Novolin N 100 [iU]/mL
Human Insulin · INJECTION, SUSPENSION · Novo Nordisk
Novolin N is a injection, suspension containing human insulin at 100 [iU]/mL, taken subcutaneous. Manufactured by Novo Nordisk.
Key Facts
- Brand Name
- Novolin N
- Generic Name
- Human Insulin
- NDC Code (Product)
0169-3004- Manufacturer
- Novo Nordisk
- Strength
- 100 [iU]/mL
- Dosage Form
- INJECTION, SUSPENSION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA019959
- Drug Class
- Insulin [EPC]
- Marketing Start
- 09/06/2019
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 NOVOLIN N is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. NOVOLIN N is an intermediate-acting human insulin indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • See Full Prescribing Information for important administration instructions. ( 2.1 ) • Inject subcutaneously in abdominal wall, thigh, upper arm, or buttocks and rotate injection sites to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.1 ) • Individualize and adjust dosage based on metabolic needs, blood glucose monitoring results and glycemic control goal. ( 2.2 ) • Administer NOVOLIN N once or twice daily. ( 2.2 ) • In patients with type 1 diabetes, NOVOLIN N should generally be used in regimens that include a short-acting insulin. ( 2.2 ) • NOVOLIN N can be mixed with NOVOLIN R. ( 2.4 ) 2.1 Important Administration Instructions • Always check insulin labels before administration [see Warnings and Precautions ( 5.4 )]. • NOVOLIN N is a suspension that must be resuspended immediately before use. Resuspension is easier when the insulin has reached room temperature. • To resuspend vial, roll the vial gently in your hands in a horizontal position 10 times until the suspension appears uniformly white and cloudy. Inject immediately. • To resuspend FlexPen, gently move the pen up and down 20 times so the glass ball moves from one en…
Contraindications
4 CONTRAINDICATIONS NOVOLIN N is contraindicated: • During episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] • In patients who have hypersensitivity reactions to NOVOLIN N or any of its excipients [see Warnings and Precautions ( 5.5 )] • During episodes of hypoglycemia ( 4 ) • Hypersensitivity to NOVOLIN N or any of its excipients ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Table 1: Clinically Significant Drug Interactions with NOVOLIN N 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 NOVOLIN N is co-administered with these drugs. Drugs that May Decrease the Blood Glucose Lowering Effect of NOVOLIN N 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 NOVOLIN N is co-administered with these drugs. Drugs that May Increase or Decrease the Blood Glucose Lowering Effect of NOVOLIN N 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 Reactions [see Warnings and Precautions ( 5.5 )] • Hypokalemia [see Warnings and Precautions ( 5.6 )] 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 NOVOLIN N. 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 improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. Over the long-term, improved glycemic control decreases the risk of diabetic retinopathy and neuropathy. Hypersensitivity …
Frequently Asked Questions
What is Novolin N used for?
Novolin N contains Human Insulin. It is a injection, suspension taken subcutaneous. Consult your doctor for specific uses.
Is Novolin N a controlled substance?
Novolin N is not classified as a controlled substance by the DEA.
What is the generic name for Novolin N?
The generic name for Novolin N is Human Insulin. There are 5 other brand versions of Human Insulin.
What is the NDC code for Novolin N 100 [iU]/mL?
The NDC (National Drug Code) for Novolin N 100 [iU]/mL is 0169-3004, listed by Novo Nordisk.