Generic
Insulin Degludec + Insulin Aspart Premixed
Indications
Insulin degludec (a long-acting human insulin analog) and insulin aspart (a rapid-acting human insulin analog) indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus
Pharmacology
Insulin degludec and insulin aspart binds specifically to the human insulin receptor and results 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.
Dosage Administration
This is a soluble insulin product consisting of the basal insulin degludec and the rapid-acting prandial insulin aspart. This is to be dosed in accordance with the individual patient's needs. Dose-adjustments are recommended to be primarily based on fasting plasma glucose measurements. Patients with type 2 diabetes mellitus: The recommended total daily starting dose is 10 units with meal(s) followed by individual dosage adjustments. Patients with type 1 diabetes mellitus: The recommended starting dose is 60-70% of the total daily insulin requirements. This is to be used once-daily at meal-time in combination.
Contraindications
Hypersensitivity to the active substances or to any of the excipients.
Side Effects
Hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema and weight gain
Pregnancy And Lactation
Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks There are no data on the presence of insulin degludec in human milk, the effects on the breastfed infant, or the effect on milk production. Insulin degludec is present in rat milk. One small published study reported that exogenous nsulin, including insulin aspart, was present in human milk. However, there is insufficient information to determine the effects of insulin aspart on the breastfed infant and no available information on the effects of insulin aspart on milk production.
Therapeutic
Combination Insulin
Over The Counter Products
