Humulin R

Insulin human · Injection, Solution · Parenteral

Over the counter Insulin

Uses

1 INDICATIONS AND USAGE HUMULIN R is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. HUMULIN ® R is a short-acting human insulin indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 )

Directions

See Full Prescribing Information for important administration instructions. ( 2.1 ) Subcutaneous injection: inject subcutaneously 30 minutes before a meal into the thigh, upper arm, abdomen, or buttocks. Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.2 ) Intravenous infusion: administer intravenously ONLY under medical supervision at concentrations from 0.1 unit/mL to 1 unit/mL in infusion systems containing 0.9% Sodium Chloride Injection. ( 2.2 ) Individualize dose based on route of administration, metabolic needs, blood glucose monitoring results and glycemic control goal. ( 2.3 ) HUMULIN R given by subcutaneous injection should generally be used in regimens with an intermediate- or long-acting insulin. ( 2.3 ) Do not mix with insulin preparations other than HUMULIN ® N. ( 2.5 ) 2.1 Important Administration Instructions Always check the insulin label before administration to confirm the correct insulin product is being used [see Warnings and Precautions ( 5.4 )] . Inspect HUMULIN R visually before use. It should appear clear and colorless. Do not use HUMULIN R if particulate matter or coloration is seen. 2.2 Route of Administration Subcutaneous Injection Inject HUMULIN R subcutaneously approximately 30 minutes before meals into the thigh, upper arm, abdomen, or buttocks. Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6 )] . HUMULIN R may be diluted with Sterile Diluent for HUMULIN R for subcutaneous injection ONLY under medical supervision. Dilute one part HUMULIN R to nine parts diluent to yield a concentration one-tenth that of HUMULIN R (equivalent to U-10). Dilute one part HUMULIN R to one part diluent to yield a concentration one-half that of HUMULIN R (equivalent to U-50). Diluted HUMULIN R may be used for 28 days when stored at 41°F (5°C) or for 14 days when stored at 86°F (30°C). Intravenous Administration Administer HUMULIN R intravenously ONLY under medical supervision with close monitoring of blood glucose and potassium levels to reduce the risk of hypoglycemia and hypokalemia [see Warnings and Precautions ( 5.3 , 5.6 )] . For intravenous use, HUMULIN R should be used at concentrations from 0.1 unit/mL to 1 unit/mL in infusion systems containing 0.9% Sodium Chloride Injection. Intravenous infusion bags prepared with HUMULIN R are stable when stored in a refrigerator (36° to 46°F [2° to 8°C]) for 48 hours and then may be used at room temperature for up to an additional 48 hours. 2.3 Dosing Instructions Individualize and adjust the dosage of HUMULIN R based on the route of administration, the patient's metabolic needs, blood glucose monitoring results, and glycemic control goal. HUMULIN R given by subcutaneous injection should generally be used in regimens with an intermediate- or long-acting insulin. During changes to a patient's insulin regimen, increase the frequency of blood glucose monitoring [see Warnings and Precautions ( 5.2 )] . Dosage adjustments may be needed with changes in physical activity, changes in meal patterns (e.g., macronutrient content or timing of food intake), changes in renal or hepatic function, or during acute illness [see Warnings and Precautions ( 5.2 , 5.3 ), Use in Specific Populations ( 8.6 , 8.7 )] . Dosage adjustment may be needed when changing from another insulin to HUMULIN R [see Warnings and Precautions ( 5.2 )] . 2.4 Dosage Adjustment due to Drug Interactions Dosage adjustment may be needed when HUMULIN R is co-administered with certain drugs [see Drug Interactions ( 7 )] . 2.5 Instructions for Mixing with Other Insulins for Subcutaneous Injection Do not mix HUMULIN R with insulin preparations other than HUMULIN N. To mix HUMULIN R and HUMULIN N, draw HUMULIN R into the syringe first. Inject immediately after mixing.

Other information

Storage Not in-use (unopened): Humulin R 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 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 U-100. Admixture: Infusion bags prepared with Humulin R 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 U-100 after the expiration date stamped on the label or if it has been frozen.

Label text from the FDA structured product label by A-S Medication Solutions (revised Oct 31, 2023). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Insulin Human in 1 product

Humulin R NDC products (1)

NDC	Strength & form	Labeler	Type
50090-0353	Insulin Human 100 [iU]/mL Injection, Solution	A-S Medication Solutions	BLA

Frequently asked questions

What is Humulin R used for?

Who makes Humulin R?

Humulin R is listed by 1 labeler in the FDA NDC directory, including A-S Medication Solutions.