Overview
Fomepizole is used as an antidote in confirmed or suspected methanol or ethylene glycol poisoning. Fomepizole is a competitive inhibitor of alcohol dehydrogenase, the enzyme that catalyzes the initial steps in the metabolism of ethylene glycol and methanol to their toxic metabolites.
Indication
Antizol 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
Associated Conditions
- Ethylene glycol poisoning
- Methanol poisoning
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/03/18 | Early Phase 1 | Completed | |||
2015/04/14 | N/A | Completed | |||
2008/04/18 | Phase 2 | Completed | |||
2006/06/30 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Zydus Pharmaceuticals USA Inc. | 70710-1478 | INTRAVENOUS | 1 g in 1 mL | 2/10/2023 | |
| PALADIN LABORATORIES (USA) INC | 46129-200 | INTRAVENOUS | 1 g in 1 mL | 7/27/2009 | |
| Navinta LLC | 68475-510 | INTRAVENOUS | 1 g in 1 mL | 1/31/2023 | |
| Mylan Institutional LLC | 67457-211 | INTRAVENOUS | 1 g in 1 mL | 8/15/2018 | |
| American Regent, Inc. | 0517-0710 | INTRAVENOUS | 1 g in 1 mL | 2/11/2020 | |
| American Regent, Inc. | 0517-0710 | INTRAVENOUS | 1 g in 1 mL | 12/6/2019 | |
| Gland Pharma Limited | 68083-510 | INTRAVENOUS | 1 g in 1 mL | 7/10/2023 | |
| Sagent Pharmaceuticals | 25021-829 | INTRAVENOUS | 1.5 g in 1.5 mL | 12/19/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ANTIZOL fomepizole 1.5g/1.5mL concentrated injection vial | 263913 | Medicine | A | 12/1/2016 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| FOMEPIZOLE FOR INJECTION | Sterimax Inc | 02435667 | Solution - Intravenous | 1 G / ML | 9/22/2015 |
| ANTIZOL | Endo Operations Ltd. | 02242980 | Liquid - Intravenous | 1 G / ML | 3/30/2001 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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