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Nursing Mothers-- It is unknown whether Humalog is excreted in significant amounts in human milk. Many drugs, including human insulin, are excreted in human milk. For this reason, caution should be exercised when Humalog is administered to a nursing woman. Patients with diabetes who are lactating may require adjustments in Humalog dose, meal plan, or both. Pediatric Use-- Text Continues Below
In a 9-month, cross-over study of pre-pubescent children (n= 60), aged 3 to 11 years, comparable glycemic control as measured by HbA1c was achieved regardless of treatment group: human regular insulin 30 minutes before meals 8.4%, Humalog immediately before meals 8.4%, and Humalog immediately after meals 8.5%. In an 8-month, cross-over study of adolescents (n= 463), aged 9 to 19 years, comparable glycemic control as measured by HbA1c was achieved regardless of treatment group; human regular insulin 30 to 45 minutes before meals 8.7% and Humalog immediately before meals 8.7%. The incidence of hypoglycemia was similar for all three treatment regimens. Adjustment of basal insulin may be required. To improve accuracy in dosing in pediatric patients, a diluent may be used. If the diluent is added directly to the Humalog vial, the shelf-life may be reduced (see DOSAGE AND ADMINISTRATION). Geriatric Use-- Of the total number of subjects (n= 2,834) in eight clinical studies of Humalog, twelve percent (n= 338) were 65 years of agge or over. The majority of these were type 2 patients. HbA1c values and hypoglycemia rates did not differ by age. Pharmacokinetic/ pharmacodynamic studies to assess the effect of age on the onset of Humalog action have not been performed. Page: << Prev | 1 | 2 | 3 | 4 | 5
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