Biosulin N
Latin name: Biosulin N
ATX code: A10AC01
Active ingredient: human insulin-isophane (Insulin-isophane Human)
Manufacturer: Pharmstandard-UfaVITA (Russia); Marvel LifeSignes Pvt. Ltd (Marvel LifeSciences Pvt. Ltd) (India)
Description and photo update: 28.11.2018
Prices in pharmacies: from 499 rubles.
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Biosulin N is a medium-acting insulin that regulates carbohydrate metabolism.
Release form and composition
The drug is available in the form of a suspension for subcutaneous (s / c) administration: homogeneous white liquid; during storage, it is divided into two layers - a supernatant transparent, colorless or almost colorless and white precipitate, which is quickly resuspended with gentle shaking (3 ml each in colorless glass cartridges for use with a syringe pen Biosulin Pen or BiomaticPen; 1, 3 or 5 cartridges in a blister contour package, in a cardboard box 1 package; 5 and 10 ml each in colorless glass bottles, in a cardboard box 1 bottle or a cell contour packaging containing 2, 3 or 5 bottles; each pack also contains instructions for the use of Biosulin H) …
Composition of 1 ml of suspension:
- active substance: insulin-isophane (human genetic engineering) - 100 IU (International units);
- auxiliary components: glycerol, metacresol, protamine sulfate, zinc oxide, phenol (crystalline phenol), sodium hydrogen phosphate dihydrate (disodium hydrogen phosphate dihydrate), sodium hydroxide solution 10% or hydrochloric acid solution 10%, water for injection.
Pharmacological properties
Pharmacodynamics
Biosulin N is a human insulin produced using recombinant DNA (deoxyribonucleic acid) technology.
Insulin-isophane, interacting with a specific receptor of the outer cytoplasmic membrane of cells, forms an insulin-receptor complex that stimulates intracellular processes, including the synthesis of a number of key enzymes, including glycogen synthetase, pyruvate kinase, and hexokinase.
A decrease in the level of glucose in the blood occurs due to an increase in its intracellular transport, an increase in absorption and assimilation by tissues, a decrease in the rate of glucose production by the liver, and stimulation of lipogenesis and glycogenogenesis.
The duration of action of insulin is mainly determined by the rate of absorption, which depends on several factors (including the dose used, the route and site of administration). For this reason, the action profile of insulin-isophane is subject to significant fluctuations not only in different people, but also in the same patient.
The effect of insulin develops approximately 1–2 hours after subcutaneous administration, reaches a maximum after 6–12 hours, and lasts for 18–24 hours.
Pharmacokinetics
The degree of absorption and the beginning of the development of the effect of insulin depend on the volume of injected insulin, its concentration in the preparation and the injection site (thigh, abdomen, buttock).
The hormone is unevenly distributed in tissues. Does not penetrate the placental barrier and into breast milk.
Insulin isophane is metabolized mainly in the liver and kidneys under the influence of insulinase. It is excreted in the urine in an amount of 30 to 80% of the dose.
Indications for use
- type 1 diabetes mellitus;
- type 2 diabetes mellitus in the presence of resistance to oral hypoglycemic drugs or partial resistance to these drugs in the case of combination therapy, as well as in the presence of an intercurrent disease (an additional disease that developed against the background of diabetes mellitus and aggravates its course).
Contraindications
Absolute:
- hypoglycemia;
- hypersensitivity to insulin or any auxiliary component of the Biosulin N.
The drug should be used with caution in the following cases (dose adjustment may be required):
- impaired renal function;
- impaired liver function;
- the presence of an intercurrent disease;
- severe stenosis of the coronary and cerebral arteries;
- dysfunction of the thyroid gland;
- Addison's disease;
- hypopituitarism;
- proliferative retinopathy, especially in patients who have not received laser therapy (photocoagulation treatment);
- age over 65.
Biosulin N, instructions for use: method and dosage
The target glucose concentration, dosing regimen (dose and time of administration) are determined and strictly adjusted by the doctor individually for each patient in such a way as to correspond to the patient's lifestyle, level of physical activity and diet.
The Biosulin N suspension is injected subcutaneously, usually in the thigh. It can also be injected into the shoulder (in the deltoid view), the anterior abdominal wall, or the buttock. In order to avoid the development of lipodystrophies, it is recommended to alternate the injection sites within the anatomical region. The suspension should be administered carefully to prevent it from entering the blood vessel. No need to massage the injection site.
The doctor prescribes the dose depending on the blood glucose level and the individual characteristics of the patient. The average daily dose ranges from 0.5-1 IU / kg.
Each patient should be instructed by a medical professional on the frequency of glucose measurements and recommendations on the insulin therapy regimen in case of any changes in lifestyle or diet, as well as teach the correct use of the device for the administration of Biosulin N.
In severe hyperglycemia (in particular in ketoacidosis), the use of insulin is part of a comprehensive treatment, including measures to protect patients from possible complications due to a rapid decrease in blood glucose levels. Such a therapeutic regimen requires careful monitoring in the intensive care unit, which includes monitoring the vital signs of the body, determining the electrolyte balance, the state of acid-base balance and metabolic status.
The temperature of the injected suspension should be room temperature.
It is forbidden to inject a suspension if after stirring it does not become homogeneous, cloudy, white. Do not use the drug if after mixing it contains flakes, or if solid white particles adhere to the bottom / walls of the bottle (effect of "frosty pattern").
Switching to Biosulin N from another type of insulin
When transferring a patient from one type of insulin to another, it may be necessary to adjust the dosage regimen, for example, when replacing insulin of animal origin with human insulin, when switching from one human insulin to another, when switching from soluble human insulin to longer-acting insulin, etc.
When switching from insulin of animal origin to human insulin, it may be necessary to reduce the dose of the drug, especially in patients who are prone to developing hypoglycemia; previously had fairly low blood glucose concentrations; previously needed high doses of insulin due to the presence of antibodies to it.
The need to reduce the dose of the drug may arise immediately after the transfer to a new type of insulin, or develop gradually over several weeks.
During the transfer of the patient to another insulin preparation and in the first weeks of its use, blood glucose levels should be carefully monitored. Patients who previously needed high doses of insulin due to the presence of antibodies are recommended to be transferred to another type of insulin in a hospital under close medical supervision.
Additional change in insulin dose
With improved metabolic control, insulin sensitivity may increase, as a result of which the need for it may decrease.
Dose adjustment may also be necessary when the patient's body weight, lifestyle, or other circumstances change that may increase the predisposition to the development of hyper- or hypoglycemia.
The need for insulin often decreases in the elderly. In order to avoid hypoglycemic reactions, it is recommended to start therapy with caution, increase the dosage and select maintenance doses.
Decreased insulin requirements are also common in renal / hepatic impairment.
Application of Biosulin N in vials
Using only one type of insulin:
- Disinfect the rubber membrane on the vial.
- Draw air into the syringe in a volume that corresponds to the required dose of insulin. Introduce it into the vial with the drug.
- Turn the bottle (together with the syringe) upside down and draw the required dose of the suspension into the syringe. Remove the syringe from the vial and remove air from it. Check the correct dose.
- Inject immediately.
Mixing two types of insulin:
- Disinfect rubber membranes on two vials.
- Roll the vial of long-acting insulin (cloudy) between palms until the drug is evenly cloudy and white.
- Draw air into the syringe in a volume equal to the dose of turbid insulin, inject it into the appropriate bottle and remove the needle (you do not need to dial the drug yet).
- Draw air into the syringe in a volume equal to the dose of short-acting insulin (transparent) and enter it into the appropriate vial. Without removing the syringe, turn the bottle upside down and dial the required dose. Remove the syringe from the vial and remove air from it. Check the correct dose.
- Insert the needle into the vial of cloudy insulin. Without removing the syringe, turn it upside down and dial the required dose. Remove air, check the correct dose.
- Inject the mixture immediately.
You should always recruit different types of insulin in the sequence described above.
Application of Biosulin N in cartridges
The cartridge is intended for use with Biosulin Pen and Biomatic Pen syringe pens.
Before insertion, the patient must ensure that the cartridge is not damaged (eg cracked), otherwise it cannot be used.
The suspension must be mixed just before the injection (and the cartridge is inserted into the pen): turn the cartridge up and down at least 10 times so that the glass ball moves from end to end of the cartridge until all the liquid is evenly mixed. If the cartridge is already installed in the syringe pen, turn it over with the cartridge. This procedure should be performed before each administration of Biosulin N.
After installing the cartridge in the pen, a colored strip will be visible in the holder window.
Each Biosulin N cartridge is intended for individual use only. Do not refill cartridges.
Before injection, you should wash your hands, and also wipe the skin at the injection site with an alcohol napkin, but after the dose of insulin is set in the pen and let the alcohol dry.
The procedure for injection of Biosulin N with a syringe pen:
- Gather a fold of skin with two fingers and insert a needle into its base at an angle of 45 °, inject insulin.
- While holding down the button, leave the needle under the skin for at least 6 seconds to ensure correct dose delivery and to limit the flow of blood / lymph into the needle / cartridge.
- Remove the needle. If blood comes out at the injection site, lightly press the injection site with a cotton swab moistened with a disinfectant solution (for example, alcohol).
Attention! The needle is sterile, no need to touch it. A new needle must be used for each injection.
The patient should carefully follow the instructions in the instructions for use of a particular syringe pen, which describes in detail how to prepare it, choose a dose, and administer the drug.
Side effects
Side effects from organs and systems according to the frequency of their development (gradation: very often - ≥ 1/10, often - from ≥ 1/100 to 1/10, infrequently - from ≥ 1/1000 to <1/100, rarely - from ≥ 1/10000 to <1/1000, very rare - <1/10000, unknown frequency - it is not possible to determine the frequency from the available data):
- on the part of metabolism and nutrition: very often - hypoglycemic conditions * (increased sweating, pallor of the skin, headache, decreased visual acuity, dizziness, chills, palpitations, paresthesia of the oral mucosa, hunger, tremor, agitation), severe hypoglycemia can lead to hypoglycemic coma; often - edema; unknown frequency - sodium retention;
- from the immune system: rarely - skin rashes, Quincke's edema; very rarely - anaphylactic reactions; unknown frequency - the formation of antibodies to insulin (in rare cases, due to the presence of antibodies, it may be necessary to change the dose of Biosulin H to correct the tendency to develop hypo- or hyperglycemia);
- on the part of the organ of vision: infrequently - transient refractive errors (usually at the beginning of treatment); unknown frequency - temporary worsening of the course of diabetic retinopathy; against the background of severe hypoglycemic episodes - transient amaurosis (complete loss of vision);
- on the part of the skin and subcutaneous tissues: infrequently with long-term treatment - lipodystrophy at the injection site;
- others: infrequently - reactions at the injection site (swelling, itching, hyperemia at the injection site).
* Hypoglycemia is the most common side effect of insulin. The risk of its development arises if the dose of the drug exceeds the need for it. Severe repetitive episodes can lead to neurological impairment, including seizures and coma. Severe and / or prolonged episodes can be life threatening. In many patients, before signs of a lack of glucose in the brain (neuroglycopenia) appear, symptoms of reflex activation of the sympathetic nervous system (in response to developing hypoglycemia) may develop. In the case of a significant or more rapid decrease in glucose levels, the phenomenon of reflex activation of the sympathetic nervous system and its symptoms are usually more pronounced. A sharp decrease in glucose concentration can lead to the development of hypokalemia or cerebral edema.
Overdose
In case of an overdose of insulin, hypoglycemia develops.
In mild manifestations, the patient can independently eliminate the symptoms by eating carbohydrate-rich foods or sugar. In this regard, patients are advised to constantly carry sweets, sugar, sweet fruit juice or something similar.
In severe cases of hypoglycemia, loss of consciousness is possible. In this case, a 40% dextrose solution is injected intravenously; subcutaneously, intramuscularly or intravenously - glucagon. After the restoration of consciousness, in order to avoid a repeated attack of hypoglycemia, the patient is offered food rich in carbohydrates.
special instructions
During the period of insulin therapy, the patient should regularly monitor the blood glucose level.
If with the help of Biosulin N it is not possible to achieve optimal glycemic control, as well as in cases where there is a tendency to episodes of hypo- or hyperglycemia, the doctor will adjust the dose. However, it must first check the patient's clear compliance with the prescribed regimen, including the correct adherence to the injection regimen and injection technique, the choice of the injection site and other factors that may affect the effect of the drug.
At the same time, the drugs used can both enhance and weaken the effect of Biosulin N, therefore, no medication should be taken without the consent of the attending physician.
The risk of developing hypoglycemia is highest at the initial stage of therapy, when switching to another type of insulin, as well as with a low maintenance blood glucose concentration.
The following factors can also lead to the development of hypoglycemia: replacement of the drug, change of the injection site, diarrhea or vomiting, skipping meals, the occurrence of concomitant diseases that reduce the need for insulin (functional impairment of the kidneys or liver, hypofunction of the thyroid gland, pituitary gland or adrenal cortex) and simultaneous taking other drugs.
With extreme caution and under intensive glucose control, treatment should be carried out in patients for whom the occurrence of hypoglycemic episodes may be of particular clinical significance: in the presence of proliferative retinopathy (especially in cases where photocoagulation was not performed), severe stenosis of the cerebral or coronary arteries.
A patient with diabetes mellitus and his relatives should be aware of certain clinical symptoms that may indicate developing hypoglycemia. These include: moisture in the skin, excessive sweating, chest pain, increased blood pressure, heart rhythm disturbances, tachycardia, pallor of the skin, paresthesia in and around the mouth, hunger, anxiety, irritability, sleep disturbances, drowsiness, anxiety, or fear, headache, tremors, unusual behavior, impaired coordination of movements, depression, as well as transient neurological disorders (impaired vision and speech, paralytic symptoms) and other unusual sensations. If the decrease in glucose concentration increases, the patient may lose self-control and even consciousness. In these cases, moisture and coldness of the skin, cramps are possible. In case of mild disorders, the patient himself can adjust the glucose level by eating food rich in carbohydrates or sugar (it is recommended to always carry 20 g of glucose with him). In severe conditions, subcutaneous administration of glucagon is required, after improvement of the patient's condition, the patient should eat. If hypoglycemia does not stop, it is necessary to immediately call a doctor and warn him about the developing condition to make a decision on the advisability of adjusting the insulin dose.it is necessary to immediately call a doctor and warn him about the developing condition to make a decision on the advisability of adjusting the insulin dose.it is necessary to immediately call a doctor and warn him about the developing condition to make a decision on the advisability of adjusting the insulin dose.
In some cases, symptoms of hypoglycemia may be absent or mild. This is more often observed in the elderly, patients with lesions of the nervous system (neuropathies) or concomitant mental illness, when changing insulin or low maintenance blood glucose concentration, as well as in the case of the simultaneous administration of certain medications.
The following circumstances can lead to the development of hyperglycemia (possibly with ketoacidosis): skipping insulin injection, non-compliance with diet, decreased physical activity, infectious or other diseases. The first symptoms of this condition usually develop gradually, over several hours or even days. These include: thirst, dry mouth, loss of appetite, nausea, vomiting, redness and dryness of the skin, dizziness, increased urination, the smell of acetone in the exhaled air. Untreated, hyperglycemia in type 1 diabetes can cause life-threatening diabetic ketoacidosis. If you experience any of the above symptoms, you should immediately consult a doctor.
Biosulin N reduces alcohol tolerance.
There are known cases of the development of chronic heart failure in patients receiving insulin in combination with thiazolidinediones, especially in the presence of concomitant risk factors for the transition of heart failure to a chronic form. This fact should be taken into account when conducting combination therapy. Before the combined appointment of these drugs, the patient is carefully examined. In case of worsening of the course of the existing heart failure, thiazolidinediones are canceled.
Biosulin N is not recommended for use in insulin pumps due to the risk of precipitation.
When changing a doctor (for example, in case of illness while on vacation or hospitalization due to an accident), it is imperative to inform the healthcare professional that the patient has diabetes.
Influence on the ability to drive vehicles and complex mechanisms
It should be borne in mind that a decrease in the ability to concentrate and the speed of reactions is possible with the primary appointment of insulin, a change in its type, the presence of pronounced mental or physical stress.
Application during pregnancy and lactation
Insulin does not cross the placental barrier, therefore it is not contraindicated for use during pregnancy. However, when planning pregnancy and during its course, it is recommended to intensify the treatment of diabetes mellitus. The woman should be under close medical supervision in connection with the need to adjust the dose of Biosulin H. In the first trimester, the need for insulin, as a rule, decreases, and gradually increases in the II and III trimesters. During labor and immediately after delivery, the need for insulin can decrease dramatically. Insulin returns to baseline levels (pre-pregnancy) soon after delivery.
Insulin does not penetrate into breast milk, therefore it is not contraindicated for use during lactation, but the need for it may decrease. Therefore, it is recommended that women be closely monitored for several months after starting breastfeeding until insulin levels stabilize.
With impaired renal function
Biosulin N should be used with caution in patients with impaired renal function. Dose adjustment required.
For violations of liver function
Biosulin N should be used with caution in patients with impaired hepatic function. Dose adjustment required.
Use in the elderly
Biosulin N should be used with caution in patients over 65 years of age. Dose adjustment required.
Drug interactions
The hypoglycemic effect of insulin is weakened by blockers of H1-histamine receptors, oral contraceptives, glucocorticosteroids, blockers of slow calcium channels, sympathomimetics, loop diuretics, iodine-containing thyroid hormones, tricyclic antidepressants, estrogens, thiazidine diuretines, gipharylutinamide, somatropin, epinephrine, nicotine.
The hypoglycemic effect of insulin is enhanced by tetracyclines, monoamine oxidase inhibitors, lithium preparations, angiotensin-converting enzyme inhibitors, sulfonamides, ethanol-containing drugs, anabolic steroids, carbonic anhydrase inhibitors, nonselective beta-blockers, oral hypoglycemic agents, meburamino-phosphate-blockers, meburamino-phosphate, octreotide, pyridoxine.
With the simultaneous use of salicylates or reserpine, the effect of Biosulin N can be both weakened and enhanced.
Analogs
Biosulin N analogs are Vozulim-30/70, Vozulim-N, Gensulin N, Insuman Bazal GT, Insuran NPH, Protamine-insulin ChS, Protafan HM, Protafan HM Penfill, Rinsulin NPH, Rosinsulin C, Humodar B 100 Rek, Humulin NPH.
Terms and conditions of storage
Keep out of the reach of children, protected from light, at a temperature of 2-8 ° C. Do not freeze.
Shelf life is 2 years.
Store the used vial, cartridge and syringe pen with a cartridge in a dark place at a temperature of 15–25 ° C for no more than 4 weeks.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Biosulin N
The reviews about Biosulin N found on specialized medical sites are quite contradictory. Some patients write that the drug helps them to control blood glucose well. However, there are many reports that describe the lack of the desired effect of insulin therapy with this particular drug and / or the development of side effects.
Price for Biosulin N in pharmacies
Approximate prices for Biosulin N: 1 bottle of 10 ml - 273 rubles, 5 cartridges of 3 ml - 1184 rubles.
Biosulin N: prices in online pharmacies
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Drug name Price Pharmacy |
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Biosulin N 100 IU / ml suspension for subcutaneous administration 10 ml 1 pc. RUB 499 Buy |
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Biosulin N 100 IU / ml suspension for subcutaneous administration 3 ml 5 pcs. 1059 r Buy |
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Biosulin N suspension for n / a input. 100 IU / ml 3ml 5 pcs. 1086 RUB Buy |
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Biosulin N 100 IU / ml suspension for subcutaneous administration 3 ml 5 pcs. 1086 RUB Buy |
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!
