insulin regular, concentrated (U-500)

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Pronunciation: IN soo lin

Brand: HumuLIN R (Concentrated), HumuLIN R KwikPen (Concentrated)

What is the most important information I should know about U-500 insulin?

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

What is concentrated (U-500) insulin?

Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Concentrated (U-500) insulin is a long-acting insulin that starts to work several hours after injection and keeps working evenly for 24 hours. U-500 insulin is five times more concentrated than regular U-100 insulin.

U-500 insulin is used to improve blood sugar control in adults and children with diabetes mellitus who have significant daily insulin needs (more than 200 units per day).

U-500 insulin may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using U-500 insulin?

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

To make sure U-500 insulin 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.

Follow your doctor's instructions about using insulin if you are pregnant or breast-feeding a baby. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy. Your dose needs may also be different while you are breast-feeding.

How should I use U-500 insulin?

U-500 insulin is concentrated and contains 500 units of insulin in each milliliter (mL). This is five times more concentrated than regular U-100 insulin, which contains 100 units per mL. Measure each dose of U-500 insulin carefully. Using too much insulin can lead to insulin shock or death. 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 this medicine if you do not understand how to use the injection and properly dispose of used needles and syringes.

U-500 insulin must not be given with an insulin pump, or mixed with other insulins. Do not inject U-500 insulin into a vein or a muscle.

Your care provider will show you the best places on your body to inject U-500 insulin. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

After using U-500 insulin, you should eat a meal within 30 minutes.

If you use an injection pen, use only the injection pen that comes with U-500 insulin. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe. The injection pen has a dial on it that allows you to set your correct doses of U-500 insulin.

If you use U-500 insulin from a vial (bottle), use only a U-500 insulin syringe to inject the medicine. Do not use any other type of syringe.

Do not convert your dose when using a U-500 injection pen or U-500 insulin syringe.

Never share an 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, blurred vision, headache, and tiredness.

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

U-500 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 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) U-500 insulin:

  • Refrigerate and use until expiration date; or
  • Store at room temperature and use within 28 days.

Storing opened (in use) U-500 insulin:

  • Store the vial in a refrigerator or at room temperature and use within 40 days. Do not shake the vial.
  • Store the injection pen at room temperature (do not refrigerate) and use within 28 days. Do not store the injection pen with a needle attached.

Do not use the medicine if it looks cloudy, has changed colors, or has any particles in it. Call your pharmacist for new medicine.

Wear a diabetes medical alert tag or carry an ID card, in case of emergency. Any medical care provider who treats you should know that you have diabetes.

What happens if I miss a dose?

Follow your doctor's directions if you miss a dose. To prevent missed doses, keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

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.

What should I avoid while using U-500 insulin?

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.

What are the possible side effects of U-500 insulin?

Get emergency medical help if you have signs of insulin allergy: 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 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.

What other drugs will affect U-500 insulin?

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.

Where can I get more information?

Your pharmacist can provide more information about concentrated insulin (U-500).


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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