Paladin Laboratories (usa) Inc

Paladin Laboratories (usa) Inc Drugs

• Antizol
  

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  Antizol

  

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

  Hemodialysis: Hemodialysis should be considered in addition to Antizol® 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 Antizol® Treatment: Treatment with Antizol® 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 Antizol®: 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: Antizol® (fomepizole) Injection is dialyzable and the frequency of dosing should be increased to every 4 hours during hemodialysis

  Antizol® Dosing in Patients Requiring Hemodialysis DOSE AT THE BEGINNING OF HEMODIALYSIS If <6 hours since last Antizol® dose If ≥ 6 hours since last Antizol® 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: Antizol® solidifies at temperatures less than 25° C (77° F). If the Antizol® 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 Antizol®. Using sterile technique, the appropriate dose of Antizol® 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. Antizol®, like all parenteral products, should be inspected visually for particulate matter prior to administration.

  Stability: Antizol® 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. Antizol® 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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• Antizol-vet
  

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  Antizol-vet

  

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  Directions for Dilution

  Antizol-Vet® is supplied as a sterile concentrate. If the Antizol-Vet® solution has solidified in the vial, the solution should be liquefied by running the vial under warm water or holding it in the hand. Solidification does not affect the efficacy, safely, or stability of Antizol-Vet®. The intravenous dose should be prepared aseptically by withdrawing the entire contents of the Antizol-Vet® (fomepizole) for injection vial into a syringe containing 28.5 mL of sterile 0.9% sodium chloride. Shake the solution very well to mix. Inspect visually for particulate matter prior to administration. Store the diluted solution at room temperature. DISCARD ANY UNUSED SOLUTION 72 HOURS FOLLOWING DILUTION.

  Directions for Dosing

  Following dilution, Antizol-Vet® should be administered intravenously over five to ten minutes. An initial loading dose of 20 mg/kg should be administered intravenously (IV) as soon as practical upon suspicion of ethylene glycol poisoning (use Table 1 below to determine the number of mL to inject). At 12, 24, and 36 hours following the initial loading dose of Antizol-Vet®, doses of 15, 15, and 5 mg/kg, respectively, should be administered. If the animal has not recovered following this regimen and there is a suspicion or documentation of remaining ethylene glycol in the bloodstream of the affected animal, the practitioner should continue to dose the animal with 5 mg/kg every 12 hours until ethylene glycol is undetectable in the bloostream or the animal has visibly recovered.

  TABLE 1 Volume of diluted (50 mg/kg) Antizol-Vet® needed to dose a dog of the following body weights at the indicated dose Animal body weight (kg) Inject IV at: Initial loading dose 12 and 24 hours after initial dose 36 hours after initial dose 1 Kg = 2.2 Lbs. Milliliters of diluted Antizol-Vet® needed for a dose of 20 mg/kg Milliliters of diluted Antizol-Vet® needed for a dose of 15 mg/kg Milliliters of diluted Antizol-Vet® needed for a dose of 5 g/kg 5 2.0 mL 1.5 mL 0.5 mL 10 4.0 mL 3.0 mL 1.0 mL 15 6.0 mL 4.5 mL 1.5 mL 20 8.0 mL 6.0 mL 2.0 mL 25 10.0 mL 7.5 mL 2.5 mL 30 12.0 mL 9.0 mL 3.0 mL 35 14.0 mL 10.5 mL 3.5 mL 40 16.0mL 12.0 mL 4.0 mL 45 18.0 mL 13.5 mL 4.5 mL 50 20.0 mL 15.0 mL 5.0 mL 55 22.0 mL 16.5 mL 5.5 mL 60 24.0 mL 18.0mL 6.0 mL 65 26.0 mL 19.5 mL 6.5 mL 70 28.0 mL 21.0 mL 7.0 mL Example calculation: Use the 50 mg/mL solution of diluted Antizol-Vet ® for the 20 mg/kg dose. The number of milliliters of the reconstituted Antizol-Vet ® needed for an animal weighting 7.6 kg =  20 mg/kg (dose required) x 7.6 kg (body weight in kg)

  —————————————————————-———    =    3.04 mL

  50 mg/mL (Antizol-Vet® concentration)

  Additional Therapy

  Supportive care to correct fluid, acid-base, and electrolyte imbalances may also be necessary. If ingestion of antifreeze is witnessed, vomiting should be induced. Gastric lavage with activated charcoal is indicated within 1 to 2 hours of ingestion; beyond this time, the procedure is of little benefit.

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