Universal reference book for medicines
Product name: LANTUS ® (LANTUS ® )

Active substance: insulin glargine

Type: Long-acting human insulin

Manufacturer: SANOFI-AVENTIS DEUTSCHLAND (Germany)
Composition, form of production and packaging
The solution for administration is transparent, colorless or almost colorless.
1 ml
insulin glargine 3.6378 mg,
which corresponds to the content of human insulin 100 U
Excipients: m-cresol (m-cresol), zinc chloride, glycerol (85%), sodium hydroxide, hydrochloric acid, water d / u.
3 ml - colorless glass cartridges (5) - packings of cellular contour (1) - packs of cardboard.
3 ml - colorless glass cartridges (1) - Optic syringe pens (5) - cardboard packs.
3 ml - colorless glass cartridges (1) - cartridge systems OpticKlik (5) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Insulin glargine is an analog of human insulin. It was obtained by recombination of DNA from bacteria of the species Escherichia coli (strains K12). It is characterized by low solubility in a neutral medium. As part of the preparation Lantus ®, it is completely soluble, which is provided by an acidic solution solution for injection (pH = 4). After introduction into the subcutaneous fat, the solution, due to its acidity, enters a neutralization reaction to form micro-precipitates, from which small amounts of insulin glargine are constantly released, providing a smooth (without peaks) profile of the concentration-time curve, as well as a long duration of the drug.
The binding parameters with insulin receptors of insulin glargine and human insulin are very similar. Insulin glargine has a biological effect similar to endogenous insulin.
The most important action of insulin is the regulation of glucose metabolism. Insulin and its analogues reduce blood glucose, stimulating glucose consumption by peripheral tissues (especially skeletal muscle and fat tissue), and also inhibiting the formation of glucose in the liver (gluconeogenesis). Insulin inhibits lipolysis in adipocytes and proteolysis while simultaneously enhancing protein synthesis.
The increased duration of action of insulin glargine is directly due to the low rate of its absorption, which makes it possible to apply the drug 1 time / day. The onset of action is an average of 1 hour after the administration. The average duration of action is 24 hours, the maximum duration is 29 hours. The nature of the action of insulin and its analogues (for example, insulin glargine) can vary significantly in time in both 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 serum injections in healthy people and patients with diabetes showed delayed and significantly longer absorption, as well as a lack of peak concentration in insulin glargine compared to insulin-isophane.
With n / to the introduction of the drug 1 time / day, the stable average concentration of insulin glargine in the blood is reached after 2-4 days after the first dose.
With the / in the introduction of T 1/2 insulin glargine and human insulin are comparable.
In humans, in the subcutaneous fat, insulin glargine is partially cleaved from the carboxyl end of the C-terminus of the B chain (beta chain) to form 21 A- Gly-insulin and 21 A -Gly-des-30 B -Thr-insulin . In plasma there are both unchanged insulin glargine, and the products of its cleavage.
INDICATIONS
- diabetes, requiring insulin treatment, in adults, adolescents and children older than 6 years.
DOSING MODE
The dose of the drug and the time of day for it are set individually. Lantus ® is administered SC once / day always at the same time. Lantus ® should be injected into the subcutaneous fat of the abdomen, shoulder or thigh. Place for injection should alternate with each new injection of the drug within the recommended areas for the administration of the drug.
The drug can be used as a monotherapy, or in combination with other hypoglycemic drugs.
When transferring a patient from long-term or medium-duration insulins to Lantus ®, a daily dose of basal insulin may need to be adjusted or a change in concomitant antidiabetic therapy (doses and mode of administration of short-acting insulin or their analogs and doses of oral hypoglycemic drugs).
When transferring a patient from a two-fold administration of insulin-isophane to a single administration 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 in the night and early morning hours. During this period, a decrease in the dose of Lantus should be compensated for by an increase in short-acting insulin doses followed by an individual correction of the dosing regimen.
As with other human insulin analogues, in patients receiving high doses of drugs due to the presence of antibodies to human insulin, an increase in the response to insulin administration may occur when switching to Lantus ® . During the transition to Lantus ® and in the first weeks after it requires careful monitoring of blood glucose and, if necessary, correction of the insulin dosage regimen.
In the case of an improvement in the regulation of metabolism and the consequent increase in sensitivity to insulin, further correction of the dosing regimen may become necessary. Correction of the dose may also be required, for example, with a change in the patient's body weight, lifestyle, time of the day for drug administration or other circumstances that contribute to an increase in predisposition to the development of hypo- or hyperglycemia.
The drug should not be administered iv. In / in the introduction of the usual dose, intended for SC administration, can cause the development of severe hypoglycemia.
Before the introduction, it must be ensured that the syringes do not contain the remains of other medicinal products.
Rules of use and handling of the drug
Pre-filled Optic syringe pens
Before use, inspect the cartridge inside the syringe pen. It should only be used if the solution is clear, colorless, contains no visible solid particles and resembles water in a consistency. Empty Optic syringes are not intended for reuse and must be destroyed.
To prevent infection, the pre-filled syringe pen is intended for use by only one patient and can not be transferred to another person.
Handling of syringe-handle OptiSet
Always use a new needle every time you use it. Use only needles that are suitable for the OptiSet syringe.
Always give a safety test before each injection.
If a new OptiSet pen is used, the readiness check should be performed using 8 units preset by the manufacturer.
The dose selector can only be rotated in one direction.
Never turn the dose selector (dose change) after pressing the injection pushbutton.
If the injection is made by another person, then he needs to take extra care to avoid accidentally injuring the needle and infecting the infectious disease.
Never use a damaged OptiSet syringe, or if it is suspected to be defective.
It is necessary to have a spare syringe-handle OptiSet in case of loss or damage used.
Insulin testing
After removing the cap from the syringe pen, check the labeling on the insulin tank to make sure it contains the proper insulin. You should also check the appearance of insulin: the insulin solution should be clear, colorless, free of visible solids and have a consistency similar to water. Do not use the OptiSet pen if the insulin solution is cloudy, colored, or contains foreign particles.
Attaching the needle
After removing the cap, you should carefully and tightly connect the needle to the syringe pen.
Checking the availability 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 stand on the figure 8, as was previously set by the manufacturer.
If a syringe pen is used, the dispenser should be rotated until the dose indicator stops at 2. The dispenser will rotate in only one direction.
Pull out the fully-actuated button to dial the dose. Never rotate the dose selector after the start button is pulled out.
The outer and inner needle caps must be removed. Save the outer cap to remove the used needle.
Holding the syringe handle with the needle pointing upwards, gently tap with your finger on the insulin reservoir so that the air bubbles rise up towards the needle.
Then press the start button as far as it will go.
If a drop of insulin is released from the tip of the needle, the syringe-pen and the needle function correctly.
If a drop of insulin is not displayed at the tip of the needle, repeat the readiness check of the syringe pen until the insulin appears on the tip of the needle.
Selecting an insulin dose
A dose of 2 units up to 40 units can be set in increments of 2 units. If a dose exceeding 40 units is required, it must be administered in two or more injections. Make sure you have enough insulin for the right dose.
The scale of the residual insulin on a transparent container for insulin shows how much, approximately, of the insulin remains in the syringe-handle OptiSet. This scale can not be used to take a dose of insulin.
If the black piston is at the beginning of the color strip, then there are approximately 40 units of insulin.
If the black piston is at the end of a colored strip, then there are about 20 units of insulin.
The dose selector should be rotated until the arrow-dose indicator indicates the desired dose.
Insulin Dose Fence
The injection button must be pulled to the limit to fill the insulin pen.
It should be checked whether the correct dosage is taken. The button is shifted according to the amount of insulin left in the insulin container.
The start button allows you to check which dose is dialed. During the test, the start button must be kept under tension. The last visible wide line on the start button shows the amount of insulin taken. When the start button is held, only the upper part of this wide line is visible.
Introduction of insulin
Specially trained personnel should explain the technique of injection to the patient.
The needle is injected sc. Press the injection button to the limit. The click will stop when the injection pushbutton is depressed. Then press the injection button for 10 seconds before pulling the needle out of the skin. This will ensure the introduction of the entire dose of insulin.
Removing the needle
After each injection, the needle should be removed from the syringe-pen and discarded. This will prevent infection, as well as leakage of insulin, air intake and possible blockage of the needle. Needles can not be reused.
After this, put back the cap for the syringe pen.
Cartridges
Cartridges should 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 for installing the cartridge, connecting the needle and performing insulin injection should be carried out exactly. Inspect the cartridge before use. It should be used only if the solution is clear, colorless and does not contain visible solids. Before installing the cartridge in the syringe pen, the cartridge should be at room temperature for 1-2 hours. Before carrying out the injection, remove air bubbles from the cartridge. It is necessary to strictly follow the instructions. Empty cartridges are not used again. If the OptiPen Pro1 syringe pen is damaged, you can not use it.
If the syringe pen is faulty, if necessary, insulin can be injected into the patient by typing the solution from the cartridge into a plastic syringe (suitable for insulin at a concentration of 100 IU / ml).
To prevent infection with a reusable pen, only one person should use it.
OptiKlik cartridge system
The Optiklik cartridge system is a glass cartridge containing 3 ml of the glargine insulin solution, which is placed in a transparent plastic container with an attached piston mechanism.
The Optiklik cartridge system should be used together with the Optiklik syringe in accordance with the instruction manual attached to it.
It is necessary to follow exactly all the recommendations contained in the instructions for installing the cartridge system in the Optiklik syringe, connecting the needle and injecting.
If the OpticClip syringe is damaged, replace it with a new one.
Before installing the cartridge system in the syringe handle Optiklik, it should be at room temperature for 1-2 hours. Before installation, the cartridge system should be inspected. It should only be used if the solution is clear, colorless, and contains no visible solid particles. Before carrying out the injection, remove the air bubbles from the cartridge system (as well as when using a pen syringe). Empty cartridge systems are not reused.
If the syringe pen is defective, then, if necessary, insulin can be administered to the patient by typing the solution from the cartridge into a plastic syringe (suitable for insulin at a concentration of 100 IU / ml).
To prevent infection with a reusable pen, only one person should use it.
SIDE EFFECT
Determination of the frequency of adverse reactions: very often (? 10%), often (? 1%, <10); sometimes (? 0.1%, <1%); rarely (? 0.01%, <0.1%), very rarely (<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 recurrent, can lead to damage to the nervous system. Episodes of prolonged and severe hypoglycemia can endanger the lives of patients.
Psychoneurological disorders in 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 significantly 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 lens of the eye.
Long-term normalization of blood glucose reduces the risk of progression of diabetic retinopathy. Against the backdrop of insulin therapy, accompanied by sharp fluctuations in blood glucose, a temporary deterioration in the course of diabetic retinopathy is possible. In patients with proliferative retinopathy, especially those who do not receive photocoagulation treatment, episodes of severe hypoglycemia can lead to the development of transient loss of vision.
From the skin and subcutaneous fat: often - as with any other insulin preparations, lipodystrophy (1-2%) and local insulin absorption delay are possible; infrequently - lipoatrophy. The constant change of injection sites within the body regions recommended for 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, swelling (especially if intensified insulin therapy leads to an improvement in previously inadequate regulation of metabolic processes).
Allergic reactions: rarely - allergic reactions of immediate type to insulin (including insulin glargine) or auxiliary components of the drug - generalized skin reactions, angioedema, bronchospasm, arterial hypotension, shock. These reactions can pose a threat to the life of the patient.
The use of insulin can cause the formation of antibodies to it. The formation of antibodies that cross-reacted with human insulin was observed at the same frequency. In rare cases, the presence of such antibodies to insulin may cause the need for dose adjustment in order to eliminate the tendency to develop hypo- or hyperglycemia.
Local reactions: often (3-4%) - redness, pain, itching, hives, swelling or inflammation at the site of injection. In most cases, minor reactions are resolved within a period of several days to several weeks.
The safety profile for patients younger than 18 years generally similar to the safety profile for patients older than 18 years. In patients younger than 18 years of relatively more likely to occur at the injection site reactions and skin reactions (rash, urticaria). safety data in children under 6 years are not available.
CONTRAINDICATIONS
- Children under 6 years (clinical data on the use of no);
- Hypersensitivity to the components of the drug.
With careful use of Lantus ® in pregnancy.
PREGNANCY AND LACTATION
Caution should be used Lantus ® during pregnancy.
For patients with previously existing or gestational diabetes is important during pregnancy to maintain adequate regulation of metabolism. The I trimester insulin requirements may be reduced, in trimesters II and III - increasing. Immediately after delivery, insulin requirements reduced, and therefore increases the risk of hypoglycemia. Under these conditions, significant importance is careful control of blood glucose.
In experimental studies on animals have not received direct or indirect evidence of embryotoxic or foetotoxic effect of insulin glargine.
Controlled clinical trials of the drug safety of Lantus ® during pregnancy was conducted. There is evidence of the use of Lantus ® in 100 pregnant women with diabetes. And during pregnancy outcome in these patients did not differ from those of the pregnant women with diabetes who received other drugs of insulin.
In women during breastfeeding may require adjustment of insulin dosage regimen and diet.
APPLICATION FOR FUNCTIONS OF THE LIVER
Due to the limited experience of the use of Lantus ® has not been possible to assess its efficacy and safety in patients with moderate or severe renal insufficiency.
In patients with renal impairment, insulin requirements may be reduced due to the weakening of his elimination processes. Elderly patients progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Due to the limited experience of the use of Lantus ® has not been possible to assess its efficacy and safety in patients with hepatic impairment.
In patients with severe hepatic impairment, insulin requirements may be reduced due to the reduced capacity for gluconeogenesis and biotransformation of insulin.
APPLICATION FOR CHILDREN
clinical data on use in children under the age of 6 years no.
APPLICATION IN ELDERLY PATIENTS
Elderly patients progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
SPECIAL INSTRUCTIONS
Lantus ® is not a drug of choice for the treatment of diabetic ketoacidosis. In such cases, in / in a short-acting insulin.
Due to the limited experience of the use of Lantus ® has not been possible to assess its efficacy and safety in patients with impaired liver function or renal insufficiency patients moderate or severe.
In patients with renal impairment, insulin requirements may be reduced due to the weakening of his elimination processes. Elderly patients progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
In patients with severe hepatic impairment, insulin requirements may be reduced due to the reduced capacity for gluconeogenesis and biotransformation of insulin.
In the case of ineffective control over the level of blood glucose, as well as a trend towards the development of hypo- or hyperglycemia, before proceeding to the correction of the dosing regime, check the accuracy of compliance with the prescribed regimen, and places of administration of competent art p / injection taking into account all the factors affecting it.
hypoglycemia
Time of hypoglycemia depends on the profile of action of insulin and can thus be varied by changing the treatment regimen. Due to the increase time of exposure long acting insulin when applied Lantus ®, one should expect a smaller probability of nocturnal hypoglycemia, whereas in the early morning hours, this probability is higher. At occurrence of hypoglycemia in patients receiving Lantus ® , must consider the possibility of slowing down the output of the state hypoglycemia due to prolonged action of insulin glargine.
In patients who have episodes of hypoglycemia may be of particular clinical importance, including in patients with severe stenosis of the coronary arteries or the vessels of the brain (risk of cardiac and cerebral hypoglycemia complications), as well as in patients with proliferative retinopathy, particularly if they do not receive treatment photocoagulation (risk of transient loss of vision due to hypoglycemia), you should take special precautions and carefully monitor blood glucose.
Patients should be warned about the conditions under which, the harbingers of the symptoms of hypoglycemia may be reduced, become less pronounced or be absent in certain risk groups, which include:
- patients in whom the regulation of blood glucose significantly improved;
- Patients in whom hypoglycaemia develops gradually;
- elderly patients;
- Patients with neuropathy;
- Patients with a long history of diabetes;
- patients suffering from mental disorders;
- Patients translated from animal insulin to human insulin;
- Patients receiving concomitant treatment with other drugs.
Such situations can lead to the development of severe hypoglycemia (with the possible loss of consciousness) before the patient is aware that he develops hypoglycemia.
If normal or marked decline in glycated hemoglobin, is necessary to consider the possibility of repeating unrecognized hypoglycemia episodes (especially at night).
Patient compliance with dosing regimens, diet and nutrition, proper use of insulin and control symptoms of hypoglycemia contribute to a significant reduction in the risk of hypoglycemia. In the presence of factors that increase susceptibility to hypoglycemia, especially need careful observation, because It may require adjustment of insulin dose. These factors include:
- change the site of injection of insulin;
- increased sensitivity to insulin (e.g., elimination of stress factors);
- unaccustomed, increased or prolonged physical activity;
- intercurrent illness accompanied by vomiting, diarrhea;
- violation of diet and nutrition;
- missed meals;
- consumption of alcohol;
- some uncompensated endocrine disorders (e.g., hypothyroidism, or adenohypophysis insufficiency of the adrenal cortex);
- concomitant treatment with certain other medicines.
intercurrent disease
When intercurrent diseases require more intensive control of blood glucose. In many cases, the analysis shows the presence of ketone bodies in urine, it is also often required insulin correction dosing regimen. Insulin requirement is often increased. Patients with type 1 diabetes must continue to regular consumption of at least a small amount of carbohydrates, even when eating only small amounts or no opportunity to eat, as well as vomiting. These patients should never discontinue insulin completely.
OVERDOSE
Symptoms: severe and sometimes prolonged hypoglycemia, threatening the patient's life.
Treatment: episodes of moderate hypoglycemia typically cropped by oral fast utilizable carbohydrates. You may need to change the drug dosing regimen, diet or physical activity.
More episodes of severe hypoglycemia accompanied coma, seizures or neurological disorders, require / m or p / glucagon administration, and on / in a 40% dextrose solution. It may require prolonged intake of carbohydrates and surveillance specialist since hypoglycemia possible relapse after apparent clinical improvement.
DRUG INTERACTION
Oral hypoglycemic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, dextropropoxyphene, salicylates and sulfa antimicrobial agents may enhance the hypoglycemic effect of insulin, and increase the susceptibility to the development of hypoglycemia. In these combinations may require correction insulin glargine doses.
Corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens, progestins, phenothiazine derivatives, somatropin, sympathomimetics (such as epinephrine, salbutamol, terbutaline), thyroid hormones, protease inhibitors, some antipsychotics (e.g., olanzapine and clozapine) may reduce hypoglycemic effect of insulin. In these combinations may require correction insulin glargine doses.
With the simultaneous application of the drug Lantus ® with beta-blockers, clonidine, lithium salts, ethanol may both amplification and attenuation hypoglycemic action of insulin. Pentamidine in combination with insulin may cause hypoglycemia which is sometimes replaced by hyperglycemia.
While the use of drugs having sympatholytic action, such as beta-blockers, clonidine, guanfacine and reserpine may decrease or absence kontrregulyatsii adrenergic symptoms (the activation of the sympathetic nervous system) as the development of hypoglycemia.
Pharmaceutical interaction
Lantus ® not be mixed with other insulin formulations, with any other drugs or plant. Upon mixing or dilution may change its profile action in time, in addition, mixing with other insulin can cause precipitation.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be kept out of the reach of children, protected from light at a temperature of from 2 ° to 8 ° C; Do not freeze. Shelf life - 3 years.
After the start of use of cartridges pre-filled pen and cartridge OptiSet OptiKlik system stored in reach of children, protected from light at a temperature not higher than 25 ° C. It should be stored in their own cartons for protection against exposure to light pre-filled pen OptiSet, cartridges and cartridge OptiKlik system.
Pre-filled insulin pen OptiSet not cool.
After the first use of the shelf life of the drug in the cartridge, pre-filled pen OptiSet and cartridge systems OptiKlik - 4 weeks. It is recommended to mark the date on the label of the first intake of the drug.
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