insulin regular, concentrated (U-500)

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Pronunciation: IN soo lin

Brand: HumuLIN R (Concentrated)

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

Concentrated (U-500) insulin works differently from other types of insulin. Always check your medicine when it is refilled to make sure you have received the correct brand and type prescribed by your doctor.

Do not use this medicine if you are having an episode of hypoglycemia (low blood sugar).

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 insulin is a long-acting form of insulin.

Concentrated insulin (U-500) is used to treat type 1 (insulin-dependent) diabetes in people with 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?

Concentrated (U-500) insulin works differently than other types of insulin, and its effects may last for up to 24 hours after a single dose. The length of insulin effect will depend on your dose, your level of physical activity, and many other factors.

Do 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 you can safely use insulin, tell your doctor if you have liver or kidney disease.

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

FDA pregnancy category B. Concentrated insulin is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether concentrated insulin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby. Your dose needs may be different while you are nursing.

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.

U-500 insulin is injected under the skin. 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 cause severely low blood sugar (hypoglycemia), which could lead to insulin shock or death.

Use only an insulin syringe or a tuberculin ("volumetric") syringe to inject U-500 insulin. 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 of U-500 in the type of syringe you are using.

Use a disposable needle only once, then throw away in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). 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, pale skin, irritability, dizziness, feeling shaky, or trouble concentrating. 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 there are any changes in the brand, strength, or type of insulin you use, your dosage needs may change. Always 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 are a diabetic.

Insulin 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.

Storing unopened vials: Store in a refrigerator, protected from light. Throw away any insulin not used before the expiration date on the medicine label. Do not freeze concentrated insulin, and throw away the medication if it has become frozen.

Storing after your first use: Keep "in-use" vials at cool room temperature and use within 31 days. Do not refrigerate. Protect from light.

Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription. Concentrated insulin should look as clear as water.

What happens if I miss a dose?

Follow your doctor's directions if you miss a dose of insulin. To prevent missed doses, be sure to keep insulin on hand at all times, especially when you are traveling away from home.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. 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?

Avoid drinking alcohol while using concentrated insulin. Alcohol can lower your blood sugar.

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

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have shortness of breath, swelling in your hands or feet, or rapid weight gain (especially if you are taking an oral diabetes medication).

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). Carry hard candy or glucose tablets with you in case you have low blood sugar.

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

What other drugs will affect U-500 insulin?

Using certain medicines can make it harder for you to tell when you have low blood sugar. Tell your doctor if you use any of the following:

  • albuterol;
  • clonidine;
  • reserpine; or
  • a beta-blocker such as atenolol, carvedilol, labetalol, metoprolol, nadolol, nebivolol, propranolol, sotalol, and others.

This list is not complete and 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.

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