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Humulin (Insulin Human Recombinant) - Warnings and Precautions



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.

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

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.

Page last updated: 2006-02-06

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