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Antizol
Overview
What is Antizol?
Antizol (fomepizole) Injection is a competitive inhibitor of alcohol dehydrogenase.
The chemical name of fomepizole is 4-methylpyrazole. It has the molecular formula CHN and a molecular weight of 82.1. The structural formula is:
It is a clear to yellow liquid at room temperature. Its melting point is 25° C (77° F) and it may present as solid at room temperature. Fomepizole is soluble in water and very soluble in ethanol, diethyl ether, and chloroform. Each vial contains 1.5 mL (1 g/mL) of fomepizole.
What does Antizol look like?
What are the available doses of Antizol?
Sorry No records found.
What should I talk to my health care provider before I take Antizol?
Sorry No records found
How should I use Antizol?
Treatment Guidelines:
Treatment consists of blocking the formation of toxic metabolites using inhibitors of alcohol dehydrogenase, such as Antizol, and correction of metabolic abnormalities. In patients with high ethylene glycol or methanol concentrations (≥ 50 mg/dL), significant metabolic acidosis, or renal failure, hemodialysis should be considered to remove ethylene glycol or methanol and the respective toxic metabolites of these alcohols.
Treatment with Antizol:
Begin Antizol treatment immediately upon suspicion of ethylene glycol or methanol ingestion based on patient history and/or anion gap metabolic acidosis, increased osmolar gap, visual disturbances, or oxalate crystals in the urine, a documented serum ethylene glycol or methanol concentration greater than 20 mg/dL.
Hemodialysis:
Discontinuation of Antizol Treatment:
Dosing of Antizol:
Dosage with Renal Dialysis:
at least 100 mL of sterile 0.9% sodium chloride injection or dextrose 5% injection.
Stability:
What interacts with Antizol?
Antizol should not be administered to patients with a documented serious hypersensitivity reaction to Antizol or other pyrazoles.
What are the warnings of Antizol?
Sorry No Records found
What are the precautions of Antizol?
General
Antizol should not be given undiluted or by bolus injection.
Minor allergic reactions (mild rash, eosinophilia) have been reported in a few patients receiving Antizol (see ). Therefore, patients should be monitored for signs of allergic reactions.
Laboratory Tests
In addition to specific antidote treatment with Antizol, patients intoxicated with ethylene glycol or methanol must be managed for metabolic acidosis, acute renal failure (ethylene glycol), adult respiratory distress syndrome, visual disturbances (methanol), and hypocalcemia. Fluid therapy and sodium bicarbonate administration are potential supportive therapies. In addition, potassium and calcium supplementation and oxygen administration are usually necessary. Hemodialysis is necessary in the anuric patient, or in patients with severe metabolic acidosis or azotemia (see ). Treatment success should be assessed by frequent measurements of blood gases, pH, electrolytes, BUN, creatinine, and urinalysis, in addition to other laboratory tests as indicated by individual patient conditions. At frequent intervals throughout the treatment, patients poisoned with ethylene glycol should be monitored for ethylene glycol concentrations in serum and urine, and the presence of urinary oxalate crystals. Similarly, serum methanol concentrations should be monitored in patients poisoned with methanol. Electrocardiography should be performed because acidosis and electrolyte imbalances can affect the cardiovascular system. In the comatose patient, electroencephalography may also be required. In addition, hepatic enzymes and white blood cell counts should be monitored during treatment, as transient increases in serum transaminase concentrations and eosinophilia have been noted with repeated Antizol dosing.
Drug Interactions
Oral doses of Antizol (10-20 mg/kg), via alcohol dehydrogenase inhibition, significantly reduced the rate of elimination of ethanol (by approximately 40%) given to healthy volunteers in moderate doses. Similarly, ethanol decreased the rate of elimination of Antizol (by approximately 50%) by the same mechanism.
Reciprocal interactions may occur with concomitant use of Antizol and drugs that increase or inhibit the cytochrome P450 system (e.g., phenytoin, carbamazepine, cimetidine, ketoconazole), though this has not been studied.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
There have been no long-term studies performed in animals to evaluate carcinogenic potential. There was a positive Ames test result in the tester strain WP2A and the tester strain TA102 in the absence of metabolic activation.
There was no evidence of a clastogenic effect in the mouse micronucleus assay.
In rats, fomepizole (110 mg/kg) administered orally for 40 to 42 days resulted in decreased testicular mass (approximately 8% reduction). This dose is approximately 0.6 times the human maximum daily exposure based on surface area (mg/m2). This reduction was similar for rats treated with either ethanol or fomepizole alone. When fomepizole was given in combination with ethanol, the decrease in testicular mass was significantly greater (approximately 30% reduction) compared to those rats treated exclusively with fomepizole or ethanol.
Pregnancy
Pregnancy Category C: Animal reproduction studies have not been conducted with fomepizole. It is also not known whether Antizol can cause fetal harm when administered to pregnant women or can affect reproduction capacity. Antizolshould be given to pregnant women only if clearly needed.
Nursing Mothers
It is not known whether fomepizole is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Antizol is administered to a nursing woman.
Pediatric Use
Geriatric Use
What are the side effects of Antizol?
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 and were as follows:
Body as a Whole:
Cardiovascular:
Gastrointestinal:
Hemic/Lymphatic:
Nervous:
Respiratory:
Skin/Appendages:
Special Senses:
Urogenital:
What should I look out for while using Antizol?
Sorry No records found
What might happen if I take too much Antizol?
Nausea, dizziness, and vertigo were noted in healthy volunteers receiving 50 and 100 mg/kg doses of Antizol (at plasma concentrations of 290-520 mol/L, 23.8-42.6 mg/L). These doses are 3-6 times the recommended dose. This dose-dependent CNS effect was short-lived in most subjects and lasted up to 30 hours in one subject.
Antizol is dialyzable, and hemodialysis may be useful in treating cases of overdosage.
How should I store and handle Antizol?
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .Antizol is supplied as a sterile, preservative-free solution for intravenous use as:Supplied in packages of four vials or one vial. Each vial contains 1.5 mL (1 g/mL) of fomepizole. NDC 46129-200-02 (four vials)NDC 46129-200-01 (one vial)Store at controlled room temperature, 20° to 25° C (68° to 77° F)Distributed in the U.S. by:Paladin Labs (USA) Inc. Antizol is supplied as a sterile, preservative-free solution for intravenous use as:Supplied in packages of four vials or one vial. Each vial contains 1.5 mL (1 g/mL) of fomepizole. NDC 46129-200-02 (four vials)NDC 46129-200-01 (one vial)Store at controlled room temperature, 20° to 25° C (68° to 77° F)Distributed in the U.S. by:Paladin Labs (USA) Inc. Antizol is supplied as a sterile, preservative-free solution for intravenous use as:Supplied in packages of four vials or one vial. Each vial contains 1.5 mL (1 g/mL) of fomepizole. NDC 46129-200-02 (four vials)NDC 46129-200-01 (one vial)Store at controlled room temperature, 20° to 25° C (68° to 77° F)Distributed in the U.S. by:Paladin Labs (USA) Inc. Antizol is supplied as a sterile, preservative-free solution for intravenous use as:Supplied in packages of four vials or one vial. Each vial contains 1.5 mL (1 g/mL) of fomepizole. NDC 46129-200-02 (four vials)NDC 46129-200-01 (one vial)Store at controlled room temperature, 20° to 25° C (68° to 77° F)Distributed in the U.S. by:Paladin Labs (USA) Inc. Antizol is supplied as a sterile, preservative-free solution for intravenous use as:Supplied in packages of four vials or one vial. Each vial contains 1.5 mL (1 g/mL) of fomepizole. NDC 46129-200-02 (four vials)NDC 46129-200-01 (one vial)Store at controlled room temperature, 20° to 25° C (68° to 77° F)Distributed in the U.S. by:Paladin Labs (USA) Inc. Antizol is supplied as a sterile, preservative-free solution for intravenous use as:Supplied in packages of four vials or one vial. Each vial contains 1.5 mL (1 g/mL) of fomepizole. NDC 46129-200-02 (four vials)NDC 46129-200-01 (one vial)Store at controlled room temperature, 20° to 25° C (68° to 77° F)Distributed in the U.S. by:Paladin Labs (USA) Inc. Antizol is supplied as a sterile, preservative-free solution for intravenous use as:Supplied in packages of four vials or one vial. Each vial contains 1.5 mL (1 g/mL) of fomepizole. NDC 46129-200-02 (four vials)NDC 46129-200-01 (one vial)Store at controlled room temperature, 20° to 25° C (68° to 77° F)Distributed in the U.S. by:Paladin Labs (USA) Inc.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Non-Clinical Toxicology
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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