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.
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.
Blood and urine glucose, glycohemoglobin, and urine ketones should be monitored frequently.
The concurrent use of oral hypoglycemic agents with Humulin R (U–500) is not recommended since there are no data to support such use.
Insulin requirements may be increased by medications with hyperglycemic activity such as corticosteroids, isoniazid, certain lipid-lowering drugs (e.g., niacin), estrogens, oral contraceptives, phenothiazines, and thyroid replacement therapy (see CLINICAL PHARMACOLOGY).
Insulin requirements may be decreased in the presence of drugs that increase insulin sensitivity or have hypoglycemic activity, such as oral antidiabetic agents, salicylates, sulfa antibiotics, certain antidepressants (monoamine oxidase inhibitors), angiotensin-converting-enzyme inhibitors, angiotensin II receptor blocking agents, beta-adrenergic blockers, inhibitors of pancreatic function (e.g., octreotide), and alcohol. Beta-adrenergic blockers may mask the symptoms of hypoglycemia in some patients.
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.
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.
There are no special precautions relating to the use of this insulin formulation in the pediatric age group.