Rinsulin R
Latin name: Rinsulin R
ATX code: A10AB01
Active ingredient: insulin soluble (human genetically engineered) [Insulin soluble (human biosynthetic)]
Manufacturer: JSC "GEROPHARM" (Russia)
Description and photo update: 2019-14-12
Rinsulin R - hypoglycemic drug; short-acting insulin.
Release form and composition
The drug is produced in the form of a solution for injection: a clear, colorless liquid (10 ml each in a vial of colorless glass, rolled in a cap made of aluminum and plastic with a rubber disc or sealed with a rubber stopper with a combined cap with a plastic tear-off pad, in a cardboard box 1 bottle; 3 ml in a glass cartridge with a rubber plunger, rolled in an aluminum cap with a rubber disc, in a blister strip 5 cartridges, in a cardboard box 1 pack; 3 ml in a glass cartridge mounted in a disposable plastic multi-dose syringe pen for multiple injections Rinastra or Rinastra II, in a carton box of 5 pre-filled multi-dose syringe pens, each box also contains instructions for the use of Rinsulin R).
1 ml of solution contains:
- active substance: human insulin - 100 International units (ME);
- additional substances: glycerol (glycerin), metacresol, water for injection.
Pharmacological properties
Pharmacodynamics
Rinsulin R is a short-acting human insulin produced using recombinant DNA technology.
By interacting with a specific receptor located on the outside of the cytoplasmic membrane of cells, the drug forms an insulin-receptor complex that stimulates intracellular processes, including the synthesis of a number of important enzymes (pyruvate kinase, hexokinase, glycogen synthase, etc.).
A decrease in the level of glucose in the blood is associated with an increase in its intracellular transport, an increase in absorption and assimilation by tissues, an activation of lipogenesis, glycogenesis, a decrease in the rate of glucose production by the liver and other reasons. The duration of the effect of insulin preparations mainly depends on the rate of absorption, which is influenced by factors such as dose, route and site of administration. As a result, the profile of insulin action both in different individuals and in the same patient is subject to impressive fluctuations.
After subcutaneous (subcutaneous) injection, the effect of the drug appears after about 30 minutes and lasts about 8 hours. The maximum effect is recorded 1-3 hours after administration.
Pharmacokinetics
The completeness of absorption and the onset of action of insulin are determined by the method of administration [sc, intramuscular (i / m) or intravenous (i / v)], the volume of insulin injected, the content of the latter in the preparation, the area of administration (thigh, abdomen, buttocks).
The agent is distributed unevenly through the tissues, does not pass through the placenta and is not excreted in breast milk. It is broken down mainly in the liver and kidneys by the enzyme insulinase.
Insulin is excreted by the kidneys (30–80%), the half-life (T 1/2) of the drug is several minutes.
Indications for use
- type I diabetes mellitus;
- type II diabetes mellitus: stage of resistance to oral hypoglycemic drugs, partial resistance to these drugs (during combination therapy), intercurrent diseases;
- type II diabetes mellitus in pregnant women;
- emergency conditions in patients with diabetes mellitus, proceeding with decompensation of carbohydrate metabolism.
Contraindications
Rinsulin R is contraindicated in patients with hypoglycemia and with proven hypersensitivity to any component of the drug.
Rinsulin R, instructions for use: method and dosage
Rinsulin R is administered subcutaneously, intramuscularly and intravenously.
The route of administration and the dose of the solution are set individually, based on the concentration of glucose in the blood. The daily dose on average can vary from 0.5 to 1 IU / kg, depending on the individual characteristics of the patient and the blood glucose content.
Injections are made 30 minutes before a meal containing carbohydrates. The insulin injected should be at room temperature.
In persons with insulin resistance (during puberty, in patients with obesity), the need for insulin may be higher, and in persons with residual secretion of endogenous insulin - lower. It is necessary to adjust the dose of insulin for the following diseases / conditions: thyroid disorders, hypopituitarism, Addison's disease, liver and / or kidney dysfunction, age over 65 years. If the level of physical activity increases or the habitual diet changes, it may also be necessary to change the doses of Rinsulin R. Concomitant diseases, primarily infections and conditions occurring with fever, cause an increase in the need for insulin.
When the drug is used in monotherapy, the frequency of injections is usually 3 times a day (if necessary, 5–6 times). If the daily dose exceeds 0.6 IU / kg, it is necessary to inject the solution two or more times in different areas of the body. As a rule, injections are made subcutaneously into the anterior abdominal wall; injections into the buttock, thigh or shoulder in the projection of the deltoid muscle are also allowed.
In order to prevent lipodystrophy, it is necessary to constantly change the needle insertion sites within the anatomical region. When s / c injections, care must be taken not to enter the blood vessel. The site of injection after injection should not be massaged.
Patients should be taught how to properly use the insulin delivery device. Rinsulin R can be administered intravenously and intramuscularly only under medical supervision.
The solution can only be used if the liquid upon visual inspection is colorless and completely transparent, without visible particles. In the presence of sediment, the drug should not be used.
Rinsulin R is a short-acting insulin and is usually used in combination with intermediate-acting insulin (Rinsulin NPH). The drug in use should be stored for no more than 28 days at a temperature of 15-25 ° C.
Application of Rinsulin R in vials
Injection technique and dosing procedure using one type of insulin:
- Disinfect the vial membrane.
- Draw air into the syringe in a volume that corresponds to the required dose of insulin and inject it into the vial.
- Turn the bottle upside down, without removing the syringe, and draw in the last required dose of Rinsulin R. Remove the needle from the bottle and remove air from the syringe, check that the prescribed dose is set correctly.
- Collect a fold on the previously disinfected area of the skin with two fingers and, introducing a needle into its base at an angle of about 45 °, make a subcutaneous injection.
- After injection, leave the needle under the skin for at least 6 seconds to ensure that the solution is completely injected.
- Remove the needle and press the injection site with a cotton swab moistened with alcohol or other disinfectant solution.
Injection technique, if necessary, a combination of two types of insulin:
- Disinfect the membranes of both vials.
- Roll the vial of long-acting insulin (suspension) immediately before the procedure between the palms until the preparation becomes evenly white and cloudy.
- Draw air into the syringe in an amount equal to a dose of long-acting insulin, and enter into a vial with cloudy insulin, remove the needle from the vial.
- Draw air into the syringe in a volume equal to the dose of short-acting insulin (transparent). Introduce air into the vial with the latter, turn the vial with the syringe upside down and collect the required dose of clear insulin. Remove the needle from the vial and remove air bubbles from the syringe.
- Insert the needle into the vial containing "cloudy" insulin, turn the vial with the syringe upside down and draw the required dose of Rinsulin R. Remove air from the syringe and immediately introduce the collected insulin mixture.
The use of Rinsulin R in cartridges
The contents of the cartridge are not mixed with other types of insulin directly in the cartridge. Cartridges are not intended for refilling.
Rinsulin P cartridges can be used with reusable syringe pens:
- Autopen Classic 3 ml 1 Unit (1–21 units) AN3810, Autopen Classic 3 ml 2 Unit (2–42 units) AN3800] produced by Owen Mumford Ltd. / Owen Mumford Ltd, Great Britain;
- syringe pen BiomaticPen manufactured by Ipsomed AG / Ypsomed AG, Switzerland;
- Pen-injectors for insulin administration HumaPen (Ergo II and Luxura) manufactured by Eli Lilly and Company, USA;
- insulin syringe pen OptiPen Pro 1 manufactured by Aventis Pharma Deutschland GmbH / Aventis Pharma Deutschland GmbH, Germany.
It is necessary to strictly follow the instructions of the manufacturer of the syringe pen regarding the installation of the cartridge, the attachment of the needle and the administration of the drug.
Immediately after injection, the needle must be unscrewed using its outer cap and disposed of in a safe manner. Removing the needle ensures sterility, prevents leakage, air ingress and possible needle clogging. After that, put a cap on the handle.
The use of Rinsulin R in a pre-filled syringe pen
Before using the pre-filled multi-dose disposable syringe pen for multiple injections for the first time, remove it from the refrigerator and allow the solution to reach room temperature.
Rinsulin R in a pen and needles are for one patient only. Refilling the pen cartridge and reusing the needle is prohibited. The pen should not be used by multiple persons.
Do not store used Rinsulin R in a syringe pen in the refrigerator.
It is necessary to carefully follow the instructions for use of syringe pens for the administration of insulin provided by their manufacturers.
Instructions for use of the Rinastra disposable multi-dose for multiple injections syringe pen supplied with Rinsulin R:
- Assembly: holding the pen with one hand, pull the cap with the other hand and remove it. Rub the rubber membrane with an alcohol wipe. Select a needle from the kit and remove the protective sticker from it. Attach the needle directly to the cartridge holder with an external tip and screw tight. Pull slightly to remove the outer tip and store it for later disposal of the used needle.
- Preparation: carefully remove the inner nozzle and then discard, hold the pen with the needle up (the needle becomes visible after removing the inner nozzle). Knock the cartridge gently so that the air bubbles rise up, allowing small bubbles to remain. By scrolling the dosage selector, set the dosage so that the number 2 in the dosage window coincides with the pointer. The set of each unit should be accompanied by a click (if the selector accidentally missed the desired dose, it should be adjusted by scrolling the selector in the opposite direction; when setting the dose, you do not need to press the trigger). Holding the pen with the needle up, press the start button all the way, when the selector reaches the number 0 you will hear a click. Check that a drop of solution appears on the tip of the needle, if it does not come out,it is recommended to repeat the scrolling of the dosage selector and setting the dosage, but no more than 6 times. If a drop does not appear, remove the needle and select a new one, repeating all the above steps. The exit of the drop from the needle must be checked before each injection.
- Dose setting: Scroll the dosage selector until the assigned dose matches the pointer in the dosage window. For example, if the required dose is 40 units, you must scroll the selector to 40. If the selector does not scroll, then there is not enough drug in the pen. In this case, the pen should be thrown away or the remaining dose units should be introduced, and then to use the missing dose of the agent, use a new pen.
- Dose administration: make sure the correct dose is taken. Wipe the skin on the injection site with an alcohol wipe and clamp it in the desired place, then insert the needle under the skin in one continuous motion. To avoid accidental puncture injury, the needle should be clamped at least 2.5 cm of skin and the needle should not be inserted at an angle towards the fingers. Press the start button until the 0 mark is at the level of the pointer in the dosage window. Hold the syringe pen at the injection site and continue to press the button for 10 seconds after the click of a stop is heard to fully deliver the required dose of insulin. In the case when the solution continues to flow out after the injection, the needle should be kept in the skin for a longer time during subsequent injections.
- Disposal of the needle and storage of the syringe pen: carefully pull the outer nozzle onto the needle until it stops, and then unscrew the needle and discard it along with the nozzle. Put the cap on the syringe pen and store it until the next injection away from direct sunlight. Do not reuse an empty pen.
Side effects
When using Rinsulin P, the following side effects may develop:
- local reactions: swelling, itching, hyperemia at the injection site; with a long course - lipodystrophy at the injection site;
- allergic reactions: skin rash, anaphylactic shock, Quincke's edema;
- effects caused by the effect on carbohydrate metabolism: hypoglycemic conditions - increased sweating, weakness, pallor of the skin, headache, dizziness, palpitations, decreased visual acuity, hunger, tremors, agitation, chills, paresthesia of the oral mucosa; severe hypoglycemia can cause the development of hypoglycemic coma;
- others: edema, transient deterioration in visual acuity (in most cases at the beginning of therapy).
If the development of hypoglycemia is noted or episodes of loss of consciousness are recorded, or any other adverse reactions not described above occur, you must immediately inform your doctor about it.
Overdose
In case of an overdose of Rinsulin R, hypoglycemia may appear (symptoms in the section "Side effects").
With mild hypoglycemia, symptoms can be controlled by ingesting sugar or carbohydrate-fortified foods. Patients with diabetes are advised to always carry sweets, sugar or sweet fruit juice with them.
In severe hypoglycemia, if the patient has lost consciousness, intravenous administration of a solution of dextrose (glucose) 40% and intramuscular, intravenous or subcutaneous administration of glucagon is indicated. To prevent the recurrence of hypoglycemia after recovery of consciousness, you should eat a carbohydrate-rich food.
special instructions
During the period of insulin therapy, constant monitoring of blood glucose is required.
The transition of a patient to the use of a new type of insulin or insulin preparation of another manufacturer should be carried out only under the supervision of a specialist.
In addition to an overdose of insulin, the following diseases / conditions can provoke the appearance of hypoglycemia: disorders of the liver and kidneys, hypofunction of the pituitary gland, adrenal cortex or thyroid gland (diseases that reduce the need for insulin), vomiting, diarrhea, skipping meals, changing the drug, increasing physical activity, change of the area of introduction, interaction with other means.
The development of hyperglycemia, especially in people with type I diabetes mellitus, can lead to missed insulin delivery and incorrect dosing. The first symptoms of this complication occur mainly gradually, over several hours or days, and include disorders such as redness and dryness of the skin, thirst, dry mouth, loss of appetite, nausea, vomiting, increased urination, dizziness, and the smell of acetone in the exhaled air. If there is no timely treatment for type I diabetes, hyperglycemia exacerbates the risk of diabetic ketoacidosis, a life-threatening acute complication.
It is necessary to use the drug with extreme caution in the presence of severe stenosis of the coronary and cerebral arteries due to the increased threat of cardiac and cerebral complications of hypoglycemia. Rinsulin R should also be used with caution in patients with proliferative retinopathy, especially those who do not receive treatment with laser photocoagulation (laser coagulation), due to the risk of developing amaurosis (complete blindness).
In the case when insulin preparations are prescribed for type II diabetes mellitus in combination with thiazolidinediones, fluid retention in the body may occur, as a result of which the likelihood of the development and intensification of chronic heart failure (CHF) increases, especially with concomitant diseases of the cardiovascular system and the presence of risk factors CHF. Patients receiving this treatment should be monitored regularly for possible signs of heart failure. When this disease occurs, therapy is required according to current treatment standards. It is also required to consider the possibility of discontinuing or reducing the dose of thiazolidinedione.
Influence on the ability to drive vehicles and complex mechanisms
Against the background of the primary appointment of insulin, a change in its type, or with severe physical or mental stress, there may be a decrease in the ability to drive vehicles or control various moving mechanisms.
Application during pregnancy and lactation
There are no restrictions on insulin therapy for diabetes mellitus during pregnancy, since it does not penetrate the placental barrier. In the case of planning pregnancy and during its course, more intensive treatment of diabetes mellitus is necessary. In the first trimester of pregnancy, the need for insulin, as a rule, decreases, and in the II-III trimesters, it gradually increases.
During and immediately after childbirth, the need for insulin medications can decrease dramatically. However, soon after giving birth, it quickly reaches the level seen before pregnancy.
There are no restrictions on insulin treatment for diabetes during lactation. At the same time, it is necessary to take into account the possibility of reducing the required dose of insulin, as a result of this, the sugar content should be carefully monitored for several months until the need for insulin stabilizes.
With impaired renal function
Patients with functional impairment of the kidneys due to the increased risk of hypoglycemia may require more frequent adjustment of the dose of Rinsulin P and increased blood glucose control.
For violations of liver function
Patients with impaired liver function, due to the increased risk of hypoglycemia, may require more frequent changes in the dose of Rinsulin P and control of blood glucose.
Use in the elderly
Individuals over the age of 65 need to adjust the dose of Rinsulin R, since they are at increased risk of hypoglycemia due to the presence of concomitant pathology and the combined use of several drugs.
Drug interactions
- iodine-containing thyroid hormones, oral contraceptives, estrogens, glucagon, somatropin, glucocorticosteroids, loop and thiazide diuretics, tricyclic antidepressants, sympathomimetics, heparin, H 1 blockers, histamine receptor blockers, calyphonid, morphine, danzin diazoxide, nicotine, phenytoin: weaken the hypoglycemic effect of insulin;
- monoamine oxidase inhibitors (MAOIs), oral hypoglycemic agents, angiotensin converting enzyme (ACE inhibitors) inhibitors, nonselective β-blockers, carbonic anhydrase inhibitors, anabolic steroids, sulfonamides, bromocriptine, tetreotide, phendophenylamines, ketoconazol lithium preparations, ethanol-containing agents: enhance the hypoglycemic effect of insulin;
- salicylates, reserpine: weaken or enhance the effect of Rinsulin P;
- ethanol: the tolerance to this substance decreases.
Analogs
Rinsulin R analogs are Actrapid HM, Biosulin R, Monoinsulin CHR, Vozulim-R, Insuran R, Gensulin R, Insuman Rapid GT, Rosinsulin R, Humodar R 100, Humulin Regular, etc.
Terms and conditions of storage
Store out of the reach of children, protected from light, at a temperature of 2–8 ° C, do not freeze.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Rinsulin R
Reviews of Rinsulin P are in most cases positive. Patients note that the drug effectively reduces elevated blood glucose levels and is well tolerated without causing unwanted side reactions. The advantages of the drug also include a convenient form of release - cartridges and pre-filled syringe pens, ready to use, which greatly simplifies the introduction of insulin. However, it is recommended to use Rinsulin R only after passing a thorough examination, as prescribed by the attending physician and in the doses established by him.
The price of Rinsulin R in pharmacies
The approximate price for Rinsulin R, solution for injection (100IU / ml) is 350–400 rubles for 1 bottle of 10 ml, 850–1300 rubles for 5 cartridges of 3 ml.
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
