the first 20 h. Osmotic diuresis was observed which led to moderately severe dehydration. with normal renal function was effective and safe. Jobard, et al. and haemodialysis in ethylene glycol poisoning.” Clinical Toxicology, 34(4), 373-377 (1996). Reported as S12 in the dossier Both patients intubated, ventilation; 30 yr old man given IV loading dose of 10 mg/kg 4MP, then haemodialysis started; between 4-6hr of dialysis, infusion of 2.5 mg/kg/h of 4MP given to compensate for loss of 4MP in dialysate. The 50yr old man given 4MP loading dose of 20mg/kg, one hr later haemodialysis started and maintenance dose of 4MP 1.5mg/kg/h infused during haemodialysis. The 30 yr old man recovered from coma in 48 h, anuria and haemodialysis given for 8 days; hospital stay of 14 days and complete recovery observed. The 50yr old man had flat EEG and QRS complexes with severe acidosis, anuria on admission, despite symptomatic treatment- he had haemodynamic instability and died 48hr after admission due to multiorgan failure and disseminated intravascular coagulation. Data from these 2 patients suggested that in cases of severe EG poisoning with toxic plasma EG levels and renal failure, a 4MP loading dose of followed by continuous infusion of 1 to 1.5mg/kg/h during the hrs of may be effective. Secondary pharmacodynamic effects Not evaluated. Time course of pharmacodynamic effects In the study reported by McMartin, 2012 (in healthy subjects, the time above the presumed minimum effective concentration of 10µmol/L ranged from 24 to 36 h (mean = 32.4 h; SD: 5.8), for both oral and IV routes of administration (Figure 1). Methylpyrazole
38(7), (2000) minutes her pH dropped to 7.03. the patient’s clinical status, haemodialysis was initiated but discontinued temporarily due to catheter thrombus formation. The initial (3-hour post-admission) EG was 13 mg/dL. EG was 5 mg/dL 3 hours after haemodialysis this then was discontinued. No further fomepizole was administered as headache, nausea, and dizziness was not reported. Overall, fomepizole appeared safe in this patient although she developed transient nystagmus. 3 Boyer, 2001. ‘Severe EG ingestion treated without Pediatrics 2001;107;172 13-year-old female ingested approx. 4 fluid ounces of antifreeze BUN=11.0 mg/dL, creatinine 0.8 mg/dL, and glucose 105 mg/dL. Anion gap was 14 mg/dL. An arterial blood gas showed pH 7.38, osmolar gap of 53 mosM/L. The measured serum EG was 103 mg/dL. Ethanol was given at primary hospital; Six hrs after EG ingestion she received fomepizole 15 mg/kg IV loading dose. Arterial pH remained above 7.35. fomepizole, 10 mg/kg, was given every 12 hrs for total of 5 doses. Serum EG was after 23 mg/mL after 24hrs after ingestion, 13mg/ml by 36 hrs. Discharged 3 days with no sequelae. At discharge on the third hospital day, she had BUN= 10 mg/ml & serum creatinine = 0.6 mg/mL Authors suggest that use of fomepizole averted IV ethanol infusion & limited the duration of intensive care monitoring & decreased overall cost of treatment. However, important to note that patient had normal renal function at admission. 4 Detaille, 2004. ‘Fomepizole alone for severe infant EG poisoning.’ Pediatr Crit 5-month old boy ingested 200ml of antifreeze solution. Presented with metabolic acidosis- Antidotal therapy with a total of seven doses of fomepizole given IV with an The infant made a complete recovery with no change in renal function. Although not yet approved for this indication in the child, fomepizole