Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Insulin, short-acting

Generic name
Insulin, short-acting
Brand name
ATC Code
A10AB01

Pharmacokinetics in children

Limited data suggest that the PK profile in children is similar to that in adults. However, there were differences in Cmax between the age groups, which emphasises the importance of  individual dose titration. [SmPC Actrapid 09/20]

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Diabetes mellitus, insulin-dependent
  • Subcutaneous
    • < 10 years
      [1] [2] [3] [4] [5]
      • 0.4 - 1 IU/kg/day in 2 - 4 doses. adjust depending on the blood sugar level.

      • There is no fixed insulin dose. The dose should be adjusted for every patient individually.
        Treatment by or after consulting a paediatric specialist (paediatric endocrinologist) who has experience of using insulins

    • ≥ 10 years
      [1] [2] [3] [4] [5]
      • 0.6 - 1.7 IU/kg/day in 2 - 4 doses. adjust depending on the blood sugar level.

      • There is no fixed insulin dose. The dose should be adjusted for every patient individually.
        Treatment by or after consulting a paediatric specialist (paediatric endocrinologist) who has experience of insulin for this indication.

         
Neonatal hyperglycemias
  • Intravenous
    • Preterm neonates Gestational age < 37 weeks
      • 0.013 - 0.025 IU/kg/hour, continuous infusion. adjust the dose depending on the blood sugar level.

      • There is no fixed insulin dose. The dose should be adjusted for every patient individually.
        Treatment by or after consulting a paediatric specialist (neonatologist) who has experience in treatment of neonatal hyperglycemias with insulin.

    • Term neonate
      [6] [10] [11] [12]
      • 0.013 - 0.025 IU/kg/hour, continuous infusion. adjust the dose depending on the blood sugar level.

      • There is no fixed insulin dose. The dose should be adjusted for every patient individually.
        Treatment by or after consulting a paediatric specialist (neonatologist) who has experience in treatment of neonatal hyperglycemias with insulin.
Acute diabetic ketoacidosis
  • Intravenous
    • 1 month up to 18 years
      [1] [2] [3] [4] [5] [7] [8] [9] [13]
      • 0.025 - 0.05 IU/kg/hour, continuous infusion. Adjust the dose depending on the blood sugar level.
        • In children less than 2 years of age, starting at 0.0125 - 0.025 IU/kg/hr may be considered, based on experience.
        • There is no fixed insulin dose. The dose should be adjusted for every patient individually.
        • In case of doubt consult a paediatric specialist (paediatric endocrinologist or pediatric intensivist) who has experience in treatment with insulin for diabetic keto-acidosis.
Neonatal hyperkaleamia
  • Intravenous
    • Gestational age < 28 weeks and < 1500 g
      [14] [15] [16] [17] [18]
      • 0.05 - 0.2 IU/kg/hour, continuous infusion. Adjust dosage based on potassium and glucose levels.
        • There is no fixed dose of insulin. The dose should be adjusted individually for each patient.
        • Administer in combination with glucose 10%, 0.5-1 g/kg/h (corresponding to 5-10 ml/kg/h) 

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Renal impaiment in children > 3 months

The insulin requirement may be decreased in cases of reduced renal function. The dosage is adjusted depending on the blood glucose measurements in this case.

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Based on post-marketing experience and from clinical trials, the frequency, type and severity of observed adverse events in children and adolescents do not indicate a difference from the broader experience in the overall population. [SmPC Actrapid]

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

For intravenous administration, short-acting insulin should be diluted with 0.9% NaCl and administered with an infusion pump. A solution of 0.5-1 IU/ml should preferably be prepared.
The concentration of insulin in a physiological saline infusion is affected by adsorption onto the plastic of the syringe and administration equipment. This adsorption occurs primarily in the first 30-60 minutes after preparation and there are indications that it occurs mainly at concentrations below 0.2 IU/ml.

Watch out for hypoglycaemia. Watch out for incompatibilities with a catheter.
 

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Insulins and analogues for injection, fast-acting
A10AB04
Insulins and analogues for injection, intermediate-acting
A10AC01
Insulins and analogues for injection, intermediate- or long-acting combined with fast-acting
A10AD06
A10AD01
Insulins and analogues for injection, long-acting
A10AE

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References

  1. Danne T, et al, A comparison of postprandial and preprandial administration of insulin aspart in children and adolescents with type 1 diabetes, Diabetes Care, 2003, Aug;26(8), 2359-64
  2. Galli-Tsinopoulou A. , Insulin therapy in children and adolescents with diabetes, Diabetes Res Clin Pract, 2011, Aug;93 Suppl 1, S114-7
  3. Mortensen HB, et al, Rapid appearance and onset of action of insulin aspart in paediatric subjects with type 1 diabetes, Eur J Pediatr, 2000 , Jul;159(7), 483-8
  4. Mortensen HB, et al , Insulin management and metabolic control of type 1 diabetes mellitus in childhood and adolescence in 18 countries. Hvidore Study Group on Childhood Diabetes, Diabet Med, 1998, Sep;15(9), 752-9
  5. Weinzimer SA, et al, A randomized trial comparing continuous subcutaneous insulin infusion of insulin aspart versus insulin lispro in children and adolescents with type 1 diabetes, Diabetes Care, 2008, Feb;31(2), 210-5
  6. Bottino M, et al, Interventions for treatment of neonatal hyperglycemia in very low birth weight infants, Cochrane Database Syst Rev, 2011, (10), CD007453
  7. Puttha, R., et al, Low dose (0.05 units/kg/h) is comparable with standard dose (0.1 units/kg/h) intravenous insulin infusion for the initial treatment of diabetic ketoacidosis in children with type 1 diabetes-an observational study., Pediatr Diabetes, 2010, 11 (1), 12-7
  8. Al Hanshi, S. et al, Insulin infused at 0.05 versus 0.1 units/kg/hr in children admitted to intensive care with diabetic ketoacidosis., Pediatr Crit Care Med, 2011, 12 (2), 137-40
  9. Nallasamy, K., et al, Low-dose vs standard-dose insulin in pediatric diabetic ketoacidosis: a randomized clinical trial., JAMA Pediatr, 2014, 168 (11), 999-1005
  10. Özdemir, H., et al, Persistent hyperglycemia in a neonate: Is it a complication of therapeutic hypothermia?, Turk J Pediatr , 2017, 59 (2), 193-196
  11. Passanisi, S.,et al, Treatment of transient neonatal diabetes mellitus: insulin pump or insulin glargine? Our experience., Diabetes Technol Ther, 2014, 16 (12), 880-4
  12. Heald, A. et al, Insulin infusion for hyperglycaemia in very preterm infants appears safe with no effect on morbidity, mortality and long-term neurodevelopmental outcome, J Matern Fetal Neonatal Med, 2012, 25 (11), 2415-8
  13. Kapellen, T., et al, Treatment of diabetic ketoacidosis (DKA) with 2 different regimens regarding fluid substitution and insulin dosage (0.025 vs. 0.1 units/kg/h), Exp Clin Endocrinol Diabetes , 2012, 120 (5), 273-6
  14. Lui K, et al. , Treatment with hypertonic dextrose and insulin in severe hyperkalaemia of immature infants., Acta Paediatr, 1992, 81(3), 213-6
  15. Hu PS, et al., Glucose and insulin infusion versus kayexalate for the early treatment of non-oliguric hyperkalemia in very-low-birth-weight infants., Acta Paediatr Taiwan, 1999, 40(5):, 314-8
  16. Malone TA., Glucose and insulin versus cation-exchange resin for the treatment of hyperkalemia in very low birth weight infants., J Pediatr. , 1991, 118(1), 121-3
  17. Oschman A, et al., Safety and efficacy of two potassium cocktail formulations for treatment of neonatal hyperkalemia., Ann Pharmacother., 2011, 45(11), 1371-7
  18. Janjua HS, et al., Continuous infusion of a standard combination solution in the management of hyperkalemia. , Nephrol Dial Transplant., 2011, 26(8), 2503-8

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Changes

Changes