Humulin is synthesized in a special non-disease-producing laboratory strain of Escherichia coli bacteria that has been genetically altered by the addition of the gene for human insulin production. Humulin R consists of zinc-insulin crystals dissolved in a clear fluid. Humulin R has had nothing added to change the speed or length of its action. It takes effect rapidly and has a relatively short duration of activity (4 to 12 hours) as compared with other insulins. The time course of action of any insulin may vary considerably in different individuals or at different times in the same individual. As with all insulin preparations, the duration of action of Humulin R is dependent on dose, site of injection, blood supply, temperature, and physical activity. Humulin R is a sterile solution and is for subcutaneous injection. It should not be used intramuscularly. The concentration of Humulin R is 100 units/mL (U-100).

Last updated on RxList: 9/21/2007

Humulin R (U-500) is especially useful for the treatment of diabetic patients with marked insulin resistance (daily requirements more than 200 units), since a large dose may be administered subcutaneously in a reasonable volume.

Humulin R (U-500) should only be administered subcutaneously. It is inadvisable to inject Humulin R (U-500) intravenously because of possible inadvertent overdosage.

It is recommended that an insulin syringe or tuberculin-type syringe be used for the measurement of dosage. Variations in dosage are frequently possible in the insulin-resistant patient, since the individual is unresponsive to the pharmacologic effect of the insulin. Nevertheless, accuracy of measurement is to be encouraged because of the potential danger of the preparation.

STORAGE

Insulin should be kept in a cold place, preferably in a refrigerator, but must not be frozen.

Do not inject insulin that is not water-clear. Discoloration, turbidity, or unusual viscosity indicates deterioration or contamination.

Use of a package of insulin should not be started after the expiration date stamped on it.

Vials, 500 units/mL, 20 mL (HI-500) (1s), NDC 0002-8501-01

Literature revised April 9, 2007., Eli Lilly and Company, Indianapolis, IN 46285, USA. FDA rev date: 9/10/2007

Last updated on RxList: 9/21/2007

As with other human insulin preparations, hypoglycemic reactions may be associated with the administration of Humulin R (U-500). However, deep secondary hypoglycemic reactions may develop 18 to 24 hours after the original injection of Humulin R (U-500). Consequently, patients should be carefully observed, and prompt treatment of such reactions should be initiated with glucagon injections and/or with glucose by intravenous injection or gavage.

Hypoglycemia

Hypoglycemia is one of the most frequent adverse events experienced by insulin users.

Symptoms of mild to moderate hypoglycemia may occur suddenly and can include:

• sweating • dizziness • palpitation • tremor • hunger • restlessness • tingling in the hands, feet, lips, or tongue • lightheadedness • inability to concentrate • headache

• drowsiness • sleep disturbances • anxiety • blurred vision • slurred speech • depressive mood • irritability • abnormal behavior • unsteady movement • personality changes

Signs of severe hypoglycemia can include:

• disorientation • unconsciousness

• seizures • death

Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as long duration of diabetes, diabetic nerve disease, medications such as beta-blockers, change in insulin preparations, or intensified control (3 or more insulin injections per day) of diabetes.

A few patients who have experienced hypoglycemic reactions after transfer from animal-source insulin to human insulin have reported that the early warning symptoms of hypoglycemia were less pronounced or different from those experienced with their previous insulin.

Without recognition of early warning symptoms, the patient may not be able to take steps to avoid more serious hypoglycemia. Patients who experience hypoglycemia without early warning symptoms should monitor their blood glucose frequently, especially prior to activities such as driving. Mild to moderate hypoglycemia may be treated by eating foods or taking drinks that contain sugar. Patients should always carry a quick source of sugar, such as candy mints or glucose tablets.

Hypoglycemia when using Humulin R (U-500) can be prolonged and severe.

Lipodystrophy

Rarely, administration of insulin subcutaneously can result in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue).

Allergy to Insulin

Local Allergy - Patients occasionally experience erythema, local edema, and pruritus at the site of injection of insulin. This condition usually is self-limiting. In some instances, this condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique.

Systemic Allergy - Less common, but potentially more serious, is generalized allergy to insulin, which may cause rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast pulse, or sweating. Severe cases of generalized allergy (anaphylaxis) may be life threatening.

The concurrent use of oral hypoglycemic agents with Humulin R (U-500) is not recommended since there are no data to support such use.

Last updated on RxList: 9/21/2007

THIS LILLY HUMAN INSULIN PRODUCT DIFFERS FROM ANIMAL-SOURCE INSULINS BECAUSE IT IS STRUCTURALLY IDENTICAL TO THE INSULIN PRODUCED BY YOUR BODY'S PANCREAS AND BECAUSE OF ITS UNIQUE MANUFACTURING PROCESS.

ANY CHANGE OF INSULIN SHOULD BE MADE CAUTIOUSLY AND ONLY UNDER MEDICAL SUPERVISION. CHANGES IN PURITY, STRENGTH, BRAND (MANUFACTURER), TYPE (REGULAR, NPH, LENTE®, ETC), SPECIES (BEEF, PORK, BEEF-PORK, HUMAN), AND/OR METHOD OF MANUFACTURE (rDNA VERSUS ANIMAL-SOURCE INSULIN) MAY RESULT IN THE NEED FOR A CHANGE IN DOSAGE.

SOME PATIENTS TAKING HUMULIN® (HUMAN INSULIN, rDNA ORIGIN, LILLY) MAY REQUIRE A CHANGE IN DOSAGE FROM THAT USED WITH ANIMAL-SOURCE INSULINS. IF AN ADJUSTMENT IS NEEDED, IT MAY OCCUR WITH THE FIRST DOSE OR DURING THE FIRST SEVERAL WEEKS OR MONTHS.

This insulin preparation contains 500 units of insulin in each milliliter. Extreme caution must be observed in the measurement of dosage because inadvertent overdose may result in irreversible insulin shock. Serious consequences may result if it is used other than under constant medical supervision.

General - Every patient exhibiting insulin resistance who requires Humulin R (U-500) for control of diabetes should be under close observation until appropriate dosage is established. The response will vary among patients. Some patients can be controlled with a single dose daily; others may require 2 or 3 injections per day. Most patients will show a “tolerance” to insulin, so that minor variations in dosage can occur without the development of untoward symptoms of insulin shock. Insulin resistance is frequently self-limited; after several weeks or months during which high dosage is required, responsiveness to the pharmacologic effect of insulin may be regained and dosage can be reduced.

Information for Patients

Patients should be instructed regarding their dosage and should be reminded that this formulation requires the administration of a smaller volume of solution than is the case with less concentrated formulations.

Laboratory Tests - Blood and urine glucose, glycohemoglobin, and urine ketones should be monitored frequently.

Pregnancy-Teratogenic Effects - No reproduction studies have been conducted in animals, and there are no adequate and well-controlled studies in pregnant women. It would be anticipated that the benefits of this insulin preparation would outweigh any risk to the developing fetus.

Nonteratogenic Effects - Insulin does not cross the placenta as does glucose.

Labor and Delivery - Careful monitoring of the patient is required, since the insulin requirement may decrease following delivery.

Nursing Mothers - It is not known whether insulin is excreted in significant amounts in human milk. Because many drugs are excreted in human milk, caution should be exercised when Humulin R (U-500) insulin injection is administered to a nursing woman.

Pediatric Use - There are no special precautions relating to the use of this insulin formulation in the pediatric age group.

Last updated on RxList: 9/21/2007

No information provided.

Humulin R (U-500) is contraindicated in hypoglycemia.

Last updated on RxList: 9/21/2007

Adequate insulin dosage permits the diabetic patient to utilize carbohydrates and fats in a comparatively satisfactory manner. Regardless of concentration, the action of insulin is basically the same: to enable carbohydrate metabolism to occur and thus to prevent the production of ketone bodies by the liver. Although, under usual circumstances, diabetes can be controlled with doses in the vicinity of 40 to 60 units or less, an occasional patient develops such resistance or becomes so unresponsive to the effect of insulin that daily doses of several hundred, or even several thousand, units are required. Patients who require doses in excess of 300 to 500 units daily usually have impaired insulin receptor function.

Occasionally, a cause of the insulin resistance can be found (such as hemochromatosis, cirrhosis of the liver, some complicating disease of the endocrine glands other than the pancreas, allergy, or infection), but in other cases, no cause of the high insulin requirement can be determined.

Humulin R (U-500) is unmodified by any agent that might prolong its action; however, clinical experience has shown that it frequently has a time action similar to a repository insulin preparation. It takes effect rapidly but has a relatively long duration of activity following a single dose (up to 24 hours) as compared with other Regular insulins. This effect has been credited to the high concentration of the preparation. The time course of action of any insulin may vary considerably in different individuals or at different times in the same individual. As with all insulin preparations, the duration of action of Humulin R (U-500) is dependent on dose, site of injection, blood supply, temperature, and physical activity.

Last updated on RxList: 9/21/2007

HUMULIN® R
REGULAR
U-500 (CONCENTRATED)
INSULIN HUMAN INJECTION, USP
(rDNA ORIGIN)

WARNINGS

THIS LILLY HUMAN INSULIN PRODUCT DIFFERS FROM ANIMAL-SOURCE INSULINS BECAUSE IT IS STRUCTURALLY IDENTICAL TO THE INSULIN PRODUCED BY YOUR BODY'S PANCREAS AND BECAUSE OF ITS UNIQUE MANUFACTURING PROCESS.

ANY CHANGE OF INSULIN SHOULD BE MADE CAUTIOUSLY AND ONLY UNDER MEDICAL SUPERVISION. CHANGES IN PURITY, STRENGTH, BRAND (MANUFACTURER), TYPE (REGULAR, NPH, E.G., LENTE), SPECIES (BEEF, PORK, BEEF-PORK, HUMAN), AND/OR METHOD OF MANUFACTURE (rDNA VERSUS ANIMAL-SOURCE INSULIN) MAY RESULT IN THE NEED FOR A CHANGE IN DOSAGE.

SOME PATIENTS TAKING HUMULIN® (HUMAN INSULIN, rDNA ORIGIN, LILLY) MAY REQUIRE A CHANGE IN DOSAGE FROM THAT USED WITH ANIMAL-SOURCE INSULINS. IF AN ADJUSTMENT IS NEEDED, IT MAY OCCUR WITH THE FIRST DOSE OR DURING THE FIRST SEVERAL WEEKS OR MONTHS.

This insulin preparation contains 500 units of insulin in each milliliter. Extreme caution must be observed in the measurement of dosage because inadvertent overdose may result in irreversible insulin shock. Serious consequences may result if it is used other than under constant medical supervision.

DIABETES

Insulin is a hormone produced by the pancreas, a large gland that lies near the stomach. This hormone is necessary for the body's correct use of food, especially sugar. Diabetes occurs when the pancreas does not make enough insulin to meet your body's needs.

To control your diabetes, your doctor has prescribed injections of insulin products to keep your blood glucose at a near-normal level. You have been instructed to test your blood and/or your urine regularly for glucose. Studies have shown that some chronic complications of diabetes such as eye disease, kidney disease, and nerve disease can be significantly reduced if the blood sugar is maintained as close to normal as possible. The American Diabetes Association recommends that if your pre-meal glucose levels are consistently above 130 mg/dL or your hemoglobin A1c (HbA_1c) is more than 7%, consult your doctor. A change in your diabetes therapy may be needed. If your blood tests consistently show below-normal glucose levels you should also let your doctor know. Proper control of your diabetes requires close and constant cooperation with your doctor. Despite diabetes, you can lead an active and healthy life if you eat a balanced diet, exercise regularly, and take your insulin injections as prescribed.

Always keep an extra supply of insulin as well as a spare syringe and needle on hand. Always wear diabetic identification so that appropriate treatment can be given if complications occur away from home.

REGULAR HUMAN INSULIN

DESCRIPTION

Humulin is synthesized in a special non-disease-producing laboratory strain of Escherichia coli bacteria that has been genetically altered by the addition of the gene for human insulin production. Humulin R (U-500) consists of zinc-insulin crystals dissolved in a clear fluid. Humulin R (U-500) has had nothing added to change the speed or length of its action. It takes effect rapidly but has a relatively long duration of activity (up to 24 hours) as compared with other Regular insulins. The time course of action of any insulin may vary considerably in different individuals or at different times in the same individual. As with all insulin preparations, the duration of action of Humulin R (U-500) is dependent on dose, site of injection, blood supply, temperature, and physical activity. Humulin R (U-500), is a sterile solution and is for subcutaneous injection only. It should not be used intravenously or intramuscularly. The concentration of Humulin R (U-500) is 500 units/mL.

Identification

Human insulin by Eli Lilly and Company has the trademark Humulin and is available in 6 formulations - Regular (R), NPH (N), Lente (L), Ultralente® (U), 50% Human Insulin Isophane Suspension [NPH]/50% Human Insulin Injection [regular] (50/50), and 70% Human Insulin Isophane Suspension [NPH]/30% Human Insulin Injection [regular] (70/30). Humulin R (U-500) is the only human insulin by Eli Lilly and Company that has a concentration of 500 units/mL. Your doctor has prescribed the type of insulin that he/she believes is best for you.

DO NOT USE ANY OTHER INSULIN EXCEPT ON HIS/HER ADVICE AND DIRECTION.

Always check the carton and the bottle label for the name and letter designation of the insulin you receive from your pharmacy to make sure it is the same as that your doctor has prescribed.

Always examine the appearance of your bottle of insulin before withdrawing each dose. Humulin R (U-500) is a clear and colorless liquid with a water-like appearance and consistency. Do not use if it appears cloudy, thickened, or slightly colored or if solid particles are visible. Always check the appearance of your bottle of insulin before using, and if you note anything unusual in the appearance of your insulin or notice your insulin requirements changing markedly, consult your doctor.

Storage

Insulin should be stored in a refrigerator but not in the freezer. If refrigeration is not possible, the bottle of insulin that you are currently using can be kept unrefrigerated as long as it is kept as cool as possible (below 30°C [86°F]) and away from heat and light. Do not use insulin if it has been frozen. Do not use a bottle of Humulin R (U-500) after the expiration date stamped on the label.

INJECTION PROCEDURES

Correct Syringe Type

Doses of insulin are measured in units. U-500 insulin contains 500 units/mL (1 mL=1 cc). With Humulin R (U-500), it is important to use a tuberculin (or similar) syringe as instructed by your doctor. Failure to use the proper syringe type can lead to a mistake in dosage, causing serious problems for you, such as a blood glucose level that is too low or too high.

Syringe Use

To help avoid contamination and possible infection, follow these instructions exactly.

Disposable plastic syringes and needles should be used only once and then discarded in a responsible manner. NEEDLES AND SYRINGES MUST NOT BE SHARED.

Reusable glass syringes and needles must be sterilized before each injection. Follow the package directions supplied with your syringe. Described below are 2 methods of sterilizing.

Boiling

1. Put syringe, plunger, and needle in strainer, place in saucepan, and cover with water. Boil for 5 minutes.
2. Remove articles from water. When they have cooled, insert plunger into barrel, and fasten needle to syringe with a slight twist.
3. Push plunger in and out several times until water is completely removed.

Isopropyl Alcohol

If the syringe, plunger, and needle cannot be boiled, as when you are traveling, they may be sterilized by immersion for at least 5 minutes in Isopropyl Alcohol, 91%. Do not use bathing, rubbing, or medicated alcohol for this sterilization. If the syringe is sterilized with alcohol, it must be absolutely dry before use.

Preparing the Dose

1. Wash your hands.
2. Inspect the insulin. Humulin R (U-500) should look clear and colorless. Do not use Humulin R (U-500) if it appears cloudy, thickened, or slightly colored or if solid particles are visible.
3. If using a new bottle, flip off the plastic protective cap, but do not remove the stopper. When using a new bottle, wipe the top of the bottle with an alcohol swab.
4. Draw air into the syringe equal to your insulin dose. Put the needle through the rubber top of the insulin bottle and inject the air into the bottle.
5. Turn the bottle and syringe upside down. Hold the bottle and syringe firmly in one hand.
6. Making sure the tip of the needle is in the insulin, withdraw the correct dose of insulin into the syringe.
7. Before removing the needle from the bottle, check your syringe for air bubbles which reduce the amount of insulin in it. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push them out with the plunger and withdraw the correct dose.
8. Remove the needle from the bottle and lay the syringe down so that the needle does not touch anything.

Injection

Once you have chosen an injection site, cleanse the skin with alcohol where the injection is to be made. Stabilize the skin by spreading it or pinching up a large area. Insert the needle as instructed by your doctor. Push the plunger in as far as it will go. Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub the area. To avoid tissue damage, give the next injection at a site at least 1/2 inch from the previous site.

DOSAGE

Your doctor has told you which insulin to use, how much, and when and how often to inject it. Because each patient's case of diabetes is different, this schedule has been individualized for you.

Your usual insulin dose may be affected by changes in your food, activity, or work schedule. Carefully follow your doctor's instructions to allow for these changes. Other things that may affect your insulin dose are:

Illness

Illness, especially with nausea and vomiting, may cause your insulin requirements to change. Even if you are not eating, you will still require insulin. You and your doctor should establish a sick day plan for you to use in case of illness. When you are sick, test your blood glucose/urine glucose and ketones frequently and call your doctor as instructed.

Pregnancy

Good control of diabetes is especially important for you and your unborn baby. Pregnancy may make managing your diabetes more difficult. If you are planning to have a baby, are pregnant, or are nursing a baby, consult your doctor.

Medication

Insulin requirements may be increased if you are taking other drugs with blood-glucose-raising activity, such as oral contraceptives, corticosteroids, or thyroid replacement therapy. Insulin requirements may be reduced in the presence of drugs with blood-glucose-lowering activity, such as oral antidiabetic agents, salicylates (for example, aspirin), sulfa antibiotics, alcohol, certain antidepressants and some kidney and blood pressure medicines. Your Health Care Professional may be aware of other medications that may affect your diabetes control. Therefore, always discuss any medications you are taking with your doctor.

Exercise

Exercise may lower your body's need for insulin during and for some time after the activity. Exercise may also speed up the effect of an insulin dose, especially if the exercise involves the area of injection site (for example, the leg should not be used for injection just prior to running). Discuss with your doctor how you should adjust your regimen to accommodate exercise.

Travel

Persons traveling across more than 2 time zones should consult their doctor concerning adjustments in their insulin schedule.

COMMON PROBLEMS OF DIABETES

Hypoglycemia (Low Blood Sugar)

Hypoglycemia (too little glucose in the blood) is one of the most frequent adverse events experienced by insulin users. It can be brought about by:

1. Missing or delaying meals.
2. Taking too much insulin.
3. Exercising or working more than usual.
4. An infection or illness (especially with diarrhea or vomiting).
5. A change in the body's need for insulin.
6. Diseases of the adrenal, pituitary, or thyroid gland, or progression of kidney or liver disease.
7. Interactions with other drugs that lower blood glucose, such as oral antidiabetic agents, salicylates (for example, aspirin), sulfa antibiotics, certain antidepressants and some kidney and blood pressure medicines.
8. Consumption of alcoholic beverages.

 

Symptoms of mild to moderate hypoglycemia may occur suddenly and can include:

• sweating • dizziness • palpitation • tremor • hunger • restlessness • tingling in the hands, feet, lips, or tongue • lightheadedness • inability to concentrate • headache

• drowsiness • sleep disturbances • anxiety • blurred vision • slurred speech • depressive mood • irritability • abnormal behavior • unsteady movement • personality changes

Signs of severe hypoglycemia can include:

• disorientation • unconsciousness

• seizures • death

Therefore, it is important that assistance be obtained immediately.

Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as long duration of diabetes, diabetic nerve disease, medications such as beta-blockers, change in insulin preparations, or intensified control (3 or more insulin injections per day) of diabetes.

A few patients who have experienced hypoglycemic reactions after transfer from animal-source insulin to human insulin have reported that the early warning symptoms of hypoglycemia were less pronounced or different from those experienced with their previous insulin.

Without recognition of early warning symptoms, you may not be able to take steps to avoid more serious hypoglycemia. Be alert for all of the various types of symptoms that may indicate hypoglycemia. Patients who experience hypoglycemia without early warning symptoms should monitor their blood glucose frequently, especially prior to activities such as driving. If the blood glucose is below your normal fasting glucose, you should consider eating or drinking sugar-containing foods to treat your hypoglycemia.

Mild to moderate hypoglycemia may be treated by eating foods or taking drinks that contain sugar. Patients should always carry a quick source of sugar, such as candy mints or glucose tablets. More severe hypoglycemia may require the assistance of another person. Patients who are unable to take sugar orally or who are unconscious require an injection of glucagon or should be treated with intravenous administration of glucose at a medical facility.

Hypoglycemia when using Humulin R (U-500) can be prolonged and severe. All hypoglycemic episodes should be reported to your doctor.

You should learn to recognize your own symptoms of hypoglycemia. If you are uncertain about these symptoms, you should monitor your blood glucose frequently to help you learn to recognize the symptoms that you experience with hypoglycemia.

If you have frequent episodes of hypoglycemia or experience difficulty in recognizing the symptoms, you should consult your doctor to discuss possible changes in therapy, meal plans, and/or exercise programs to help you avoid hypoglycemia.

Hyperglycemia and Diabetic Ketoacidosis (DKA)

Hyperglycemia (too much glucose in the blood) may develop if your body has too little insulin. Hyperglycemia can be brought about by:

1. Omitting your insulin or taking less than the doctor has prescribed.
2. Eating significantly more than your meal plan suggests.
3. Developing a fever, infection, or other significant stressful situation.

In patients with type 1 or insulin-dependent diabetes, prolonged hyperglycemia can result in DKA. The first symptoms of DKA usually come on gradually, over a period of hours or days, and include a drowsy feeling, flushed face, thirst, loss of appetite, and fruity odor on the breath. With DKA, urine tests show large amounts of glucose and ketones. Heavy breathing and a rapid pulse are more severe symptoms. If uncorrected, prolonged hyperglycemia or DKA can lead to nausea, vomiting, dehydration, loss of consciousness or death. Therefore, it is important that you obtain medical assistance immediately.

Lipodystrophy

Rarely, administration of insulin subcutaneously can result in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue). If you notice either of these conditions, consult your doctor. A change in your injection technique may help alleviate the problem.

Allergy to Insulin

Local Allergy - Patients occasionally experience redness, swelling, and itching at the site of injection of insulin. This condition, called local allergy, usually clears up in a few days to a few weeks. In some instances, this condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique. If you have local reactions, contact your doctor.

Systemic Allergy - Less common, but potentially more serious, is generalized allergy to insulin, which may cause rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast pulse, or sweating. Severe cases of generalized allergy may be life threatening. If you think you are having a generalized allergic reaction to insulin, notify a doctor immediately.

ADDITIONAL INFORMATION

Additional information about diabetes may be obtained from your diabetes educator.

DIABETES FORECAST is a magazine designed especially for people with diabetes and their families. It is available by subscription from the American Diabetes Association (ADA), P.O. Box 363, Mt. Morris, IL 61054-0363, 1-800-DIABETES (1-800-342-2383).

Another publication, COUNTDOWN, is available from the Juvenile Diabetes Research Foundation International (JDRFI), 120 Wall Street 19th Floor, New York, NY 10005, 1-800-533-CURE (1-800-533-2873).

Additional information about Humulin can be obtained by calling The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979).

Last updated on RxList: 9/21/2007

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

INSULIN REGULAR HUMAN - INJECTION

(IN-sue-lin)

COMMON BRAND NAME(S): Humulin R, Novolin R

USES: This man-made insulin product is identical to human insulin. It is used to treat diabetes mellitus. Like other insulin products, it works by helping sugar (glucose) get into cells. It is a short-acting insulin.

This insulin is usually used in combination with a medium- or long-acting insulin product injected under the skin to control high blood sugar. In some people with diabetes, insulin may be used alone or with oral diabetes drugs (e.g., sulfonylureas like glyburide or glipizide).

Even with diabetes, you can lead an active and healthy life if you eat a balanced diet, exercise regularly, and take your insulin as directed. Controlling high blood sugar helps prevent heart disease, strokes, kidney disease, circulation problems, blindness, and sexual function problems.

HOW TO USE: The cartridge form of this insulin comes with a Patient Information Leaflet. Read it before you start using this insulin and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

This insulin must be injected. Learn all preparation and usage instructions, including how to inject this medication properly and how to self-manage your diabetes (e.g., monitoring blood glucose, recognizing and treating high/low blood sugar). Your health care professional will teach you how to use this medication. If you have any questions, consult your doctor, diabetes educator, or pharmacist.

Before using, inspect this product visually for particles or discoloration. If either is present, do not use the insulin.

Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site daily to avoid developing problem areas under the skin (lipodystrophy). To reduce discomfort at the injection site, do not inject cold insulin. The insulin container you are currently using can be kept at room temperature. Insulin may be injected in the abdominal wall, the thigh, or the back of the upper arm.

Inject this medication under the skin within 30-60 minutes before eating a meal or immediately after the meal as directed by your doctor. Because this insulin is fast-acting, not eating immediately after a dose of this insulin may lead to low blood sugar (hypoglycemia). After pulling out the needle, apply gentle pressure on the injection site. Do not rub the area.

The dosage is based on your medical condition and response to therapy. Measure each dose very carefully because even small changes in the amount of insulin may have a large effect on your blood sugar levels.

Check your urine/blood sugar as directed by your doctor. Keep track of your results and share them with your doctor. This is very important in order to determine the correct insulin dose.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day.

If you are directed to inject this insulin with an infusion pump, read the instruction manual and directions that come with the infusion pump. If you have any questions, consult your doctor, diabetes educator, or pharmacist. Avoid exposing the pump or its tubing to direct sunlight or other heat sources.

This product may be mixed only with certain other insulin products such as NPH insulin. Always draw this insulin into the syringe first, then follow with the longer-acting insulin. Consult your pharmacist about which products may be mixed and the proper method for mixing insulin. Never inject a mixture of different insulins into a vein. Do not mix insulins if you are using an insulin pump.

Do not change brands or types of insulin without directions on how to do so from your doctor.

Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.

SIDE EFFECTS: Injection site reactions (e.g., pain, redness, irritation) may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication can cause low blood sugar (hypoglycemia). This effect may occur if you do not consume enough calories (from food, juices, fruit, etc.) or if you have taken too much insulin. The symptoms include chills, cold sweat, blurred vision, dizziness, drowsiness, shaking, fast heartbeat, weakness, headache, fainting, tingling of the hands/feet, and hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, quickly raise your blood sugar level by eating a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or non-diet soda. Tell your doctor immediately about the reaction. To help prevent hypoglycemia, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist about what you should do if you miss a meal.

Too little insulin can cause symptoms of high blood sugar (hyperglycemia). Symptoms include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your dosage may need to be increased.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, fast heartbeat, sweating, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking insulin, tell your doctor or pharmacist if you are allergic to it; or to other types of insulins; or if you have any other allergies.

Do not use this medication when you have low blood sugar (hypoglycemia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, thyroid problems.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels; use caution engaging in activities requiring alertness and clear vision such as driving or using machinery.

Limit alcohol while taking this medication because it can increase the risk of developing hypoglycemia.

During times of stress, such as fever, infection, injury or surgery, it may be more difficult to control your blood sugar. Consult your doctor because a change in your medication or how often you test your blood sugar may be required.

Check your blood sugar readings before and after exercise. You may need a snack beforehand.

If traveling across time zones, ask your doctor about how to adjust your insulin schedule. Take extra insulin and supplies with you.

The elderly may be more sensitive to the effects of this drug, especially hypoglycemia.

Children may be more sensitive to the effects of this drug, especially hypoglycemia. When used in children, diluting insulin before injecting is recommended. Ask your pharmacist about the correct way to dilute insulin.

Tell your doctor if you are pregnant before using this medication. If you are planning pregnancy, discuss a plan for managing your blood sugars with your doctor before you become pregnant. Your doctor may switch the type of insulin you use during pregnancy. Consult your doctor for more details.

This medication does not pass into breast milk. Consult your doctor before breast-feeding. Your insulin needs may change while breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other insulin products (e.g., insulin aspart, NPH), oral diabetes medicine (e.g., glyburide, pioglitazone), ACE inhibitors (e.g., enalapril, lisinopril), clonidine, corticosteroids (e.g., prednisone), danazol, disopyramide, estrogens and progestins (including birth control pills), fibrates (e.g., clofibrate, gemfibrozil), fluoxetine, guanethidine, isoniazid, lithium, MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine), niacin, pentamidine, pentoxifylline, propoxyphene, protease inhibitors (e.g., indinavir, ritonavir), anti-psychotic drugs (e.g., phenothiazines such as chlorpromazine, atypical anti-psychotics such as clozapine and olanzapine), quinolone antibiotics (e.g., ciprofloxacin), reserpine, salicylates (e.g., aspirin), somatropin, sulfa antibiotics (e.g., sulfamethoxazole), sympathomimetic drugs (e.g., albuterol, epinephrine), thyroid medicine, "water pills" (diuretics such as furosemide, hydrochlorothiazide).

Beta-blocker medications (e.g., metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of low blood sugar such as dizziness, hunger, or sweating are unaffected by these drugs.

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that could affect your blood sugar. Ask your pharmacist about the safe use of those products.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include headache, sweating, shakiness, increased hunger, vision changes, nervousness, tiredness, seizures, loss of consciousness.

NOTES: Do not share this medication with others.

It is recommended you attend a diabetes education program to understand diabetes and all the important aspects of its treatment, including meals/diet, exercise, personal hygiene, medications, and getting regular eye, foot and medical exams.

Keep all medical appointments. Laboratory and/or medical tests (e.g., liver and kidney function tests, fasting blood glucose, hemoglobin A1c, complete blood counts) should be performed periodically to monitor for side effects and response to therapy.

Wear or carry identification stating that you have diabetes and are using this drug. See Medical Alert section.

MISSED DOSE: It is very important to follow your insulin regimen exactly. Do not miss any doses of insulin. Discuss specific instructions with your doctor now in case you miss a dose of insulin in the future.

STORAGE: It is best to refrigerate the unopened vial/cartridge between 36-46 degrees F (2-8 degrees C). Unopened insulin may also be stored at room temperature below 86 degrees F (30 degrees C), but in that case it must be discarded after 28 days. Once opened, this medication may be stored in the refrigerator or at room temperature below 86 degrees F (30 degrees C). Discard 28 days after opening. Do not freeze. Discard the insulin if it has been frozen.

If using this drug in an insulin pump, do not store this drug in the pump for more than 48 hours. Doing so may lead to ineffective therapy and high blood sugars. Do not expose the insulin in your pump to direct sunlight or temperatures above 98.6 degrees F (37 degrees C).

Protect insulin from direct sunlight, heat, and moisture. Keep all medicines away from children and pets.

Keep extra supplies of insulin, syringes, and needles on hand.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.