Fomepizole

Fomepizole Manufacturers

• Emcure
  

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  Fomepizole | Emcure

  

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  Treatment Guidelines : If ethylene glycol or methanol poisoning is left untreated, the natural progression of the poisoning leads to accumulation of toxic metabolites, including glycolic and oxalic acids (ethylene glycol intoxication) and formic acid (methanol intoxication). These metabolites can induce metabolic acidosis, nausea/vomiting, seizures, stupor, coma, calcium oxaluria, acute tubular necrosis, blindness, and death. The diagnosis of these poisonings may be difficult because ethylene glycol and methanol concentrations diminish in the blood as they are metabolized to their respective metabolites. Hence, both ethylene glycol and methanol concentrations and acid base balance, as determined by serum electrolyte (anion gap) and/or arterial blood gas analysis, should be frequently monitored and used to guide treatment.

  Treatment consists of blocking the formation of toxic metabolites using inhibitors of alcohol dehydrogenase, such as fomepizole, 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 fomepizole : Begin fomepizole 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, OR a documented serum ethylene glycol or methanol concentration greater than 20 mg/dL.

  Hemodialysis : Hemodialysis should be considered in addition to fomepizole in the case of renal failure, significant or worsening metabolic acidosis, or a measured ethylene glycol or methanol concentration of greater than or equal to 50 mg/dL. Patients should be dialyzed to correct metabolic abnormalities and to lower the ethylene glycol concentrations below 50 mg/dL.

  Discontinuation of fomepizole Treatment : Treatment with fomepizole may be discontinued when ethylene glycol or methanol concentrations are undetectable or have been reduced below 20 mg/dL, and the patient is asymptomatic with normal pH.

  Dosing of fomepizole : A loading dose of 15 mg/kg should be administered, followed by doses of 10 mg/kg every 12 hours for 4 doses, then 15 mg/kg every 12 hours thereafter until ethylene glycol or methanol concentrations are undetectable or have been reduced below 20 mg/dL, and the patient is asymptomatic with normal pH. All doses should be administered as a slow intravenous infusion over 30 minutes (see Administration).

  Dosage with Renal Dialysis : Fomepizole Injection is dialyzable and the frequency of dosing should be increased to every 4 hours during hemodialysis.

   

   

  
  Fomepizole Dosing in Patients Requiring Hemodialysis DOSE AT THE BEGINNING OF HEMODIALYSIS
  If <6 hours since last fomepizole dose
  
  If ≥ 6 hours since last fomepizole dose
  
  Do not administer dose
  
  Administer next scheduled dose
  

   

  
  DOSING DURING HEMODIALYSIS
  Dose every 4 hours
  

   

  
  DOSING AT THE TIME HEMODIALYSIS IS COMPLETED
  Time between last dose and the end of
  
  hemodialysis
  
   
  
  <1 hour
  
  Do not administer dose at the end of
  
  hemodialysis
  
  1-3 hours
  
  Administer 1/2 of next scheduled dose
  
  >3 hours
  
  Administer next scheduled dose
  

   

  
  MAINTENANCE DOSING OFF HEMODIALYSIS
  Give next scheduled dose 12 hours from last dose administered
  

  Administration : Fomepizole solidifies at temperatures less than 25°C (77°F). If the fomepizole solution has become solid in the vial, the solution should be liquefied by running the vial under warm water or by holding in the hand. Solidification does not affect the efficacy, safety, or stability of fomepizole. Using sterile technique, the appropriate dose of fomepizole should be drawn from the vial with a syringe and injected into at least 100 mL of sterile 0.9% sodium chloride injection or dextrose 5% injection. Mix well. The entire contents of the resulting solution should be infused over 30 minutes. Fomepizole, like all parenteral products, should be inspected visually for particulate matter prior to administration.

  Stability : Fomepizole diluted in 0.9% sodium chloride injection or dextrose 5% injection remains stable and sterile for at least 24 hours when stored refrigerated or at room temperature. Fomepizole does not contain preservatives. Therefore, maintain sterile conditions, and after dilution do not use beyond 24 hours.

  Solutions showing haziness, particulate matter, precipitate, discoloration, or leakage should not be used.

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• Sandoz Inc.
  

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  Fomepizole | Sandoz Inc.

  

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  Treatment Guidelines : If ethylene glycol or methanol poisoning is left untreated, the natural progression of the poisoning leads to accumulation of toxic metabolites, including glycolic and oxalic acids (ethylene glycol intoxication) and formic acid (methanol intoxication). These metabolites can induce metabolic acidosis, nausea/vomiting, seizures, stupor, coma, calcium oxaluria, acute tubular necrosis, blindness, and death. The diagnosis of these poisonings may be difficult because ethylene glycol and methanol concentrations diminish in the blood as they are metabolized to their respective metabolites. Hence, both ethylene glycol and methanol concentrations and acid base balance, as determined by serum electrolyte (anion gap) and/or arterial blood gas analysis, should be frequently monitored and used to guide treatment.
  
  Treatment consists of blocking the formation of toxic metabolites using inhibitors of alcohol dehydrogenase, such as fomepizole, 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 fomepizole :Begin fomepizole 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, OR a documented serum ethylene glycol or methanol concentration greater than 20 mg/dL.
  
  Hemodialysis :Hemodialysis should be considered in addition to fomepizole in the case of renal failure, significant or worsening metabolic acidosis, or a measured ethylene glycol or methanol concentration of greater than or equal to 50 mg/dL. Patients should be dialyzed to correct metabolic abnormalities and to lower the ethylene glycol concentrations below 50 mg/dL.
  
  Discontinuation of fomepizole Treatment :Treatment with fomepizole may be discontinued when ethylene glycol or methanol concentrations are undetectable or have been reduced below 20 mg/dL, and the patient is asymptomatic with normal pH.
  
  Dosing of fomepizole :A loading dose of 15 mg/kg should be administered, followed by doses of 10 mg/kg every 12 hours for 4 doses, then 15 mg/kg every 12 hours thereafter until ethylene glycol or methanol concentrations are undetectable or have been reduced below 20 mg/dL, and the patient is asymptomatic with normal pH. All doses should be administered as a slow intravenous infusion over 30 minutes (see Administration).
  
  Dosage with Renal Dialysis : Fomepizole Injection is dialyzable and the frequency of dosing should be increased to every 4 hours during hemodialysis.
  
   
  Fomepizole Dosing in Patients Requiring Hemodialysis
   
  DOSE AT THE BEGINNING OF HEMODIALYSIS  If <6 hours since last fomepizole dose  If ≥ 6 hours since last fomepizole dose  Do not administer dose  Administer next scheduled dose
   
   DOSING DURING HEMODIALYSIS  Dose every 4 hours
   
  DOSING AT THE TIME HEMODIALYSIS IS COMPLETED Time between last dose and the end of
  hemodialysis <1 hour Do not administer dose at the end of
  hemodialysis 1-3 hours Administer 1/2 of next scheduled dose >3 hours Administer next scheduled dose
  
  
  
  MAINTENANCE DOSING OFF HEMODIALYSIS  Give next scheduled dose 12 hours from last dose administered
  
  Administration : Fomepizole solidifies at temperatures less than 25°C (77°F). If the fomepizole solution has become solid in the vial, the solution should be liquefied by running the vial under warm water or by holding in the hand. Solidification does not affect the efficacy, safety, or stability of fomepizole. Using sterile technique, the appropriate dose of fomepizole should be drawn from the vial with a syringe and injected into at least 100 mL of sterile 0.9% sodium chloride injection or dextrose 5% injection. Mix well. The entire contents of the resulting solution should be infused over 30 minutes. Fomepizole, like all parenteral products, should be inspected visually for particulate matter prior to administration.

  Stability : Fomepizole diluted in 0.9% sodium chloride injection or dextrose 5% injection remains stable and sterile for at least 24 hours when stored refrigerated or at room temperature. Fomepizole does not contain preservatives. Therefore, maintain sterile conditions, and after dilution do not use beyond 24 hours.

  Solutions showing haziness, particulate matter, precipitate, discoloration, or leakage should not be used.

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• Mylan Institutional Llc
  

  ×

  Fomepizole | Mylan Institutional Llc

  

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  Treatment Guidelines

  If ethylene glycol or methanol poisoning is left untreated, the natural progression of the poisoning leads to accumulation of toxic metabolites, including glycolic and oxalic acids (ethylene glycol intoxication) and formic acid (methanol intoxication). These metabolites can induce metabolic acidosis, nausea/vomiting, seizures, stupor, coma, calcium oxaluria, acute tubular necrosis, blindness, and death. The diagnosis of these poisonings may be difficult because ethylene glycol and methanol concentrations diminish in the blood as they are metabolized to their respective metabolites. Hence, both ethylene glycol and methanol concentrations and acid base balance, as determined by serum electrolyte (anion gap) and/or arterial blood gas analysis, should be frequently monitored and used to guide treatment.

  Treatment consists of blocking the formation of toxic metabolites using inhibitors of alcohol dehydrogenase, such as fomepizole injection, 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 Fomepizole Injection

  Begin fomepizole injection 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, OR a documented serum ethylene glycol or methanol concentration greater than 20 mg/dL.

  Hemodialysis

  Hemodialysis should be considered in addition to fomepizole injection in the case of renal failure, significant or worsening metabolic acidosis, or a measured ethylene glycol or methanol concentration of greater than or equal to 50 mg/dL. Patients should be dialyzed to correct metabolic abnormalities and to lower the ethylene glycol concentrations below 50 mg/dL.

  Discontinuation of Fomepizole Injection Treatment

  Treatment with fomepizole injection may be discontinued when ethylene glycol or methanol concentrations are undetectable or have been reduced below 20 mg/dL, and the patient is asymptomatic with normal pH.

  Dosing of Fomepizole Injection

  A loading dose of 15 mg/kg should be administered, followed by doses of 10 mg/kg every 12 hours for 4 doses, then 15 mg/kg every 12 hours thereafter until ethylene glycol or methanol concentrations are undetectable or have been reduced below 20 mg/dL, and the patient is asymptomatic with normal pH. All doses should be administered as a slow intravenous infusion over 30 minutes (see Administration).

  Dosage with Renal Dialysis

  Fomepizole Injection is dialyzable and the frequency of dosing should be increased to every 4 hours during hemodialysis.

  Fomepizole Injection Dosing in Patients Requiring Hemodialysis DOSE AT THE BEGINNING OF HEMODIALYSIS If < 6 hours since last Fomepizole Injection dose If > 6 hours since last Fomepizole Injection dose Do not administer dose Administer next scheduled dose DOSING DURING HEMODIALYSIS Dose every 4 hours DOSING AT THE TIME HEMODIALYSIS IS COMPLETED Time between last dose and the end of hemodialysis < 1 hour Do not administer dose at the end of hemodialysis 1 to 3 hours Administer 1/2 of the next scheduled dose > 3 hours Administer next scheduled dose MAINTENANCE DOSING OFF HEMODIALYSIS Give next scheduled dose 12 hours from last dose administered Administration

  Fomepizole injection solidifies at temperatures less than 25° C (77° F). If the fomepizole injection solution has become solid in the vial, the solution should be liquefied by running the vial under warm water or by holding in the hand. Solidification does not affect the efficacy, safety, or stability of fomepizole injection. Using sterile technique, the appropriate dose of fomepizole injection should be drawn from the vial with a syringe and injected into at least 100 mL of sterile 0.9% sodium chloride injection or dextrose 5% injection. Mix well. The entire contents of the resulting solution should be infused over 30 minutes. Fomepizole injection, like all parenteral products, should be inspected visually for particulate matter prior to administration.

  Stability

  Fomepizole injection diluted in 0.9% sodium chloride injection or dextrose 5% injection remains stable and sterile for at least 24 hours when stored refrigerated or at room temperature. Fomepizole injection does not contain preservatives. Therefore, maintain sterile conditions, and after dilution do not use beyond 24 hours. Solutions showing haziness, particulate matter, precipitate, discoloration, or leakage should not be used.

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• X-gen Pharmaceuticals, Inc.
  

  ×

  Fomepizole | X-gen Pharmaceuticals, Inc.

  

  ---

  Treatment Guidelines: If ethylene glycol or methanol poisoning is left untreated, the natural progression of the poisoning leads to accumulation of toxic metabolites, including glycolic and oxalic acids (ethylene glycol intoxication) and formic acid (methanol intoxication). These metabolites can induce metabolic acidosis, nausea/vomiting, seizures, stupor, coma, calcium oxaluria, acute tubular necrosis, blindness, and death. The diagnosis of these poisonings may be difficult because ethylene glycol and methanol concentrations diminish in the blood as they are metabolized to their respective metabolites. Hence, both ethylene glycol and methanol concentrations and acid base balance, as determined by serum electrolyte (anion gap) and/or arterial blood gas analysis, should be frequently monitored and used to guide treatment.

  Treatment consists of blocking the formation of toxic metabolites using inhibitors of alcohol dehydrogenase, such as Fomepizole Injection, 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 Fomepizole Injection: Begin Fomepizole Injection 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, OR a documented serum ethylene glycol or methanol concentration greater than 20 mg/dL.

  Hemodialysis: Hemodialysis should be considered in addition to Fomepizole Injection in the case of renal failure, significant or worsening metabolic acidosis, or a measured ethylene glycol or methanol concentration of greater than or equal to 50 mg/dL. Patients should be dialyzed to correct metabolic abnormalities and to lower the ethylene glycol concentrations below 50 mg/dL.

  Discontinuation of Fomepizole Injection Treatment: Treatment with Fomepizole Injection may be discontinued when ethylene glycol or methanol concentrations are undetectable or have been reduced below 20 mg/dL, and the patient is asymptomatic with normal pH.

  Dosing of Fomepizole Injection

  A loading dose of 15 mg/kg should be administered, followed by doses of 10 mg/kg every 12 hours for 4 doses, then 15 mg/kg every 12 hours thereafter until ethylene glycol or methanol concentrations are undetectable or have been reduced below 20 mg/dL, and the patient is asymptomatic with normal pH. All doses should be administered as a slow intravenous infusion over 30 minutes (see Administration).

  Dosage with Renal Dialysis: Fomepizole Injection is dialyzable and the frequency of dosing should be increased to every 4 hours during hemodialysis.

  Fomepizole Injection Dosing in Patients Requiring Hemodialysis   DOSE AT THE BEGINNING OF HEMODIALYSIS   DOSING DURING HEMODIALYSIS  If <6 hours since last Fomepizole Injection dose  If ≥6 hours since last Fomepizole Injection dose  Do not administer dose  Administer next scheduled dose  Dose every 4 hours   DOSING AT THE TIME HEMODIALYSIS IS COMPLETED  Time between last dose and the end of hemodialysis    <1 hour  Do not administer dose at the end of hemodialysis  1–3 hours  Administer 1/2 of next scheduled dose  >3 hours  Administer next scheduled dose   MAINTENANCE DOSING OFF HEMODIALYSIS  Give next scheduled dose 12 hours from last dose administered

  Administration: Fomepizole Injection solidifies at temperatures less than 25° C (77° F). If the Fomepizole Injection solution has become solid in the vial, the solution should be liquefied by running the vial under warm water or by holding in the hand. Solidification does not affect the efficacy, safety, or stability of Fomepizole Injection. Using sterile technique, the appropriate dose of Fomepizole Injection should be drawn from the vial with a syringe and injected into at least 100 mL of sterile 0.9% sodium chloride injection or dextrose 5% injection. Mix well. The entire contents of the resulting solution should be infused over 30 minutes. Fomepizole Injection, like all parenteral products, should be inspected visually for particulate matter prior to administration.

  Stability: Fomepizole diluted in 0.9% sodium chloride injection or dextrose 5% injection remains stable and sterile for at least 24 hours when stored refrigerated or at room temperature. Fomepizole Injection does not contain preservatives. Therefore, maintain sterile conditions, and after dilution do not use beyond 24 hours. Solutions showing haziness, particulate matter, precipitate, discoloration, or leakage should not be used.

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