Actrapid HM solution for injection 100IU / ml, 10ml No. 1

Type 1 diabetes mellitus, type 2 diabetes mellitus:

• the stage of resistance to oral hypoglycemic agents;

• diabetic ketoacidosis, diabetic coma;

• diabetes mellitus that occurs during pregnancy (with the ineffectiveness of diet therapy);

• for intermittent use in patients with diabetes mellitus against the background of infections accompanied by high fever;

• with upcoming surgical operations, trauma, childbirth, metabolic disorders, before switching to treatment with prolonged insulin preparations.

The dose and route of administration of the drug are determined individually in each case based on the blood glucose content before meals and 1-2 hours after meals, as well as depending on the degree of glucosuria and the characteristics of the course of the disease.

Enter, as a rule, s / c 15-20 minutes before a meal. The injection sites are changed each time. If necessary, intramuscular or intravenous administration is allowed.

Can be combined with long-acting insulins.

Solution for injection is transparent, colorless.

1 ml 1 fl.

soluble insulin (human genetically engineered) 100 IU *

Excipients: zinc chloride, glycerol, metacresol, sodium hydroxide and / or hydrochloric acid (to maintain the pH level), water d / i.

* 1 IU corresponds to 35 ?g of anhydrous human insulin.

• Hypoglycemia

• hypersensitivity to this insulin.

pharmachologic effect

A hypoglycemic agent, short-acting insulin. Interacting with a specific receptor in the outer membrane of cells, it forms an insulin-receptor complex. By increasing the synthesis of cAMP (in fat cells and liver cells) or directly penetrating into the cell (muscles), the insulin-receptor complex stimulates intracellular processes, incl. synthesis of a number of key enzymes (including hexokinase, pyruvate kinase, glycogen synthetase).

A decrease in the concentration of glucose in the blood is due to an increase in its intracellular transport, an increase in absorption and assimilation by tissues, stimulation of lipogenesis, glycogenesis, protein synthesis, a decrease in the rate of glucose production by the liver (a decrease in the breakdown of glycogen).

The onset of action is after 30 minutes, the maximum effect is after 1-3 hours, the duration of action is 8 hours.

Pharmacokinetics

The degree of absorption depends on the route of administration (s / c, i / m), the site of administration (abdomen, thigh, buttocks), dose, concentration of insulin in the preparation. Distribution in tissues is uneven. Does not penetrate the placental barrier and into breast milk. Destroyed by insulinase, mainly in the liver and kidneys. T1 / 2 up to 10 min. It is excreted by the kidneys - 30-80%.

Side effect

Allergic reactions: urticaria, angioedema, fever, shortness of breath, decreased blood pressure.

From the endocrine system: hypoglycemia with such manifestations as pallor, increased sweating, palpitations, sleep disorders, tremors; neurological disorders; immunological cross-reactions with human insulin; an increase in the titer of anti-insulin antibodies with a subsequent increase in glycemia.

From the side of the organ of vision: transient visual impairment (usually at the beginning of therapy).

Local reactions: hyperemia, itching and lipodystrophy (atrophy or hypertrophy of subcutaneous adipose tissue) at the injection site.

Others: at the beginning of treatment, swelling is possible (disappear with continued treatment).

Application during pregnancy and lactation

During pregnancy, it is necessary to take into account a decrease in the need for insulin in the first trimester or an increase in the II and III trimesters. During and immediately after childbirth, the need for insulin can drop dramatically.

During the period of breastfeeding, the patient needs daily monitoring for several months (until the insulin requirement stabilizes).

Application for violations of liver function

With liver disease, the need for insulin may vary.

Application for impaired renal function

With kidney disease, the need for insulin may vary.

Use in elderly patients

Insulin dose adjustment is required for diabetes mellitus in patients over 65 years of age.

special instructions

The dose selection of the drug is carried out with caution in patients with previous ischemic cerebral circulation disorders and with severe forms of ischemic heart disease.
The need for insulin can change in the following cases: when switching to another type of insulin; when changing the diet, diarrhea, vomiting; when the usual volume of physical activity changes; with diseases of the kidneys, liver, pituitary gland, thyroid gland; when changing the injection site.
Insulin dose adjustment is required for infectious diseases, thyroid dysfunction, Addison's disease, hypopituitarism, chronic renal failure and diabetes mellitus in patients over 65 years of age.

The transfer of a patient to human insulin should always be strictly justified and carried out only under the supervision of a physician.

The causes of hypoglycemia can be: insulin overdose, drug replacement, skipping meals, vomiting, diarrhea, physical exertion; diseases that reduce the need for insulin (severe kidney and liver diseases, as well as hypofunction of the adrenal cortex, pituitary gland or thyroid gland), change of injection site (for example, skin on the abdomen, shoulder, thigh), as well as interactions with other drugs. A decrease in the concentration of glucose in the blood is possible when a patient is transferred from animal insulin to human insulin.

The patient should be informed about the symptoms of a hypoglycemic state, the first signs of a diabetic coma and the need to inform the doctor about all changes in his condition.

In case of hypoglycemia, if the patient is conscious, dextrose is prescribed by mouth; s / c, i / m or i / v injected glucagon or intravenous hypertonic dextrose solution. With the development of hypoglycemic coma, 20-40 ml (up to 100 ml) of 40% dextrose solution is injected intravenously, until the patient comes out of the coma.

Patients with diabetes mellitus can relieve themselves of mild hypoglycemia by eating sugar or foods high in carbohydrates (patients are advised to always have at least 20 g of sugar with them).

Alcohol tolerance in patients receiving insulin is reduced.

Influence on the ability to drive vehicles and mechanisms

The tendency to develop hypoglycemia can impair the ability of patients to drive vehicles and work with mechanisms.

Drug interactions

The hypoglycemic effect is enhanced by sulfonamides (including oral hypoglycemic drugs, sulfonamides), MAO inhibitors (including furazolidone, procarbazine, selegiline), carbonic anhydrase inhibitors, ACE inhibitors, NSAIDs (including salicylates), anabolic steroids (including stanozolol, oxandrolone, methandrostenolone), androgens, bromocriptine, tetracyclines, clofibrate, ketoconazole, mebendazole, theophylline, cyclophosphamide, fenfluramine, lithium preparations, pyridoxine, quinidine, quinine, chloroquinine.

The hypoglycemic effect is reduced by glucagon, corticosteroids, histamine H1 receptor blockers, oral contraceptives, estrogens, thiazide and 'loop' diuretics, slow calcium channel blockers, sympathomimetics, thyroid hormones, tricyclic antidepressants, danoxidazine, morphine, somatrazine marijuana, nicotine, phenytoin, epinephrine.

Beta-blockers, reserpine, octreotide, pentamidine can both increase and decrease the hypoglycemic effect of insulin.

Concomitant use of beta-blockers, clonidine, guanethidine or reserpine may mask the symptoms of hypoglycemia.

Pharmaceutically incompatible with solutions of other drugs.