Insulin Degludec 200 U/mL
insulin degludec · INJECTION, SOLUTION · A-S Medication Solutions
Insulin Degludec is a injection, solution containing insulin degludec at 200 U/mL, taken subcutaneous. Manufactured by A-S Medication Solutions.
Key Facts
- Brand Name
- Insulin Degludec
- Generic Name
- insulin degludec
- NDC Code (Product)
50090-7175- Manufacturer
- A-S Medication Solutions
- Strength
- 200 U/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA203314
- Drug Class
- Insulin Analog [EPC]
- Marketing Start
- 07/01/2022
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.
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 Degludec is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Limitations of Use • Not recommended for the treatment of diabetic ketoacidosis. Insulin Degludec is a long-acting human insulin analog indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus ( 1 ). Limitations of Use: • Not recommended for the treatment of diabetic ketoacidosis.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • See Full Prescribing Information for important administration instructions ( 2.1 ). • Inject Insulin Degludec subcutaneously into the thigh, upper arm, or abdomen ( 2.1 ). • Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis ( 2.1 ). • For pediatric patients requiring less than 5 units of Insulin Degludec each day, use an Insulin Degludec U-100 vial ( 2.1 ). • In adults, inject subcutaneously once daily at any time of day ( 2.2 ). • In pediatric patients inject subcutaneously once daily at the same time every day ( 2.2 ). • Individualize dose based on type of diabetes, metabolic needs, blood glucose monitoring results and glycemic control goal ( 2.2 ). • The recommended days between dose increases are 3 to 4 days ( 2.2 ). • See Full Prescribing Information for recommended starting dose in insulin naïve patients and patients already on insulin therapy ( 2.3 , 2.4 ). 2.1 Important Administration Instructions • Always check insulin labels before administration. This product is Tresiba (insulin degludec) [see Warnings and Precautions ( 5.4 ) ] . • Inspect visually for particulate matter and discoloration. Only use In…
Contraindications
4 CONTRAINDICATIONS Insulin Degludec is contraindicated: • During episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] . • In patients with hypersensitivity to insulin degludec or any of the excipients in Insulin Degludec [see Warnings and Precautions ( 5.5 )] . • During episodes of hypoglycemia ( 4 ). • Hypersensitivity to insulin degludec or any of the excipients in Insulin Degludec ( 4 ).
Drug Interactions
7 DRUG INTERACTIONS Table 5 includes clinically significant drug interactions with Insulin Degludec. Table 5: Clinically Significant Drug Interactions with Insulin Degludec 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 analogs (e.g., octreotide), and sulfonamide antibiotics, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors. Intervention: Dosage reductions and increased frequency of glucose monitoring may be required when Insulin Degludec is co-administered with these drugs. Drugs That May Decrease the Blood Glucose Lowering Effect of Insulin Degludec 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: Dosage increases and increased frequency of glucose monitorin…
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 commonly associated with Insulin Degludec are: • hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain ( 6.1 ). 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 Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Insulin Degludec in subjects with type 1 diabetes or type 2 diabetes was evaluated in nine trials of 6-12 month duration in adults and in one trial of 12-month duration in pediatric patients 1 year of age and older with type 1…
Frequently Asked Questions
What is Insulin Degludec used for?
Insulin Degludec contains insulin degludec. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is Insulin Degludec a controlled substance?
Insulin Degludec is not classified as a controlled substance by the DEA.
What is the generic name for Insulin Degludec?
The generic name for Insulin Degludec is insulin degludec. There are 7 other brand versions of insulin degludec.
What is the NDC code for Insulin Degludec 200 U/mL?
The NDC (National Drug Code) for Insulin Degludec 200 U/mL is 50090-7175, listed by A-S Medication Solutions.