Levemir is a man-made form of insulin, a hormone that is produced in the body. Insulin works by lowering levels of glucose (sugar) in the blood.

Levemir is a long-acting insulin that starts to work several hours after injection and keeps working evenly for up to 24 hours.

Levemir is used to improve blood sugar control in people with diabetes mellitus. This medicine is for use in adults and children at least 2 years old.

You should not use Levemir if you are allergic to insulin detemir, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with a short-acting insulin).

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

Many other drugs can potentially interfere with the effects of Levemir. It is extremely important that you tell your doctor about all the prescription and over-the-counter medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. An insulin overdose can cause life-threatening hypoglycemia. Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating. Be sure your family and close friends know how to help you in an emergency.

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

Levemir is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. 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 Levemir. 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 this medicine once daily, use the injection at your evening meal or at bedtime. If you use the medicine twice daily, use your evening dose at least 12 hours after your morning dose.

Your doctor may want you to also use a short-acting insulin. Always inject your insulins separately. Levemir must not be given with an insulin pump, or mixed with other insulins. Do not inject into a vein or a muscle.

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

Never share a Levemir 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.

Levemir 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 this medicine 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) Levemir:

• Refrigerate and use until expiration date; or

• Store at room temperature and use within 42 days.

Storing opened (in use) Levemir:

• Store the vial in a refrigerator or at room temperature and use within 42 days.

• Store the injection pen at room temperature (do not refrigerate) and use within 42 days. Do not store the injection pen with a needle attached.

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

You should not use Levemir if you are allergic to iinsulin detemir. Do not use during an episode of hypoglycemia (low blood sugar) or diabetic ketoacidosis (call your doctor for treatment).

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

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

• liver or kidney disease.

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 Levemir may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor's instructions about using Levemirif 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.

Call your doctor for instructions if you miss a dose. 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.

Get emergency medical help if you have signs of an allergic reaction to Levemir: 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 Levemir side effects include:

• low blood sugar;

• weight gain;

• swelling in your hands and feet;

• rash, 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.