Drugplain

NOVOLOG 100 [iU]/mL

insulin aspart · INJECTION, SOLUTION · A-S Medication Solutions

2 Recalls on RecordCurrently in Shortage
Plain English

NOVOLOG is a injection, solution containing insulin aspart at 100 [iU]/mL, taken intravenous. Manufactured by A-S Medication Solutions.

Key Facts

Brand Name
NOVOLOG
Generic Name
insulin aspart
NDC Code (Product)
50090-1678
Manufacturer
A-S Medication Solutions
Strength
100 [iU]/mL
Dosage Form
INJECTION, SOLUTION
Route
INTRAVENOUS, SUBCUTANEOUS
Marketing Status
Application #
BLA020986
Drug Class
Insulin Analog [EPC]
Marketing Start
01/22/2003

Recall History

2 Recalls on Record
Class I03/22/2021

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.

TerminatedVoluntary: Firm initiated
Class I03/22/2021

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.

TerminatedVoluntary: Firm initiated

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE NOVOLOG is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. NOVOLOG is rapid acting human insulin analog 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 preparation, administration, and dosage instructions ( 2.1, 2.2, 2.3, 2.4, 2.5 ). • Subcutaneous injection ( 2.2 ): o Inject subcutaneously within 5-10 minutes before a meal into the abdominal area, thigh, buttocks or upper arm. o Rotate injection sites within the same region from one injection to the next to reduce risk of lipodystrophy and localized cutaneous amyloidosis. o Should generally be used in regimens with an intermediate- or long-acting insulin. • Continuous Subcutaneous Infusion (Insulin Pump) ( 2.2 ): o Refer to the insulin infusion pump user manual to see if NOVOLOG can be used. Use in accordance with the insulin pump instructions for use. o Administer by continuous subcutaneous infusion using an insulin pump in a region recommended in the instructions from the pump manufacturer. o Rotate the injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy and localized cutaneous amyloidosis. o Do not mix with other insulins or diluents in the pump. • Intravenous Administration ( 2.2 ) : o Dilute NOVOLOG to concentrations from 0.05 unit/mL to 1 unit/mL …

Contraindications

4 CONTRAINDICATIONS NOVOLOG is contraindicated: • During episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] • In patients with hypersensitivity to NOVOLOG or one of its excipients, [see Warnings and Precautions ( 5.5 )] • During episodes of hypoglycemia ( 4 ). • Hypersensitivity to NOVOLOG or one of its excipients.

Drug Interactions

7 DRUG INTERACTIONS The table below presents clinically significant drug interactions with NOVOLOG. 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 NOVOLOG is concomitantly administered with these drugs. Drugs That May Decrease the Blood Glucose Lowering Effect of NOVOLOG 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 NOVOLOG is concomitantly administered with these drugs. Drugs That May Increase or Decrease the Blood Glucose Lowering Effe…

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 NOVOLOG include: hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc. at 1-800-727-6500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying designs, 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 safety of NOVOLOG was evaluated in two treat-to-target trials of 6 months duration, conducted in patients with type 1 diabetes or type 2 diabetes [see Clinical Studies (14) ]. The data in Table 1 reflect the exposure of 596 patients with type 1 diabetes to NOVOLOG in …

Frequently Asked Questions

What is NOVOLOG used for?

NOVOLOG contains insulin aspart. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is NOVOLOG a controlled substance?

NOVOLOG is not classified as a controlled substance by the DEA.

What is the generic name for NOVOLOG?

The generic name for NOVOLOG is insulin aspart. There are 11 other brand versions of insulin aspart.

What is the NDC code for NOVOLOG 100 [iU]/mL?

The NDC (National Drug Code) for NOVOLOG 100 [iU]/mL is 50090-1678, listed by A-S Medication Solutions.

Product NDC

50090-1678

Package NDC

50090-1678-0

Other NOVOLOG Dosages

Other Insulin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)