Admelog is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin lispro is a fast-acting insulin that starts to work about 15 minutes after injection, peaks in about 1 hour, and keeps working for 2 to 4 hours.

Admelog is used to improve blood sugar control in adults and children with diabetes mellitus.

Admelog is used to treat type 2 diabetes in adults, or type 1 diabetes in adults and children who are at least 3 years old.

Admelog injection 100 units/ml (U-100) is available in 10 ml multiple-dose vials, 3 ml multiple-dose vials, and a 3 ml single-patient-use SoloStar prefilled pens.

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

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed.

Before taking this medicine

Admelog should not be given to a child younger than 3 years old. This medicine should not be used to treat type 2 diabetes in a child of any age.

To make sure Admelog is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;

• heart problems; or

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

Tell your doctor if you also take medicine that contains pioglitazone or rosiglitazone. Taking certain oral diabetes medicines while you are using Admelog may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor's instructions about using insulin 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.

Use Admelog exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Admelog is injected under the skin with a syringe and needle, a SoloStar injection pen, or with an infusion pump. A healthcare provider will teach you how to properly use the injection by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors or has particles in it. Call your pharmacist for new medicine.

Admelog is given within 15 minutes before a meal, or right after eating.

Your healthcare provider will show you where on your body to inject Admelog. 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 into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

Never share the SoloStar injection pen, Admelog vial, 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.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or 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.

Keep this medicine in its original container protected from heat and light. Do not freeze Admelog or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) Admelog:

• Refrigerate and use until expiration date; or

• Store at room temperature and use within 28 days.

Storing opened (in use) Admelog:

• Store the vial in a refrigerator until the expiration date on the pen or vial, or at room temperature and use within 28 days.

• Store the SoloStar injection pen (without a needle attached) at room temperature and use within 28 days.

Use a needle and syringe only once and place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Admelog should not be given to a child younger than 3 years old. This medicine should not be used to treat type 2 diabetes in a child of any age.

To make sure Admelog is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;

• heart problems; or

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

Tell your doctor if you also take medicine that contains pioglitazone or rosiglitazone. Taking certain oral diabetes medicines while you are using Admelog may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor's instructions about using insulin 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 Admelog is used with meals, you may not be on a timed dosing schedule. Whenever you use Admelog, follow the directions for your specific brand about whether to use the medicine before of after you eat. Do not use two doses at one time.

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 Admelog will affect you.

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

Avoid drinking alcohol.

Get emergency medical help if you have signs of an allergy to Admelog: 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:

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

• low blood sugar--headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky; 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 Admelog side effects may include:

• low blood sugar;

• weight gain;

• swelling in your hands or feet;

• itching; 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.