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Humulin R

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Humulin R

INDICATIONS

Humulin R (insulin (human recombinant)) U-100 is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 1 and type 2 diabetes mellitus.

Humulin R (insulin (human recombinant)) U-100 may be administered intravenously under proper medical supervision in a clinical setting for glycemic control (see DOSAGE AND ADMINISTRATION and Storage).

DOSAGE AND ADMINISTRATION

Humulin R (insulin (human recombinant)) U-100, when used subcutaneously, is usually given three or more times daily before meals. The dosage and timing of Humulin R (insulin (human recombinant)) U-100 should be individualized and determined, based on the physician's advice, in accordance with the needs of the patient. Humulin R (insulin (human recombinant)) U-100 may also be used in combination with oral antihyperglycemic agents or longer-acting insulin products to suit the needs of the individual patients with diabetes. The injection of Humulin R (insulin (human recombinant)) U-100 should be followed by a meal within approximately 30 minutes of administration.

The average range of total daily insulin requirement for maintenance therapy in insulin-treated patients without severe insulin resistance lies between 0.5 and 1 unit/kg/day. However, in prepubertal children it usually varies from 0.7 to 1 unit/kg/day, but can be much lower during the period of partial remission. In situations of insulin resistance, e.g. during puberty or due to obesity, the daily insulin requirement may be substantially higher. Initial dosages for patients with diabetes are often lower, e.g., 0.2 to 0.4 units/kg/day.

Humulin R (insulin (human recombinant)) U-100 may be administered by subcutaneous injection in the abdominal wall, the thigh, the gluteal region or in the upper arm. Subcutaneous injection into the abdominal wall ensures a faster absorption than from other injection sites. Injection into a lifted skin fold minimizes the risk of intramuscular injection. Injection sites should be rotated within the sameregion. As with all insulin, the duration of action will vary according to the dose, injection site, blood flow, temperature, and level of physical activity.

Intravenous administration of Humulin R (insulin (human recombinant)) U-100 is possible under medical supervision with close monitoring of blood glucose and potassium levels to avoid hypoglycemia and hypokalemia.

For intravenous use, Humulin R (insulin (human recombinant)) U-100 should be used at concentrations from 0.1 unit/mL to 1 unit/mL in infusion systems with the infusion fluids 0.9% sodium chloride using polyvinyl chloride infusion bags.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Never use Humulin R (insulin (human recombinant)) U-100 if it has become viscous (thickened) or cloudy; use it only if it is clear and colorless. Humulin R (insulin (human recombinant)) U-100 should not be used after the printed expiration date.

Mixing of Insulins

  • Humulin R (insulin (human recombinant)) U-100 should only be mixed as directed by the physician
  • Humulin R (insulin (human recombinant)) U-100 is short-acting and is often used in combination with intermediate- or long-acting insulins.
  • The order of mixing and brand or model of syringe should be specified by the physician. A U-100 insulin syringe should always be used. Failure to use the correct syringe can lead to dosage errors.
  • In general, when an intermediate-acting insulin (e.g., NPH insulin isophane suspension) is mixed with short-acting soluble insulin (e.g., regular), the short-acting insulin should be drawn into the syringe first.

Storage

Not in-use (unopened): Humulin R (insulin (human recombinant)) U-100 vials not in-use should be stored in a refrigerator (2° to 8°C [36° to 46°F]), but not in the freezer.

In-use (opened): The Humulin R (insulin (human recombinant)) U-100 vial currently in-use can be kept unrefrigerated as long as it is kept as cool as possible [below 30°C (86°F)] away from heat and light. In-use vials must be used within 31 days or be discarded, even if they still contain Humulin R (insulin (human recombinant)) U-100.

Admixture: Infusion bags prepared with Humulin R (insulin (human recombinant)) U-100 as indicated under DOSAGE AND ADMINISTRATION are stable when stored in a refrigerator (2° to 8°C [36° to 46°F]) for 48 hours and then may be used at room temperature for up to an additional 48 hours.

Do not use Humulin R (insulin (human recombinant)) U-100 after the expiration date stamped on the label or if it has been frozen.

HOW SUPPLIED

Humulin R (insulin (human recombinant)) U-100, Regular, insulin human injection, USP (rDNA origin), 100 units/mL, is supplied as follows:

10 mL vials NDC 0002-8215-01 (HI-210)
3 mL vials NDC 0002-8215-17 (HI-213)

Literature issued March, 2011. Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA

Last reviewed on RxList: 5/12/2011
This monograph has been modified to include the generic and brand name in many instances.

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