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

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.

On average, after subcutaneous administration, Rinsulin® R begins to function after 30 minutes, the maximum effect develops between 1 and 3 hours, the duration of action is 8 hours.

Pharmacokinetics:

Completeness of absorption and the beginning of the effect of insulin depends on the mode of administration (subcutaneously, intramuscularly, intravenously), the injection site (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;

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

- fromdiabetes mellitus type 2 in pregnant women;

- 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;

- ghypoglycaemia.

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 II and III trimester.

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:

The drug 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 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.

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, the drug should be administered as 2 or more injections in various areas of the body.

The drug is usually administered subcutaneously in 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. Patients should be trained in the correct use of the insulin delivery device.

Intramuscular and intravenous drug can be administered only under the supervision of a doctor.

Vials can only be used if their contents are a clear, colorless liquid without visible particles.Do not use the drug if a precipitate appears in the solution. Rinsulin® P is a short-acting insulin and is usually used in combination with insulin of medium duration (Rinsulin® NPH).

It is possible to store the drug in use at room temperature (15 to 25 ° C) for no more than 28 days.

Side effects:

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

Allergic reactions: skin rash, angioedema, anaphylactic shock.

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

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

If the patient noted the development of hypoglycemia or had an episode of loss of consciousness, he should immediately inform the doctor about it.

If any other side effects, not described above, are identified, the patient should also consult a doctor.

Overdose:Overdose may develop hypoglycemia (symptoms - see Side effect).

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 (glucose); 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:

Subcutaneously Rinsulin® P can be administered in a single syringe with insulin of medium duration (Rinsulin® NPH). Do not inject Rinsulin® P in one syringe with other medications and insulin from other manufacturers.

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.

The drug reduces tolerance to alcohol.

Special instructions:

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 may include: 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), change of injection site, as well as 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 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 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.

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

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

Do not use the drug if a precipitate appears in the solution.

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 vial with the "turbid" insulin and remove the needle from the vial.

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 vial with "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 make an injection of the dialed mixture of insulin.

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

Injection procedure

- It is necessary to disinfect the area of the skin where insulin will be injected.

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

- 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.

- If after removing the needle at the injection site, blood appears, gently press the site of the injection with a swab moistened with 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 disrupt the ability to drive vehicles or various moving mechanisms, as well as engage in other potentially hazardous activities requiring increased attention and speed of reactions.

Form release / dosage:

Solution for injection, 100 IU / ml.

Packaging:

For 10 ml of the drug in a bottle of colorless glass, hermetically wrapped with a cap combined of aluminum and plastic with a rubber disc or sealed with rubber stopper capped with a cap made of aluminum and plastic with a detachable plastic cover.

A self-adhesive label is applied to each bottle.

Each vial with instructions for use is placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of 2 to 8 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LS-001808

Date of registration:01.04.2011

The owner of the registration certificate:GEROPHARM-BIO, JSC GEROPHARM-BIO, JSC Russia

Manufacturer: & nbsp

GEROPHARM-BIO, JSC Russia

Information update date: & nbsp28.10.2015

Illustrated instructions

Instructions

Rinsulin® R (Rinsulin® R)