Humalog Mix contains a mixture of insulin lispro and insulin lispro protamine. Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin lispro is a fast-acting insulin. Insulin lispro protamine is an intermediate-acting insulin. This combination insulin starts to work within 10 to 20 minutes after injection, peaks in 2 hours, and keeps working for up to 24 hours.

Humalog Mix is used to improve blood sugar control in adults with diabetes mellitus. This medicine may be used for type 1 or type 2 diabetes.

Humalog Mix may also be used for purposes not listed in this medication guide.

Use Humalog Mix within 15 minutes before eating a meal.

Never share a Humalog Mix injection pen, cartridge, or syringe with another person, even if the needle has been changed. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

You should not use Humalog Mix is injected under the skin. if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Humalog Mix is injected under the skin. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Insulin is injected under the skin. You will be shown how to use injections at home. Do not give yourself Humalog Mix if you do not understand how to use the injection and properly dispose of used needles and syringes. Do not inject Humalog Mix into a vein.

Use this medication within 15 minutes before eating a meal.

Your care provider will show you the best places on your body to inject Humalog Mix. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Do not inject this medicine into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

If you use an injection pen, use only the injection pen that comes with Humalog Mix. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe.

Never share a Humalog Mix injection pen, cartridge, or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Insulin is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Keep Humalog Mix in its original container protected from heat and light. Do not draw insulin from a vial into a syringe until you are ready to give an injection. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) Humalog Mix:

• Refrigerate and use until expiration date; or

• Store at room temperature and use the vial within 28 days or use the injection pen within 10 days.

Storing opened (in use) Humalog Mix:

• Store the vial in a refrigerator or at room temperature and use within 28 days.

• Store the injection pen at room temperature (do not refrigerate) and use within 10 days. Do not store the injection pen with a needle attached.

Humalog Mix should look cloudy. Do not use the medicine if it looks clear or has particles in it. Call your pharmacist for new medicine.

In case of emergency, wear or carry medical identification to let others know you have diabetes.

You should not use Humalog Mix if you are allergic to insulin lispro, or if you are having an episode of hypoglycemia (low blood sugar).

Humalog Mix is not approved for use by anyone younger than 18 years old.

To make sure Humalog Mix is safe for you, tell your doctor if you have:

• liver or kidney disease; or

• low levels of potassium in your blood (hypokalemia).

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor's instructions about using Humalog Mix if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

Since Humalog Mix is used before meals, you may not be on a timed dosing schedule. Whenever you use the medicine, be sure to eat a meal within 15 minutes. Do not use two doses at one time.

Keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how Humalog Mix will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol. It can cause low blood sugar and may interfere with your diabetes treatment.

Get emergency medical help if you have signs of an allergy to Humalog Mix: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• fluid retention - weight gain, swelling in your hands or feet, feeling short of breath; or

• low potassium - leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common Humalog Mix side effects may include:

• low blood sugar;

• itching, mild skin rash; or

• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.