Humulin R U-500 500 [iU]/mL
Insulin human · INJECTION, SOLUTION · Eli Lilly and Company
Humulin R U-500 is a fast-acting insulin injection used to help control blood sugar levels in people with diabetes. This concentrated form contains 500 units of insulin per milliliter, making it useful for patients who require large insulin doses.
Key Facts
- Brand Name
- Humulin R U-500
- Generic Name
- Insulin human
- NDC Code (Product)
0002-8501- Manufacturer
- Eli Lilly and Company
- Strength
- 500 [iU]/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA018780
- Drug Class
- Insulin [EPC]
- Marketing Start
- 03/31/1994
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE HUMULIN R U-500 is a concentrated human insulin indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus requiring more than 200 units of insulin per day. HUMULIN ® R U-500 is a concentrated human insulin indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus requiring more than 200 units of insulin per day. ( 1 ) Limitation of Use: The safety and efficacy of HUMULIN R U-500 used in combination with other insulins has not been determined. The safety and efficacy of HUMULIN R U-500 delivered by continuous subcutaneous infusion has not been determined. ( 1.1 ) 1.1 Limitation of Use The safety and efficacy of HUMULIN R U-500 used in combination with other insulins has not been determined. The safety and efficacy of HUMULIN R U-500 delivered by continuous subcutaneous infusion has not been determined.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Adhere to administration instructions to reduce the risk of dosing errors. ( 2.1 , 2.3 , 2.4 , 5.1 ) HUMULIN R U-500 is available as a single-patient-use KwikPen or multiple-dose vial. Patients using the vial must be prescribed the U-500 insulin syringe to avoid medication errors. ( 2.1 ) Individualize dose of HUMULIN R U-500 based on metabolic needs, blood glucose monitoring results and glycemic control goal. ( 2.2 ) Administer HUMULIN R U-500 subcutaneously two or three times daily 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. ( 2.1 , 2.2 ) Do NOT mix HUMULIN R U-500 with other insulins. ( 2.1 ) Do NOT administer HUMULIN R U-500 intravenously ( 2.1 ) Do NOT perform dose conversion when using the HUMULIN R U-500 KwikPen. The dose window of the HUMULIN R U-500 KwikPen shows the number of units of HUMULIN R U-500 to be injected. ( 2.3 ) Do NOT transfer HUMULIN R U-500 from the HUMULIN R U-500 KwikPen into any syringe. ( 2.3 ) Do NOT perform dose conversion when using a U-500 insulin syringe. Use only a U-500 insulin syringe with the HUMU…
Contraindications
4 CONTRAINDICATIONS HUMULIN R U-500 is contraindicated: During episodes of hypoglycemia [see Warnings and Precautions ( 5.4 )] In patients who are hypersensitive to HUMULIN R U-500 or any of its excipients [see Warnings and Precautions ( 5.5 )] Do not use during episodes of hypoglycemia. ( 4 ) Do not use in patients with hypersensitivity to HUMULIN R U-500 or any of its excipients. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Table 1: Clinically Significant Drug Interactions with HUMULIN R U-500 Drugs That May Increase the Risk of Hypoglycemia Drugs : Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), and sulfonamide antibiotics. Intervention : Dose adjustment and increased frequency of glucose monitoring may be required when HUMULIN R U-500 is co-administered with these drugs. Drugs That May Decrease the Blood Glucose Lowering Effect of HUMULIN R U 500 Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. Intervention: Dose adjustment and increased frequency of glucose monitoring may be required when HUMULIN R U-500 is co-administered with these drugs. Drugs That May Increase or Decrease the Blood Glucose Lowering Effect of…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere: Hypoglycemia [see Warnings and Precautions ( 5.4 )] . Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] . Hypokalemia [see Warnings and Precautions ( 5.6 )] . The following additional adverse reactions have been identified during post-approval use of HUMULIN R U-500. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure. Adverse reactions associated with HUMULIN R U-500 include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Hypoglycemia Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including HUMULIN R U-500. Allergic Reactions Severe, life-threatening, generalized allergy, including anaphylaxis, generalized skin reactions, rash, angioedema, bronchospasm, hypotension, and shock may occur with insulins…
Frequently Asked Questions
What is Humulin R U-500 used for?
Humulin R U-500 is a fast-acting insulin injection used to help control blood sugar levels in people with diabetes. This concentrated form contains 500 units of insulin per milliliter, making it useful for patients who require large insulin doses.
Is Humulin R U-500 a controlled substance?
Humulin R U-500 is not classified as a controlled substance by the DEA.
What is the generic name for Humulin R U-500?
The generic name for Humulin R U-500 is Insulin human. There are 11 other brand versions of Insulin human.
What is the NDC code for Humulin R U-500 500 [iU]/mL?
The NDC (National Drug Code) for Humulin R U-500 500 [iU]/mL is 0002-8501, listed by Eli Lilly and Company.