Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin detemir is a man-made long-acting insulin that starts to work several hours after injection and keeps working evenly for 24 hours.

Insulin detemir is used to improve blood sugar control in people with diabetes mellitus.

Insulin detemir is for use in adults and children at least 2 years old.

Insulin detemir is not to be used to treat diabetic ketoacidosis.

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

Before taking this medicine

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

To make sure insulin detemir 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 insulin detemir 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 detemir 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 insulin detemir exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Insulin detemir 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 insulin detemir 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 insulin detemir. 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 insulin detemir into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

If you use insulin detemir 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. Insulin detemir 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 insulin detemir. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe.

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.

Insulin detemir 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 insulin detemir 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) insulin detemir:

• Refrigerate and use until expiration date; or

• Store at room temperature and use within 42 days.

Storing opened (in use) insulin detemir:

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

To make sure insulin detemir 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 insulin detemir 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 detemir 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.

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 insulin detemir 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 insulin detemir: 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 insulin detemir side effects may 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.