Insuran R - instructions for use, dose, side effects, contraindications

Insuran R is a human insulin obtained using recombinant DNA technology. It is a short-acting insulin preparation. It interacts with a specific receptor of the external cytoplasmic cell membrane and forms an insulin-receptor complex that stimulates intracellular processes, including the synthesis of a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthase, etc.).

Reduction of glucose in the blood due to an increase of intracellular transport, absorption and assimilation tissue enhancement, stimulation of lipogenesis, glikogenogeneza decreased hepatic glucose rate and other products.

The duration of action of insulin preparations is mainly due to the rate of absorption, which depends on several factors (for example, on the dose, method and site of administration), and therefore the profile of insulin activity is subject to significant fluctuations, both in different people and in the same rights.

Activity profile with subcutaneous injection (approximate figures): the onset of action after 30 minutes, the maximum effect - in the interval between 2 and 4 hours, the duration of action - 6-8 hours.

Pharmacokinetics:

Completeness of absorption and the beginning of the effect of insulin depends on the mode of administration (subcutaneously, intramuscularly), the place of administration (abdomen, thigh, buttocks), the dose (volume of insulin administered), the concentration of insulin in the preparation, etc. Distributed in tissues unevenly; does not penetrate the placental barrier and into breast milk. It is destroyed by insulinase mainly in the liver and kidneys. The half-life is a few minutes. It is excreted by the kidneys (30-80%).

Indications:

- Type 1 diabetes mellitus;

- Type 2 diabetes mellitus: the stage of resistance to oral hypoglycemic agents, partial resistance to these drugs (with combined therapy), intercurrent diseases;

- urgent conditions in patients with diabetes mellitus, accompanied by decompensation of carbohydrate metabolism.

Contraindications:

- Increased individual sensitivity to insulin or any of the components of the drug;

- hypoglycemia.

Pregnancy and lactation:

There are no restrictions on the treatment of diabetes mellitus with insulin, since insulin does not penetrate the placental barrier. When planning pregnancy and during it, it is necessary to intensify the treatment of diabetes. The need for insulin usually decreases in the first trimester of pregnancy and gradually rises in the II and III trimesters.

During and immediately after delivery, the need for insulin can dramatically decrease. Shortly after birth, the need for insulin quickly returns to the level that was before pregnancy.

There are no restrictions on the treatment of diabetes mellitus with insulin during breastfeeding. However, it may require a reduced dose of insulin, so careful observation for several months to stabilize insulin requirements.

Dosing and Administration:

Insuran R is intended for subcutaneous, intramuscular and intravenous administration. The dose and route of administration of the drug is determined by the physician individually in each case based on the concentration of glucose in the blood.

On average, the daily dose of the drug ranges from 0.5 to 1 IU / kg body weight (depends on the individual characteristics of the patient andblood glucose concentration).

The drug is administered 30 minutes before a meal or a light snack containing carbohydrates. The temperature of the insulin should be appropriate at room temperature.

When monotherapy with the drug, the frequency of administration is 3 times a day (if necessary, up to 5-6 times a day). At a daily dose exceeding 0.6 IU / kg, it is necessary to inject 2 or more injections into different areas of the body.

Insuran P is usually injected subcutaneously into the anterior abdominal wall. Injections can also be done in the thigh, buttock, or shoulder in the projection of the deltoid muscle. It is necessary to change the injection site within the anatomical area to prevent the development of lipodystrophy. Intramuscularly and intravenously, Insuran P can be administered only under the supervision of a physician.

Insuran P is a short-acting insulin and is usually used in combination with insulin of medium duration (Insuran NPH).

Side effects:

Due to the effect on carbohydrate metabolism: hypoglycemic conditions (pallor of the skin, increased sweating, palpitation, tremor, hunger, excitement, paresthesia of the oral mucosa, headache).Pronounced hypoglycemia can lead to the development of hypoglycemic coma.

Allergic reactions: rarely - skin rash, angioedema; extremely rare - anaphylactic shock.

Local Reactions: hyperemia, puffiness and itching at the injection site; with prolonged use - lipodystrophy at the injection site.

Other: edema, transient visual impairment (usually at the beginning of therapy).

Overdose:

In case of an overdose it is possible to develop hypoglycemia up to hypoglycemic coma.

Symptoms: increased sweating, palpitation, tremor, hunger, anxiety, paresthesia of the oral mucosa, pallor of the skin, headache, drowsiness, insomnia, a sense of fear, depressed mood, irritability, unusual behavior, impaired coordination, speech and vision disorders, convulsions, shallow breathing, impaired consciousness.

Treatment: an easy hypoglycemia patient can eliminate himself by taking sugar inside or carbohydrate-rich foods. Therefore, patients with diabetes are encouraged to always carry sugar, sweets, cookies or sweet fruit juice.

In severe cases, subcutaneously, intramuscularly or intravenously glucagon. With the development of hypoglycemic coma and loss of consciousness by the patient, 20-40 ml (up to 100 ml) of 40% dextrose solution is injected intravenously in jet strips until the patient leaves comatose state. After restoration of consciousness the patient is recommended to take food rich in carbohydrates, to prevent the repeated development of hypoglycemia.

Interaction:

Pharmaceutically incompatible with solutions of other drugs.

There are a number of drugs that affect the need for insulin. The hypoglycemic action of insulin is enhanced by nonselective beta-blockers, quinidine, quinine, chloroquine, monoamine oxidase inhibitors, angiotensin converting enzyme inhibitors, carbonic anhydrase inhibitors, octreotide, bromocriptine, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium preparations, preparations containing ethanol.

Hypoglycemic action of insulin weakens glucagon, somatropin, estrogens, oral contraceptives, glucocorticosteroids, iodine-containing thyroid hormones, thiazide diuretics, loop diuretics, heparin,tricyclic antidepressants, sympathomimetics, danazol, clonidine, sulfinpyrazone, epinephrine, blockers H₁-gistaminovyh receptors, blockers of "slow" calcium channels, diazoxide, morphine, phenytoin, nicotine.

Reserpine, salicylates can both enhance and weaken the hypoglycemic effect of insulin.

Special instructions:

Do not use Insuran P if it becomes cloudy, colored, or if solid particles are detected.

On the background of insulin therapy, a constant control of the concentration of glucose in the blood is necessary.

Causes hypoglycemia In addition to an overdose of insulin, there may be: drug substitution, skipping meals, vomiting, diarrhea, increased physical activity, diseases that reduce the need for insulin (liver and kidney dysfunction, hypofunction of the adrenal cortex, pituitary gland or thyroid gland), injection site change, and interaction with other drugs.

Incorrect dosing or breaks in the administration of insulin, especially in patients with type 1 diabetes, can lead to hyperglycemia. Usually the first symptoms of hyperglycemia develop gradually, over a period of 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, odor of acetone in the exhaled air. If not treated, hyperglycemia in type 1 diabetes mellitus can lead to the development of life-threatening diabetic ketoacidosis.

The dose of insulin must be corrected in case of thyroid dysfunction, Addison's disease, hypopituitarism, liver and kidney dysfunction and sugar diabetes in persons older than 65 years.

Patients receiving more than 100 ME insulin per day, with a change in the drug require hospitalization.

Correction of the dose of insulin may also be required if the patient increases the intensity of physical activity or changes the habitual 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 the concentration of glucose in the blood.

The drug reduces tolerance to alcohol.

Due to the possibility of precipitation in some catheters, the use of the drug in insulin pumps is not recommended.

Instructions to be given to the patient

The technique of injection with the use of insulin in vials

If the patient uses only one type of insulin

1. Disinfect the rubber membrane of the vial.

2. Draw the air into the syringe in the volume corresponding to the desired dose of insulin. Insert air into the vial with insulin.

3. Turn the bottle with the syringe upside down and type the desired dose of insulin into the syringe. Remove the needle from the vial and remove air from the syringe. Check the correctness of the dose of insulin.

4. Immediately inject.

If the patient needs to mix two types of insulin

1. Disinfect the rubber membranes of the vials.

2. Directly before typing, roll a vial of long-acting insulin ("cloudy") between the palms until the insulin becomes evenly white and cloudy.

3. Draw the air into the syringe in a volume corresponding to the dose of "cloudy" insulin. Enter the air into the bottle with a "cloudy" insulin and remove the needle from the bottle.

4. Insert the air in the syringe in the amount corresponding to the dose of insulin of short action ("transparent"). Insert air into the bottle with "transparent" insulin. Turn the bottle with the syringe upside down and type the desired dose of "transparent" insulin. Remove the needle and remove air from the syringe. Check the correctness of the dialed dose.

5.Insert the needle into the bottle with a "cloudy" insulin, flip the bottle with the syringe upside down and type the desired dose of insulin. Remove air from the syringe and check the correctness of the dialed dose. Immediately inject the dialed mixture of insulin.

6. Always take the insulin in the same sequence described above.

Injection procedure

1. Disinfect the skin area where insulin will be injected.

2. With two fingers, assemble the skin fold, insert the needle into the base of the fold at an angle of about 45 ° and insert insulin under the skin.

3. After the injection, the needle should remain under the skin for at least 6 seconds, in order to ensure that the insulin is injected completely.

4. If after removing the needle, blood appears on the site of the injection, gently press the site of the injection with a swab moistened with a disinfectant solution, for example, with alcohol.

5. It is necessary to change the injection site.

Effect on the ability to drive transp. cf. and fur:

In connection with the primary appointment of insulin, a change in its type or in the presence of significant physical or mental stress, it is possible to reduce the ability to drive a car or to manage various mechanisms, as well as engage in other potentially hazardous activities,requiring increased attention and speed of mental and motor reactions.

Form release / dosage:Solution for injection, 100 IU / ml.

Packaging:

In bottles of 10 ml.

On 1 bottle together with the instruction on application place in a pack from a cardboard.

Storage conditions:

In a place protected from light and inaccessible to children at a temperature of 2 to 8 ° C. Do not freeze.

The used vial of insulin should be stored at room temperature (not above 25 ° C) for 6 weeks.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-000049

Date of registration:05.04.2010 / 11.09.2012

Expiration Date:Unlimited

The owner of the registration certificate:Institute of Bioorganic Chemistry, Academy of Sciences MM Shemyakin and Yu.A. Ovchinnikov Institute of RAS Institute of Bioorganic Chemistry, Academy of Sciences MM Shemyakin and Yu.A. Ovchinnikov Institute of RAS Russia

Manufacturer: & nbsp

Institute of Bioorganic Chemistry, Academy of Sciences MM Shemyakin and Yu.A. Ovchinnikov Institute of RAS Russia

Information update date: & nbsp30.10.2017

Illustrated instructions

Instructions

Insuran R (Insuran R)