Isordil (Isosorbide Dinitrate) is Not Approved or Recommended for Pediatric Use
Isosorbide dinitrate (Isordil) has no established minimum dose for children and should not be used in the pediatric population, as there is no evidence supporting its safety or efficacy in this age group.
Critical Evidence Gap
- The available pediatric emergency medication guidelines from the American Academy of Pediatrics do not include isosorbide dinitrate in their comprehensive drug formulary for children 1
- All published research on isosorbide dinitrate dosing pertains exclusively to adult populations, with studies examining doses ranging from 1.25 mg to 40 mg in adults only 2, 3, 4, 5
- No pediatric pharmacokinetic, safety, or efficacy data exist for this medication in children
Why This Medication is Not Used in Children
- Lack of pediatric indications: Isosorbide dinitrate is primarily used for angina pectoris, chronic heart failure, and hypertensive emergencies in adults—conditions that are exceedingly rare in the pediatric population 2, 4, 5
- No dosing guidelines: Unlike other medications where pediatric dosing can be extrapolated from adult doses using weight-based calculations, no such framework exists for isosorbide dinitrate 6
- Safety concerns: The hemodynamic effects of nitrates (profound vasodilation, hypotension, reflex tachycardia) have not been studied in children and could be particularly dangerous in the pediatric population 4
Clinical Recommendation
- If a child requires nitrate therapy, alternative agents with established pediatric safety profiles should be considered, and consultation with pediatric cardiology or critical care specialists is essential
- Do not attempt to extrapolate adult dosing to children for this medication, as the risk-benefit profile is completely unknown 6