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.
Drug Name | Dosage Form | Approved Age Requirements * | Maximum Recommended Dosage * |
---|---|---|---|
Insulin aspart |
| Children greater than or equal to 2 years and adolescents | No maximum recommended dosage to exceed; insulin and other antidiabetic drugs should be adjusted to target glycemic goals and meet patients’ needs |
Insulin glulisine |
| Children greater than or equal to 4 years and adolescents | No maximum recommended dosage to exceed; insulin and other antidiabetic drugs should be adjusted to target glycemic goals and meet patients’ needs |
Insulin lispro |
| Children greater than or equal to 3 years and adolescents | No 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
Drug Name | Dosage Form | Approved Age Requirements * | Maximum Recommended Dosage * |
---|---|---|---|
Regular insulin |
| No specific age requirement reported | No 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
Drug Name | Dosage Form | Approved Age Requirements * | Maximum Recommended Dosage * |
---|---|---|---|
Isophane insulin (NPH) |
| No specific age requirement reported | No 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
Drug Name | Dosage Form | Approved Age Requirements * | Maximum Recommended Dosage * |
---|---|---|---|
Insulin degludec |
|
| No maximum recommended dosage to exceed; insulin and other antidiabetic drugs should be adjusted to target glycemic goals and meet patients’ needs |
Insulin detemir |
| Children greater than 2 years and adolescents | No maximum recommended dosage to exceed; insulin and other antidiabetic drugs should be adjusted to target glycemic goals and meet patients’ needs |
Insulin glargine |
| Children greater than 6 years and adolescents | No 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
Drug Name | Dosage Form | Approved Age Requirements * | Maximum Recommended Dosage * |
---|---|---|---|
Isophane insulin (NPH) and regular insulin |
| Children and adolescents | No 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