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Humalog 50-50

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Humalog Mix 50-50

Indications
Dosage
How Supplied

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

Table 1*: Summary of Pharmacodynamic Properties of Insulin Products (Pooled Cross-Study Comparison)

Insulin Products Dose, U/kg Time of Peak Activity, Hours After Dosing Percent of Total Activity Occurring inthe 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%)
* 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.

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.

HOW SUPPLIED

Humalog Mix50/50 [50% insulin lispro protamine suspension and 50% insulin lispro injection, (rDNA origin)] is available in the following package sizes: each presentation containing 100 units insulin lispro per mL (U-100).

10 mL vials NDC 0002-7512-01 (VL-7512)
5 x 3 mL prefilled insulin delivery devices (Pen) NDC 0002-8793-59 (HP-8793)
5 x 3 mL prefilled insulin delivery devices (KwikPen™) NDC 0002-8798-59 (HP-8798)

Storage

Humalog Mix50/50 should be stored in a refrigerator [2° to 8°C (36° to 46°F)], but not in the freezer. Do not use Humalog Mix50/50 if it has been frozen. Unrefrigerated [below 30°C (86°F)] vials must be used within 28 days or be discarded, even if they still contain Humalog Mix50/50. Unrefrigerated [below 30°C (86°F)] Pens, and KwikPens must be used within 10 days or be discarded, even if they still contain Humalog Mix50/50. Protect from direct heat and light. See table below:

  Not In-Use (Unopened) Room Temperature [Below30°C (86°F)] Not In-Use (Unopened) Refrigerated In-Use (Opened) Room Temperature [Below30°C (86°F)]
10 mL Vial 28 days Until expiration date 28 days,refrigerated/room temperature.
3 mL Pen and KwikPen (prefilled) 10 days Until expiration date 10 days. Do not refrigerate.

Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA. www.humalog.com.

Last reviewed on RxList: 3/26/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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