Gensoulin N

Gensulin N is a hypoglycemic drug containing insulin.

[ 1 ]

Indications Gensulina N

It is used for therapy in people with diabetes mellitus, which requires the use of insulin.

Release form

The drug is released as an injection suspension, in glass bottles with a volume of 10 ml (1 bottle inside the box). It is also produced in cartridges with a capacity of 3 ml (5 pieces inside the pack).

Pharmacodynamics

Gensulin H is a recombinant human isophane insulin drug that is produced using genetic engineering technologies that use genetically modified, non-pathogenic strains of E. coli.

Insulin is a hormone produced by pancreatic cells. It is involved in carbohydrate, fat and protein metabolism processes – for example, it reduces blood sugar levels. Insulin deficiency in the body leads to diabetes.

Insulin administered by injection has an effect similar to that of the hormone produced by the body.

Pharmacokinetics

The effect of the drug begins half an hour after the injection. Peak indicators of the therapeutic effect are noted in the period of 2-8 hours from the moment of administration, and its total duration is 24 hours and is determined by the size of the portion used.

In a healthy person, about 5% of insulin is synthesized with blood protein. The presence of insulin in the cerebrospinal fluid has been recorded - in values equal to approximately 25% of the level found in the blood serum.

Insulin exchange processes occur inside the kidneys and liver. A small part of the substance is metabolized inside fatty tissues and muscles. Metabolism in diabetics proceeds similarly to metabolic processes in a healthy person.

The excretion of the substance is carried out by the kidneys. Trace amounts of the drug are excreted with bile. The half-life of the component is about 4 minutes.

Liver or kidney pathologies may delay insulin excretion. In elderly people, insulin excretion processes occur at a slower rate, which is why the period of hypoglycemic effect of the drug increases.

[ 2 ]

Dosing and administration

There are many different treatment regimens using human insulin. The doctor selects the most suitable treatment method for each patient, taking into account the patient's need to receive insulin. Based on the selected blood sugar concentration, the doctor selects the appropriate dose and type of insulin medication for a specific patient.

Gensulin is administered subcutaneously. Only in exceptional cases is its intramuscular administration allowed. The drug should be used 15-30 minutes before meals. In this case, the drug should be removed from the refrigerator 10-20 minutes before the injection - so that the drug warms up to room temperature.

Before using the substance, carefully inspect the cartridge or vial with insulin. The injection suspension should have an opaque, uniform appearance (milky or uniformly cloudy). It is prohibited to use a suspension that remains transparent after mixing, or if a white sediment appears at the bottom of the container. In addition, the medication is not used in situations where, after mixing, flakes of the substance float inside the cartridge/vial or small particles remain on its walls (this gives the medicine a frozen appearance). It is also extremely important to ensure that the needle does not enter the lumen of the vessel when administering the injection.

Injections of medicine through syringes.

Special syringes with dosage markings can be used for insulin injections. If disposable needles and syringes are not available, reusable ones can be used (they are sterilized before each new procedure). One type of syringe from one manufacturer should be used. In addition, it is always necessary to check whether the syringe used is calibrated in accordance with the portion of the insulin agent used.

It is necessary to shake the bottle with the suspension until it acquires a milky or cloudy homogeneous appearance.

Insulin must be injected over a minimum of 5 seconds, having first pushed the plunger of the syringe used all the way in. After removing the needle, a tampon soaked in alcohol must be applied to the injection site for a few seconds. The skin in the injection area must not be wiped.

To avoid damage to skin and subcutaneous tissue, each new injection must be performed in a new place - each of them should be at a distance of 1-2 cm from the previous one.

Use of Gensulin in cartridges for special syringe pens.

The medication cartridges are used together with reusable pens of the “Pen” type. When filling the pen, attaching the needle to it, and injecting the medication, it is necessary to strictly follow the instructions in the manufacturer’s manual. If necessary, the substance can be drawn from the cartridge into a standard insulin syringe.

Use Gensulina N during pregnancy

Insulin is unable to cross the placenta.

Those patients who developed diabetes before or during pregnancy (gestational diabetes) need to carefully monitor carbohydrate metabolism processes throughout this period. The body's need for insulin may decrease in the 1st trimester and increase in the 2nd and 3rd. After the birth of the child, the patient's need for insulin decreases sharply, which increases the likelihood of hypoglycemia. In this regard, it is very important to carefully monitor glucose levels.

There are no restrictions regarding the use of Gensulin during lactation. However, breastfeeding women may need to change the dosage of the drug and diet.

Contraindications

Main contraindications:

• hypoglycemia;
• the presence of severe sensitivity to the drug and its components (the only exceptions are cases of using desensitizing treatment);
• intravenous administration of medication.

Side effects Gensulina N

A side effect of the drug is hypoglycemia - it is observed most often during insulin therapy. This disease develops in cases where the dose of insulin used is many times greater than the existing need for its receipt. In severe attacks of this disease (especially with their repeated development), damage to the nervous system function is possible. Hypoglycemia, which is prolonged or severe, can be life-threatening for the patient.

Symptoms of moderate hypoglycemia include dizziness, hunger, hyperhidrosis, anxiety, severe tremors, and tingling in the feet, palms, tongue, or lips. There may also be a feeling of confusion or drowsiness, impaired alertness or sleep, blurred vision, depression, mydriasis, irritability, and speech disorder. Severe manifestations include loss of consciousness, disorientation, and seizures.

In many patients, the development of signs demonstrating a deficiency in glucose supply to the brain tissue (the appearance of neuroglycopenia) is preceded by symptoms of adrenergic counterregulation. Usually, the faster and in greater volumes the blood glucose level decreases, the more intense the counterregulation is, and its characteristic manifestations become more pronounced.

Visual disturbances may also occur. A significant change in blood glucose levels may result in transient visual disturbances due to transient changes in turgor, as well as refractive disturbances in the lens area.

The risk of progression of diabetic retinopathy is reduced by achieving long-term glycemic control. However, increasing the intensity of insulin therapy together with a sharp drop in blood glucose levels may lead to a worsening of the disease. In individuals with proliferative retinopathy (especially those who have undergone laser photocoagulation procedures), severe hypoglycemia may cause transient blindness.

As with any insulin, lipodystrophy may develop at the injection site, which reduces the rate of absorption of the drug from that site. Regularly varying injection sites within the limited injection area can reduce or prevent this phenomenon.

Signs at the injection site of the drug, as well as allergy symptoms - among them swelling, skin redness, itching, pain, hematoma, swelling, hives or inflammation. Most mild reactions to insulin action that appear at the injection site often disappear within a few days or weeks.

An allergy to insulin, which is generalized (this includes severe forms of the disorder), manifests itself in the form of dyspnea, rashes all over the body, decreased blood pressure, wheezing, hyperhidrosis and increased heart rate.

Immediate manifestations of intolerance appear sporadically. Among them are reactions such as generalized skin symptoms, bronchial spasms, Quincke's edema, decreased blood pressure and shock, which can be life-threatening for the patient.

Among other signs, the formation of antibodies to insulin as a reaction to its use is highlighted. Occasionally, the presence of antibodies may provoke the need to change the dose of the drug to prevent the development of hyper- or hypoglycemia.

Insulin can cause sodium retention within the body and the development of edema, especially in situations where increasing the intensity of insulin therapy improves previously inadequate glycemic control.

[ 3 ]

Overdose

Insulin intoxication causes signs of hypoglycemia, including dizziness, apathy, hunger, disorientation, anxiety or confusion, as well as muscle tremors, vomiting, increased heart rate, hyperhidrosis and headaches. Moderate hypoglycemia can be eliminated by eating carbohydrate-rich foods or drinking sweet liquids. It is also necessary to rest a little. Patients should always carry glucose, sugar cubes or candy with them. It is forbidden to eat chocolate, because the fat it contains prevents the absorption of glucose.

In severe hypoglycemia, convulsions occur, loss of consciousness is observed, and death may occur. The patient in a comatose state is given glucose intravenously.

In case of poisoning with Gensulin, hypoglycemia may be accompanied by signs of hypokalemia, which then develop into myopathy. If severe hypokalemia is observed, in which the patient is unable to consume food orally, it is necessary to administer glucagon intramuscularly (1 mg) or glucose solution intravenously. When consciousness returns, the patient needs to eat. In addition, there may be a need to continue consuming carbohydrates with subsequent monitoring of blood sugar levels, because hypoglycemia may develop even after the patient has recovered.

Interactions with other drugs

Gensulin N is prohibited to be combined with insulins of animal origin, as well as with biosynthetic insulins from other manufacturers.

A large number of medications (including cardiac and antihypertensive drugs, drugs that lower serum lipid levels, drugs used in pancreatic diseases, anticonvulsants, certain antidepressants, antibacterial drugs, salicylates, and oral contraception) have an effect on insulin activity and the effectiveness of insulin treatment.

Medicines and substances that increase the effect of insulin: MAOIs (antidepressants), chloroquine, β-adrenergic blockers, clonidine with methyldopa and salicylates, as well as ACE inhibitors, pentamidine, tetracycline with cyclophosphamide, anabolic steroids, ethyl alcohol, sulfonamides and antibiotics from the quinolone category.

Medicines that reduce the effectiveness of insulin: estrogens (including oral contraceptives), heparin, dobutamine with phenytoin and diltiazem, as well as corticosteroids, phenothiazines, pancreatic hormones, niacin with calcitonin, antiviral drugs used to treat HIV, and thiazide diuretics.

An increased need for insulin may be observed when using drugs that have a hyperglycemic effect - among these are thyroid hormones, GCS, thiazides, STH, danazol and β2-sympathomimetics (among these are salbutamol with ritodrine and terbutaline).

The reduction in the need for medication is weakened by the use of drugs that have a hypoglycemic effect - among them salicylates (for example, aspirin), alcoholic beverages, non-selective β-blockers, orally taken antidiabetic drugs, some ACE inhibitors (including enalapril with captopril), and also some antidepressants (MAOIs).

Substances that are somatostatin analogues (such as lanreotide or octreotide) are capable of both reducing and increasing the body's need for insulin.

When Gensulin is used in combination with pioglitazone, symptoms of heart failure may occur, especially in people with risk factors for the latter. If such a combination is necessary, the patient should be constantly monitored for symptoms of heart failure and edema, as well as weight gain. If cardiac symptoms begin to worsen, pioglitazone should be stopped.

[ 4 ], [ 5 ], [ 6 ]

Storage conditions

Gensulin H should be kept in a place closed to children and sunlight. It is prohibited to freeze the drug. The temperature during storage is within the range of 2-8°C.

Shelf life

Gensulin N is allowed to be used within 24 months from the date of release of the therapeutic drug. Open packaging can be stored at temperatures no higher than 25°C for 42 days.

Application for children

There is insufficient data regarding the use of the drug in pediatrics.

Analogues

The analogues of the drug are the drugs B-insulin, Monodar and Rinsulin with Vosulin and Monotard, and in addition Insuman, Protafan and Humulin nph with Pharmasulin.

[ 7 ], [ 8 ]