Biosulin N, 100 me/ml suspension 10 ml

Biosulin H is a medium-acting insulin preparation. It is a human insulin obtained using recombinant DNA technology.

It interacts with specific receptor of outer cytoplasmic cell membrane and forms insulin-receptor complex which stimulates intracellular processes including synthesis of several key enzymes (including hexokinase, pyruvate kinase, glycogen synthetase).

Lower blood glucose content is due to increased intracellular transport, increased absorption and assimilation by tissues, stimulation of lipogenesis and glycogenogenesis and decreased rate of glucose production by liver.

The duration of action of Biosulin H is mainly due to the rate of absorption, which depends on several factors (e.g., the dose, route and site of administration) and therefore the action profile of insulin is subject to significant variations both between and in the same patient.

Indications

Diabetes mellitus type 1 (insulin dependent);

Diabetes mellitus type 2 (non-insulin dependent): stage of resistance to oral hypoglycemic agents, partial resistance to these drugs (during combination therapy), intercurrent diseases.

Pharmacological effect

Biosulin N is a medium-acting insulin preparation. It is human insulin obtained using recombinant DNA technology.

Interacts with a specific receptor on the outer cytoplasmic membrane of cells and forms an insulin-receptor complex that stimulates intracellular processes, incl. synthesis of a number of key enzymes (including hexokinase, pyruvate kinase, glycogen synthetase).

The decrease in blood glucose levels is due to an increase in its intracellular transport, increased absorption and assimilation by tissues, stimulation of lipogenesis, glycogenogenesis, and a decrease in the rate of glucose production by the liver.

The duration of action of Biosulin N is mainly determined by the rate of absorption, which depends on several factors (for example, on the dose, route and site of administration), and therefore the action profile of insulin is subject to significant fluctuations, both in different and in the same patient.

Special instructions

It is necessary to change injection sites within the anatomical region to prevent the development of lipodystrophies.

During insulin therapy, constant monitoring of blood glucose levels is necessary. The causes of hypoglycemia, in addition to insulin overdose, can be: drug replacement, skipping meals, vomiting, diarrhea, increased physical activity, diseases that reduce the need for insulin (impaired liver and kidney function, hypofunction of the adrenal cortex, pituitary gland or thyroid gland), change of injection site, as well as interaction with other drugs.

Incorrect dosing or interruptions in insulin administration, especially in patients with type 1 diabetes, can lead to hyperglycemia. Typically, the first symptoms of hyperglycemia develop gradually, over several hours or days. They include the appearance of thirst, increased urination, nausea, vomiting, dizziness, redness and dryness of the skin, dry mouth, loss of appetite, and the smell of acetone in the exhaled air. If left untreated, hyperglycemia in type 1 diabetes can lead to life-threatening diabetic ketoacidosis.

The dose of insulin must be adjusted in cases of thyroid dysfunction, Addison’s disease, hypopituitarism, impaired liver and kidney function, and diabetes mellitus in patients over 65 years of age. A change in insulin dose may also be necessary if the patient increases the intensity of physical activity or changes the usual diet.

Concomitant diseases, especially infections and conditions accompanied by fever, increase the need for insulin.

The transition from one type of insulin to another should be carried out under the control of blood glucose levels.

The drug reduces tolerance to alcohol.

In connection with the primary prescription of insulin, a change in its type, or in the presence of significant physical or mental stress, there may be a decrease in the ability to drive a car or operate various mechanisms, as well as engage in other potentially hazardous activities that require increased attention and speed of mental and motor reactions.

Active ingredient

Insulin-isophane human genetically engineered

Composition

1 ml of suspension for subcutaneous administration contains:

active ingredient:

human isophane insulin 100 units

Pregnancy

Data on the use of the drug during pregnancy and breastfeeding are not provided.

Contraindications

Hypersensitivity, hypoglycemia.

Side Effects

Caused by the effect on carbohydrate metabolism: hypoglycemic conditions (pallor of the skin, increased sweating, palpitations, tremor, hunger, agitation, paresthesia in the mouth, headache). Severe hypoglycemia can lead to the development of hypoglycemic coma.

Allergic reactions: rarely – skin rash, Quincke’s edema; extremely rarely – anaphylactic shock.

Other: edema, transient refractive errors (usually at the beginning of therapy).

Local reactions: hyperemia, swelling and itching at the injection site; with long-term use – lipodystrophy at the injection site.

Interaction

There are a number of medications that affect the need for insulin.

The hypoglycemic effect of insulin is enhanced by oral hypoglycemic drugs, MAO inhibitors, non-selective beta-blockers, ACE inhibitors, sulfonamides, anabolic steroids, carbonic anhydrase inhibitors, bromocriptine, octreotide, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium preparations, preparations containing ethanol.

The hypoglycemic effect of insulin is reduced by oral contraceptives, corticosteroids, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, calcium channel blockers, diazoxide, morphine, phenytoin, nicotine. Under the influence of reserpine and salicylates, it is possible to both weaken and enhance the effect of the drug.

Overdose

Symptoms: hypoglycemia may develop.

Treatment: the patient can eliminate mild hypoglycemia himself by ingesting sugar or carbohydrate-rich foods (diabetes patients are advised to carry sugar, sweets, cookies or sweet fruit juice with them at all times).

In severe cases, in case of loss of consciousness, a 40% dextrose solution is administered intravenously; IM, SC or IV – glucagon.

After regaining consciousness, the patient is advised to take a carbohydrate-rich meal to prevent the recurrence of hypoglycemia.

Storage conditions

In a place protected from light, at a temperature of 2–8 °C (do not freeze).

Shelf life

2 years.

Manufacturer

Pharmstandard-UfaVITA, Russia