Monoinsulin CR - instructions for use, dose, side effects, contraindications

The drug Monoinsulin CR is a preparation of 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 in blood glucose is due to increased intracellular transport, increased absorption and assimilation by tissues, stimulation of lipogenesis, glycogenogenesis, a decrease in the rate of production of glucose by the liver, etc. The duration of action of insulin preparations is mainly due to the rate of absorption, which depends on several factors (for example, , method and place of administration), and therefore the profile of insulin action is subject to significant fluctuations, both in different people and in the same person.

The action profile for 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 the 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 injection site (abdomen, thigh, buttocks), the dose (volume of insulin administered), the concentration of insulin in the preparation, etc. Distributed by 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. Displayed kidneys (30-80%).

Indications:

- Diabetes mellitus, requiring insulin therapy;

- Mr.Emergency 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 the period of breastfeeding. However, it may require a reduced dose of insulin, so careful observation for several months to stabilize insulin requirements.

Dosing and Administration:

The drug Monoinsulin CR is intended for intravenous, intramuscular and subcutaneous 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 and the concentration of blood glucose).

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.

With 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.

The drug Monoinsulin CR 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.

With subcutaneous administration of insulin, care must be taken so that when injected do not enter the blood vessel. After injection, do not massage the injection site. Intramuscular and intravenous drug can be administered only under the supervision of a doctor.

The drug Monoinsulin CR is a short-acting insulin and is usually used in combination with an insulin of average duration (with the drug Protamine-insulin ES).

Switching from another type of insulin

When the patient moves from one type of insulin to another, it may be necessary to correct the dosage regimen.When switching from animal insulin to human insulin, a reduction in the insulin dose may be required. The need for correcting the dose of insulin can occur immediately after switching to a new kind of insulin or develop gradually over several weeks. When switching from one type of insulin to another in the first weeks, careful monitoring of the concentration of glucose in the blood is recommended. In patients who required high doses of insulin because of the presence of antibodies, it is recommended to switch to another type of insulin under medical supervision in the hospital.

Dosage regimen in selected patient groups

Elderly patients

In elderly patients with diabetes, the need for insulin can be reduced. It is recommended to start insulin therapy, increase the dose and dose selection in elderly patients with caution in order to avoid hypoglycemic reactions.

Patients with renal or hepatic insufficiency

In patients with renal or hepatic insufficiency, the need for insulin may decrease.

Side effects:

The frequency of side effects of the drug is assessed as follows:

Very often: ≥1 / 10

Frequently: ≥ 1/100, <1/10

Infrequently: ≥ 1/1000, <1/100

Rarely: ≥ 1/10 000, <1/1000

Very rarely: <1/10 000

The frequency is not known (according to the available data, it is not possible to determine the frequency).

Immune system disorders: rarely - skin rash, angioedema; very rarely anaphylactic reactions; frequency is unknown - the formation of antibodies to insulin.

Disorders from the metabolism and nutrition: very often - hypoglycemic conditions (pallor of the skin, increased sweating, palpitation, tremor, chills, hunger, excitement, paresthesia of the oral mucosa, headache, dizziness, decreased visual acuity). Pronounced hypoglycemia can lead to the development of hypoglycemic coma. Often - peripheral edema; frequency is unknown - sodium retention.

Disorders from the side of the organ of vision: infrequent - transient refractive disorders (usually at the beginning of therapy); frequency unknown - temporary worsening of the course of diabetic retinopathy, transient amaurosis (complete loss of vision in the background of severe hypoglycemic episodes).

Disturbances from the skin and subcutaneous tissues: infrequently - with prolonged use of lipodystrophy at the injection site.

General disorders and disorders in the place of reference: infrequently - reactions at the site of administration (congestion, swelling and itching at the injection site).

Hypoglycaemia, the most frequent side effect insulin therapy, can develop, if the dose of insulin administered exceeds need in him. Severe repeated episodes of hypoglycemia can lead to the development of neurological symptoms, including coma and convulsions. Prolonged or severe episodes hypoglycemia can endanger the lives of patients.

With a sharp decrease in the concentration of glucose in the blood may develop hypokalemia or cerebral edema.

Overdose:

Overdose may develop hypoglycemia.

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

In severe cases, if the patient lost consciousness, intravenously injected 40% solution of dextrose; intramuscularly, subcutaneously, intravenously - glucagon. After restoration of consciousness the patient is recommended to take food rich in carbohydrates, to prevent the repeated development of hypoglycemia.

Interaction:

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

Hypoglycemic action of insulin enhances oral hypoglycemic agents, monoamine oxidase inhibitors, angiotensin converting enzyme inhibitors, carbonic anhydrase inhibitors, nonselective beta-blockers, bromocriptine, octreotide, 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, epinephrine, blockers H₁-gistaminovyh receptors, blockers of "slow" calcium channels, diazoxide, morphine, phenytoin, nicotine. Under the influence of reserpine and salicylates, both weakening and enhancement of the action of the drug are possible.

Special instructions:

Do not use the drug Monoinsulin CR 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.

The causes of hypoglycemia, in addition to an overdose of insulin, can be: drug substitution, skipping meals, vomiting, diarrhea, increased physical activity, diseases that reduce the need for insulin (violations of the liver and kidneys, hypofunction of the adrenal cortex, pituitary gland or thyroid gland) injections, as well as interaction with other drugs.

Special care should be taken to carefully monitor blood glucose concentrations in patients in whom hypoglycemic conditions may be of particular clinical significance-with severe stenosis of the coronary or cerebral arteries, as well as in patients with proliferative retinopathy, especially if they have not been photocoagulated, since there is a risk of transient amaurosis (complete blindness).

Under certain circumstances, the symptoms of hypoglycemia may be mild or may be absent. Such situations are observed in elderly patients, with the presence of neuropathy, with concomitant mental illnesses, with concomitant therapy with other drugs, with low maintenance glucose concentration in the blood, with a change in the type of insulin.

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 I diabetes 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 diabetes mellitus in persons over 65 years of age.

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.

Cases of chronic heart failure in the treatment of patients with thiazolidinediones in combination with insulin preparations have been reported, especially if such patients have risk factors for developing chronic heart failure. This fact should be taken into account when appointing patients combination therapy with thiazolidinediones and insulin preparations. In the appointment of such combination therapy, it is necessary to conduct medical examinations of patients to identify signs and symptoms of chronic heart failure, increase in body weight and the presence of peripheral edema. If the symptoms of heart failure worsen in patients, treatment with thiazolidinediones should be discontinued. The drug lowers 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. Put the air in the syringe in the volume corresponding to the required 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. Immediately before the recruitment, take a bottle of long-acting insulin ("cloudy") between the palms until the insulin becomes evenly white and cloudy,

3. Type in the syringe air in a volume corresponding to the dose of "turbid" insulin.

4. Enter the air into the bottle with a "cloudy" insulin and remove the needle from the bottle.

5. Put the air in the syringe in the volume corresponding to the dose of insulin of short action ("transparent").Insert air into the bottle with "transparent" insulin.

6. 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.

7. 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.

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

Injection procedure

- With two fingers, take a skin fold, insert the needle into the base of the fold at an angle of about 45 ° and insert 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 injected completely.

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

- It is necessary to change the injection site.

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

In connection with the primary purpose 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 vehicles and mechanisms, as well as engage in other potentially dangerous activities that require increased attention and speed of mental and motor reactions.

Form release / dosage:

Solution for injection, 100 IU / ml.

Packaging:

10 ml in bottles of colorless transparent neutral glass class I, sealed with rubber stoppers and rolled with aluminum caps.

A sticker of writing paper or a self-adhesive label is applied to the bottle.

Each bottle, together with the instructions for use, is placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 8 ° C. Do not freeze.

Used vial Do not store more than 6 weeks in a dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years and 6 months.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002896

Date of registration:04.03.2015

Expiration Date:04.03.2020

Date of cancellation:2020-03-04

The owner of the registration certificate:VIAL, LLC VIAL, LLC Russia

Manufacturer: & nbsp

BELMEDPREPARATY, RUP Republic of Belarus

NOVO NORDISK, A / S Denmark

Representation: & nbspVIAL, LLCVIAL, LLC

Information update date: & nbsp02.06.2018

Illustrated instructions

Instructions

Monoinsulin CR (MONOINSULIN HR)