Generic
Insulin Degludec + Insulin Aspart Premixed
1 brands available in the market
At a glance
Insulin Degludec + Insulin Aspart Premixed is used to improve glycemic control in patients 1 year of age and older with diabetes mellitus.
Description
Insulin Degludec + Insulin Aspart Premixed is a soluble insulin product consisting of basal insulin degludec and rapid-acting prandial insulin aspart. It can be administered once- or twice-daily with the main meal(s). Insulin degludec and insulin aspart bind specifically to the human insulin receptor and result in the same pharmacological effects as human insulin.
Indications
- Improvement of glycemic control in patients 1 year of age and older with diabetes mellitus
Therapeutic class
Combination Insulin
Pharmacological class
Basal + Prandial Insulin Analog
Pharmacology
Insulin degludec and insulin aspart bind specifically to the human insulin receptor and result in the same pharmacological effects as human insulin. The blood glucose-lowering effect of insulin is due to the facilitated uptake of glucose following the binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
Mechanism of action
Lowers blood glucose by binding to insulin receptors, facilitating glucose uptake in muscle and fat cells, and inhibiting glucose output from the liver.
Dosage
Adult Dose (Subcutaneous):
- Type 2 Diabetes: Recommended total daily starting dose: 10 units with meal(s), followed by individual dosage adjustments
- Type 1 Diabetes: Recommended starting dose: 60-70% of the total daily insulin requirements
- Administered once- or twice-daily with the main meal(s)
- Dose-adjustments recommended to be primarily based on fasting plasma glucose measurements
Child Dose: Safety and efficacy not established in children and adolescents
Administration
Administer once- or twice-daily with the main meal(s) as subcutaneous injection; can change time of administration when needed (dose with largest meal when taken once daily); in type 2 diabetes can be alone or in combination with oral anti-diabetic products or bolus insulin; in type 1 diabetes combined with short-/rapid-acting insulin at remaining meals.
Missed dose
If you miss a dose, please consult your doctor.
Side effects
Side Effects:
- Hypoglycemia
- Allergic reactions
- Injection site reactions
- Lipodystrophy
- Pruritus
- Rash
- Edema
- Weight gain
Precautions & warnings
Precautions:
- Hypoglycemia: Omission of meal or unplanned strenuous physical exercise may lead to hypoglycemia; may occur if insulin dose is too high
- Hyperglycemia: Inadequate dosing and/or discontinuation of treatment may lead to hyperglycemia and potentially diabetic ketoacidosis
- Eye disorder: Intensification of insulin therapy with abrupt improvement may be associated with temporary worsening of diabetic retinopathy
- Avoidance of accidental mix-ups: Always check insulin label before each injection
- Older patients (>65 years): Can be used; glucose monitoring intensified and dose adjusted on individual basis
Contraindications
Contraindications:
- Hypersensitivity to active substances or any excipients
Drug interactions
There are no known drug interactions and none well documented.
Food interactions
No food interaction found/established.
Use in pregnancy
Use in Pregnancy: Category C; animal studies have shown adverse effect on fetus; no adequate human studies; potential benefits may warrant use despite potential risks.
Pregnancy Category: C — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: No data on presence of insulin degludec in human milk, effects on breastfed infant, or effects on milk production; present in rat milk; insulin aspart present in human milk in one small study; insufficient information to determine effects on breastfed infant.
Pediatric use
Safety and efficacy not established in children and adolescents; has been administered to children and adolescents up to 18 years for pharmacokinetic investigation.
Geriatric use
Can be used in older patients (>65 years); glucose monitoring intensified and dose adjusted on individual basis.
Renal / hepatic impairment
Renal Impairment: Can be used in renal impaired patients; glucose monitoring intensified and dose adjusted on individual basis.
Hepatic Impairment: Can be used in hepatic impaired patients; glucose monitoring intensified and dose adjusted on individual basis.
Overdose effects
No information on overdose; do not exceed recommended dose.
Storage conditions
Store in a cool & dry place, protected from light; keep out of reach of children.
Chemical structure
Insulin Degludec + Insulin Aspart Premixed