FOMEPIZOLE WAYMADE

Posology The treatment should begin whenever ethylene glycol poisoning is suspected, as early as possible after its ingestion, even in the absence of signs of toxicity. In the absence of ethylene glycol assay, ethylene glycol poisoning should be suspected on the following criteria: - patient's history; - osmolar gap > 20 mOsm/kg H20; - metabolic acidosis with anion gap > 16 mmol/l (presence of high levels of glycolates); - calcium oxalate crystals in the urine.

An assay for plasma ethylene glycol should be performed at admission, but this determination should not delay start of treatment with fomepizole. Plasma ethylene glycol levels should be monitored every 12 to 24 hours. 2 mmol/l). 5 to 15 5 to 15 The number of maintenance doses and the dose after 48 hours will depend on initial concentration and the time course of the ethylene glycol levels.

6 to 24 mmol/l). -patients with severe impaired renal function as assessed by serum creatinine (> 265 mmol/l) Hemodialysis is indicated in combination with fomepizole. A loading dose of 15 mg/kg is infused over 30 to 45 minutes, followed by 1 mg/kg/hour continuous infusion for the entire duration of the hemodialysis.

The dosage of fomepizole during continuous venovenous hemodiafiltration, another mode of extracorporal elimination, is not known. Hemodialysis and fomepizole administration should be discontinued when the metabolic acidosis is corrected and plasma ethylene glycol levels have been reduced below 0.

2 mmol/l). 30 despite bicarbonate therapy; - decrease in serum bicarbonate concentration of more than 5 mmol/l despite bicarbonate therapy; - rise in serum creatinine by > 90 mmol/l (1 mg/dl).

Elderly patients:

Clinical experience in elderly patients is limited. The regimen has to be adjusted to the renal function (see above).

Children:

There is no available data regarding the pharmacokinetics of fomepizole in children. Clinical experience is limited and based on similar weight-adjusted doses.

Patients with impaired liver function:

No clinical data are available. 6). The diluted solution should be administered by slow intravenous infusion.

Adverse reactions are ranked under the heading of frequency, the most frequent first, using the following convention: Very Common (>1/10), Common (>1/100, <1/10), Uncommon (>1/1000, <1/100), Rare (>1/10,000, <1/1,000), Very Rare (<1/10,000), not known (cannot be estimated from the available data).

System Organ Class Frequency:

Adverse drug reactions Blood and lymphatic system disorders: Common: Eosinophilia, anaemia Psychiatric disorders: Common: Anxiety, agitation Very common: Dizziness, headacheNervous system disorders: Common Vertigo, convulsion, nystagmus, speech disorder Eye disorders: Common: Visual impairment Cardiac disorders: Common: Bradycardia, tachycardia Vascular disorders: Common: Increased blood pressure Gastrointestinal disorders: Common: Nausea, vomiting, diarrhoea, dyspepsia, hiccups Hepatobiliary disorders: Common: Increased transaminases Skin and subcutaneous tissue disorders: Common: Pruritus, rash Musculoskeletal and connective tissue disorders: Common: Increased blood creatine phosphokinase General disorders and administration site conditions: Common: Injection site reaction, injection site inflammation Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Previous treatment of ethylene glycol poisoning with ethanol does not preclude the use of fomepizole. Nevertheless, the combination of ethanol and fomepizole is usually not recommended. ) Minor hypersensitivity reactions have been reported in a few patients (rash, hypereosinophilia).

These symptoms should be monitored. Management should be modified in case of a major hypersensitivity reaction (angioedema, bronchospasms, anaphylactic shock). In these cases, the fomepizole infusion should be immediately discontinued in the absence of another established cause; symptomatic treatment should start and fomepizole should not be re- administered to the patient.

Treatment by ethanol should be started and hemodialysis considered Ethylene glycol poisoning in its severe forms is expressed by metabolic acidosis (anion gap > 16 mmol/l), convulsive coma and renal failure. Treatment of ethylene glycol intoxication involves prevention of the metabolism of ethylene glycol to its toxic metabolites, correction of metabolic acidosis, sufficient hydration (oral or venous if applicable) to prevent the risks of dehydration and hypernatremia and to increase urine clearance of ethylene glycol, and if necessary, removal of toxic metabolites with hemodialysis.

Monitoring requires frequent measurements of plasma ethylene glycol, blood gas, pH, electrolytes, serum creatinine, urine analysis and presence of urinary oxalate crystals. Evaluation of hepatic transaminases and blood cell counts before and one month after treatment is recommended.

Pre-existing impaired liver function requires careful monitoring of hepatic transaminases. Fomepizole concentrate for solution for infusion, should not be given undiluted. The diluted concentrate should not be given by bolus injection.

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