Revised SPC: Dexamethasone 3.3 mg/ml solution for injection – HAMELN brand
SPC adds detail with respect to propylene glycol content. Each ml contains 20mg, and therefore any use in neonates should only be following careful assessment of risks and benefit. Caution in use is advised in patients <5 years, and in those with reduced hepatic or renal function
Source:
electronic Medicines compendium
SPS commentary:
For use in infants and children younger than 5 years old a safety threshold of 50 mg/kg/day has been set for excipient propylene glycol by the European Medicines Agency (corresponding to an 8.5 mg/kg/day dose of this product). When high doses are required (e.g. for the treatment of life-threatening cerebral oedema– see section 4.2), the corresponding propylene glycol exposure may exceed the 50 mg/kg/day threshold in some patients from this population.
SPC notes that when exceeding these thresholds serious adverse effects may be induced, especially when co-administering with any substrate for alcohol dehydrogenase such as ethanol. The potential for propylene glycol toxicity should therefore be considered as part of any benefit-risk assessment of the use of this brand of dexamethasone.
In terms of use in patients with hepatic or renal impairment, various adverse events attributable to propylene glycol have been reported such as renal dysfunction (acute tubular necrosis), acute renal failure, and liver dysfunction. Medical monitoring in this population is required when this product is administered at doses of 8.5 mg / kg / day (equivalent to 50 mg / kg / day propylene glycol) and above.