HUMULIN R 100 [iU]/mL
Insulin human · INJECTION, SOLUTION · A-S Medication Solutions
HUMULIN R is a injection, solution containing insulin human at 100 [iU]/mL, taken parenteral. Manufactured by A-S Medication Solutions.
Key Facts
- Brand Name
- HUMULIN R
- Generic Name
- Insulin human
- NDC Code (Product)
50090-0353- Manufacturer
- A-S Medication Solutions
- Strength
- 100 [iU]/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- PARENTERAL
- Marketing Status
- Application #
- BLA018780
- Drug Class
- Insulin [EPC]
- Marketing Start
- 06/27/1983
Recall History
Eli Lilly & Company
CGMP Deviations
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Side 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 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 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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.…
Contraindications
4 CONTRAINDICATIONS HUMULIN R is contraindicated: during episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] in patients with hypersensitivity to HUMULIN R 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 or any of its excipients. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Table 1: Clinically Significant Drug Interactions with HUMULIN R 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 is co-administered with these drugs. Drugs that May Decrease the Blood Glucose Lowering Effect of HUMULIN R 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 is co-administered with these drugs. Drugs that May Increase or Decrease the Blood Glucose Lowering Effect of HUMULIN R Drugs: Alcohol, …
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere in the labeling: Hypoglycemia [see Warnings and Precautions ( 5.3 )] Hypoglycemia Due to Medication Errors [see Warnings and Precautions ( 5.4 )] Hypersensitivity [see Warnings and Precautions ( 5.5 )] Hypokalemia [see Warnings and Precautions ( 5.6 )] Adverse reactions observed with HUMULIN R include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, weight gain, edema, 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. Adverse Reactions from Clinical Studies or Postmarketing Reports The following additional adverse reactions have been identified during clinical studies or from postmarketing reports with use of HUMULIN R. Because some of 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 insulin initiation and glucose control intensification Intensification or rapid improveme…
Frequently Asked Questions
What is HUMULIN R used for?
HUMULIN R contains Insulin human. It is a injection, solution taken parenteral. Consult your doctor for specific uses.
Is HUMULIN R a controlled substance?
HUMULIN R is not classified as a controlled substance by the DEA.
What is the generic name for HUMULIN R?
The generic name for HUMULIN R is Insulin human. There are 11 other brand versions of Insulin human.
What is the NDC code for HUMULIN R 100 [iU]/mL?
The NDC (National Drug Code) for HUMULIN R 100 [iU]/mL is 50090-0353, listed by A-S Medication Solutions.