Lantus is a hypoglycemic drug used to treat diabetes mellitus.

Release form and composition

Lantus is produced in the form of a solution: colorless or almost colorless, transparent (in 10 ml vials, 3 ml in OptiSet syringe pens, in 3 ml cartridges; 1 or 5 cartridges in the "Opticlik" cartridge system and 5 pcs. in contoured cell packs; one bottle, 5 syringe pens, 1 or 5 cartridge systems, 1 or 60 packs in a cardboard box).

1 ml of solution contains:

• Active ingredient: insulin glargine - 3.6378 mg (corresponds to the content of human insulin - 100 units);
• Auxiliary components: sodium hydroxide, water for injection, zinc chloride, hydrochloric acid, glycerol (85%), m-cresol (m-cresol).

Indications for use

Lantus is used in children over 6 years old, adolescents and adults with diabetes mellitus requiring insulin therapy.

Contraindications

The drug is contraindicated in childhood (up to 6 years), as well as with hypersensitivity to the components that make up it.

During pregnancy, the drug should be used with caution.

Method of administration and dosage

The solution is injected into the subcutaneous fat of the shoulder, abdomen or thigh, once a day at the same time. The sites for the injection of the drug should be alternated with each new injection. The dose of Lantus and the time of day for its use are established by the doctor on an individual basis.

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

• Transfer from insulins of long or medium duration of action: it may be necessary to adjust the daily dose of basal insulin or change the concomitant antidiabetic treatment;
• Transfer from a double administration of insulin-isophane to a single administration of Lantus: in the first weeks of therapy, it is necessary to reduce by 20-30% daily dose basal insulin (to reduce the risk of hypoglycemia during the night and early morning hours). During this period, a decrease in the dose of the drug should be compensated for by an increase in the amount of insulin used. short acting with further individual correction of the dosage regimen;
• Transfer from high doses of insulin: it should be borne in mind that, as with the use of other analogs of human insulin, due to the presence of antibodies to it, in patients transferring to Lantus, the response to insulin administration may increase. During the transfer process and during the first weeks thereafter, careful monitoring of blood glucose is required, if necessary, correction of the insulin dosing regimen is allowed;
• Correction of the applied doses of insulin glargine. With an improvement in the regulation of metabolism and, as a consequence, an increase in insulin sensitivity, further adjustment of the dosage regimen may be required. Also, such a correction is carried out when the lifestyle changes, the patient's body weight, the time of day of the drug use and other circumstances that increase the predisposition to the development of hypo- or hyperglycemia.

The drug should not be administered intravenously, since the use of a dose intended for subcutaneous administration in this way can lead to the development of severe hypoglycemia.

Before using the solution, make sure that there are no residues of other drugs in the syringes.

Before using the pre-filled OptiSet syringe pen, it is necessary to inspect the cartridge contained inside it: if the solution is colorless, transparent, resembles water in consistency and is free of visible solid particles, the cartridge can be used. A used pen cannot be reused. It should only be used by one patient (to prevent infection).

When handling the OptiSet syringe pen, a safety test should be carried out before each injection.

The dose selector can only be turned in one direction. Do not change the dose (turn the dose selector) after pressing the injection trigger.

A new needle (suitable for a pen) must be used with each use. Checking the readiness for use of a new syringe pen (injector) is carried out by using 8 units of solution pre-selected by the manufacturer.

If you suspect a malfunction, or if there is obvious damage, the handle must not be used. It is recommended to have a spare pen in case of damage or loss of a used one.

If someone else is injecting the patient, it is important that they take extra care (to avoid accidental needlestick injury and contamination of the patient with an infectious disease).

After removing the cap from the injector, the markings on the insulin reservoir should be checked to ensure that it contains the correct insulin. It is also recommended to check appearance insulin: if it is colored, contains foreign particles, or is cloudy, it must not be used.

The needle should be gently and tightly attached to the injector after removing the cap.

Before each injection, you should check the readiness of the syringe pen for use:

• The dose indicator on a new and unused injector should be at number 8 (pre-set by the manufacturer);
• The dispenser in the syringe pen, which is already in use, should be turned until the dose indicator stops at number 2;
• The start button for a set of a dose is fully withdrawn. Do not rotate the dose selector after removing the trigger;
• The inner and outer needle caps must be removed. The outer cap should be retained to remove the used needle;
• The pen should be held with the needle up, gently tapping the insulin reservoir with your finger so that the air bubbles rise up towards the needle;
• The release button is pressed all the way, a drop of insulin should emerge from the tip of the needle, this is an indicator that the injector and the needle are functioning correctly;
• The check of the readiness of the syringe pen is repeated until insulin appears at the tip of the needle, after which the injection can be performed.

The patient can be given a dose from 2 to 40 units in 2 units increments. If the prescribed dose exceeds 40 units, it should be divided into 2 or more injections. On the scale of residual insulin on a transparent container, you should check that there is a sufficient amount of solution for the required dose. This scale cannot be used to draw insulin doses.

If the black plunger is at the beginning of the colored strip, then there are approximately 40 units of insulin, if at the end - 20 units of insulin.

To fill the pen with insulin, you need to pull out the trigger to the limit. It is recommended to make sure that the correct dose is fully drawn up. The release button moves according to the amount of insulin remaining in the container, it allows you to check which dose has been selected. The button must be held under pressure during the test. The visible wide line on it shows how much insulin was drawn. When you hold down the trigger, only the top of this wide line is visible.

The correct injection technique must be explained to the patient by specially trained personnel. Insulin Injection Recommendations:

• The needle should be injected subcutaneously;
• The start button must be pressed to the limit: the audible click will stop at the moment when it is pressed all the way down;
• To inject the entire dose of insulin, hold down the trigger for 10 seconds before removing the needle from the skin;
• After each injection, the needles should be removed from the pen and discarded (they cannot be reused). Then the cap should be put on the injector.

The cartridges should be used together with the OptiPen Pro1 syringe pen, following the recommendations given by the device manufacturer. It is important to follow the instructions for installing the cartridge, connecting the needle, and injecting insulin exactly.

Before using the cartridge, it is recommended to carefully examine it: the solution contained in it must be colorless, transparent and free of visible solid particles. Before installing, the cartridge should be at room temperature for 1-2 hours. Immediately before the injection, air bubbles must be removed from it.

Empty cartridges are not reused. A damaged OptiPen Pro1 syringe cannot be used.

If the pen is faulty, if necessary, you can inject insulin by drawing the solution from the cartridge into a plastic syringe suitable for insulin at a concentration of 100 IU / ml.

The reusable syringe should only be used by one person (to prevent infection).

The OptiKlik cartridge system is a glass cartridge containing a solution of insulin glargine (3 ml), placed in a transparent plastic container with an attached piston mechanism. It is necessary to use the cartridge system together with the OptiKlik syringe pen, precisely following all the recommendations specified in the instructions attached to it: regarding the installation of the cartridge system into the syringe pen, connecting the needle and injecting.

The damaged OptiKlik syringe pen must be replaced with a new one. The cartridge system must be at room temperature for 1-2 hours before installation. Also, before installation, it should be carefully inspected: if the solution contained in it is colorless, transparent and free of visible solid particles, it can be used.

Immediately before use, air bubbles must be removed from the cartridge system (as well as from a syringe pen). Empty cartridge systems cannot be reused. In cases of malfunction of the pen syringe, insulin, if necessary, can be injected by drawing the solution from the cartridge into a plastic syringe suitable for insulin at a concentration of 100 IU / ml.

Side effects

The use of Lantus can cause side effects from some body systems:

• Organ of vision: rarely - retinopathy, visual impairment;
• Skin and subcutaneous fat: often - lipodystrophy, local delay in the absorption of insulin; infrequently - lipoatrophy;
• Nervous system: very rarely - dysgeusia;
• Musculoskeletal system: very rarely - myalgia;
• Metabolism: rarely - sodium retention, edema;
• Allergic reactions: rarely - bronchospasm, angioedema, arterial hypotension, shock, generalized skin reactions;
• Local reactions: often - pain, hives, itching, redness, inflammation or swelling at the injection site.

special instructions

The drug is not intended for the treatment of diabetic ketoacidosis. In this condition, short-acting intravenous insulin is recommended.

Since the experience of using the drug is limited, the effectiveness and safety of its use in case of impaired liver function and renal failure moderate or severe not established.

In patients with impaired renal function, the need for insulin may decrease, which is associated with a weakening of the processes of its elimination.

A persistent decrease in the need for insulin in elderly patients can lead to a progressive deterioration in renal function.

In severe liver failure, the need for insulin can be reduced due to a decrease in its ability to biotransformation and gluconeogenesis.

In cases of a tendency to the development of hypo- or hyperglycemia, as well as in case of ineffective control of blood glucose levels, before adjusting the dosing regimen, it is necessary to make sure that the prescribed therapy regimen, the injection site and the technique of correct subcutaneous injection (taking into account all factors affecting this ) are observed exactly.

The time of hypoglycemia development depends on the action profile of the insulins used; it can change when the therapy regimen is changed. Since the time for long-acting insulin to enter the body is increased, when using Lantus, you should expect a lesser likelihood of developing nocturnal hypoglycemia, while in the early morning hours this probability is higher.

Patients receiving the drug should take into account that due to the prolonged action of its active substance, in the event of hypoglycemia, it is possible to slow down the recovery from this state.

Follow special measures Precautions in the use of insulin glargine and careful monitoring of blood glucose are necessary in patients whose episodes of hypoglycemia may be of particular clinical significance (including with severe cerebral stenosis or coronary arteries), as well as with proliferative retinopathy, especially if they are not receiving photocoagulation therapy.

Patients should be warned about conditions in which the symptoms of hypoglycemia may become less pronounced, decrease or be absent, and patients can be attributed to certain risk groups:

• Concomitant therapy with other drugs;
• The presence of mental disorders;
• Elderly age;
• Marked improvement in blood glucose regulation;
• Long course of diabetes mellitus;
• Go to human insulin with animal insulin;
• Neuropathy;
• Hypoglycemia that develops gradually.

In such situations, it is possible for the patient to develop severe hypoglycemia (with loss of consciousness) before the patient realizes that he is developing hypoglycemia.

In cases where there are normal or decreased indicators glycated hemoglobin, the possibility of recurrent unrecognized episodes of hypoglycemia should be considered, especially at night.

A significant decrease in the risk of developing hypoglycemia is facilitated by correct application insulin, control of the onset of symptoms of the condition, as well as patient compliance with the dosage regimen, diet and diet.

Factors that increase the predisposition to the development of hypoglycemia:

• Intercurrent diseases accompanied by diarrhea, vomiting;
• Changing the site of insulin injection;
• Insulin hypersensitivity;
• Unusual, prolonged or increased physical activity;
• Concomitant treatment with certain other drugs;
• Violation of the diet and diet;
• Skipped meal
• Alcohol consumption;
• Some uncompensated endocrine disorders.

In the presence of such factors, especially careful monitoring is necessary, since an adjustment of the insulin dose may be required.

In cases of intercurrent illness, more intensive blood glucose control is required. In most cases, a correction of the insulin dosing regimen and an analysis for the presence of ketone bodies in the urine are required. Often, these patients have an increased need for insulin. With type 1 diabetes, you should regularly consume at least a small amount of carbohydrates, even when eating a small amount of food, not being able to eat, and also when vomiting. Such patients cannot completely stop the administration of insulin.

Drug interactions

Disopyramide, monoamine oxidase inhibitors, fluoxetine, dextropropoxyphene, sulfanilamide antimicrobial agents, fibrates, oral hypoglycemic agents, pentoxifylline, salicylates, angiotensin converting agents can enhance the hypoglycemic effect of insulin and increase the susceptibility to hypoglycemia. When using such combinations, dose adjustment of insulin glargine may be required.

Diuretics, gestagens, isoniazid, protease inhibitors, glucagon, diazoxide, somatotropin, danazol, hormones can reduce the hypoglycemic effect of insulin thyroid gland, phenothiazine derivatives, some antipsychotics (for example, clozapine or olanzapine), estrogens, glucocorticosteroids, sympathomimetics (for example, epinephrine, terbutaline, salbutamol). When using these combinations, a dose adjustment of the drug may be required.

When using Lantus in combination with clonidine, ethanol, lithium salts or beta-blockers, it is possible to increase or decrease the effect of insulin. The use of pentamidine in combination with insulin can cause hypoglycemia, which sometimes gives way to hyperglycemia.

A decrease or absence of signs of adrenergic counterregulation with the development of hypoglycemia is possible with simultaneous use with drugs with sympatholytic action: reserpine, beta-blockers, guanfacine, clonidine.

Lantus should not be mixed or diluted with other insulin preparations (its precipitation is possible) or any other drugs, as this can change its profile of action over time.

Terms and conditions of storage

Store at a temperature of 2-8 ° C (without freezing) out of the reach of children, dry and protected from light. Cartridges pre-filled with OptiSet syringe pens, OptiKlik cartridge systems should be stored in their own cardboard packaging at temperatures up to 25 ° C, protected from light and out of reach of children. It is impossible to cool pre-filled OptiSet syringe pens.

Shelf life:

• Solution - 3 years;
• Cartridges, pre-filled syringe pens OptiSet and cartridge systems OptiKlik after the first use - 28 days.

Lantus is an insulin preparation with a sugar-reducing effect. The active component of lantus is insulin glargine, an analogue of human insulin, poorly soluble in a neutral medium.

In the Lantus preparation, the substance is completely dissolved due to a special acidic medium, and when administered subcutaneously, the acid is neutralized and microprecipitates are formed, of which insulin glargine is gradually released in small quantities. Thus, there is no sharp fluctuation in the amount of insulin in the blood plasma, but a smooth profile of the concentration-time curve is observed. Microprecipitates provide the drug with prolonged action.

Pharmacological actions

The active ingredient in lantus has an affinity for insulin receptors similar to that of human insulin. Glargine binds to the insulin receptor IGF-1 5-8 times more strongly than human insulin, and its metabolites are weaker.

Healing Aggregate Concentration active ingredient insulin and its metabolites in the blood of patients with type 1 diabetes mellitus has a lower value than is necessary to ensure a half-maximum connection with IGF-1 receptors and further trigger the mitogenic-proliferative mechanism catalyzed by this receptor.

This mechanism is normally activated by endogenous IGF-1, but the therapeutic doses of insulin used in insulin therapy are much lower than the pharmacological concentrations required to trigger the mechanism by IGF-1.

The main task of any insulin, including glargine, is to regulate glucose metabolism (carbohydrate metabolism). Insulin lantus accelerates glucose uptake in adipose and muscle tissues, resulting in a decrease in plasma sugar levels. Also, this drug inhibits the production of glucose in the liver.

Insulin activates protein synthesis in the body, while inhibiting the processes of proteolysis and lipolysis in adipocytes.

Clinical and pharmacological studies have proven that when intravenous administration the same doses of insulin glargine and human insulin are equivalent. The effect of insulin glargine over time, like other representatives of this series, depends on physical activity and many other factors.

When administered subcutaneously, Lantus is absorbed very slowly, so it can be used once a day. It is important to remember that there is a pronounced interindividual variability in the nature of insulin action over time. Studies have shown that the dynamics of diabetic retinopathy does not differ greatly when using insulin glargine and insulin NPH.

When using Lantus in children and adolescents, the development of nocturnal hypoglycemia is observed much less frequently than in the group of patients receiving NPH insulin.

Unlike NPH insulin, glargine, due to its slow absorption, does not peak after subcutaneous administration. The equilibrium concentration of the drug in the blood plasma is observed on days 2-4 of treatment with a single daily administration. The half-life of intravenous insulin glargine corresponds to that of human insulin.

During the metabolism of insulin glargine, two active compounds M1 and M2 are formed. Subcutaneous injections Lantusa exert their effect mainly due to exposure to M1, while M2 and insulin glargine are not detected in the vast majority of the subjects.

The effectiveness of the drug Lantus is the same in different groups of patients. In the course of the studies, subgroups were formed by age and sex, and the effect of insulin in them was the same as in the general population (in terms of efficiency and safety factors). Pharmacokinetic studies have not been conducted in children and adolescents.

Indications for use

Lantus is prescribed for treatment insulin-dependent diabetes in adults and children over six years of age.

Mode of application.

The drug is used for subcutaneous administration, it is prohibited to put it intravenously. The prolonged effect of lantus is associated with its introduction into the subcutaneous fat.

It is very important not to forget that with intravenous administration of the usual therapeutic dose of the drug, severe hypoglycemia can develop. Using of this drug there are several rules to follow:

1. During the period of treatment, you need to follow a certain lifestyle and correctly place injections.
2. The drug can be injected into the abdominal area, as well as into the thigh or deltoid muscle. There is no clinically perceptible difference with these methods of administration.
3. It is best to inject each injection into a new site within the recommended areas.
4. You can not dilute Lantus or mix it with other drugs.

Dosage

Lantus is a long-acting insulin, so it should be administered once a day, preferably at the same time. The dosage regimen for each person is selected individually, as well as the dose and time of administration.

It is permissible to prescribe the drug Lantus to patients diagnosed with type 2 diabetes mellitus together with antidiabetic agents for oral administration.

It is important to consider that the units of action of this medicinal product differ from the units of action of other drugs containing insulin.

Elderly patients need to adjust the dose, as their need for insulin may decrease due to progressive renal impairment. Also, in patients with impaired liver function, the need for insulin may decrease. This is due to the fact that insulin metabolism slows down and gluconeogenesis decreases.

Switching to Lantus from other types of insulin

If a person has previously used drugs of medium and long duration of action, then when switching to Lantus, he will most likely need to adjust the dose of the main inulin, as well as review concomitant therapy.

To reduce the risk of hypoglycemia in the morning and at night, when changing from two-time basal insulin (NPH) to single injections (Lantus), the basal insulin dose should be reduced by 20-30% during the first twenty days of treatment. And the dose of insulin given in connection with food intake will need to be increased slightly. After two to three weeks, dose adjustment should be carried out individually for each patient.

If the patient has antibodies to human insulin, then when using Lantus, the body's response to insulin injections changes, which may also require a dose revision. It is also necessary when changing lifestyle, changing body weight or other factors affecting the nature of the drug's action.

Introduction

The drug Lantus must be administered only with the use of OptiPen Pro1 or KlikSTAR syringe pens. Before starting to use, you need to carefully study the instructions for the pen and follow all the manufacturer's recommendations. Some rules for using syringe pens:

1. If the handle is broken, dispose of it and use a new one.
2. If necessary, the drug from the cartridge can be injected with a special insulin syringe with a scale of 100 units in 1 ml.
3. The cartridge must be kept at room temperature for several hours before being placed in a syringe pen.
4. You can use only those cartridges in which the appearance of the solution has not changed, its color and transparency, no sediment has appeared.
5. Before injecting the solution from the cartridge, it is imperative to remove air bubbles (how to do this is written in the instructions for the pen).
6. It is strictly forbidden to refill cartridges.
7. To prevent accidental administration of insulin other than glargine, check the label before each shot.

Side effect

The most common undesirable effect in patients when using Lantus is hypoglycemia. It develops if the drug is administered in a dosage that is higher than that required for the patient. Also, the following side reactions may occur on the introduction of Lantus:

• from the senses and nervous system - dysgeusia, deterioration of visual acuity, retinopathy;
• on the part of the skin, as well as subcutaneous tissue - lipohypertrophy and lipoatrophy;
• hypoglycemia (metabolic disorder);
• allergic manifestations - edema and redness of the skin at the injection site, urticaria, anaphylactic shock, bronchospasm, Quincke's edema;
• retention of sodium ions in the body, muscle pain.

It should be borne in mind that if severe hypoglycemia develops quite often, then the risk of developing disorders in the functioning of the nervous system is high. Prolonged and intense hypoglycemia is life-threatening for the patient.

During treatment with insulin, antibodies can be produced to the drug.

Children and adolescents may develop undesirable effects on Lantus, such as muscle pain, allergic manifestations, pain at the injection site. In general, for both adults and children, the safety of Lantus is on the same level.

Contraindications

Lantus should not be prescribed to patients with intolerance to the active substance or auxiliary components in solution, as well as to people with hypoglycemia.

In children, Lantus can be prescribed only if they reach the age of six years or older.

It is not prescribed as the drug of choice for the treatment of diabetic ketoacidosis.

It is necessary to use Lantus very carefully in patients with an increased risk to health when moments of hypoglycemia occur, especially in patients with narrowing of cerebral and coronary vessels or proliferative retinopathy, the instruction indicates this moment.

It is necessary to be very careful with patients in whom the manifestations of hypoglycemia can be masked, for example, with autonomic neuropathy, mental disorders, gradual development of hypoglycemia, long-term course of diabetes mellitus. It is also necessary to carefully prescribe Lantus to the elderly and patients who have switched to human insulin from a drug of animal origin.

When using the drug Lantus, you need to carefully monitor the dosage in people with a high risk of developing severe hypoglycemia. This can be the case when:

1. increasing the sensitivity of cells to insulin, for example, in the case of eliminating factors that cause stress;
2. diarrhea and vomiting;
3. unbalanced nutrition, including when skipping meals;
4. drinking alcoholic beverages;
5. concomitant administration of certain medications.

When treating with Lantus, it is better not to engage in activities that require attention, because hypoglycemia (like hyperglycemia) can provoke a decrease in visual acuity and concentration.

Lantus and pregnancy

On pregnant women, no clinical research this drug has not been tested. The data were obtained only in post-marketing studies (approximately 400 - 1000 cases), and they indicate that insulin glargine does not have a negative effect on the course of pregnancy and the development of the child.

Experiments on animals have shown that insulin glargine does not have a toxic effect on the fetus and does not adversely affect reproductive function.

For pregnant women, Lantus can be prescribed by a doctor if necessary. At the same time, it is important to constantly monitor the concentration of sugar and do everything to keep it, as well as monitor general state expectant mother during the period of bearing a child. In the first trimester, the need for insulin may decrease, and increase in the second and third trimesters. Immediately after the birth of the baby, the body's need for this substance drops sharply and hypoglycemia may begin.

During lactation, the use of Lantus is also possible under constant careful monitoring of the dosage of the drug. When sucked into gastrointestinal tract insulin glargine is broken down into amino acids and does not cause any harm to the baby when breastfeeding... The instruction does not contain data that glargine passes into breast milk.

Interaction with other drugs

With the simultaneous use of the drug Lantus with some other agents that affect carbohydrate metabolism, it is necessary to adjust the dose.

The antihyperglycemic effect of insulin is enhanced by drugs for the treatment of diabetes mellitus for oral administration, inhibitors of the angiotensin-converting effect, disopyramide, fibrates, monoamine oxidase inhibitors, fluoxetine, pentoxifylline, salicylates, propoxyphene, sulfonamides.

The hypoglycemic effect of Lantus is reduced by the action of danazol, diazoxide, corticosteroids, glucagon, diuretics, estrogens and progestins, somatotropin, sympathomimetic agents, isoniazid, phenothiazine derivatives, olanzapine, protease inhibitors, clozapine, thyroid hormones.

Some drugs, such as clonidine, beta-blockers, lithium and ethanol, can both increase or decrease the effect of Lantus.

The instruction for the simultaneous use of this drug with pentamidine indicates that hypoglycemia may first occur, which subsequently turns into hyperglycemia.

Overdose

Overestimated doses of the drug Lantus can provoke very strong, prolonged and severe hypoglycemia, dangerous to the health and life of the patient. If the overdose is mild, it can be stopped by consuming carbohydrates.

In cases of regular development of hypoglycemia, the patient needs to change his lifestyle and adjust the dose that was prescribed for use.

If hypoglycemia manifests itself very brightly, accompanied by convulsions, neurological changes, then it is imperative to inject glucagon subcutaneously or intramuscularly or make an intravenous injection of a strong glucose solution. by the way, the condition has the most severe manifestation, and, and this is it, you need to know.

It must be remembered that the drug Lantus has a prolonged effect, therefore, even if the patient's condition has improved, it is necessary to continue taking carbohydrates for a long time and monitor the state of the body.

Release form

Lantus is available in the form of a solution for injection, packaged in 3 ml cartridges. 5 cartridges are packed in blisters and one blister pack is placed in cardboard boxes.

Storage conditions

The shelf life of Lantus is 3 years, this time it is suitable for use, the temperature must be maintained within 2 - 8 degrees Celsius. It is forbidden to freeze the solution. After opening, the cartridge must be stored at a temperature of 15 - 25 degrees. The shelf life of an open preparation is no more than 1 month.