Biosulin^® N (Suspension) Instructions for Use

ATC Code

A10AC01 (Human insulin)

Active Substance

Human insulin isophane rDNA origin

Human insulin isophane rDNA origin (USP United States Pharmacopeia)

Clinical-Pharmacological Group

Intermediate-acting human insulin

Pharmacotherapeutic Group

Intermediate-acting insulin

Pharmacological Action

Intermediate-acting human insulin obtained using recombinant DNA technology.

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 a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthase).

The decrease in blood glucose is due to increased intracellular transport, enhanced uptake and utilization by tissues, stimulation of lipogenesis, glycogenesis, and a decrease in the rate of glucose production by the liver.

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 insulin action profile is subject to significant fluctuations, both in different people and in the same person.

On average, after subcutaneous administration, this insulin begins to act within 1.5 hours, the maximum effect develops between 4 and 12 hours, and the duration of action is up to 24 hours.

Pharmacokinetics

The completeness of absorption and the onset of the insulin effect depends on the injection site (abdomen, thigh, buttocks), dose, and insulin concentration in the preparation.

It is distributed unevenly in tissues; does not cross the placental barrier and into breast milk. It is metabolized in the liver and kidneys under the action of the enzyme insulinase. It is excreted by the kidneys (30-80%).

Indications

Type 1 diabetes mellitus; Type 2 diabetes mellitus: stage of resistance to oral hypoglycemic agents, partial resistance to these drugs (during combination therapy), intercurrent illnesses; Type 2 diabetes mellitus in pregnancy.

ICD codes

Dosage Regimen

Administer Biosulin N by subcutaneous injection only; do not administer intravenously or intramuscularly.

Determine the dosage individually for each patient based on blood glucose measurements.

The typical total daily insulin requirement ranges from 0.5 to 1.0 IU per kg of body weight.

Divide the total daily dose into one or two injections per day.

Inject the suspension subcutaneously into the thigh, abdominal wall, gluteal region, or upper arm; rotate injection sites within the same region to prevent lipodystrophy.

Prepare the vial for administration by rolling it gently between your palms to resuspend the insulin until it appears uniformly cloudy or milky; do not shake vigorously.

Inspect the suspension visually before use; use only if it resembles water in whiteness and contains no visible particles or clumps.

Administer the dose immediately after resuspension and drawing into the syringe.

Adjust the dosage during concomitant illness, stress, or changes in physical activity and diet.

Exercise caution and consider dose adjustment in patients with hepatic impairment, renal impairment, or in elderly patients.

Monitor patients regularly for signs and symptoms of hypoglycemia.

Transfer a patient to a different type or brand of insulin under strict medical supervision with dose adjustment.

Adverse Reactions

Adverse effects due to the effect on carbohydrate metabolism: hypoglycemic conditions (pallor of the skin, increased sweating, palpitations, tremor, hunger, agitation, paresthesia of the oral mucosa, headache, dizziness, decreased visual acuity). Severe hypoglycemia can lead to the development of hypoglycemic coma.

Allergic reactions: skin rash, angioedema, anaphylactic shock.

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

Other: edema, transient decrease in visual acuity (usually at the beginning of therapy).

Contraindications

Hypersensitivity to insulin; hypoglycemia.

Use in Pregnancy and Lactation

There are no restrictions on the treatment of diabetes mellitus with insulin during pregnancy, since insulin does not cross the placental barrier.

When planning pregnancy and during it, it is necessary to intensify the treatment of diabetes mellitus.

The need for insulin usually decreases in the first trimester of pregnancy and gradually increases in the second and third trimesters.

During childbirth and immediately after them, the need for insulin may decrease sharply.

Soon after childbirth, the need for insulin quickly returns to the level that was before pregnancy.

Use in Hepatic Impairment

Should be used with caution in patients with impaired liver function. Dose adjustment is necessary.

Use in Renal Impairment

Should be used with caution in patients with impaired renal function. Dose adjustment is necessary.

Geriatric Use

Should be prescribed with caution to elderly patients. Dose adjustment is necessary.

Special Precautions

During insulin therapy, constant monitoring of blood glucose concentration is necessary.

Causes of hypoglycemia, in addition to insulin overdose, may include: changing the drug, skipping a meal, 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), changing the injection site, as well as interaction with other drugs.

Incorrect dosing or interruptions in insulin administration, especially in patients with type 1 diabetes mellitus, can lead to hyperglycemia.

Usually, the first symptoms of hyperglycemia develop gradually over several hours or days.

They include the appearance of thirst, frequent 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 mellitus can lead to the development of life-threatening diabetic ketoacidosis.

The insulin dose must be adjusted in case of thyroid dysfunction, Addison’s disease, hypopituitarism, impaired liver and kidney function, and in diabetes mellitus in patients over 65 years of age.

Due to the increased risk of cardiac and cerebral complications of hypoglycemia, the insulin preparation should be used with caution in patients with severe stenosis of the coronary and cerebral arteries.

Use with caution in patients with proliferative retinopathy, especially those not receiving photocoagulation (laser coagulation) treatment due to the risk of amaurosis (complete blindness).

If the patient increases the intensity of physical activity or changes the usual diet, adjustment of the insulin dose may be required.

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

Transfer of a patient to a new type of insulin or an insulin preparation from another manufacturer must be carried out under medical supervision.

When using insulin preparations in combination with drugs of the thiazolidinedione group in patients with type 2 diabetes mellitus, fluid retention in the body may occur, resulting in an increased risk of development and progression of chronic heart failure, especially in patients with cardiovascular diseases and the presence of risk factors for chronic heart failure.

Patients receiving such therapy should be regularly examined to identify signs of heart failure.

If heart failure occurs, therapy should be carried out in accordance with current treatment standards.

Drug Interactions

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

The hypoglycemic effect of insulin is weakened by glucagon, somatropin, estrogens, oral contraceptives, glucocorticosteroids, iodine-containing thyroid hormones, thiazide diuretics, loop diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, epinephrine, histamine H₁-receptor blockers, slow calcium channel blockers, diazoxide, morphine, phenytoin, nicotine.

Under the influence of reserpine and salicylates, both weakening and enhancement of the action of insulin is possible.

Reduces tolerance to ethanol.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.