Insulin Aspart 100 [iU]/mL
insulin aspart · INJECTION, SOLUTION · Novo Nordisk Pharma, Inc.
Insulin Aspart is a injection, solution containing insulin aspart at 100 [iU]/mL, taken intravenous. Manufactured by Novo Nordisk Pharma, Inc..
Key Facts
- Brand Name
- Insulin Aspart
- Generic Name
- insulin aspart
- NDC Code (Product)
73070-102- Manufacturer
- Novo Nordisk Pharma, Inc.
- Strength
- 100 [iU]/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS, SUBCUTANEOUS
- Marketing Status
- Application #
- BLA020986
- Drug Class
- Insulin Analog [EPC]
- Marketing Start
- 08/27/2001
Recall History
Novo Nordisk Inc
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Novo Nordisk Inc
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Novo Nordisk Inc
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Novo Nordisk Inc
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Novo Nordisk Inc
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
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 Insulin Aspart Protamine and Insulin Aspart Mix 70/30 is a mixture of insulin aspart protamine and insulin aspart indicated to improve glycemic control in adult patients with diabetes mellitus. Limitations of Use: • Insulin Aspart Protamine and Insulin Aspart Mix 70/30 is not recommended for the treatment of diabetic ketoacidosis. • The proportions of rapid-acting and long-acting insulins in Insulin Aspart Protamine and Insulin Aspart Mix 70/30 are fixed and do not allow for basal versus prandial dose adjustments. Insulin Aspart Protamine and Insulin Aspart Mix 70/30 is a mixture of insulin aspart protamine, an intermediate-acting human insulin analog, and insulin aspart, a rapid-acting human insulin analog, indicated to improve glycemic control in adult patients with diabetes mellitus. Limitations of Use: • Not recommended for the treatment of diabetic ketoacidosis. • The proportions of rapid-acting and long-acting insulins are fixed and do not allow for basal versus prandial dose adjustments (1) .
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Inspect visually before use. Appearance should be uniformly white and cloudy. Do not use it if it looks clear or if it contains solid particles ( 2.1 ). • Insulin Aspart Protamine and Insulin Aspart Mix 70/30 must be resuspended immediately before use. Resuspension is easier when the insulin has reached room temperature ( 2.1 ). • Inject Insulin Aspart Protamine and Insulin Aspart Mix 70/30 subcutaneously in the abdominal region, buttocks, thigh, or upper arm (2.1). • Administer the dose within 15 minutes before meal initiation. For patients with type 2 diabetes, the dose may also be given after meal initiation ( 2.1 ). • Rotate injection sites within the same region from one injection to the next to reduce risk of lipodystrophy and localized cutaneous amyloidosis (2.1) . • Do not administer intravenously or use in insulin infusion pumps ( 2.1 ). • Insulin Aspart Protamine and Insulin Aspart Mix 70/30 is typically dosed twice-daily (with each dose intended to cover 2 meals or a meal and a snack) (2.2) . • Individualize dosage based on metabolic needs, blood glucose monitoring results, glycemic control goal ( 2.2 ). • Dosage adjustments may be needed wi…
Contraindications
4 CONTRAINDICATIONS Insulin Aspart Protamine and Insulin Aspart Mix 70/30 is contraindicated: • During episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] • In patients with hypersensitivity to Insulin Aspart Protamine and Insulin Aspart Mix 70/30 or one 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 Insulin Aspart Protamine and Insulin Aspart Mix 70/30 or one of its excipients (4) .
Drug Interactions
7 DRUG INTERACTIONS The table below presents clinically significant drug interactions with Insulin Aspart Protamine and Insulin Aspart Mix 70/30 Table 3: Clinically Significant Drug Interactions with Insulin Aspart Protamine and Insulin Aspart Mix 70/30 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 Insulin Aspart Protamine and Insulin Aspart is concomitantly administered with these drugs. Drugs that May Decrease the Blood Glucose Lowering Effect of Insulin Aspart Protamine and Insulin Aspart 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 hormo…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere: • 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 observed with insulin therapy include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash and pruritus (6) . To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Pharma, Inc. at 1-800-727-6500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Clinical trials are conducted under widely varying designs, therefore, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice. The data in: • Table 1 reflects the exposure of 55 patients with type 1 diabetes to Insulin Aspart Protamine and Insulin Aspart Mix 70/30 (referred to as Insulin Aspart Protamine and Insulin Aspart ) with a mean exposure duration of three months. The mea…
Frequently Asked Questions
What is Insulin Aspart used for?
Insulin Aspart contains insulin aspart. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Insulin Aspart a controlled substance?
Insulin Aspart is not classified as a controlled substance by the DEA.
What is the generic name for Insulin Aspart?
The generic name for Insulin Aspart is insulin aspart. There are 10 other brand versions of insulin aspart.
What is the NDC code for Insulin Aspart 100 [iU]/mL?
The NDC (National Drug Code) for Insulin Aspart 100 [iU]/mL is 73070-102, listed by Novo Nordisk Pharma, Inc..
Other Insulin Aspart Dosages
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- NovoLog Mix 70/30100 [iU]/mL70518-2119
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- Fiasp100 [iU]/mL0169-3206
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)