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Humulin R (Concentrated) (U-500)

Generic Name: insulin regular, concentrated (U-500) (IN soo lin)
Brand Name: HumuLIN R (Concentrated), HumuLIN R KwikPen (Concentrated)

What is concentrated (U-500) insulin?

Insulin is a man-made form of a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. Concentrated (U-500) insulin is a long-acting form of insulin.

U-500 insulin is used to improve blood sugar control in adults and children with diabetes who have significant daily insulin needs (more than 200 units per day). U-500 insulin is five times more concentrated than regular U-100 insulin.

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

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

Concentrated (U-500) insulin works differently from other types of insulin.

Do not use U-500 insulin if you are having an episode of hypoglycemia (low blood sugar).

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

Concentrated insulin works differently than other types of insulin, and its effects may last for up to 24 hours after a single dose.

Do not use U-500 insulin if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

To make sure you can safely use U-500 insulin, tell your doctor if you have liver or kidney disease.

Tell your doctor about all other medications you use, especially oral diabetes medicine such as pioglitazone or rosiglitazone (which are sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medications while you are using concentrated insulin may increase your risk of serious heart problems.

Concentrated insulin is not expected to harm an unborn baby. Your dose needs may be different during pregnancy. Tell your doctor if you are pregnant or if you become pregnant.

Your dose needs may also be different while you are nursing. Tell your doctor if you are breast-feeding a baby.

U-500 insulin is not approved for use by anyone younger than 18 years old.

How should I use U-500 insulin?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended. Do not mix or dilute U-500 insulin with any other insulin. Do not use U-500 insulin with an insulin pump.

U-500 insulin is injected under the skin, 30 minutes before eating a meal. You will be shown how to use injections at home. Use a different place on your stomach, thigh, or upper arm each time you give the injection. Do not inject into the same place two times in a row.

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.

The prefilled 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), do use only an insulin syringe or a tuberculin ("volumetric") syringe to inject the medicine. The markings on these syringes do not equal the actual unit dose of U-500 insulin.

  • An insulin syringe is marked in units for measuring U-100 insulin products. Divide your U-500 insulin dose by 5 to equal the U-100 unit markings on an insulin syringe. For example, 200 units of U-500 insulin would be equal 40 units in the U-100 syringe (200 divided by 5 = 40).

  • A tuberculin syringe is marked in milliliters (mL) rather than units. Divide your U-500 insulin dose by 500 to equal the volume (mL) markings on a tuberculin syringe. For example, 200 units of U-500 insulin would be equal 0.4 mL in the tuberculin syringe (200 divided by 500 = 0.4).

  • Be sure you know your dose amount in both units and milliliters, and know which type of syringe you are using. Ask your pharmacist if you have questions about correctly measuring your dose.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow diseases such as hepatitis or HIV 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.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, confusion, irritability, dizziness, or feeling shaky. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency.

If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor's advice.

If your doctor changes your brand, strength, or type of insulin, your dosage needs may change. Check your medicine when it is refilled to make sure you have received the correct brand and type prescribed by your doctor.

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

Do not freeze insulin or expose it to high heat or bright light. Do not use any insulin that has been frozen or has been in temperatures above 98 degrees F.

Storing unopened U-500 insulin in a refrigerator: Store in the original carton and do not freeze. Throw away unopened insulin if the expiration date on the label has passed.

Storing unopened U-500 insulin at room temperature: Store in the original carton. Throw away an unopened vial if not used within 40 days. Throw away an unopened injection pen if not used within 28 days.

Storing "in-use" vials: Store the vial in a refrigerator or at room temperature. Use within 40 days.

Storing "in-use" injection pens: Store the injection pen at room temperature. Do not refrigerate. Use within 28 days.

Do not use the medicine if it looks cloudy or has particles in it. Call your pharmacist for new medication.

What happens if I miss a dose?

Follow your doctor's directions if you miss a dose. To prevent missed doses, be sure to keep insulin on hand at all times.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An insulin overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, seizure (convulsions), or coma.

What should I avoid while using U-500 insulin?

This medicine can cause low blood sugar. Avoid driving or operating machinery until you know how this medicine will affect you.

Avoid drinking alcohol.

U-500 insulin side effects

Get emergency medical help if you have signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Call your doctor at once if you have:

  • heart problems--shortness of breath, swelling in your hands or feet, or rapid weight gain (especially if you are taking an oral diabetes medication); or

  • low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Hypoglycemia, or low blood sugar, is the most common side effect of insulin. Symptoms include headache, hunger, dizziness, sweating, irritability, trouble concentrating, rapid breathing, fast heartbeat, fainting, or seizure (severe hypoglycemia can be fatal).

Tell your doctor if you have itching, swelling, redness, or thickening of the skin where you inject U-500 insulin.

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.

See also: Side effects (in more detail)

What other drugs will affect U-500 insulin?

Taking certain oral diabetes medications while you are using U-500 insulin may increase your risk of serious heart problems. Tell your doctor if you also take medicines such as pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin).

There are many other medicines that can increase or decrease the effects of insulin on lowering your blood sugar. Other drugs may also interact with insulin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. Not all possible interactions are listed in this medication guide.

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.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.01. Revision Date: 2016-05-12, 4:24:30 PM.

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