1.3. Pediatrics

Safety and efficacy for inhaled insulin (Afrezza), insulin lispro/lispro protamine combinations (HumaLog Mix 50/50 and 75/25), insulin aspart/insulin aspart protamine combinations (NovoLog Mix 70/30), and insulin-GLP-1 combinations (Soliqua 100/33 and Xultophy 100/3.6) have not been studied or established in pediatric patients. 10-13, 14, 19, 32, 35, 36-38

The insulin aspart formulation sold under the trade name Fiasp was approved for pediatric use in patients 2 years of age or older in 2020.39

Recommended age requirements for insulin products approved in pediatric patients are summarized in the following tables.

Usual dosage regimens and maximum recommended dosages are similar to adult patients.

Table 8. Pediatric Insulin Recommended Dosages for Single Insulin Products: Rapid-Acting11-17
Drug NameDosage FormApproved Age Requirements *Maximum Recommended Dosage *
Insulin aspart
  • Fiasp® vial (100 units/mL – 10 mL)
  • Fiasp® FlexTouch (100 units/mL – 5 x 3 mL)
  • Fiasp® PenFill® cartridges (100 units/mL – 5 x 3 mL) for FlexTouch® device
  • NovoLog® vial (100 units/mL – 10 mL)
  • NovoLog® FlexPen® (100 units/mL – 5 x 3 mL)
  • NovoLog® PenFill® cartridges (100 units/mL – 5 x 3 mL) for NovoPen Echo® device
Children greater than or equal to 2 years and adolescentsNo maximum recommended dosage to exceed; insulin and other antidiabetic drugs should be adjusted to target glycemic goals and meet patients’ needs
Insulin glulisine
  • Apidra® vial (100 units/mL – 10 mL)
  • Apidra® SoloStar® pen (100 units/mL – 5 x 3 mL)
Children greater than or equal to 4 years and adolescentsNo maximum recommended dosage to exceed; insulin and other antidiabetic drugs should be adjusted to target glycemic goals and meet patients’ needs
Insulin lispro
  • Admelog® vial (100 units/mL – 3 or 10 mL)
  • Admelog® SoloStar® pen (100 units/mL – 3 mL)
  • HumaLog® cartridges (100 units/mL – 5 x 3 mL) for 
  • HumaLog® vial (100 units/mL – 3 mL)
  • HumaLog® KwikPen® (100 units/mL – 3 mL; 200 units/mL – 3 mL)
  • Humalog Tempo (100 units/mL – 5 x 3 mL)
Children greater than or equal to 3 years and adolescentsNo maximum recommended dosage to exceed; insulin and other antidiabetic drugs should be adjusted to target glycemic goals and meet patients’ needs

Legend:

  • No maximum recommended dosage to exceed; insulin and other antidiabetic drugs should be adjusted to target glycemic goals and meet patients’ needs
Table 9. Pediatric Insulin Recommended Dosages for Single Insulin Products: Short-Acting11,12,20-22
Drug NameDosage FormApproved Age Requirements *Maximum Recommended Dosage *
Regular insulin
  • Humulin® R vial (100 units/mL – 10 mL; 500 unit/mL – 20 mL)
  • Humulin® R KwikPen® (500 units/mL – 2 x 3 mL)
  • Novolin® R vial (100 units/mL – 10 units)
  • Novolin® R FlexPen® (100 units/mL – 5 x 3 mL
No specific age requirement reportedNo maximum recommended dosage to exceed; insulin and other antidiabetic drugs should be adjusted to target glycemic goals and meet patients’ needs

Legend:

  • No maximum recommended dosage to exceed; insulin and other antidiabetic drugs should be adjusted to target glycemic goals and meet patients’ needs
Table 10. Pediatric Insulin Recommended Dosages for Single Insulin Products: Intermediate-Acting11,12,23,24
Drug NameDosage FormApproved Age Requirements *Maximum Recommended Dosage *
Isophane insulin (NPH)
  • Humulin N vial (100 units/mL – 3 or 10 mL)
  • Humulin N KwikPen (100 units/mL – 5 x 3 mL)
  • Novolin N vial (100 units/mL – 10 mL)
  • Novolin N FlexPen (100 units/mL – 5 x 3 mL)
  • Novolin N KwikPen (100 units/mL – 5 x 3 mL)
No specific age requirement reportedNo maximum recommended dosage to exceed; insulin and other antidiabetic drugs should be adjusted to target glycemic goals and meet patients’ needs

Legend:

  • No maximum recommended dosage to exceed; insulin and other antidiabetic drugs should be adjusted to target glycemic goals and meet patients’ needs
Table 11. Pediatric Insulin Recommended Dosages for Single Insulin Products: Long-Acting11,12,25-31
Drug NameDosage FormApproved Age Requirements *Maximum Recommended Dosage *
Insulin degludec
  • Tresiba generic vial (100 units/mL – 10 mL)
  • Tresiba generic® FlexTouch® pen (100 units/mL – 5 x 3 mL; 200 units/mL – 3 x 3 mL)
  • Children greater than 1 year and adolescents
  • Not recommended if require less than 5 units
No maximum recommended dosage to exceed; insulin and other antidiabetic drugs should be adjusted to target glycemic goals and meet patients’ needs
Insulin detemir
  • Levemir® vial (100 units/mL – 10 mL)
  • Levemir® FlexTouch® pen (100 units/mL – 5 x 3 mL)
Children greater than 2 years and adolescentsNo maximum recommended dosage to exceed; insulin and other antidiabetic drugs should be adjusted to target glycemic goals and meet patients’ needs
Insulin glargine
  • Basaglar KwikPen (100 units/mL)
  • Basaglar Tempo Pen (100 units/ mL – 5 x 3 mL)
  • Lantus, generic vial (100 units – 10 mL)
  • Lantus SoloStar pen (100 units/mL – 5 x 3 mL)
  • Rezvoglar KwikPen (100 units/mL – 5 x 3 mL)
  • Semglee vial (100 units/mL – 10 mL)
  • Semglee 100 units/mL pen (100 units/mL – 5 x 3 mL)
  • Toujeo SoloStar® pen (300 units/mL – 3 x 1.5 mL)
  • Toujeo Max SoloStar® pen (300 units/mL – 2 x 3 mL)
Children greater than 6 years and adolescentsNo maximum recommended dosage to exceed; insulin and other antidiabetic drugs should be adjusted to target glycemic goals and meet patients’ needs

Legend:

  • No maximum recommended dosage to exceed; insulin and other antidiabetic drugs should be adjusted to target glycemic goals and meet patients’ needs
Table 12. Pediatric Insulin Age Requirements for Insulin Combination Products11,12,34
Drug NameDosage FormApproved Age Requirements *Maximum Recommended Dosage *
Isophane insulin (NPH) and regular insulin
  • Novolin® 70/30 vial (100 units/mL – 10 mL)
  • Novolin® 70/30 FlexPen (100 units/mL – 5 x 3 mL)
Children and adolescentsNo maximum recommended dosage to exceed; insulin and other antidiabetic drugs should be adjusted to target glycemic goals and meet patients’ needs

Legend:

  • No maximum recommended dosage to exceed; insulin and other antidiabetic drugs should be adjusted to target glycemic goals and meet patients’ needs