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Insulin drug Lantus to stabilize sugar levels. Lantus: instructions for use

Lantus is one of the first peakless analogues of human insulin. Obtained by replacing the amino acid asparagine in the 21st position of the A-chain with glycine and adding two arginine amino acids in the B-chain to the terminal amino acid. This drug is produced by a large French pharmaceutical corporation - Sanofi-Aventis. Numerous studies have shown that Lantus insulin not only reduces the risk of hypoglycemia compared to NPH drugs, but also improves carbohydrate metabolism. Below is brief instructions for use and reviews from diabetics.

The active substance of Lantus is insulin glargine. It is obtained by the method genetic recombination using the K-12 strain of the bacterium Escherichia coli. IN neutral environment slightly soluble, dissolves in an acidic environment to form microprecipitates, which constantly and slowly release insulin. Thanks to this, Lantus has a smooth action profile lasting up to 24 hours.

Main pharmacological properties:

  • Slow adsorption and peak-free action profile within 24 hours.
  • Suppression of proteolysis and lipolysis in adipocytes.
  • The active component binds to insulin receptors 5-8 times stronger.
  • Regulation of glucose metabolism, inhibition of glucose formation in the liver.

Compound

1 ml Lantus Solostar contains:

  • 3.6378 mg insulin glargine (calculated as 100 IU of human insulin);
  • 85% glycerol;
  • water for injections;
  • concentrated hydrochloric acid;
  • m-cresol and sodium hydroxide.

Release form

Lantus is a transparent solution for subcutaneous injection, available in the form of:

  • cartridges for the OptiClick system (5 pcs per package);
  • 5 syringe pens Lantus Solostar;
  • OptiSet syringe pens in one package 5 pcs. (step 2 units);
  • 10 ml bottles (1000 units in one bottle).

Indications for use

  1. Adults and children over 2 years of age with type 1 diabetes.
  2. Diabetes mellitus type 2 (in case of ineffectiveness of tablet drugs).

Effective for obesity combination treatment– Lantus Solostar and Metformin.

Interaction with other drugs

There are medicines, which influence carbohydrate metabolism, while the need for insulin increases or decreases.

Reduce sugar: oral antidiabetic agents, sulfonamides, ACE inhibitors, salicylates, angioprotectors, monoamine oxidase inhibitors, antiarrhythmic Disopyramide, narcotic analgesics.

Raises sugar: hormones thyroid gland, diuretics, sympathomimetics, oral contraceptives, phenothiazine derivatives, protease inhibitors.

Some substances have both a hypoglycemic and hyperglycemic effect. These include:

  • beta blockers and lithium salts;
  • alcohol;
  • clonidine (hypotensive drug).

Contraindications

  1. Do not use in patients who are intolerant to insulin glargine or its auxiliary components.
  2. Hypoglycemia.
  3. Treatment of diabetic ketoacidosis.
  4. Children under 2 years old.

Possible adverse reactions occur rarely, the instructions say that they may:

  • lipoatrophy or lipohypertrophy;
  • allergic reactions(Quincke's edema, allergic shock, bronchospasm);
  • muscle pain and sodium ion retention in the body;
  • dysgeusia and visual impairment.

Switching to Lantus from other insulins

If the diabetic used insulin average duration, then when switching to Lantus, the dosage and mode of administration of the drug changes. Changing insulin should only be done in a hospital.

Video instructions:

Analogues

In Russia, all insulin-dependent diabetics were forcibly transferred from Lantus to Tujeo. According to studies, the new drug has a lower risk of developing hypoglycemia, but in practice, most people complain that after switching to Tujeo, their sugar levels jumped significantly, so they are forced to buy Lantus Solostar insulin on their own.

Levemir is an excellent drug, but it has a different active ingredient, although the duration of action is also 24 hours.

Aylar has not encountered insulin; the instructions say that it is the same Lantus, but cheaper and a different manufacturer.

Insulin Lantus during pregnancy

Official clinical studies Lantus has not been administered to pregnant women. According to unofficial sources, the drug does not have any effect negative influence on the course of pregnancy and the child itself.

Experiments were conducted on animals, during which it was proven that insulin glargine does not have toxic influence on reproductive function.

Pregnant women can be prescribed Lantus Solostar if NPH insulins are ineffective. Expectant mothers should monitor their sugar levels, because in the first trimester the need for insulin may decrease, and in the second and third trimester it may increase.

Do not be afraid to breastfeed your baby; there is no information in the instructions that Lantus can pass into breast milk.

How to store

The shelf life of Lantus is 3 years. Should be stored in a dark place, protected from sun rays place at a temperature of 2 to 8 degrees. Usually the best place is the refrigerator. At the same time, be sure to look behind temperature conditions, because freezing Lantus insulin is prohibited!

From the moment of first use, the drug can be stored for a month in a dark place at a temperature of no more than 25 degrees (not in the refrigerator). Do not use expired insulin.

Where to buy, price

Lantus Solostar is prescribed free of charge with a prescription by an endocrinologist. But it also happens that a diabetic has to buy this drug at the pharmacy on his own. Average price insulin – 3300 rub. In Ukraine, Lantus can be bought for 1200 UAH.

Lantus is a long-acting human insulin.

Release form and composition

Lantus is available in the form of a solution for subcutaneous administration: transparent, almost colorless or colorless (3 ml in colorless glass cartridges, 5 cartridges in blister packs, 1 package in a cardboard box; 5 OptiClick cartridge systems in a cardboard box; 5 OptiSet syringe pens in a cardboard box) .

The composition of 1 ml of the drug includes:

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

Indications for use

Lantus is prescribed to children over 6 years of age and adults with diabetes mellitus requiring insulin treatment.

Contraindications

  • Age up to 6 years (reliable data on the effectiveness and safety of using Lantus in this age group no patients);
  • Hypersensitivity to the components of the drug.

Pregnant women should use Lantus with caution.

Directions for use and dosage

The Lantus dose and time of day for its administration are determined individually.

The drug should be administered subcutaneously (in subcutaneous fat shoulder, abdomen or thigh) 1 time per day, always at the same time. Injection sites should be rotated with each new Lantus injection within the recommended injection areas.

It is possible to use Lantus as monotherapy or simultaneously with other hypoglycemic drugs.

When transferring patients from intermediate-acting or long-acting insulins to Lantus, changes in concomitant antidiabetic therapy (doses of oral hypoglycemic drugs, as well as the administration regimen and doses of insulins) may be required short acting or their analogues) or correction daily dose basal insulin.

When transferring patients from double administration of insulin-isophane to administration of Lantus in the first weeks of treatment, it is necessary to reduce the daily dose of basal insulin by 20-30% (to reduce the risk of hypoglycemia at night and early morning hours). During this period, the decrease in the dose of Lantus must be compensated by increasing the doses of short-acting insulin and subsequently adjusting the dosage regimen.

Careful monitoring of your blood glucose levels is necessary during the transition to Lantus and in the first weeks thereafter. If necessary, the insulin dosage regimen is adjusted. Dose adjustment may also be required for other reasons, for example, changes in the patient's lifestyle and body weight, time of day of drug administration, or under other circumstances that increase the susceptibility to the development of hyper- or hypoglycemia.

The drug should not be administered intravenously (severe hypoglycemia may develop). Before starting administration, you need to make sure that the syringe does not contain residues of other medications.

Before using OptiSet pre-filled pens, ensure that the solution is colorless, clear, water-like in consistency and free of visible solids. You can only use needles suitable for OptiSet syringe pens. To prevent infection, a reusable syringe pen should only be used by one person.

Side effects

During therapy, the following may develop: side effects:

  • Musculoskeletal system: very rarely – myalgia;
  • Nervous system: very rarely - dysgeusia;
  • Organ of vision: rarely – retinopathy, visual impairment. During insulin therapy, which is accompanied by sharp fluctuations in blood glucose levels, the course of diabetic retinopathy may temporarily worsen. Long-term normalization of blood glucose levels reduces the risk of disease progression. In patients with proliferative retinopathy, episodes of severe hypoglycemia may lead to the development of transient vision loss;
  • Metabolism: rarely - edema, sodium retention;
  • Skin and subcutaneous fat: often – lipodystrophy and local delay in insulin absorption; infrequently – lipoatrophy. Reducing the severity or preventing the development of lipoatrophy is facilitated by a constant change of injection sites within the areas of the body recommended for subcutaneous administration of insulin;
  • Local reactions: often - pain, redness, itching, urticaria, inflammation or swelling at the injection site. Minor reactions usually resolve within a few days to a few weeks;
  • Allergic reactions: rarely - allergic reactions immediate type on the components of the drug, manifested as angioedema, shock, generalized skin reactions, arterial hypotension, bronchospasm (these reactions can pose a threat to the patient’s life). IN in some cases in the presence of antibodies that cross-react with human insulin, dose adjustment may be necessary to eliminate the tendency to develop hyper- or hypoglycemia.

Also, when using Lantus, it is possible to develop side effects associated with the effect on carbohydrate metabolism. Most often, hypoglycemia develops if the dose of insulin exceeds the need for it. Repeated episodes of severe hypoglycemia can lead to damage nervous system. Episodes of severe and prolonged hypoglycemia can be life-threatening for patients.

Against the background of hypoglycemia, the development of psychoneurological disorders is possible ( convulsive syndrome, “twilight” consciousness or loss of consciousness), which is usually preceded by such signs of adrenergic counterregulation as a feeling of hunger, cold sweat, irritability, tachycardia (the more significant and faster the hypoglycemia develops, the more pronounced these symptoms are).

The safety profile for patients under 18 years of age is generally similar to the safety profile for adult patients. Patients under 18 years of age are relatively more likely to develop skin reactions in the form of rash or urticaria and local reactions. There are no data on the safety of Lantus in children under 6 years of age.

Special instructions

Lantus should not be used in the treatment of diabetic ketoacidosis (in this case it is indicated intravenous administration short-acting insulin).

Due to limited experience with Lantus, assess its effectiveness and safety in the treatment of patients with impaired liver function or patients with renal failure severe or medium degree there was no possibility.

In patients with functional disorders kidneys, the need for insulin may decrease due to a weakening of its elimination processes. In elderly patients, progressive deterioration of renal function can lead to a persistent decrease in insulin requirements.

In patients with severe liver failure the need for insulin may be less, which is associated with a decrease in the ability to biotransform insulin and gluconeogenesis.

If control over blood glucose levels is ineffective, as well as with a tendency to develop hyper- or hypoglycemia, before adjusting the dosage regimen, you need to check the accuracy of compliance with the prescribed therapy regimen, Lantus injection sites and proper administration technique subcutaneous injections taking into account all factors influencing this.

If hypoglycemia develops in patients receiving Lantus, the possibility of slowing recovery from hypoglycemia due to the prolonged action of the drug should be taken into account.

Patients in whom episodes of hypoglycemia have a special clinical significance, incl. with severe stenosis of cerebral vessels or coronary arteries(risk of developing cerebral and cardiac complications of hypoglycemia), as well as patients with proliferative retinopathy, it is necessary to carefully monitor blood glucose levels and observe special measures precautions.

Patients should be warned about conditions in which warning symptoms of hypoglycemia may be less severe or absent. The risk group includes patients whose blood glucose regulation has significantly improved or hypoglycemia develops gradually, patients with neuropathy, long course diabetes mellitus, mental disorders. Also, symptoms of hypoglycemia may be less pronounced in elderly patients and in patients switched from animal insulin to human insulin or receiving concomitant treatment other medicines. In this case, severe hypoglycemia may occur (with possible loss consciousness) before the patient realizes that he is developing hypoglycemia.

Reducing the risk of developing hypoglycemia is facilitated by patient compliance with the dosage regimen, diet and diet, monitoring the appearance of symptoms of hypoglycemia and correct application insulin. When factors appear that increase the predisposition to the development of hypoglycemia, especially careful monitoring of the patient's condition is required, since adjustment of the insulin dose may be required. These factors include:

  • Changing the site of insulin injection;
  • Alcohol consumption;
  • Unusual, prolonged or increased physical activity;
  • Increased insulin sensitivity (for example, when eliminating stress factors);
  • Missed meals;
  • Intercurrent illnesses accompanied by diarrhea or vomiting;
  • Violation of diet and nutrition;
  • Some uncompensated endocrine disorders(for example, insufficiency of the adrenal cortex or adenohypophysis, hypothyroidism);
  • Concomitant therapy with certain other drugs.

In case of intercurrent illnesses, more intensive control of blood glucose levels is necessary. In many cases it is necessary to conduct an analysis for the presence ketone bodies in urine, adjustment of the insulin dosage regimen may also be required. Often the need for insulin increases. People with type 1 diabetes need to continue to regularly consume carbohydrates, at least in small amounts, even when eating small amounts or when unable to eat, or when vomiting. Such patients should never stop taking insulin completely.

Drug interactions

Oral hypoglycemic agents, fluoxetine, angiotensin-converting enzyme inhibitors, fibrates, disopyramide, dextropropoxyphene, pentoxifylline, salicylates and sulfonamides can increase the susceptibility to hypoglycemia and enhance the hypoglycemic effect of insulin. antimicrobials(in this case, insulin dose adjustment may be required).

The hypoglycemic effect of insulin can be reduced by thyroid hormones, diuretics, glucocorticosteroids, diazoxide, danazol, isoniazid, some antipsychotics (for example, clozapine or olanzapine), glucagon, gestagens, estrogens, somatotropin, phenothiazine derivatives, sympathomimetics (for example, epinephrine, salbutamol, terbutaline) , protease inhibitors (in this case, insulin dose adjustment may be required).

Concomitant use of insulin with pentamidine may cause hypoglycemia, which may give way to hyperglycemia. With simultaneous use of Lantus with clonidine, beta-blockers, ethanol and lithium salts, it is possible to either enhance or weaken the hypoglycemic effect of insulin.

With the simultaneous use of Lantus with drugs that have a sympatholytic effect (clonidine, beta-blockers, guanfacine and reserpine), with the development of hypoglycemia, there may be a decrease or absence of signs of adrenergic counterregulation.

Lantus should not be mixed or diluted with other insulin preparations or with any other medications. When diluted or mixed, its action profile over time may change. This may also lead to sedimentation.

Terms and conditions of storage

Store in a place protected from light, out of reach of children, at a temperature of 2-8 °C, do not freeze.

Shelf life – 3 years.

After the start of use, cartridges, OptiClik cartridge systems and pre-filled OptiSet syringe pens should be stored in a place protected from light, out of reach of children at temperatures up to 25 ° C in their own cardboard packaging.

The pre-filled OptiSet pen must not be refrigerated.

The shelf life of Lantus in cartridges, OptiClick cartridge systems and pre-filled OptiSet syringe pens after the first use is 1 month.

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Insulin Lantus is a drug that has a sugar-lowering effect on the body. Active component is insulin glargine. This is an analogue of human insulin, which is poorly soluble in a neutral environment. In pharmacies you can see 3 forms of release of the drug: the OptiSet syringe pen, the OptiClick and Lantus SoloStar systems. What are the features of using the drug?

Indications

Insulin Lantus has long action, improves glucose metabolism and regulates carbohydrate metabolism. When taking the drug, sugar consumption by muscle and fat tissues is accelerated. Also hormonal agent activates protein production. At the same time, proteolysis and lipolysis in adipocytes are inhibited.

Contraindications

Contraindicated in case of intolerance active substance or auxiliary components. The drug is prescribed to adolescents only when they reach 16 years of age.

Particular care should be taken with the development of proliferative retinopathy, narrowing of coronary and cerebral vessels. Medical supervision is also required for patients with hidden signs hypoglycemia. The disease can be masked by mental disorders, autonomic neuropathy, and prolonged diabetes mellitus.

According to strict indications, it is prescribed to elderly patients. The same applies to people who switched from animal insulin to human insulin.

Instructions for use

Perform the procedure once a day at the same time. Injecting medicine intravenously is strictly prohibited. To avoid lipodystrophy, change the injection site.

The dose of the drug depends on the patient’s weight, his lifestyle and the time of administration of the drug. Selected individually by the attending physician

Selection of dosage is required when the patient’s weight or lifestyle changes. Also, the amount of the drug depends on the time of its administration.

Side effects

A typical side effect of taking the drug is hypoglycemia. It is caused by a significant excess of the drug dose relative to the needs of the diabetic. Pathological condition preceded by symptoms such as tachycardia, increased sweating, hunger, nervousness, irritability, paleness skin. Hypoglycemia itself is manifested by the following symptoms:

  • vision problems;
  • convulsions;
  • fatigue and fatigue;
  • headache;
  • noticeable decrease in concentration;
  • attacks of nausea and vomiting.

Prolonged and frequent attacks of hypoglycemia provoke damage to the nervous system. Sometimes this can be fatal.

A rare reaction to Insulin Lantus is an allergy. It is characterized by edema, skin rash, arterial hypotension or bronchospasms. In some cases, insulin resistance develops due to the appearance of corresponding antibodies in the patient's body.

Other side effects include disorders taste sensations, diabetic retinopathy, myalgia, lipoatrophy and lipodystrophy. Swelling, pain, redness and itching occur at the injection site. After a short period of time, these signs disappear on their own.

Use during pregnancy

Pregnant women are prescribed only when absolutely necessary. It is important to constantly monitor blood glucose levels and monitor general condition pregnant. In the first three months, the body's need for insulin decreases, and in the next six months it increases. Immediately after delivery, the need for this substance falls sharply. There is a risk of developing hypoglycemia.

During lactation, taking the drug is possible, but under constant control dosage. Glargine is absorbed into digestive tract and is broken down into amino acids. Harm to the baby when breastfeeding he doesn't cause.

Switching to Lantus from other types of insulin

If the patient has previously taken drugs with long and medium duration of action, then when switching to Lantus, a dose adjustment of the main insulin is necessary. Concomitant therapy should also be reconsidered.

When replacing two-time injections of basal insulin (NPH) with a single injection of Lantus, the dose of the former is reduced by 20–30%. This is done during the first 20 days of therapy. This will help prevent hypoglycemia at night and in the morning. In this case, the dose administered before meals is increased. After 2–3 weeks, the amount of the substance is adjusted individually for each patient.

Some patients' bodies produce antibodies to human insulin. In this case, the immune response to Lantus injections changes. This may also require a dose review.

Interaction with other drugs

Various medications can either enhance or weaken the hypoglycemic effect of Lantus. The first group includes oral hypoglycemic drugs, disopyramide, salicylates, propoxyphene, fluoxetine, sulfonamide antimicrobial agents, monoamine oxidase inhibitors, fibrates and pentoxifylline.

Danazol has a weakening effect, hormonal contraceptives, diuretics, glucagon, isoniazid, protease inhibitors, epinephrine, somatotropin, salbutamol, phenothiazine, terbutaline, antipsychotics, thyroid hormones, diazoxide.

Some substances have a dual effect on the hypoglycemic property of glargine. These include pentamidine, beta-blockers, lithium salts, clonidine, alcohol, guanethidine, reserpine. The last two blur the symptoms of impending hypoglycemia.

Long-acting human insulin

Active ingredient

Release form, composition and packaging

Solution for subcutaneous administration transparent, colorless or almost colorless.

Excipients: metacresol (m-cresol), zinc chloride, glycerol (85%), sodium hydroxide, hydrochloric acid, water for injection.

3 ml - colorless glass cartridges (5) - contour cell packaging (1) - cardboard packs.
3 ml - colorless glass cartridges (1) - OptiSet syringe pens (5) - cardboard packs.
3 ml - colorless glass cartridges (1) - OptiClick cartridge systems (5) - cardboard packs.

Pharmacological action

Insulin glargine is an analogue of human insulin. Obtained by the method of DNA recombination of bacteria of the species Escherichia coli (strains K12). It has low solubility in a neutral environment. As part of the drug Lantus, it is completely soluble, which is ensured by the acidic environment of the injection solution (pH=4). After injection into the subcutaneous fatty tissue, the solution, due to its acidity, enters into a neutralization reaction with the formation of microprecipitates, from which they are constantly released small quantities insulin glargine, providing a smooth (no peaks) profile of the concentration-time curve, as well as longer duration action of the drug.

The binding parameters of insulin glargine and human insulin to insulin receptors are very similar. Insulin glargine has a biological effect similar to endogenous insulin.

Most important action insulin is the regulation of 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 extended duration of action of insulin glargine is directly due to the low rate of its absorption, which allows the drug to be used once a day. On average, the onset of action is 1 hour after subcutaneous administration. The average duration of action is 24 hours, the maximum is 29 hours. The nature of the action of insulin and its analogues (for example, insulin glargine) can vary significantly over time, both different patients, and in the same patient.

The duration of action of the drug Lantus is due to its introduction into the subcutaneous fat.

Pharmacokinetics

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

With subcutaneous administration of the drug 1 time/day, a stable average concentration of insulin glargine in the blood is achieved 2-4 days after the first dose.

When administered intravenously, T1/2 of insulin glargine and human insulin are 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 21 A-Gly-insulin and 21 A-Gly-des-30 B-Thr-insulin . Both unchanged insulin glargine and its breakdown products are present.

Indications

— diabetes mellitus, requiring treatment with insulin, in adults, adolescents and children over 6 years of age.

Contraindications

— childhood up to 6 years (there are currently no clinical data on use);

— increased sensitivity to the components of the drug.

WITH caution use Lantus during pregnancy.

Dosage

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, shoulder 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 analogs, patients receiving high doses drugs due to the presence of antibodies to human insulin, when switching to Lantus there may be an increase response for insulin administration. 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 start button injections.

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 appearance 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 start button is held down, only upper part this wide line.

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).

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.

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 performing an injection, air bubbles should be removed from the cartridge system (as when using a syringe pen). Empty cartridge systems are not reused.

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.

Side effects

Frequency determination adverse reactions: very often (≥ 10%), often (≥ 1%,<10); иногда (≥ 0.1%, < 1%); редко (≥ 0.01%, < 0.1%), очень редко (< 0.01%).

Side effects associated with the effect on carbohydrate metabolism: Hypoglycemia develops most often if the dose of insulin exceeds 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 against the background of hypoglycemia ("twilight" consciousness or its loss, convulsive syndrome) are usually preceded by symptoms of adrenergic counterregulation (activation of the sympathetic-adrenal system in response to hypoglycemia): hunger, irritability, cold sweat, tachycardia (the faster and more significant hypoglycemia develops , the more pronounced the symptoms of adrenergic counterregulation).

From the side of the organ of vision: rarely - visual impairment, retinopathy.

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. Against the background of insulin therapy, which is accompanied by sharp fluctuations in blood glucose levels, a temporary worsening of the course of diabetic retinopathy is possible. In patients with proliferative retinopathy, especially those not receiving photocoagulation treatment, episodes of severe hypoglycemia may lead to transient vision loss.

For the skin and subcutaneous fat: often - as with treatment with any other insulin preparations, lipodystrophy (1-2%) and local delay in insulin absorption are possible; infrequently - lipoatrophy. 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.

From the nervous system: very rarely - dysgeusia.

From the musculoskeletal system: very rarely - myalgia.

From the side of metabolism: rarely - sodium retention, edema (especially if intensified insulin therapy leads to improvement of previously insufficient regulation of metabolic processes).

Allergic reactions: rarely - immediate allergic reactions to insulin (including insulin glargine) or auxiliary components of the drug - generalized skin reactions, angioedema, bronchospasm, arterial hypotension, shock. These reactions may pose a threat to the patient's life.

The use of insulin can cause the formation of antibodies to it. 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 dose adjustment in order to eliminate the tendency to develop hypo- or hyperglycemia.

Local reactions: often (3-4%) - redness, pain, itching, urticaria, swelling or inflammation at the injection site. In most cases, minor reactions resolve within a few days to a few weeks.

The safety profile for patients under 18 years of age is generally similar to the safety profile for patients over 18 years of age. In patients under 18 years of age, reactions at the injection site and skin reactions (rash, urticaria) are relatively more common. There are no safety data in children under 6 years of age.

Overdose

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

Treatment: episodes of moderate hypoglycemia are usually relieved by ingestion of rapidly 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 40% dextrose solution. Long-term intake of carbohydrates and specialist supervision may be required, because recurrence of hypoglycemia is possible after visible clinical improvement.

Drug interactions

Oral hypoglycemic agents, ACE inhibitors, disopyramide, fibrates, MAO inhibitors, pentoxifylline, dextropropoxyphene, salicylates and sulfonamide antimicrobial agents may enhance the hypoglycemic effect of insulin and increase the susceptibility to the development of hypoglycemia. These combinations may require dose adjustment of insulin glargine.

GCS, diazoxide, diuretics, glucagon, isoniazid, estrogens, gestagens, phenothiazine derivatives, somatotropin, sympathomimetics (for example, epinephrine, salbutamol, terbutaline), thyroid hormones, protease inhibitors, some antipsychotics (for example, olanzapine or clozapine) may reduce the hypoglycemic effect insulin. These combinations may require dose adjustment of insulin glargine.

With simultaneous use of the drug Lantus with beta-blockers, clonidine, lithium salts, ethanol, it is possible to either enhance or weaken the hypoglycemic effect of insulin. Pentamidine, when combined with insulin, can cause hypoglycemia, which sometimes gives way to hyperglycemia.

When used simultaneously with drugs that have a sympatholytic effect, such as clonidine, guanfacine and reserpine, there may be a decrease or absence of signs of adrenergic counterregulation (activation of the sympathetic nervous system) with the development of hypoglycemia.

Pharmaceutical interactions

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

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 or severe renal impairment.

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 the factors influencing this.

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 of entry into the body of long-acting insulin when using Lantus, one should expect a lower likelihood of developing nocturnal hypoglycemia, whereas in the early morning hours this likelihood is higher. If hypoglycemia occurs in patients receiving Lantus, the possibility of delayed recovery from hypoglycemia due to the prolonged action of insulin glargine should be considered.

In patients in whom episodes of hypoglycemia may have particular clinical significance, incl. in 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 of transient visual loss due to hypoglycemia), special precautions should be taken and close monitoring blood glucose level.

Patients should be warned about conditions in which the warning symptoms of hypoglycemia may decrease, become less severe, or be absent in certain risk groups, which 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 switched from animal insulin to human insulin;

- patients receiving concomitant treatment with other drugs.

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 glycated 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 of the onset of symptoms of hypoglycemia help to significantly reduce the risk of developing hypoglycemia. If there are factors that increase susceptibility to hypoglycemia, especially careful monitoring is necessary, because Insulin dose adjustment may be required. 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 control 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 when eating only small amounts or when unable to eat, or when vomiting. These patients should never stop taking insulin completely.

Pregnancy and lactation

Lantus should be used with caution during pregnancy.

For patients with pre-existing or gestational diabetes mellitus, it is important to maintain adequate metabolic regulation throughout pregnancy. In the first trimester of pregnancy, the need for insulin may decrease, and in the second and third trimesters it may increase. Immediately after childbirth, the need for insulin decreases, and therefore the risk of hypoglycemia increases. In these conditions, careful monitoring of blood glucose levels is essential.

IN experimental studies No direct or indirect data on the embryotoxic or fetotoxic effects of insulin glargine have been obtained in animals.

There have been no controlled clinical studies of the safety of Lantus 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.

Women during breastfeeding may require adjustments to their insulin dosing regimen and diet.

Use in childhood

There are currently no clinical data for use in children under 6 years of age.

For impaired renal function

Due to limited experience with Lantus, it was not possible to evaluate its effectiveness and safety in the treatment of patients with moderate or severe renal failure.

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 can lead to a persistent decrease in insulin requirements.

The drug is available with a prescription.

Storage conditions and periods

The drug should be stored out of the reach of children, protected from light at a temperature of 2° to 8°C; do not freeze. Shelf life - 3 years.

After starting use, store cartridges, pre-filled OptiSet syringe pens and OptiClick cartridge systems out of the reach of children, protected from light, at a temperature not exceeding 25°C. To protect from light exposure, pre-filled OptiSet pens, cartridges and OptiClick cartridge systems should be stored in their own cartons.

Do not refrigerate the pre-filled OptiSet pen.

After the first use, the shelf life of the drug in cartridges, pre-filled OptiSet syringe pens and OptiClick cartridge systems is 4 weeks. It is recommended to mark the date of first collection of the drug on the label.