Humalog Mix50/50
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Questions & Answers
Side Effects & Adverse Reactions
Humalog® Mix50/50™ KwikPens® must never be shared between patients, even if the needle is changed. Patients using Humalog Mix50/50 vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
Humalog differs from Regular human insulin by its rapid onset of action as well as a shorter duration of activity. Therefore, the dose of Humalog Mix50/50 should be given within 15 minutes before a meal.
Hypoglycemia is the most common adverse effect associated with the use of insulins, including Humalog Mix50/50. As with all insulins, the timing of hypoglycemia may differ among various insulin formulations. Glucose monitoring is recommended for all patients with diabetes.
Any change of insulin should be made cautiously and only under medical supervision. Changes in insulin strength, manufacturer, type (e.g., Regular, NPH, analog), species, or method of manufacture may result in the need for a change in dosage.
Fluid retention and heart failure with concomitant use of PPAR-gamma agonists: Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including Humalog Mix50/50, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Humalog Mix50/50, a mixture of 50% insulin lispro protamine suspension and 50% insulin lispro injection, (rDNA origin), is indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. Based on cross-study comparisons of the pharmacodynamics of Humalog Mix50/50 and Humulin 50/50, it is likely that Humalog Mix50/50 has a more rapid onset of glucose-lowering activity compared with Humulin 50/50 while having a similar duration of action. This profile is achieved by combining the rapid onset of Humalog with the intermediate action of insulin lispro protamine suspension.
History
There is currently no drug history available for this drug.
Other Information
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:
Insulin lispro has the empirical formula C257H383N65O77S6 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.
Sources
Humalog Mix50/50 Manufacturers
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Eli Lilly And Company
![Humalog Mix50/50 (Insulin Lispro) Injection, Suspension Humalog Mix50/50 Kwikpen (Insulin Lispro) Injection, Suspension [Eli Lilly And Company]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Humalog Mix50/50 | Eli Lilly And Company
Table 1*: Summary of Pharmacodynamic Properties of Insulin Products (Pooled Cross-Study Comparison)* The information supplied in Table 1 indicates when peak insulin activity can be expected and the percent of the total insulin activity occurring during the first 4 hours. The information was derived from 3 separate glucose clamp studies in nondiabetic subjects. Values represent means, with ranges provided in parentheses.
Insulin Products Dose, U/kg Time of Peak Activity, Hours After Dosing Percent of Total Activity Occurring in the First 4 Hours Humalog 0.3 2.4
(0.8 - 4.3) 70%
(49 - 89%) Humulin R 0.32
(0.26 - 0.37) 4.4
(4.0 - 5.5) 54%
(38 - 65%) Humalog Mix75/25 0.3 2.6
(1.0 - 6.5) 35%
(21 - 56%) Humulin 70/30 0.3 4.4
(1.5 - 16) 32%
(14 - 60%) Humalog Mix50/50 0.3 2.3
(0.8 - 4.8) 45%
(27 - 69%) Humulin 50/50 0.3 3.3
(2.0 - 5.5) 44%
(21 - 60%) NPH 0.32
(0.27 - 0.40) 5.5
(3.5 - 9.5) 14%
(3.0 - 48%) NPL component 0.3 5.8
(1.3 - 18.3) 22%
(6.3 - 40%)Humalog Mix50/50 is intended only for subcutaneous administration. Humalog Mix50/50 should not be administered intravenously. Dosage regimens of Humalog Mix50/50 will vary among patients and should be determined by the healthcare provider familiar with the patient's metabolic needs, eating habits, and other lifestyle variables. Humalog 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. The quicker glucose-lowering effect of Humalog is related to the more rapid absorption rate of insulin lispro from subcutaneous tissue.
Direct comparison between Humalog Mix50/50 and Humulin 50/50 was not performed. However, a cross-study comparison shown in Figure 3 suggests that Humalog Mix50/50 has a duration of activity that is similar to Humulin 50/50.
The rate of insulin absorption and consequently the onset of activity are known to be affected by the site of injection, exercise, and other variables. As with all insulin preparations, the time course of action of Humalog Mix50/50 may vary considerably in different individuals or within the same individual. Patients must be educated to use proper injection techniques.
Humalog Mix50/50 should be inspected visually before use. Humalog Mix50/50 should be used only if it appears uniformly cloudy after mixing. Humalog Mix50/50 should not be used after its expiration date.
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