Diabetes mellitus, when it is necessary to use insulin for adults, adolescents and children older than 6 yEars and Nose.
active substance: insulin glulisin;
1 ml of solution contains insulin glulisine (a product of recombinant DNA technology using Escherichia coli) 100 units, equivalent to 3.49 mg;
1 SoloStar® syringe contains 3 ml solution for injection, equivalent to 300 IU insulin glulisine;
Excipients: m-cresol, sodium chloride, tromethamine, polysorbate 20, concentrated hydrochloric acid, sodium hydroxide, water for injections.
Epaidra Dosage form
Solution for injection.
Main physical and chemical properties: clear colorless aqueous solution.
Antidiabetic drugs. Insulins and fast-acting analogues. ATC code A10A B06.
Insulin glulisin is a recombinant analogue of human insulin, which is similar in potency to human insulin. Insulin glulisin acts faster and has a shorter duration of action than simple human insulin.
The main action of insulins and their analogues, including insulin glulisin, is aimed at regulating glucose metabolism. Insulins lower blood glucose levels by stimulating peripheral glucose utilization, especially in skeletal muscle and adipose tissue, and by inhibiting glucose synthesis in the liver. Insulin prevents lipolysis in adipocytes, proteolysis and enhances protein synthesis.
Studies in healthy volunteers and diabetics have shown that subcutaneous administration of insulin glulisine acts faster and has a shorter duration of action than simple human insulin. If insulin glulysin is given by injection subcutaneously, the reduction in glucose levels begins within 10 to 20 minutes. After intravenous administration, the effect of the drug began earlier and lasted less, and the peak of activity was more pronounced than when administered subcutaneously. When administered intravenously, the hypoglycemic effects of insulin glulisine or simple human insulin are equally strong.
Diabetes mellitus, when insulin is required for adults, adolescents and children over 6 years of age.
Hypersensitivity to insulin glulisine or to any component of the drug. Hypoglycemia.
Interaction with other medicinal products and other forms of interaction
No studies on the types of pharmacokinetic interactions have been performed. Given the empirical knowledge of other similar drugs, the manifestation of clinically relevant pharmacokinetic interactions is unlikely.
Glucose metabolism is affected by a number of substances and drugs. Therefore, it may be necessary to adjust the dose of insulin glulisine and especially close monitoring of the patient.
Oral antidiabetic agents, angiotensin-converting enzyme inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, propoxy, and pentoxifylline, propoxyphylline, may increase the glucose-lowering activity and increase the susceptibility to hypoglycemia.
Substances that may reduce the hypoglycemic effect of insulin: corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, phenothiazine derivatives, somatropin, sympathomimetic agents (eg epinephrine, adrenaline), terbubule, salbu as part of oral contraceptives), protease inhibitors and atypical antipsychotic drugs (including olanzapine and clozapine).
Beta-blockers, clonidine, lithium salts or alcohol can both increase and decrease the ability of insulin to lower blood glucose. Pentamidine may cause hypoglycaemia, sometimes accompanied by hyperglycaemia.
In addition, under the influence of sympatholytic drugs such as clonidine, guanethidine, reserpine, and beta-blockers, the signs of adrenergic reverse regulation may be weakened or even absent.