"Miriam E. Tucker
Medscape Medical News
The U.S. Food and Drug Administration (FDA) will now require a "for single patient use only" warning on all multidose pen devices used for injectable diabetes medications.
Humalog Mix75/25, a mixture of 75% insulin lispro protamine suspension and 25% insulin lispro injection, (rDNA origin), 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 with 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.
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 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 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. Humalog Mix75/25 has a similar glucose-lowering effect as compared with 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 to 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 [75% insulin lispro protamine suspension and 25% 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 0002-7511-01 (VL-7511)|
|5 x 3 mL prefilled insulin delivery devices (Pen)||NDC 0002-8794-59 (HP-8794)|
|5 x 3 mL prefilled insulin delivery devices (KwikPen™)||NDC 0002-8797-59 (HP-8797)|
Humalog Mix75/25 should be stored in a refrigerator [2° to 8°C (36° to 46°F)], but not in the freezer. Do not use Humalog Mix75/25 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 Mix75/25. Unrefrigerated [below 30°C (86°F)] Pens, and KwikPens must be used within 10 days or be discarded, even if they still contain Humalog Mix75/25. Protect from direct heat and light. See table below:
|Not In-Use (Unopened) Room Temperature [Below 30°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.
Additional Humalog 75-25 Information
Humalog 75-25 - User Reviews
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