HUMALOG MIX50/50 � insulin lispro injection, suspension
HUMALOG MIX50/50 KWIKPEN � insulin lispro injection, suspension
Eli Lilly and Company
DESCRIPTION
Humalog� Mix50/50� [50% insulin lispro protamine suspension and 50% insulin lispro injection, (rDNA origin)] is a mixture of insulin lispro solution, a rapid-acting blood glucose-lowering agent and insulin lispro protamine suspension, an intermediate-acting blood glucose-lowering agent. Chemically, insulin lispro is Lys(B28), Pro(B29) human insulin analog, 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 to produce insulin lispro. Insulin lispro protamine suspension (NPL component) is a suspension of crystals produced from combining insulin lispro and protamine sulfate under appropriate conditions for crystal formation.
Insulin lispro has the following primary structure:
primary structure
(click image for full-size original)
Insulin lispro has the empirical formula C257 H383 N65 O77 S6 and a molecular weight of 5808, both identical to that of human insulin.
Humalog Mix50/50 vials and Pens contain a sterile suspension of insulin lispro protamine suspension mixed with soluble insulin lispro for use as an injection.
Each milliliter of Humalog Mix50/50 injection contains insulin lispro 100 units, 0.19 mg protamine sulfate, 16 mg glycerin, 3.78 mg dibasic sodium phosphate, 2.20 mg Metacresol, zinc oxide content adjusted to provide 0.0305 mg zinc ion, 0.89 mg phenol, and Water for Injection. Humalog Mix50/50 has a pH of 7.0 to 7.8. Hydrochloric acid 10% and/or sodium hydroxide 10% may have been added to adjust pH.
CLINICAL PHARMACOLOGY
Antidiabetic Activity
The primary activity of insulin, including Humalog Mix50/50, is the regulation of glucose metabolism. In addition, all insulins have several anabolic and anti-catabolic actions on many tissues in the body. In muscle and other tissues (except the brain), insulin causes rapid transport of glucose and amino acids intracellularly, promotes anabolism, and inhibits protein catabolism. In the liver, insulin promotes the uptake and storage of glucose in the form of glycogen, inhibits gluconeogenesis, and promotes the conversion of excess glucose into fat.
Insulin lispro, the rapid-acting component of Humalog Mix50/50, has been shown to be equipotent to Regular human insulin on a molar basis. One unit of Humalog� has the same glucose-lowering effect as one unit of Regular human insulin, but its effect is more rapid and of shorter duration.
