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Humulin (Insulin Human Recombinant) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

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.

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/urine 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 hyperglycemic activity, such as oral contraceptives, corticosteroids, or thyroid replacement therapy. Insulin requirements may be reduced in the presence of drugs with hypoglycemic activity, such as oral hypoglycemics, salicylates (for example, aspirin), sulfa antibiotics, and certain antidepressants. 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 (INSULIN REACTION)

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. Taking too much insulin
  2. Missing or delaying meals
  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 hypoglycemics, salicylates (for example, aspirin), sulfa antibiotics, and certain antidepressants
  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 ACIDOSIS

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 insulin-dependent diabetes, prolonged hyperglycemia can result in diabetic acidosis. The first symptoms of diabetic acidosis 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 acidosis, urine tests show large amounts of glucose and acetone. Heavy breathing and a rapid pulse are more severe symptoms. If uncorrected, prolonged hyperglycemia or diabetic acidosis 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.

HOW SUPPLIED

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

Literature issued August 15, 2000

                                                                            PA 3050 AMP

Copyright © 1996, 2000, Eli Lilly and Company. All rights reserved.

HUMULIN® R
REGULAR
U-500 (CONCENTRATED)
INSULIN HUMAN INJECTION, USP
(RDNA ORIGIN)
INFORMATION FOR THE PATIENT

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, 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.

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 premeal glucose levels are consistently above 140 mg/dL or your hemoglobin A1c(HbA1c) is more than 8%, 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

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