Insulin Lispro (insulin lispro, rDNA origin) is a human insulin analogue that is a rapid-acting, parenteral blood glucose-lowering agent. Chemically, it is Lys(B28), Pro(B29) human insulin analogue, created when the amino acids at positions 28 and 29 on the insulin B -chain are reversed. Insulin Lispro is synthesized in a special non-pathogenic laboratory strain of Escherichia coli bacteria that has been genetically altered by the addition of the gene for insulin lispro. The blood glucose lowering effect of insulin lispro is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.

Insulin Lispro is an insulin analogue that is indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. Insulin Lispro has a more rapid onset and a shorter duration of action than human regular insulin. Therefore, in patients with type 1 diabetes, Insulin Lispro should be used in regimens that include a longer-acting insulin. However, in patients with type 2 diabetes, Insulin Lispro may be used without a longer-acting insulin when used in combination therapy with sulfonylurea agents.

Adult: SC Dosing regimen should be individualised and adjusted based on patient's glycaemic response. Usual range is 0.5-1 unit/kg/day.

Type 1 diabetes mellitus: Approximately one third of the total daily insulin requirements SC; rapid-acting or short-acting, premeal insulin should be used to satisfy the remainder of the daily insulin requirements

Usual daily maintenance range: 0.5-1 unit/kg/day in divided doses; nonobese may require 0.4-0.6 unit/kg/day; obese may require 0.8-1.2 units/kg/day

Type 2 diabetes mellitus: If inadequately controlled with oral medication: 10 units/day SC (or 0.1 -0.2 unit/kg/day) of intermediate- or long-acting insulin given at bedtime generally recommended; as an alternative, rapid-acting formulations, such as insulin lispro, given before meals have also been used; dose must be adjusted carefully.

Insulin Lispro is contraindicated by patients hypersensitivity to insulin lispro or the other excipients.

Clinical studies comparing Insulin Lispro with Regular human insulin did not demonstrate a difference in frequency of adverse events between the two treatments. Adverse events commonly associated with human insulin therapy include the following: Body as a Whole: allergic reactions. Skin and Appendages: injection site reaction, lipodystrophy, pruritus, rash. Other: hypoglycemia.

Overdose Effects

Excess insulin administration may cause hypoglycemia and hypokalemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns, or exercise may be needed. More severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. Hypokalemia must be corrected appropriately.

Renal or hepatic impairment; pregnancy, lactation; transferring from other insulin. Monitor serum glucose, potassium, electrolytes, HbA1c and lipid profile. Concomitant illness esp infections.

Use in Special Populations

Pediatric Use: Insulin Lispro is approved for use in children for subcutaneous daily injections. Only the U-100 formulation of Insulin Lispro is approved for use in children by continuous subcutaneous infusion in insulin pumps. Insulin Lispro has not been studied in pediatric patients younger than 3 years of age. Insulin Lispro has not been studied in pediatric patients with type 2 diabetes. As in adults, the dosage of Insulin Lispro must be individualized in pediatric patients based on metabolic needs and results of frequent monitoring of blood glucose.

Geriatric Use: Of the total number of subjects (n=2834) in eight clinical studies of Insulin Lispro, twelve percent (n=338) were 65 years of age or over. The majority of these had type 2 diabetes. HbA1c values and hypoglycemia rates did not differ by age. Pharmacokinetic/pharmacodynamic studies to assess the effect of age on the onset of Insulin Lispro action have not been performed.

Renal Impairment: Patients with renal impairment may be at increased risk of hypoglycemia and may require more frequent Insulin Lispro dose adjustment and more frequent blood glucose monitoring.

Hepatic Impairment: Patients with hepatic impairment may be at increased risk of hypoglycemia and may require more frequent Insulin Lispro dose adjustment and more frequent blood glucose monitoring

Pregnancy & Lactation

Pregnancy Category B. All pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. This background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. It is essential for patients with diabetes or history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. In patients with diabetes or gestational diabetes insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery. Careful monitoring of glucose control is essential in these patients. Therefore, female patients should be advised to tell their physicians if they intend to become, or if they become pregnant while taking Insulin Lispro.

Nursing Mothers: It is unknown whether insulin lispro is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when insulin lispro is administered to a nursing woman. Use of insulin lispro is compatible with breastfeeding, but women with diabetes who are lactating may require adjustments of their insulin doses.