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Fomepizole Injection
  • The first "AP" Rated preservative free generic to Antizol®*1
  • Vial closure is not made with natural rubber latex




NDC Number
Strength
Size
Shelf Pack
Availability
Product Information
Arrow Up 0517-0710-01 1 g/mL 1.5 mL
Single Dose Vial
1 In Stock Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10189121 4254140 5727896 3926169 387571
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
0710-01 1 80 --


*Antizol® is a registered trademark of Par Pharm, Inc.


NDC Number
Arrow Up 0517-0710-01
Strength
1 g/mL
Size
1.5 mL
Single Dose Vial
Shelf Pack
1
Availability
In Stock
Product Information
Product Label
Full Prescribing Information
Safety Data Sheet
Bottle
Wholesaler Numbers
ABC/SAP Cardinal HD Smith McKesson Morris & Dickson
10189121 4254140 5727896 3926169 387571
Case Information
Unit of Sale NDC Order Size Case Size Case Per Tier
0710-01 1 80 --




Fomepizole Injection Caution: Must be diluted prior to use. For intravenous use only. 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. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Fomepizole Injection should not be administered to patients with a documented serious hypersensitivity reaction to Fomepizole Injection or other pyrazoles. PRECAUTIONS General: Fomepizole Injection should not be given undiluted or by bolus 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 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
USE IN SPECIFIC POPULATIONS Fomepizole Injection has not been studied sufficiently to determine whether the pharmacokinetics differ for geriatric and pediatric populations and between genders. 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 Nausea, dizziness, and vertigo were noted in healthy volunteers receiving 3 to 6 times the recommended dose. This dose-dependent CNS effect was short-lived in most subjects and lasted up to 30 hours in one subject. Fomepizole is dialyzable, and hemodialysis may be useful in treating cases of overdosage. For additional Safety Information, please see Full Prescribing Information. You are encouraged to report Adverse Drug Events to American Regent Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.




© 2018, American Regent, Inc., A Luitpold Pharmaceuticals, Inc. Company PP-CA-US-0001 (v6.0)     9/2018