Biosulin N

Indications

— type 1 diabetes mellitus (insulin-dependent);
— type 2 diabetes mellitus (insulin-independent): stage of resistance to oral hypoglycemic agents, partial resistance to these drugs (during combined therapy), intercurrent diseases

Method of Administration and Dosage

The dose of the medication is determined by the doctor individually, in each specific case based on the blood glucose level. The medication is intended for subcutaneous administration. The average daily dose varies from 0.5 to 1 IU/kg of body weight (depending on the individual characteristics of the patient and the blood glucose level). The temperature of the insulin to be injected should be at room temperature. Biosulin® N is injected subcutaneously into the thigh; injections can also be made into the anterior abdominal wall, the buttock, or the deltoid area of the arm. It is necessary to change injection sites within the anatomical area to prevent the development of lipodystrophies. Biosulin® N can be administered either as a single medication or in combination with short-acting insulin (Biosulin® R).

Section: Composition

In 1 ml of the preparation contains:
Active substance: human insulin recombinant (produced by "Diosynth France S.A.", France) - 100 IU;
excipients: glycerol, protamine sulfate, sodium dihydrogen phosphate, zinc oxide, metacresol, phenol, water for injections.

Description of the dosage form

White suspension. Upon standing, the suspension settles, forming a sediment. The supernatant liquid is clear, colorless, or almost colorless. The sediment is easily resuspended with gentle shaking.

Section: Contraindications

— hypoglycemia;
— increased sensitivity to insulin or other components of the drug.

Section: Special Instructions

The Biosulin® N preparation should not be used if, after shaking, the suspension does not become white and uniformly cloudy.
During insulin therapy, constant monitoring of blood glucose levels is necessary.
Causes of hypoglycemia, aside from insulin overdose, may include switching medications, skipping meals, vomiting, diarrhea, increased physical activity, diseases that reduce the need for insulin (liver and kidney dysfunction, adrenal cortex, pituitary, or thyroid gland hypofunction), changing the injection site, as well as interactions with other medications.
Incorrect dosing regimens 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 thirst, increased urination, nausea, vomiting, dizziness, redness and dryness of the skin, dry mouth, loss of appetite, and a fruity odor of acetone in the exhaled air. If left untreated, hyperglycemia in type 1 diabetes can lead to life-threatening diabetic ketoacidosis.
The insulin dose must be adjusted in cases of thyroid dysfunction, Addison's disease, hypopituitarism, liver and/or kidney dysfunction, and diabetes in individuals over 65 years of age.
Dose adjustment may also be necessary if the patient increases the intensity of physical activity or changes their usual diet.
Comorbidities (especially infections) and conditions accompanied by fever increase the need for insulin.
Switching from one type of insulin to another should be done under blood glucose level monitoring.
The preparation reduces alcohol tolerance.
Due to the possibility of precipitation in some catheters, the use of the preparation in insulin pumps is not recommended.

Effect on the ability to drive vehicles and operate machinery
When insulin is first prescribed, when changing its type, or during significant physical or psychological stress on the body, there may be a decrease in the ability to drive a car or operate various mechanisms, as well as engage in other potentially dangerous activities that require increased attention and quick psychomotor reactions.

Injection technique when using insulin in cartridges
The cartridge with Biosulin N is intended for use with the BiomaticPen insulin pen. The patient should be warned about the necessity to carefully follow the instructions for using the insulin pen.
Before use, ensure that the cartridge with Biosulin® N has no damage (e.g., cracks). Do not use the cartridge if there are any visible damages. Do not use Biosulin® N if, when mixing the contents of the cartridge according to the instructions, the insulin does not become uniformly white and cloudy.
Do not use Biosulin N if there are flakes after mixing. Do not use Biosulin N if solid white particles are stuck to the bottom or walls of the cartridge, creating a "frosted pattern" effect.
After the cartridge is inserted into the insulin pen, a colored stripe should be visible through the cartridge holder window.
Before placing the cartridge in the insulin pen, it should be turned upside down to move the glass ball from one end of the cartridge to the other. This procedure should be repeated at least 10 times until the entire liquid becomes white and uniformly cloudy. Immediately after this, an injection must be made.
If the cartridge is already inside the insulin pen, it should be turned with the cartridge inside up and down at least 10 times. This procedure must be repeated before each injection.
After the injection, the needle should remain under the skin for at least 6 seconds. The button should be held down until the needle is completely withdrawn from under the skin, thus ensuring the correct administration of the dose and limiting the possibility of blood or lymph entering the needle or the insulin cartridge.
The cartridge with Biosulin N is intended for individual use only and should not be refilled.
Injection procedure
• With two fingers, pinch the skin fold, insert the needle at the base of the fold at an angle of about 45°, and inject the insulin under the skin.
• After the injection, the needle should remain under the skin for at least 6 seconds to ensure that the insulin is fully administered.
• If blood appears at the injection site after removing the needle, gently press the injection site with a swab soaked in disinfectant solution (e.g., alcohol).
• It is necessary to change injection sites.

Section: Side Effects

Metabolic side effects: hypoglycemic states (pallor of the skin, increased sweating, sensation of heartbeat, tremor, feeling of hunger, agitation, paresthesia in the mouth area, headache). Severe hypoglycemia can lead to the development of hypoglycemic coma.
Allergic reactions: rarely - skin rash, angioedema; in some cases - anaphylactic shock.
Local reactions: hyperemia, swelling, and itching at the injection site; with prolonged use - lipodystrophy at the injection site.
Others: edema, transient refractive disturbances (usually at the beginning of therapy).

Overdose

It is possible to develop hypoglycemia.

Interaction

There are a number of medications that affect the need for insulin. The hypoglycemic effect of insulin is enhanced by oral hypoglycemic agents, 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, and 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, and nicotine. Under the influence of reserpine and salicylates, both weakening and enhancement of the drug's effect may occur.

Section: Pharmacodynamics

Biosulin N is human insulin obtained using recombinant DNA technology. It is a medium-acting insulin preparation. It interacts with a specific receptor on the outer cytoplasmic membrane of cells and forms an insulin-receptor complex that stimulates intracellular processes, including the synthesis of several key enzymes (hexokinase, pyruvate kinase, glycogen synthase, etc.). The reduction of glucose levels in the blood is due to an increase in its intracellular transport, enhanced absorption and utilization by tissues, stimulation of lipogenesis, glycogenogenesis, and a decrease in the rate of glucose production by the liver, among other factors.
The duration of action of insulin preparations is mainly determined by the rate of absorption, which depends on several factors (for example, dose, method, and site of administration), which is why the action profile of insulin is subject to significant fluctuations, both among different individuals and within the same individual.
The action profile for subcutaneous injection (approximate figures): onset of action in 1-2 hours, maximum effect between 6 and 12 hours, duration of action 18-24 hours.

Pharmacokinetics

The completeness of absorption and the onset of insulin effect depend on the injection site (abdomen, thigh, buttocks), dose (volume of insulin administered), concentration of insulin in the preparation, and others. It is distributed unevenly in tissues; does not cross the placental barrier and into breast milk. It is degraded by insulinase mainly in the liver and kidneys. It is excreted by the kidneys (30-80%).