Apidra SoloStar cartridges in syringe pens 100 Edl 3 ml, 5 pcs.

Composition

1 ml contains insulin glulisine 100 units (3.49 mg);

excipients:

metacresol (m-cresol),

trometamol,

sodium chloride,

polysorbate 20,

sodium hydroxide,

hydrochloric acid,

d/i water.

Pharmacological action

Hypoglycemic drug. Insulin glulisine is a recombinant analog of human insulin, which is equivalent in action to ordinary human insulin.

The effect of insulin glulisine occurs faster, and the duration of action is shorter than that of standard human insulin. The mechanism of action of insulin glulisine is to regulate glucose metabolism.

Insulin preparations lower blood glucose levels by stimulating peripheral glucose uptake, especially by skeletal muscle and adipose tissue, and by suppressing liver glucose production.

Insulin suppresses lipolysis in adipocytes, suppresses proteolysis, and stimulates protein synthesis. With subcutaneous administration, the effect of insulin glulisine begins much earlier and lasts shorter compared to human insulin preparations: its hypoglycemic activity begins after 10-20 minutes.

Hypoglycemic effects of insulin glulisine and human insulin are equivalent when administered intravenously. One unit of insulin glulisine has the same hypoglycemic effect as one unit of human insulin.

Indications

Treatment of diabetes mellitus in adults, adolescents and children aged 6 years and older, when insulin therapy is necessary.

Use during pregnancy and lactation

There is insufficient information on the use of insulin glulisine in pregnant women.

Animal reproductive studies have not shown any differences between insulin glulisine and human insulin in terms of pregnancy, fetal/fetal development, delivery, and postnatal development.

Caution should be exercised when prescribing Apidra SoloStar to pregnant women. Careful monitoring of blood glucose levels is required. Patients with pre-pregnancy or gestational diabetes mellitus should maintain optimal metabolic control throughout pregnancy.

During the first trimester of pregnancy, the need for insulin may decrease, and during the second and third trimesters, it may usually increase. Immediately after delivery, the need for insulin decreases rapidly. Nursing mothers may need to adjust their insulin doses and diet.

Contraindications

Hypersensitivity to insulin glulisine or to any of the components of the drug; Hypoglycemia.

Use with caution in pregnant women.

Side effects

Hypoglycemia is the most common undesirable effect of insulin therapy, which can occur if too high doses of insulin are used, exceeding the need for it.

The adverse reactions associated with drug administration observed in clinical trials are listed below by organ system and in order of decreasing frequency of occurrence. In the description of the frequency of occurrence of the following criteria are used: very often – > 10%; often – > 1% < 10%; sometimes > 0.1% and < 1%; rarely > 0.01% and < 0.1%; very rarely – < 0.01%.

From the side of metabolism: very often – hypoglycemia. Symptoms of hypoglycemia usually occur suddenly. However, usually neuropsychiatric disorders associated with neuroglycopenia (feeling tired, unusual fatigue or weakness, decreased ability to concentrate, drowsiness, visual disturbances, headache, nausea, confusion or loss of consciousness, convulsive syndrome) are preceded by symptoms of adrenergic counterregulation (activation of the sympathoadrenal system in response to hypoglycemia): hunger, irritability, nervous excitement or tremor, restlessness, pallor of the skin, “cold” sweat, tachycardia, pronounced heartbeat (the faster hypoglycemia develops and the more severe it is, the more pronounced the symptoms of adrenergic counterregulation).

Attacks of severe hypoglycemia, especially repeated ones, can lead to damage to the nervous system. Episodes of prolonged and severe hypoglycemia can endanger patients ‘ lives, as if hypoglycemia increases, even death is possible.

Local reactions: often – local hypersensitivity reactions (hyperemia, swelling and itching at the injection site). These reactions are usually transient and disappear with continued treatment; rarely-lipodystrophy (as a result of a violation of the alternation of places of administration of insulin in any of the areas /administration of the drug in the same place/). Allergic reactions: sometimes – hives, chest tightness, bronchospasm, allergic dermatitis, itching. Severe cases of generalized allergic reactions (including anaphylactic reactions) can be life-threatening.

Interaction

No pharmacokinetic interaction studies have been conducted. Based on the available empirical knowledge regarding other similar drugs, the occurrence of a clinically significant pharmacokinetic interaction is unlikely.

Certain substances may affect glucose metabolism, which may require adjustment of insulin glulisine doses and especially careful monitoring of treatment. Substances that can increase the hypoglycemic effect of insulin and increase the predisposition to hypoglycemia include: oral hypoglycemic agents, angiotensin-converting enzyme inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, propoxyphene, salicylates and sulfonamide antimicrobials. Substances that may reduce the hypoglycemic effect of insulin include: corticosteroids, danazol, diazoxide, diuretics, isoniazid, phenothiazine derivatives, somatropin, sympathomimetics (e. g. epinephrine (epinephrine), salbutamol, terbutaline), thyroid hormones, estrogens, progestins (e. g. in oral contraceptives), protease inhibitors, and antipsychotic medications (for example, olanzapine and clozapine).

How to take, course of administration and dosage

N / a, shortly (0-15 minutes) before or shortly after a meal.

Apidra SoloStar should be used in treatment regimens that include either medium-acting insulin, long-acting insulin, or a long-acting insulin analog.

In addition, the drug Apidra SoloStar can be used in combination with oral hypoglycemic agents.

The dosage regimen of Apidra SoloStar is selected individually.

Overdose

Symptoms: there are no specific data on insulin glulisine overdose; hypoglycemia of varying severity may develop.

Treatment: episodes of mild hypoglycemia can be stopped by taking glucose or foods containing sugar. Therefore, it is recommended that patients with diabetes always have sugar cubes, candy, cookies or sweet fruit juice with them.

Episodes of severe hypoglycemia, during which the patient loses consciousness, can be stopped by intravenous or subcutaneous administration of 0.5-1 mg of glucagon or intravenous administration of dextrose (glucose). If the patient does not respond to the introduction of glucagon for 10-15 minutes, it is also necessary to introduce intravenous dextrose.

After regaining consciousness, it is recommended to give the patient carbohydrates inside to prevent the recurrence of hypoglycemia. After administration of glucagon, the patient should be monitored in a hospital to determine the cause of this severe hypoglycemia and prevent the development of other similar episodes.

Special instructions

The transfer of a patient to a new type of insulin or insulin from another manufacturer should be carried out under strict medical supervision, since it may be necessary to change the dose due to changes in the concentration of insulin, brand (manufacturer), type of insulin (soluble, insulin-isophane, etc. ), type of insulin (animal origin) and/or method of production.

In addition, it may be necessary to adjust the concomitant oral hypoglycemic therapy.

The use of inadequate insulin doses or discontinuation of treatment, especially in patients with type 1 diabetes, can lead to the development of hyperglycemia and diabetic ketoacidosis – conditions that are potentially life-threatening.

Form of production

Solution for subcutaneous administration

Storage conditions

Store in a dark place, at a temperature of 2-8 °C (do not freeze)

Shelf life

2 years

Active ingredient

Insulin glulisine

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Purpose

Children as prescribed by a doctor, Children over 6 years of age, Adults as prescribed by a doctor

Indications

Type 2 Diabetes, Type 1 Diabetes

Weight

Weight: 169 g.