HUMULIN R � insulin human injection, solution
Eli Lilly and Company
DESCRIPTION
Humulin� R U-100 is a polypeptide hormone structurally identical to human insulin synthesized through rDNA technology in a special non-disease-producing laboratory strain of Escherichia coli bacteria. Humulin R U-100 has the empirical formula C257 H383 N65 O77 S6 and a molecular weight of 5808.
Humulin R U-100 is a sterile, clear, aqueous, and colorless solution that contains human insulin (rDNA origin) 100 units/mL, glycerin 16 mg/mL and metacresol 2.5 mg/mL, endogenous zinc (approximately 0.015 mg/100 units) and water for injection. The pH is 7.0 to 7.8. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust the pH.
Adequate insulin dosage permits patients with diabetes to effectively utilize carbohydrates, proteins and fats. Regardless of dose strength, insulin enables carbohydrate metabolism to occur and thus to prevent the production of ketone bodies by the liver. Some patients develop severe insulin resistance such that daily doses of several hundred units of insulin or more are required.
CLINICAL PHARMACOLOGY
Regulation of glucose metabolism is the primary activity of insulin. Insulin lowers blood glucose by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis, proteolysis, and gluconeogenesis, and enhance protein synthesis and conversion of excess glucose into fat.
Administered insulin, including Humulin R U-100, substitutes for inadequate endogenous insulin secretion and partially corrects the disordered metabolism and inappropriate hyperglycemia of diabetes mellitus, which are caused by either a deficiency or a reduction in the biologic effectiveness of insulin. When administered in appropriate doses at prescribed intervals to patients with diabetes mellitus, Humulin R U-100 restores their ability to metabolize carbohydrates, proteins and fats.
As with all insulin preparations, the duration of action of Humulin R U-100 is dependent on dose, site of injection, blood supply, temperature, and physical activity.
Humulin R U-100 is human insulin with a short duration of action. With subcutaneous use, the pharmacologic effect of Humulin R U-100 begins approximately 30 minutes (range: 10 to 75 minutes) after administration of doses in the 0.05 to 0.4 units/kg range. The effect is maximal at approximately 3 hours (range: 20 minutes to 7 hours) and terminates after approximately 8 hours (range: 3 to 14 hours). With intravenous use, the pharmacologic effect of Humulin R U-100 begins at approximately 10 to 15 minutes and terminates at a median time of approximately 4 hours (range: 2 to 6 hours) after administration of doses in the range of 0.1 to 0.2 units/kg. The time course of action of any insulin may vary considerably in different individuals or at different times in the same individual.