.
Indications
Fomepizole 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 ).
Contraindications
Fomepizole should not be administered to patients with a documented serious hypersensitivity reaction to fomepizole or other pyrazoles.
Adverse reactions
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). All 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
Composition
- Active ingredients
- FOMEPIZOLE 1.5GM/1.5ML (1GM/ML)
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
At a glance
- Brand name
- Fomepizole
- Pharmacologic class
- Antidote
- Route
- Injection
- Dosage form
- Injectable
- Applicant
- Navinta LLC
- Status
- Prescription
- FDA approval
- 6 Mar 2008
- Application
- ANDA078537-001



