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HUMALOG is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.
DOSAGE AND ADMINISTRATION
When given subcutaneously, HUMALOG has a more rapid onset of action and a shorter duration of action than regular human insulin.
The dosage of HUMALOG must be individualized. Blood glucose monitoring is essential in all patients receiving insulin therapy.
The total daily insulin requirement may vary and is usually between 0.5 to 1 unit/kg/day. Insulin requirements may be altered during stress, major illness, or with changes in exercise, meal patterns, or coadministered drugs.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
HUMALOG should be given within 15 minutes before a meal or immediately after a meal.
HUMALOG given by subcutaneous injection should generally be used in regimens with an intermediate- or long-acting insulin.
HUMALOG administered by subcutaneous injection should be given in the abdominal wall, thigh, upper arm, or buttocks. Injection sites should be rotated within the same region (abdomen, thigh, upper arm, or buttocks) from one injection to the next to reduce the risk of lipodystrophy [see ADVERSE REACTIONS].
Continuous Subcutaneous Infusion (Insulin Pump)
HUMALOG may be administered by continuous subcutaneous infusion by an external insulin pump. Do not use diluted or mixed insulins in external insulin pumps. Infusion sites should be rotated within the same region to reduce the risk of lipodystrophy [see ADVERSE REACTIONS]. Change the HUMALOG in the reservoir at least every 7 days, change the infusion sets and the infusion set insertion site at least every 3 days.
The initial programming of the external insulin infusion pump should be based on the total daily insulin dose of the previous regimen. Although there is significant variability among patients, approximately 50% of the total dose is usually given as meal-related boluses of HUMALOG and the remainder is given as a basal infusion. HUMALOG is recommended for use in pump systems suitable for insulin infusion such as MiniMed, Disetronic, and other equivalent pumps [see For Patients Using Continuous Subcutaneous Insulin Pumps].
HUMALOG can be administered intravenously under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia [see WARNINGS AND PRECAUTIONS, HOW SUPPLIED/Storage and Handling]. HUMALOG should be used at concentrations from 0.1 unit/mL to 1.0 unit/mL in infusion systems containing 0.9% sodium chloride.
Dosage Forms And Strengths
HUMALOG 100 units per mL (U-100) is available as:
- 10 mL vials
- 3 mL prefilled pens
- 3 mL Humalog KwikPen (prefilled)
- 3 mL cartridges
HUMALOG 100 units per mL (U-100) is available as:
|10 mL vials||NDC 0002-7510-01 (VL-7510)|
|5 x 3 mL cartridges1||NDC 0002-7516-59 (VL-7516)|
|5 x 3 mL prefilled pen||NDC 0002-8725-59 (HP-8725)|
|5 x 3 mL Humalog KwikPen (prefilled)||NDC 0002-8799-59 (HP-8799)|
Storage and Handling
Do not use after the expiration date.
Unopened HUMALOG should be stored in a refrigerator (36° to 46°F [2° to 8°C]), but not in the freezer. Do not use HUMALOG if it has been frozen. In-use HUMALOG vials, cartridges, pens, and HUMALOG KwikPen should be stored at room temperature, below 86°F (30°C) and must be used within 28 days or be discarded, even if they still contain HUMALOG. Protect from direct heat and light. See table below:
|Not In-Use (Unopened) Room Temperature (Below 86°F [30°C])||Not In-Use (Unopened) Refrigerated||In-Use (Opened) Room Temperature, (Below 86°F [30°C])|
|10 mL vial||28 days||Until expiration date||28 days, refrigerated/room temperature.|
|3 mL cartridge||28 days||Until expiration date||28 days, Do not refrigerate.|
|3 mL prefilled pen||28 days||Until expiration date||28 days, Do not refrigerate.|
|3 mL Humalog KwikPen (prefilled)||28 days||Until expiration date||28 days, Do not refrigerate.|
Use in an External Insulin Pump — Change the HUMALOG in the reservoir at least every 7 days, change the infusion sets and the infusion set insertion site at least every 3 days or after exposure to temperatures that exceed 98.6°F (37°C). A HUMALOG 3 mL cartridge used in the D-Tron pumps should be discarded after 7 days, even if it still contains HUMALOG. However, as with other external insulin pumps, the infusion set should be replaced and a new infusion set insertion site should be selected at least every 3 days.
Diluted HUMALOG for Subcutaneous Injection — Diluted HUMALOG may remain in patient use for 28 days when stored at 41°F (5°C) and for 14 days when stored at 86°F (30°C). Do not dilute HUMALOG contained in a cartridge or HUMALOG used in an external insulin pump.
Preparation and Handling
Diluted HUMALOG for Subcutaneous Injection — HUMALOG may be diluted with Sterile Diluent for HUMALOG for subcutaneous injection. Diluting one part HUMALOG to nine parts diluent will yield a concentration one-tenth that of HUMALOG (equivalent to U-10). Diluting one part HUMALOG to one part diluent will yield a concentration one-half that of HUMALOG (equivalent to U-50).
Admixture for Intravenous Administration
Infusion bags prepared with HUMALOG are stable when stored in a refrigerator (2° to 8°C [36° to 46°F]) for 48 hours and then may be used at room temperature for up to an additional 48 hours [see DOSAGE AND ADMINISTRATION].
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA. Revised: 03/2013
Last reviewed on RxList: 3/25/2013
This monograph has been modified to include the generic and brand name in many instances.
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