"The US Food and Drug Administration (FDA) gave final approval yesterday to a copycat version of insulin glargine injection (Basaglar, Eli Lilly and Company) for diabetes that is called a follow-on product by the agency and is a biosimilar "...
Mechanism Of Action
HUMULIN N lowers blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis and proteolysis, and enhance protein synthesis.
HUMULIN N is an intermediate-acting insulin with a slower onset of action and a longer duration of activity than that of regular human insulin. In a study in which healthy subjects (n=16) received subcutaneous injections of HUMULIN N (0.4 unit/kg) on 4 occasions, the median maximum effect occurred at 6.5 hours (range: 2.8 to 13 hours). In this study, insulin activity was measured by the rate of glucose infusions.
The time course of action of insulin, such as HUMULIN N may vary in different individuals or within the same individual. The parameters of HUMULIN N activity (time of onset, peak time, and duration) as designated in Figure 1 should be considered only as general guidelines. The rate of insulin absorption and consequently the onset of activity is known to be affected by the site of injection, physical activity level, and other variables [see WARNINGS AND PRECAUTIONS].
Figure 1: Mean Insulin
Activity Versus Time Profile After Subcutaneous Injection of HUMULIN N (0.4
unit/kg) in Healthy Subjects.
In healthy subjects given subcutaneous doses of HUMULIN N (0.4 unit/kg), median peak serum concentration of insulin occurred at approximately 4 hours (range: 1 to 12 hours) after dosing.
The uptake and degradation of insulin occurs predominantly in liver, kidney, muscle, and adipocytes, with the liver being the major organ involved in the clearance of insulin.
Because of the absorption-rate limited kinetics of insulin mixtures, a true half-life cannot be accurately estimated from the terminal slope of the concentration versus time curve. In healthy subjects given subcutaneous doses of HUMULIN N (0.4 unit/kg), the mean apparent half-life was approximately 4.4 hours (range: 1-84 hours).
The effects of age, gender, race, obesity, pregnancy, or smoking on the pharmacokinetics of HUMULIN N have not been studied. Careful glucose monitoring and dose adjustments of insulin, including HUMULIN N, may be necessary in patients with renal or hepatic dysfunction [see Use In Specific Populations].
Last reviewed on RxList: 1/27/2014
This monograph has been modified to include the generic and brand name in many instances.
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