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

Type 1 diabetes mellitus (insulin-dependent);

Type 2 diabetes mellitus (insulin-independent): stage of resistance to oral hypoglycemic agents, partial resistance to these drugs (when combined therapy), intercurrent diseases.

Composition

1 ml of suspension for subcutaneous administration contains:

the active ingredient:

isophane human insulin 100 units

How to take, the dosage

The dose of Biosulin N is determined by the doctor individually, in each case on the basis of blood glucose levels.

The drug is intended for subcutaneous administration.

The average daily dose varies from 0.5 to 1 IU/kg body weight (depending on the individual patient and the blood glucose level).

Interaction

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

. Hypoglycemic effect of insulin is enhanced by oral hypoglycemic drugs, MAO inhibitors, non-selective beta-adrenoblockers, ACE inhibitors, sulfonamides, anabolic steroids, Carboanhydrase inhibitors, bromocriptine, octreotide, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, phenfluramine, lithium preparations, preparations containing ethanol.

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

Special Instructions

It is necessary to change injection sites within the anatomical area to prevent the development of lipodystrophy.

In insulin therapy, blood glucose levels should be constantly monitored. The causes of hypoglycemia, in addition to insulin overdose, may be: changing the drug, skipping meals, vomiting, diarrhea, increased physical activity, diseases which reduce the need for insulin (liver and kidney function disorders, hypofunction of the adrenal cortex, pituitary or thyroid), change of injection site, and interaction with other drugs.

Inadequate dosing or intermittent insulin administration, particularly in patients with type 1 diabetes, may lead to hyperglycemia. Usually the first symptoms of hyperglycemia develop gradually over a few hours or days. They include the appearance of thirst, increased frequency of urination, nausea, vomiting, dizziness, red and dry 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 insulin dose must be adjusted in thyroid dysfunction, Addison’s disease, hypopituitarism, hepatic and renal dysfunction, and diabetes mellitus in patients over age 65. Changing the dose of insulin may also be necessary if the patient increases the intensity of physical activity or changes the habitual diet.

Companion diseases, especially infections and conditions with fever, increase the need for insulin.

Transition from one type of insulin to another should be done under control of blood glucose levels.

The drug reduces alcohol tolerance.

In connection with the initial prescription of insulin, a change of its type, or in the presence of significant physical or mental stress, it is possible to reduce the ability to drive a vehicle or to operate various mechanisms, as well as to engage in other potentially dangerous activities requiring increased attention and rapid mental and motor reactions.

Contraindications

Hypersensitivity, hypoglycemia.

Side effects

Caused by the effect on carbohydrate metabolism: hypoglycemic states (pale skin, increased sweating, palpitations, tremors, hunger, agitation, paresthesias in the mouth, headache). Severe hypoglycemia may lead to hypoglycemic coma.

Allergic reactions: rare – skin rash, Quincke’s edema; very rare – anaphylactic shock.

Others: edema, transient refractive disorders (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.

Overdose

Symptoms: hypoglycemia may occur.

Treatment: mild hypoglycemia can be corrected by the patient himself by taking sugar or carbohydrate-rich foods (diabetics are recommended to carry sugar, sweets, cookies or sweet fruit juice at all times).

In severe cases, in case of loss of consciousness – IV infusion of 40% dextrose solution; intravenous, p/c or intravenous – glucagon.

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

Pregnancy use

There are no data on the use of the drug in pregnancy and during breast-feeding.