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Humalog Mix75 / 25 (Insulin Lispro Protamine Suspension / Insulin Lispro Injection (Rdna Origin)) - Indications and Dosage



Humalog Mix75/25, a mixture of 75% insulin lispro protamine suspension and 25% insulin lispro, is indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. Humalog Mix75/25 has a more rapid onset of glucose-lowering activity compared to Humulin 70/30 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.


Table 1 *
Summary of glucodynamic properties of insulin products (pooled cross-study comparison)
Insulin Products Dose, U/kg Time of peak
activity, hours after
Percent of total
activity occurring
in the first 4 hours
Humalog 0.3 2.4
Humulin R 0.32
Humalog Mix75/25 0.3 2.6
Humulin 70/30 0.3 4.4
Humalog Mix50/50 0.3 2.3
Humulin 50/50 0.3 3.3
NPH 0.32
NPL component 0.3 5.8
*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 Mix75/25 is intended only for subcutaneous administration. Humalog Mix75/25 should not be administered intravenously. Dosage regimens of Humalog Mix75/25 will vary among patients and should be determined by the health care professional 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. Humalog Mix75/25 has a similar glucose-lowering effect as compared to Humulin 70/30 on a unit for unit basis. The quicker glucose-lowering effect of Humalog is related to the more rapid absorption rate of insulin lispro from subcutaneous tissue.

Humalog Mix75/25 starts lowering blood glucose more quickly than regular human insulin, allowing for convenient dosing immediately before a meal (within 15 minutes). In contrast, mixtures containing regular human insulin should be given 30-60 minutes before a meal.

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 Mix75/25 may vary considerably in different individuals or within the same individual. Patients must be educated to use proper injection techniques.

Humalog Mix75/25 should be inspected visually before use. Humalog Mix75/25 should be used only if it appears uniformly cloudy after mixing. Humalog Mix75/25 should not be used after its expiration date.


Humalog Mix75/25 vials are available in the following package size:

100 units per mL (U-100)

10 mL vials

NDC 0002-7511-01 (VL-7511)

Humalog Mix75/25 Pen, a disposable insulin delivery device, is available in the following package size:

5 × 3 mL disposable insulin delivery devices

NDC 0002-8794-59 (HP-8794)

Storage --Humalog Mix75/25 should be stored in a refrigerator (2° to 8°C [36° to 46°F]) before use, but not in the freezer. However, vials of Humalog Mix75/25 in use can be kept unrefrigerated at room temperature for up to 28 days, as long as they are kept as cool as possible and away from direct heat and light. Humalog Mix 75/25 Pens in use can be kept unrefrigerated at room temperature for up to 10 days, as long as they are kept as cool as possible and away from direct heat and light. Unrefrigerated vials and Pens must be used within the specified time period or be discarded. Do not use Humalog Mix 75/25 if it has been frozen.

Literature revised May 31, 2002

Manufactured by Lilly France S.A.S.

F-67640 Fegersheim, France

for Eli Lilly and Company

Indianapolis, IN 46285, USA

Copyright © 1999, 2002, Eli Lilly and Company. All rights reserved.

                                              PA 9223 FSAMP

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