Background Congenital hyperinsulinism (HIC) constitutes the more frequent cause of recidivate hypoglycaemia in neonates and lactates. Dose administration of 15 mg/kg/day is the cornerstone of HIC medical treatment.
Purpose To evaluate tolerance, effectiveness and security in a masterly formula of diazoxide 5 mg/mL with sorbitol in a patient with suspicion of congenital HIC.
Material and methods Diazoxide is an active principle with very poor water solubility, which must be mixed with ethanol and glycerol in order that it can be administered as a masterly formula. There are various formulations for the neonatal patient with congenital HIC of diazoxide suspension 5 mg/mL with sorbitol in different concentrations. Because a limit on the concentration for sorbitol does not exist, a bibliographic search on Medline was performed, combining the terms ‘excipients’ and ‘infants’. It was found that the level of sorbitol concentration to which neonates were exposed fluctuated between 0.1 and 2 g/kg/week; the upper limit is where the appearance of gastrointestinal disorders begins.
4 weekly solutions were produced with 0.5, 1, 1.5 and 2 g/kg of sorbitol. Prospective monitoring of the patient was carred out for 9 months to evaluate tolerance and effectiveness of the formula using glycaemia analytics.
Results The newborn presents with hypoglycaemia, the patient begins vomiting and has glucoscaemia of 56 mg/dL. Metabolic study shows a high glucose/insulin ratio.
With a concentration of 0.5 g/kg of sorbitol the patient presented nausea and controlled glycaemia (85.105). Weight 3.6 kg.
With a solution of 1 g/kg of sorbitol the patient did not present any nausea, with some glycaemia controls >90 mg/dL. Weight 3.6 kg.
With a solution of 1.5 g/kg of sorbitol, the patient did not present any nausea. Glycaemia controls was >90 mg/dl. Weight 4.4 kg.
With a solution of 2 g/kg of sorbitol, the patient did not present any nausea. Glycaemia was maintained controlled, in every situation, >90 mg/dl. Weight 5.2 kg.
Conclusion Thanks to sorbitol, tolerance was improved without any episodes of nausea and vomiting.
Masterly formula of diazoxide in oral suspension helped to resolve HIC in the neonate in a safe and effective way.
References and/or Acknowledgements We thank Torrecardenas Hospital
No conflict of interest.
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