Lantus SoloStar solution 100IU/ml-3ml N5 injection pen p/c at a price of 3,330 RUR buy in Irkutsk, Insulin - instructions for use, composition and description

Pharmacological properties of the drug Lantus

Pharmacodynamics . Insulin glargine is an analogue of insulin, obtained using recombinant DNA technology using the K12 strain of E scherichia coli , has a structure identical to human insulin. Reduces blood glucose levels. It has low solubility at neutral pH and is completely soluble in acidic media. The pH value of the injection solution is 4. After subcutaneous administration, the acidic solution is neutralized in the tissue, which leads to the formation of microsediment/microprecipitates, from which insulin glargine is gradually released, which ensures a smooth, peak-free drug concentration profile in the blood. These properties of insulin glargine ensure a long-lasting effect of the drug. Like human insulin, insulin glargine binds to insulin receptors, causing the same physiological effects, primarily affecting glucose metabolism. Insulin and its analogues reduce blood glucose levels by increasing its utilization in peripheral tissues, particularly in skeletal muscle and adipose tissue, and inhibiting glucose production in the liver. Insulin inhibits lipolysis and proteolysis and enhances protein biosynthesis. Pharmacokinetics. With intravenous administration of insulin glargine and human insulin in equal doses, their effects are equivalent. The onset of action of insulin glargine after subcutaneous administration is more gradual, the concentration in the blood is stable (there are no peaks in blood concentration), and the duration of action is prolonged compared to human insulin. Such effects of insulin glargine are directly due to slow absorption and allow the drug to be used once a day. In patients with type I diabetes mellitus, the time of optimal effectiveness between injection and the end of pharmacotherapeutic action is 14.5 hours (from 9.5 to 19.3 hours) for human insulins and 24 hours (from 10.8 to 24 hours or more ) for insulin glargine. Stable insulin levels are achieved 2–4 days after the start of administration. In humans, insulin glargine is partially broken down in subcutaneous fat by carboxylation of the beta chain to form the active metabolites 21A-Gly insulin and des-30B insulin. Both unchanged insulin glargine and its metabolic products are detected in blood plasma. In clinical studies, when analyzing subgroups formed by age and gender, no differences were noted regarding the safety and effectiveness of insulin glargine.

Lantus SoloStar solution 100IU/ml-3ml N5 spray pen s/c

Method of administration and dosage Subcutaneously for adults and children over 6 years of age, Lantus® SoloStar® should be used only subcutaneously 1 time per day, always at the same time. Lantus® SoloStar® should be injected into the subcutaneous fat of the abdomen, shoulders or thighs. Injection sites should be alternated with each new injection within the recommended areas for subcutaneous administration of the drug.

The dose of Lantus® SoloStar® and the time of day for its administration are selected individually. In patients with type 2 diabetes mellitus, Lantus® SoloStar® can be used both as monotherapy and in combination with other hypoglycemic drugs.

Switching from treatment with other hypoglycemic drugs to Lantus® SoloStar® When replacing a treatment regimen with intermediate-acting or long-acting insulins with a treatment regimen with Lantus® SoloStar®, it may be necessary to adjust the daily dose of basal insulin, and there may also be a need to change concomitant antidiabetic therapy (doses and administration regimens of additionally used short-acting insulins or their analogues or doses of oral hypoglycemic drugs).

When transferring patients from twice daily administration of isophane insulin to a single administration of Lantus® SoloStar® in order to reduce the risk of hypoglycemia at night and early morning, the daily dose of basal insulin should be reduced by 20-30% in the first weeks of treatment. During this period, the dose reduction, at least in part, should be compensated by increasing the doses of short-acting insulin, followed by individual adjustment of the dosage regimen.

Use of the drug Lantus

Inject s/c into the area of the anterior abdominal wall, deltoid muscle or thigh once a day, at the same time. The dose is set individually. To administer the drug, you must use only syringes graduated at 100 IU! Lantus should not be administered intravenously, since administration at the usual dose for subcutaneous administration can lead to the development of severe hypoglycemia. Lantus should not be mixed with any other insulin or diluted as this may alter the timing/pattern of action of the drug and lead to the formation of a precipitate. In patients with type II diabetes mellitus, Lantus can be used simultaneously with oral hypoglycemic agents; in this case, the average initial dose of Lantus is 10 IU/day, subsequently from 2 to 100 IU/day. Switching from other insulins. When switching from intermediate-acting insulin or from long-acting insulin to Lantus, there may be a need to adjust the dose of basal insulin, as well as change the dosage regimen of oral hypoglycemic agents and short-acting insulin analogues. In order to reduce the risk of developing nocturnal or early morning hypoglycemia, patients who are switching from double human insulin to Lantus once daily should reduce the dose of basal insulin by 20–30% during the first weeks of treatment. This reduction in the dose of basal insulin should be temporarily compensated by increasing the dose of insulin administered with meals. At the end of the preparatory period, insulin doses are adjusted again. As with the use of other insulin analogues, in patients who receive high doses of insulin, due to the presence of antibodies to human insulin, the response to insulin may improve when treated with Lantus SoloStar, which requires dose adjustment. This is especially important to consider in overweight patients when changing their lifestyle. Lantus is administered subcutaneously once a day, at the same time, in an individually selected dose. The syringe pen allows you to administer the drug in a single dose range from 2 to 40 IU. The drug should not be administered intravenously, since administration of the usual dose in this case can lead to the development of severe hypoglycemia. There are no clinically significant differences in plasma insulin or glucose levels after administration of the drug to the anterior abdominal wall, deltoid muscle or thigh. The injection site can be changed in a circle. The drug can be used only if the solution upon visual examination is transparent and colorless (or practically colorless), without particles visible to the eye. Immediately before injection, it is necessary to remove the air bubble from the syringe. Mixing the drug with other products is not allowed, as this may lead to the formation of sediment. Each time you inject, you should use a new needle for the syringe pen. After the injection, the needle must be removed and the syringe pen must be stored without a needle. There is no need to shake the pen before use. Before use, the syringe pen must be kept for 1–2 hours at room temperature. To attach the needle, remove the protective label from the needle container without removing the outer and inner needle caps. Carefully attach the needle and its outer cap exactly to the transparent reservoir (by screwing or pressing, depending on the type of needle). Do not attach the needle at an angle as this may cause it to break or cause insulin to leak out of the system and result in incorrect dosing. When attaching, do not press the needle too hard. Make sure the dose button is pressed. A safety test must be performed before each injection. For the first safety test, the dose should be 8 units of insulin using a new, previously unused pen. Make sure the dose indicator points to 8. If it does not, use a new pen. Pull out the dose button as far as possible. Do not return the dose switch if the dose button is pulled out. For a pen that has already been used, set the dose indicator to number 2 by rotating the dosing switch. The dosing switch can be rotated in any direction. Pull out the dose button. Check whether the number on the button corresponds to the dose selected on the dosing switch. Black marks indicate the number of units. The last thick line visible on the button (only the top part is visible) indicates the charged dose. To see the last thick line, you can rotate or tilt the pen. Remove the inner and outer needle caps. Holding the pen with the needle up, lightly tap the insulin container with your fingertip so that air bubbles rise up towards the needle. Press the dose button all the way to release the dose. You may feel a clicking sound that will stop when you press the dose button all the way. If insulin appears at the tip of the needle, the device is working properly. If insulin does not appear at the tip of the needle, repeat the instructions above. If a drop of insulin does not appear even after repeating the safety test, check the device for air bubbles. If they are present, repeat the safety test until they disappear. If there are no air bubbles, the needle may become clogged; in this case it should be replaced. After inserting the needle, press the dose button all the way. Leave the needle in the skin for at least 10 seconds. The dose button must remain pressed until the needle is removed. After removal, the needle is unscrewed by rotating the cap. The needle can only be used once. Checking the reservoir for remaining insulin The scale on the transparent reservoir indicates the amount of insulin remaining in the syringe pen. This scale is not intended to indicate insulin dosage. If the black plunger is near the 40 mark at the beginning of the color stop, this means that the remaining insulin volume in the pen is approximately 40 IU. The end of the colored stopper indicates that the pen contains approximately 20 IU of insulin. If the insulin level in the reservoir is low, you can check the insulin level using the dose button. You should not use a pen unless you are sure there is enough insulin left in it for the next dose. For example, if the dose indicator is set to 30 IU, but the dose button is pulled out no more than 12 IU, this means that the pen can only deliver 12 IU of insulin. In this case, the missing 18 IU can be injected using a new pen, or a new pen can be used to inject the full dose of 30 IU of insulin.

Lantus®

The dose of the drug and the time of day for its administration are determined individually. Lantus® is administered subcutaneously 1 time/day, always at the same time. Lantus® should be injected into the subcutaneous fat of the abdomen, upper arm or thigh. Injection sites should be rotated with each new injection of the drug within the recommended areas for subcutaneous injection of the drug.

The drug can be used both as monotherapy and in combination with other hypoglycemic drugs.

When transferring a patient from long-acting or intermediate-acting insulins to Lantus®, it may be necessary to adjust the daily dose of basal insulin or change concomitant antidiabetic therapy (doses and administration of short-acting insulins or their analogues, as well as doses of oral hypoglycemic drugs).

When transferring a patient from a double dose of isophane insulin to a single dose of Lantus, the daily dose of basal insulin should be reduced by 20-30% in the first weeks of treatment in order to reduce the risk of hypoglycemia at night and early morning hours. During this period, the reduction in the Lantus dose should be compensated by increasing the doses of short-acting insulin, followed by individual adjustment of the dosage regimen.

As with other human insulin analogues, patients receiving high doses of drugs due to the presence of antibodies to human insulin may experience an increase in response to insulin when switching to Lantus®. During the transition to Lantus® and in the first weeks after it, careful monitoring of blood glucose levels and, if necessary, correction of the insulin dosage regimen are required.

In the event of improved metabolic regulation and a resulting increase in insulin sensitivity, further adjustment of the dosage regimen may become necessary. Dose adjustment may also be required, for example, if there is a change in the patient’s body weight, lifestyle, time of day for drug administration, or if other circumstances arise that increase the susceptibility to the development of hypo- or hyperglycemia.

The drug should not be administered intravenously. Intravenous administration of the usual dose intended for subcutaneous administration may cause the development of severe hypoglycemia.

Before administration, you must ensure that the syringes do not contain residues of other medications.

Rules for use and handling of the drug

OptiSet pre-filled syringe pens

Before use, you should inspect the cartridge inside the syringe pen. It should only be used if the solution is clear, colorless, contains no visible solids, and has a consistency similar to water. Empty OptiSet syringe pens are not intended for reuse and must be destroyed.

To prevent infection, the prefilled pen is intended for use by one patient only and cannot be shared with another person.

Handling the OptiSet syringe pen

Always use a new needle each time you use it. Use only needles suitable for the OptiSet syringe pen.

A safety test should always be performed before each injection.

If a new OptiSet syringe pen is used, the readiness for use test should be carried out using 8 units pre-drawn by the manufacturer.

The dose selector can only be turned in one direction.

Never turn the dose selector (dose change) after pressing the injection trigger.

If another person is giving the injection to a patient, he or she must take special care to avoid accidental injury from the needle and contraction of an infectious disease.

Never use a damaged OptiSet syringe pen, or if you suspect it is malfunctioning.

It is necessary to have a spare OptiSet syringe pen in case the one you are using is lost or damaged.

Insulin check

After removing the cap from your pen, you should check the label on your insulin reservoir to make sure it contains the correct insulin. You should also check the appearance of the insulin: the insulin solution should be clear, colorless, free of visible solids, and have a consistency similar to water. Do not use the OptiSet syringe pen if the insulin solution is cloudy, colored or contains foreign particles.

Attaching a needle

After removing the cap, carefully and tightly connect the needle to the syringe pen.

Checking the readiness of the syringe pen for use

Before each injection, it is necessary to check the readiness of the syringe pen for use.

For a new and unused syringe pen, the dose indicator should be at the number 8, as was previously set by the manufacturer.

If a pen is used, the dispenser should be turned until the dose indicator stops at 2. The dispenser will rotate in one direction only.

Pull out the start button completely to dial the dose. Never rotate the dose selector after the trigger button has been pulled out.

The outer and inner needle caps must be removed. Save the outer cap to remove the used needle.

Holding the pen with the needle pointing up, you should gently tap the insulin reservoir with your finger so that air bubbles rise up towards the needle.

After this, press the start button all the way.

If a drop of insulin is released from the tip of the needle, the pen and needle are functioning correctly.

If a drop of insulin does not appear at the tip of the needle, you should repeat checking that the pen is ready for use until insulin appears at the tip of the needle.

Choosing an insulin dose

The dose can be set from 2 units to 40 units in increments of 2 units. If a dose greater than 40 units is required, it must be administered in two or more injections. Make sure you have enough insulin for the dose you need.

The residual insulin scale on the transparent insulin container shows approximately how much insulin is left in the OptiSet syringe pen. This scale cannot be used to take insulin doses.

If the black plunger is at the beginning of the colored bar, there are approximately 40 units of insulin available.

If the black plunger is at the end of the colored stripe, then there are approximately 20 units of insulin.

The dose selector should be turned until the dose indicator arrow points to the desired dose.

Taking a dose of insulin

The injection trigger must be pulled out all the way to fill the insulin pen.

You should check whether the required dose has been taken completely. The trigger button moves according to the amount of insulin remaining in the insulin container.

The start button allows you to check which dose has been taken. The start button must be kept energized during the test. The last visible wide line on the start button shows the amount of insulin withdrawn. When the trigger button is held down, only the top of this wide line is visible.

Insulin administration

Specially trained personnel must explain the injection technique to the patient.

The needle is inserted subcutaneously. The injection start button should be pressed all the way. The clicking sound will stop when the injection trigger button is pressed all the way down. The injection trigger should then be held down for 10 seconds before withdrawing the needle from the skin. This will ensure that the entire dose of insulin is delivered.

Removing the needle

After each injection, the needle should be removed from the syringe pen and discarded. This will prevent infection, as well as insulin leakage, air leakage, and possible needle blockage. Needles cannot be reused.

After this, you should put the cap back on the syringe pen.

Cartridges

Cartridges must be used together with the OptiPen Pro1 syringe pen, and in accordance with the recommendations given by the device manufacturer.

Instructions for using the OptiPen Pro1 syringe pen regarding installing the cartridge, connecting the needle and injecting insulin must be followed exactly. Inspect the cartridge before use. It should only be used if the solution is clear, colorless and free of visible solids. Before installing the cartridge into the syringe pen, the cartridge must be at room temperature for 1-2 hours. Before injection, any air bubbles should be removed from the cartridge. The instructions must be strictly followed. Empty cartridges are not reused. If the OptiPen Pro1 syringe pen is damaged, it cannot be used.

If the pen is faulty, insulin can be administered to the patient if necessary by drawing the solution from the cartridge into a plastic syringe (suitable for insulin at a concentration of 100 IU/ml).

To prevent infection, a reusable syringe pen should only be used by one person.

OptiClick cartridge system

The OptiClick cartridge system is a glass cartridge containing 3 ml of insulin glargine solution, which is placed in a transparent plastic container with an attached piston mechanism.

The OptiClik cartridge system should be used together with the OptiClik syringe pen in accordance with the instructions for use attached to it.

You should strictly follow all the recommendations contained in the instructions regarding installing the cartridge system in the OptiClick syringe pen, connecting the needle and performing the injection.

If the OptiClick syringe pen is damaged, you should replace it with a new one.

Before installing the cartridge system into the OptiClick syringe pen, it must be at room temperature for 1-2 hours. The cartridge system should be inspected before installation. It should only be used if the solution is clear, colorless and free of visible solids. Before injecting, any air bubbles should be removed from the cartridge system (as when using a pen). Empty cartridge systems are not reused.

If the syringe pen is faulty, then, if necessary, insulin can be administered to the patient by drawing the solution from the cartridge into a plastic syringe (suitable for insulin at a concentration of 100 IU/ml).

To prevent infection, a reusable syringe pen should only be used by one person.

Side effects of the drug Lantus

Hypoglycemia is the most common complication of insulin treatment (especially when used in high doses). Severe hypoglycemia can lead to neurological impairment and pose a threat to the patient's life. The following side effects that were observed during clinical studies of the drug are presented by organ system in order of decreasing frequency of their manifestations (very often - 1/10; often - 1/100, but ≤1/10; rarely - 1/1000, but ≤ 1/100; very rarely - 1/10000, but ≤1/1000; sometimes - ≤1/10000) and decreasing significance. From the side of metabolism: very often - hypoglycemia. Severe hypoglycemia, especially repeated hypoglycemia, can lead to damage to the nervous system. Prolonged or severe hypoglycemia can be life-threatening. In many patients, symptoms of hypoglycemia are preceded by symptoms of adrenergic counterregulation (activation of the sympathoadrenal system in response to hypoglycemia); The more significant and rapid the decrease in plasma glucose levels, the more pronounced the symptoms of counterregulation. From the immune system: rarely - allergic reactions. Sometimes immediate allergic reactions to insulin develop. Such reactions to insulin (including insulin glargine) or to the components of the drug (generalized skin reactions, angioedema, bronchospasm, hypotension and shock) can threaten the patient's life. The use of insulin preparations can lead to the appearance of antibodies to it. Clinical studies have shown cross-formation of antibodies to human insulin and insulin glargine. The presence of antibodies to insulin may require dose adjustment. From the sensory organs: very rarely - dysgeusia. From the side of the organ of vision: rarely - visual impairment. A pronounced change in the level of sugar in the blood plasma can cause a temporary deterioration in vision due to a temporary change in turgor and refraction of the lens of the eye. Deterioration of vision is associated with refractive error. Rarely - retinopathy. Long-term improvement in glycemia reduces the risk of progression of diabetic retinopathy. Rapidly increasing the intensity of insulin therapy after previous unsuccessful glycemic control increases the risk of progression of diabetic retinopathy. In patients with proliferative retinopathy, especially those who have not undergone photocoagulation, severe hypoglycemic conditions can lead to amaurosis. From the skin and subcutaneous tissue: often - lipohypertrophy, rarely - lipoatrophy, which lead to a slowdown in local absorption of insulin. Constantly changing the injection site can reduce the severity of these phenomena or prevent them. It is possible to develop transient hyperemia of the skin at the injection site (in 3–4% of patients), which disappears during further treatment over a period of several days to several weeks. From the musculoskeletal system: very rarely - myalgia. General and local reactions: often - reactions at the injection site (hyperemia, pain, itching, urticaria, swelling or inflammation). Most local reactions usually resolve within a few days or weeks. In some cases, the prescription of insulin drugs leads to sodium and water retention in the body and the appearance of peripheral edema if previous glycemic control was not adequate.

Special instructions for the use of Lantus

Lantus is not the insulin of choice for the treatment of diabetic ketoacidosis. In such cases, intravenous administration of simple insulin is recommended. Before initiating dose adjustments in the event of insufficient control of plasma glucose levels or a tendency to episodes of hypoglycemia or hyperglycemia, it is necessary to check the patient's compliance with the proposed treatment regimen, the site of administration, the correct administration technique, and other important factors. Hypoglycemia. Due to the peculiarities of the pharmacokinetics of Lantus (a more constant supply of basal insulin), the development of hypoglycemia is more likely in the early morning hours than at night. With extreme caution and subject to constant glycemic control, the drug is used in those patients in whom hypoglycemia is particularly severe, for example in patients with severe stenosis of the coronary arteries or cerebral vessels (risk of severe cardiac or cerebral complications of hypoglycemia), as well as in patients with proliferative retinopathy that did not undergo photocoagulation (risk of transient amaurosis). Patient compliance with drug administration and nutrition, correct administration of insulin, and knowledge of the symptoms of hypoglycemia are important to reduce the risk of developing severe hypoglycemia. Risk factors for the development of hypoglycemia include: changing the injection site, increasing sensitivity to insulin (for example, after eliminating stress), intense or prolonged physical activity, concomitant diseases, vomiting, diarrhea, skipping meals, drinking alcohol, some uncompensated endocrine diseases (hypothyroidism, insufficiency functions of the pituitary gland or adrenal glands), simultaneous use of certain medications. In some conditions, symptoms that are precursors of hypoglycemia may change, lose their severity, or be absent altogether: a long history of diabetes mellitus, mental illness, autonomic neuropathy, the combined use of certain other drugs, switching from animal insulin to human insulin, as well as elderly patients or gradual development of hypoglycemia or with a marked improvement in glycemic control. In this case, it is possible to develop severe hypoglycemia (with possible loss of consciousness) even before the patient realizes the fact of hypoglycemia. If the level of glycosylated hemoglobin is normal or reduced, it is necessary to take into account the possibility of repeated, latent (especially at night) episodes of hypoglycemia. Accompanying illnesses . In the presence of concomitant disease, intensive monitoring of the patient's metabolism is necessary. In many cases, determination of ketones in urine is indicated; it is necessary to frequently adjust the insulin dose. The need for insulin often increases. Patients with type 1 diabetes mellitus should regularly consume carbohydrates, at least in small quantities, and also in case of vomiting, etc. You should never skip insulin injections completely. Impaired liver or kidney function. Due to insufficient experience, the effectiveness and safety of Lantus in patients with impaired liver function or moderate and/or severe renal impairment have not been established. In patients with impaired renal function, insulin requirements may decrease due to decreased insulin metabolism. In elderly patients, decreased renal function may lead to a persistent decrease in insulin requirements. In patients with severe liver dysfunction, insulin requirements may be reduced due to decreased gluconeogenesis and slower insulin metabolism. During pregnancy and breastfeeding . There is no clinical experience based on clinical studies of the use of insulin glargine during pregnancy. Preclinical studies did not reveal any direct teratogenic or embryotoxic effects on the course of pregnancy, as well as on childbirth and development in the postpartum period. Therefore, caution must be exercised when prescribing the drug. During pregnancy, including for patients with gestational diabetes, it is important to control glycemic levels. The need for insulin may be reduced in the first trimester of pregnancy and increased in the second and third trimesters. Immediately after birth, the need for insulin decreases rapidly (the risk of hypoglycemia increases), so it is important to carefully monitor plasma glucose levels. During breastfeeding, insulin dosage and diet adjustments are also required. Children. The effectiveness and safety of using Lantus in children has been proven only for use in the evening. Lantus is not used in children under the age of 6 years, since the effectiveness and safety of the drug in children of this age category have not been proven. The ability to influence reaction speed when driving vehicles and operating machinery. In the case of inadequate selection of the dose or replacement of the drug, as well as in the case of irregular administration or irregular food intake, excessive fluctuations in the level of glucose in the blood plasma are possible, primarily in the direction of hypoglycemia, which can negatively affect the ability to drive vehicles, especially in the initial stages. period of treatment, as well as while taking alcohol or drugs that act on the central nervous system.

Lantus SoloStar 100 units/ml solution s/c injection 3ml syringe pen SoloStar No. 5

Dosage

100 IU/ml

Active substance

Insulin glargine

Manufacturer

Sanofi-Aventis Vostok CJSC (Germany)

Shelf life

3 years

Storage conditions

After use, store at a temperature not exceeding 25 °C in cardboard packaging (but not in the refrigerator).

Registration certificate number

P N014855/01 dated 07/21/2006

Description of the dosage form

Transparent colorless solution.

Pharmacokinetics

A comparative study of the concentrations of insulin glargine and insulin isophane in the blood serum in healthy people and patients with diabetes mellitus after subcutaneous administration of the drugs revealed a slower and significantly longer absorption, as well as the absence of a concentration peak for insulin glargine compared to insulin isophane .

With a single 24-hour subcutaneous administration of Lantus, a stable average concentration of insulin glargine in the blood is achieved 2–4 days after the first dose.

When administered intravenously, the half-lives of insulin glargine and human insulin were comparable.

In humans, in subcutaneous fat, insulin glargine is partially cleaved from the carboxyl end (C-terminus) of the B chain (Beta chain) to form 21A-Gly-insulin and 21A-Gly-des-30B-Thr-insulin. Plasma contains both unchanged insulin glargine and its breakdown products.

Pharmacodynamics

Insulin glargine is an analogue of human insulin, characterized by low solubility in a neutral environment. As part of the Lantus drug, it is completely soluble, which is ensured by the acidic environment of the injection solution (pH4). Once injected into the subcutaneous fat, the solution, due to its acidity, undergoes a neutralization reaction to form microprecipitates, from which small amounts of insulin glargine are continuously released, providing a predictable, smooth (no peaks) concentration-time curve profile, as well as a longer duration of action.

Binding to Insulin Receptors: The specific insulin receptor binding parameters of glargine and human insulin are very similar, and it is capable of mediating biological effects similar to endogenous insulin.

The most important action of insulin, and therefore insulin glargine, is the regulation of glucose metabolism. Insulin and its analogues lower blood glucose by stimulating glucose uptake by peripheral tissues (especially skeletal muscle and adipose tissue) and by inhibiting hepatic glucose production (gluconeogenesis). Insulin suppresses lipolysis in adipocytes and proteolysis, while simultaneously enhancing protein synthesis.

The long duration of action of insulin glargine is directly due to the reduced rate of its absorption, which allows the drug to be used once a day. After subcutaneous administration, the onset of action occurs, on average, after 1 hour. The average duration of action is 24 hours, the maximum is 29 hours.

Contraindications

hypersensitivity to insulin glargine or to any of the excipients;

children under 6 years of age (there are currently no clinical data on use).

Carefully

should be used in pregnant women.

Use during pregnancy and breastfeeding

No direct or indirect evidence of the embryotoxic or fetotoxic effects of insulin glargine has been obtained from animal studies.

To date, there are no relevant statistical data regarding the use of the drug during pregnancy. There is data on the use of Lantus in 100 pregnant women with diabetes. The course and outcome of pregnancy in these patients did not differ from those in pregnant women with diabetes mellitus who received other insulin preparations.

Lantus should be prescribed with caution in pregnant women. For patients with pre-existing or gestational diabetes mellitus, it is important to maintain adequate regulation of metabolic processes throughout pregnancy. Insulin requirements may decrease during the first trimester of pregnancy and increase during the second and third trimesters. Immediately after birth, the need for insulin decreases rapidly (the risk of hypoglycemia increases). In these conditions, careful monitoring of blood glucose levels is essential.

Breastfeeding women may require adjustments to their insulin dosage and diet.

Directions for use and doses

PC,

into the subcutaneous fat of the abdomen, shoulder or thigh, always at the same time, once a day. Injection sites should be alternated with each new injection within the recommended areas for subcutaneous administration of the drug.

Intravenous administration of the usual dose intended for subcutaneous administration may cause the development of severe hypoglycemia.

The dose of Lantus and the time of day for its administration are selected individually. In patients with type 2 diabetes mellitus, Lantus can be used both as monotherapy and in combination with other hypoglycemic drugs.

Switching from treatment with other hypoglycemic drugs to Lantus.

When replacing a treatment regimen with intermediate-acting or long-acting insulins with a Lantus treatment regimen, it may be necessary to adjust the daily dose of basal insulin, and there may also be a need to change concomitant antidiabetic therapy (doses and administration of additionally used short-acting insulins or their analogues or doses of oral hypoglycemic drugs ). When transferring patients from twice daily administration of isophane insulin to single administration of Lantus, in order to reduce the risk of hypoglycemia at night and early morning, the initial dose of basal insulin should be reduced by 20–30% in the first weeks of treatment. During the period of dose reduction, the dose of short-acting insulin can be increased, and then the dosage regimen should be adjusted individually.

Lantus should not be mixed with other insulin preparations or diluted. When mixed or diluted, its action profile over time may change, in addition, mixing with other insulins may cause precipitation.

As with other human insulin analogues, patients receiving high doses of drugs due to the presence of antibodies to human insulin may experience an improvement in insulin response when switching to Lantus.

During the transition to Lantus and in the first weeks after it, careful monitoring of blood glucose levels is required.

The drug should not be administered intravenously. The duration of action of Lantus is determined by its introduction into the subcutaneous adipose tissue.

Side effects

Hypoglycemia

- the most common undesirable consequence of insulin therapy, can occur if the dose of insulin is too high compared to the need for it. Attacks of severe hypoglycemia, especially repeated ones, can lead to damage to the nervous system. Episodes of prolonged and severe hypoglycemia can be life-threatening for patients. Psychoneurological disorders associated with hypoglycemia (“twilight” consciousness or its loss, convulsive syndrome) are usually preceded by symptoms of adrenergic counterregulation (activation of the sympathoadrenal system in response to hypoglycemia): hunger, irritability, “cold” sweat, tachycardia (the faster hypoglycemia develops and the more The more significant it is, the more pronounced the symptoms of adrenergic counterregulation).

Adverse effects from the eyes.

Significant changes in the regulation of blood glucose can cause temporary visual impairment due to changes in tissue turgor and the refractive index of the eye lens. Long-term normalization of blood glucose reduces the risk of progression of diabetic retinopathy. Insulin therapy, accompanied by sharp fluctuations in blood glucose levels, can lead to temporary worsening of diabetic retinopathy. In patients with proliferative retinopathy, especially those not receiving photocoagulation treatment, episodes of severe hypoglycemia may lead to transient vision loss.

Lipodystrophy.

As with treatment with any other insulin preparations, lipodystrophy and local delay in insulin absorption/absorption may develop at the injection site. During clinical studies during insulin therapy using Lantus, lipodystrophy was observed in 1–2% of patients, while lipoatrophy was generally uncharacteristic. Constantly changing injection sites within areas of the body recommended for subcutaneous insulin administration may help reduce the severity of this reaction or prevent its development.

Local reactions in the injection area and allergic reactions.

During clinical studies during insulin therapy using Lantus, reactions at the injection site were observed in 3-4% of patients. These reactions included redness, pain, itching, hives, swelling or inflammation. Most minor insulin injection site reactions usually resolve within a few days to a few weeks. Allergic reactions of immediate hypersensitivity to insulin are rare. Such reactions to insulin (including insulin glargine) or excipients may result in the development of generalized skin reactions, angioedema, bronchospasm, hypotension or shock and may thus pose a threat to the patient's life.

Other reactions.

The use of insulin can cause the formation of antibodies to it. In clinical studies in groups of patients treated with insulin isophane and insulin glargine, the formation of antibodies that cross-reacted with human insulin was observed with equal frequency. In rare cases, the presence of such antibodies to insulin may necessitate dosage adjustments in order to eliminate the tendency to develop hypo- or hyperglycemia. Rarely, insulin may cause sodium retention and edema, especially if intensified insulin therapy improves previously poor metabolic regulation.

Interaction

A number of drugs affect glucose metabolism, which may require dose adjustment of insulin glargine.

Drugs that may potentiate the hypoglycemic effect of insulin and increase susceptibility to hypoglycemia include oral hypoglycemic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoxyphene, salicylates, and sulfonamide antimicrobials. Drugs that can weaken the hypoglycemic effect of insulin include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens, gestagens, phenothiazine derivatives, somatotropin, sympathomimetics such as epinephrine (adrenaline), salbutamol, terbutaline and thyroid hormones, inhibitors proteases, some antipsychotics (eg olanzapine or clozapine).

Beta blockers, clonidine, lithium salts or alcohol can either enhance or weaken the hypoglycemic effect of insulin.

Pentamidine can cause hypoglycemia, which sometimes gives way to hyperglycemia.

In addition, under the influence of sympatholytic drugs such as beta-blockers, clonidine, guanfacine and reserpine, signs of adrenergic counterregulation may be reduced or absent.

Overdose

Symptoms:

severe and sometimes prolonged hypoglycemia, threatening the patient's life.

Treatment:

episodes of moderate hypoglycemia are usually relieved by oral administration of easily digestible carbohydrates. It may be necessary to change the drug dosage regimen, diet, or physical activity. Episodes of more severe hypoglycemia, accompanied by coma, seizures or neurological disorders, require intramuscular or subcutaneous administration of glucagon, as well as intravenous administration of a concentrated dextrose solution. Long-term intake of carbohydrates and specialist supervision may be required, because hypoglycemia can recur after visible clinical improvement.

Precautionary measures

Compatibility Notes.

Lantus cannot be mixed with any other drugs. It is necessary to ensure that the syringes do not contain residues of other drugs.

special instructions

Lantus is not the drug of choice for the treatment of diabetic ketoacidosis. In such cases, intravenous administration of short-acting insulin is recommended. Due to limited experience with Lantus, it was not possible to evaluate its effectiveness and safety in the treatment of patients with impaired liver function or patients with moderate to severe renal impairment. In patients with impaired renal function, the need for insulin may decrease due to a weakening of its elimination processes. In elderly patients, progressive deterioration of renal function may lead to a persistent decrease in insulin requirements. In patients with severe liver failure, insulin requirements may be reduced due to a decrease in the ability for gluconeogenesis and insulin biotransformation. In case of ineffective control over the level of glucose in the blood, as well as in the presence of a tendency to the development of hypo- or hyperglycemia, before proceeding with the correction of the dosage regimen, you should check the accuracy of compliance with the prescribed treatment regimen, drug administration sites and the technique of competent subcutaneous injections, taking into account all factors relevant to the problem.

Hypoglycemia.

The time for the development of hypoglycemia depends on the action profile of the insulins used and may therefore change when changing the treatment regimen. Due to the increase in the time it takes long-acting insulin to enter the body, when using Lantus, the likelihood of developing nocturnal hypoglycemia decreases, while in the morning this likelihood may increase. Patients in whom episodes of hypoglycemia may be of particular clinical importance, such as patients with severe stenosis of the coronary arteries or cerebral vessels (risk of developing cardiac and cerebral complications of hypoglycemia), as well as patients with proliferative retinopathy, especially if they are not receiving photocoagulation treatment (risk transient vision loss due to hypoglycemia), special precautions should be taken, and intensified blood glucose monitoring is recommended. Patients should be aware of the circumstances in which warning symptoms of hypoglycemia may change, become less severe, or be absent in certain risk groups. These groups include:

- patients whose blood glucose regulation has significantly improved;

- patients in whom hypoglycemia develops gradually;

— elderly patients;

— patients with neuropathy;

— patients with long-term diabetes mellitus;

— patients suffering from mental disorders;

- patients receiving concomitant treatment with other drugs (see “Interaction”).

Such situations may result in severe hypoglycemia (with possible loss of consciousness) before the patient is aware that he is developing hypoglycemia.

If normal or reduced levels of glycosylated hemoglobin are observed, it is necessary to consider the possibility of developing repeated unrecognized episodes of hypoglycemia (especially at night).

Patients' compliance with the dosage regimen, diet and nutrition regimen, correct use of insulin and control over the appearance of symptoms of hypoglycemia help to significantly reduce the risk of developing hypoglycemia. Factors that increase susceptibility to hypoglycemia require especially careful monitoring, because may require insulin dose adjustment. These factors include:

- changing the site of insulin administration;

- increasing sensitivity to insulin (for example, when eliminating stress factors);

- unusual, increased or prolonged physical activity;

— intercurrent diseases accompanied by vomiting, diarrhea;

— violation of diet and nutrition;

- missed meals;

- alcohol consumption;

- some uncompensated endocrine disorders (for example, hypothyroidism, insufficiency of the adenohypophysis or adrenal cortex);

- concomitant treatment with certain other drugs.

Intercurrent diseases.

Intercurrent illnesses require more intensive monitoring of blood glucose levels. In many cases, an analysis for the presence of ketone bodies in the urine is indicated, and adjustment of the insulin dosage regimen is also often required. The need for insulin often increases. People with type 1 diabetes should continue to regularly consume at least a small amount of carbohydrates, even if they are only able to eat small amounts of food or cannot eat at all, if they are vomiting, etc. These patients should never stop taking insulin completely.

Pharmgroups

Hypoglycemic agent. Long-acting insulin (Insulins)

Pharmaceutical actions

hypoglycemic

Lantus drug interactions

Hypoglycemia may develop with simultaneous use of Lantus with oral hypoglycemic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoxyphene, salicylates and sulfonamides. The effectiveness of Lantus can be reduced by GCS, danazol, diazoxide, glucagon, isoniazid, estrogens and progesterone, phenothiazine derivatives, somatropin, sympathomimetics (epinephrine, salbutamol, terbutaline), thyroid hormones, atypical antipsychotics (clozapine, olanzapine), protease inhibitors. β-adrenergic blockers, clonidine, lithium salts, pentamidine or alcohol can potentiate or weaken the hypoglycemic effect of insulin. When used simultaneously with insulin, β-adrenergic receptor blockers, clonidine, guanethidine, and reserpine, their effects can significantly decrease or disappear, as well as weaken the symptoms of adrenergic counterregulation. Lantus cannot be mixed with other drugs. The syringe for administering Lantus should not contain trace amounts of other drugs.