Apidra is an injection that contains insulin glulisine. Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin glulisine 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.

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

Apidra is used to treat type 1 or type 2 diabetes in adults, and type 1 diabetes children who are at least 4 years old.

Apidra is a fast-acting insulin that begins to work very quickly. You should use it within 15 minutes before or 20 minutes after you start eating a meal.

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

You should not use Apidra if you are having an episode of hypoglycemia (low blood sugar).

Apidra is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

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

Apidra is injected under the skin, or given as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine and injection pen or insulin pump. Ask your doctor or pharmacist if you don't understand all instructions.

Prepare an 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.

Your healthcare provider will show you where on your body to inject Apidra. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

After using Apidra, eat a meal within 15 minutes. If you did not use an injection before the meal, use the medicine within 20 minutes after you start eating.

If you use this medicine with an IV or insulin pump, do not mix or dilute Apidra with any other insulin.

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

Never share an injection pen 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 needle and syringe only once and then 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.

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.

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

Keep Apidra 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) Apidra:

• Refrigerate and use until expiration date; or

• Store at cool room temperature (below 77 degrees F) and use within 28 days.

Storing opened (in use) Apidra:

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

• Store the injection pen at cool room temperature (do not refrigerate) and use within 28 days. Do not store the injection pen with a needle attached.

• Store a prepared infusion bag at cool room temperature and use within 48 hours.

Do not use the medicine if it looks cloudy, has changed colors, or has any 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 Apidra if you are allergic to insulin glulisine, or if you are having an episode of hypoglycemia (low blood sugar).

Apidra is not approved for use by anyone younger than 4 years old, and should not be used to treat type 2 diabetes in a child of any age.

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

• liver or kidney disease;

• low levels of potassium in your blood (hypokalemia); or

• diabetic ketoacidosis (call your doctor for treatment).

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 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 Apidra is used before meals, you may not be on a timed dosing schedule. Whenever you use Apidra, be sure to eat a meal within 15 minutes. Do not use two doses at the same 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 this medicine 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 allergic reaction to Apidra: 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 Apidra side effects 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.