Lantus

Description overdue on 08/21/2014

• Latin name: Lantus
• ATC code: A10AE04
• Active substance: Isulin glargine (Insulinum Glarginum)
• Manufacturer: SANOFI-AVENTIS Deutschland, GmbH, Germany

Photos of the drug

Tweet

• Composition
• Product form
• Pharmacological action
• Pharmacodynamics and pharmacokinetics
• Indications
• Contraindications
• Side effects
• Instructions for use Lantus ®
• Overdose
• Cooperation
• Terms of sale
• Storage conditions
• Shelf life
• Reviews
• Price, where to buy

Composition

The structure of 1 mL Lantus SoloSTAR part 3, 6378 mg insulin glargine Corresponding to 100 IU human insulin And a number of auxiliary substances:

• m-cresol;
• zinc chloride;
• glycerol (85%);
• sodium hydroxide;
• concentrated hydrochloric acid;
• water for injections.

Product form

Lantus insulin is produced in the form of a clear, colorless (or nearly colorless) solution for subcutaneous injection.

There are three forms of the drug issue:

• Systems OptiKlik , Which includes a colorless glass cartridges capacity of 3 ml. In a blister pack has five cartridges.
• Pen OptiSet   capacity of 3 ml. One package contains five injection pens.
• Lantus SoloSTAR cartridges   3 ml of capacity which are hermetically mounted in a pen syringe for single use. The cartridge sealed with one side of bromobutyl stopper and crimped aluminum cap, the other of the plunger has a bromobutyl. In a cardboard box has five injection pens without needles for injection.

Pharmacological action

Lantus (Lantus) belongs to the pharmacotherapeutic group of antidiabetic drugs " Insulins and their analogues injectable depot ".

Pharmacodynamics and pharmacokinetics

The active component of Lantus ® insulin glargine   It is an analog of human insulin   The long-acting, which is synthesized by converting DNA . The substance is characterized by an extremely low solubility in neutral environments.

However, as the solution is present in an acidic environment (pH is outside his 4) therein insulin glargine   It dissolves without a trace.

After injection into the subcutaneous fat layer it reacts neutralization, which resulted in the formation of specific reagents mikropretsipitaty.

From mikropretsipitatov, in turn, in small amounts gradually released   insulin glargine , Thereby providing a smooth (without peaks) profile curve " concentration - time "As well as more prolonged effect of the drug.

The parameters that characterize the process of binding   insulin glargine   with insulin receptors of an organism, similar to the parameters characteristic Human insulin .

By its pharmacological properties and have a biological effect of a substance similar to endogenous insulin Which is an important regulator carbohydrate metabolism   and processes metabolism Glucose   in the body.

Insulin   and similar substances have on the glycometabolism   the following action:

• stimulate the processes of biotransformation Glucose   at glycogen   liver ;
• help to reduce the concentration indicators glucose ;
• contribute to the capture and utilization Glucose   skeletal muscle and adipose tissue;
• inhibits Glucose   from fat   and proteins in liver   ( gluconeogenesis ).

Also insulin   is the so-called hormone-builder, because of its ability to exert an active influence on the protein and fat metabolism. As a result:

• increases the production of protein (mainly muscular tissues);
• blocked enzymatic process breakdown of proteins Which is catalyzed by proteolytic enzymes, proteases;
• increases production lipids ;
• blocked the process of splitting fat   into their constituent fatty acids in the adipose tissue cells (adipocytes);

Comparative clinical study of human insulin   and insulin glargine   We showed that with intravenously administered in equal doses two substances have similar pharmacological action .

Duration of action glargine As well as the effect of other insulins It determined by physical activity and other factors.

The research was aimed at maintaining normoglycemia   a group of healthy humans and patients diagnosed with insulin-dependent diabetes Active substance insulin glargine   after its entry into the subcutaneous fat developed more slowly than neutral protamine Hagedorn action ( NPH-insulin ).

The effect of it was a smooth, characterized by longer duration and not accompanied by irregular peaks.

These effects insulin glargine   determined by the reduction in the rate of absorption. Thanks to them, Lantus enough to take not more than once a day.

However, be aware that the features of any action in time insulin   (including insulin glargine ) May vary both in various patients and in one and the same person, but at different conditions.

In clinical studies have confirmed that the manifestations hypoglycemia   (a pathological condition characterized by a reduced concentration glucose ) Or emergency response hormonal response hypoglycemia   in healthy volunteers and in patients with a diagnosis of insulin-dependent diabetes   after intravenous administration method insulin glargine   and ordinary human insulin   They were absolutely identical.

In order to assess the effect insulin glargine   the development and progression diabetic retinopathy type   was conducted an open five-year NPH-controlled study in a group of 1024 people are diagnosed with insulin dependent diabetes mellitus .

In the study, progression of the retina of the eyeball   three or more steps in accordance with the criteria identified by photographing the ETDRS the bottom of the eyeball .

At the same time during the day suggested the introduction of a one-time insulin glargine   and the introduction of a two-fold isophane insulin   ( NPH-insulin ).

A comparative study showed that the difference in the progression diabetic retinopathy type   in the treatment of diabetes   drug isophane insulin and Lantus is estimated as insignificant.

The random controlled trials, which were conducted in a group of 349 patients childhood and adolescence (from six to fifteen years) insulin-dependent form of diabetes Children over 28-weeks were treated as basal-bolus insulin therapy .

In other words, they were subjected to multiple injection therapy, which involves the introduction of regular human insulin just before eating.

Lantus was administered once per day (in the evening before going to bed), normal human NPH-insulin   - Once or twice a day.

At the same time in each group was observed about the same incidence of symptomatic hypoglycemia   (state in which develop typical symptoms hypoglycemia And sugar concentration ratio falls below 70 units) and the related effects on glycohemoglobin , Which is the main blood biochemical parameters and displays the average blood sugar levels over a long period of time.

However, in this figure Plasma glucose concentrations   fasted study group that received insulin glargine It was largely reduced compared with baseline than in the group receiving isophane insulin .

In addition, the treated group, Lantus, hypoglycemia   accompanied by less severe symptoms.

Nearly half of the study - namely, 143 people - treated in the study insulin glargine , Continued therapy with this preparation in the following advanced studies involving observation of patients on average for two years.

During the entire period of time when patients received insulin glargine It was not detected any new anxiety symptoms in terms of security.

Also, in a group of 26 patients at the age of twelve and eighteen years insulin-dependent diabetes   cross-sectional study was conducted, during which compared the efficacy of the combination   insulin "glargine + lispro"   and the effectiveness of the combination " isophane insulin plus normal human insulin ".

The duration of the experiment was sixteen weeks, the treatment given to a patient in a random sequence.

As in the case with pediatric studies, reduced concentration Glucose   fasting blood compared with baseline was more pronounced and clinically significant in the group in which the patients received insulin glargine .

Indicators of changes in the concentration glycohemoglobin   in Group insulin glargine   and group isophane insulin   They were similar.

But at the same time registered by night concentration indices Glucose   blood group where treatment was carried out using a combination of insulin "glargine + lispro" It was much higher than in the group in which the therapy was carried out using a combination of isophane insulin   and ordinary human insulin .

The mean lower levels were 5, 4 and, respectively, 4, 1 mmol / l.

Incidence hypoglycemia   in the hours of night sleep in a group   insulin "glargine + lispro"   It was 32%, while in the group " isophane insulin plus normal human insulin "- 52%.

Comparative analysis of the content insulin glargine   and isophane insulin   at   serum   healthy volunteers and in diabetic patients after the administration of drugs into the subcutaneous tissue showed that insulin glargine   slower and longer is absorbed therefrom.

At the same time, peak plasma concentrations of indicators for insulin glargine   compared to isophane insulin   absent.

Following subcutaneous injection insulin glargine   once a day plasma equilibrium concentration is achieved in about two-four days after the first injection.

After administration of the drug intravenously half-life (half-life) insulin glargine   and Hormone , Normally produced by pancreas They are comparable quantities.

Following subcutaneous injections insulin glargine   begins rapidly metabolized at the end of the beta polypeptide chain comprising an amino acid with a free carboxyl group.

This process results in the formation of two active metabolite:

• M1 - 21A-Gly-insulin;
• M2 - 21A-Gly-des-30B-Thr-insulin.

The main circulating plasma   Patient compound is the metabolite M1, which increases in proportion to the allocation of the assigned therapeutic dose Lantus ®.

Pharmacodynamic and pharmacokinetic results demonstrate that a therapeutic effect after subcutaneous injection is based primarily on the excretion of metabolites M1.

Insulin glargine   pure and metabolite M2 were not detected in the majority of patients. When they do show up, they did not depend on the concentration of the prescribed dose Lantus ®.

Clinical research and analysis groups prepared in accordance with the age and gender of patients, did not reveal any differences in the effectiveness of security and between patients, lechivshimisya Lantus, and overall study population.

Pharmacokinetic parameters in patients from two to six years insulin-dependent diabetes mellitus Which are estimated in one study showed that the minimum concentration insulin glargine   and formed during its biotransformation of metabolites M1 and M2 in children similar to that of adults.

The evidence that would indicate the ability of insulin glargine   or the products of its cumulated metabolized in the body during prolonged treatment with drugs are not available.

Indications

Lantus is used to treat insulin   and insulin-dependent diabetes   in patients aged six years and older.

Contraindications

The only contraindication to Lantus ® is a heightened sensitivity to its active substances or to any of the supporting components of the drug.

Side effects

The most common side effect of any insulin is hypoglycemia . It normally develops when the assigned dose exceeds the body's need insulin .

Be severe hypoglycemic attacks In particular arising again, can cause lesions Nervous System . If in addition to this they are protracted, in some cases, can pose a serious threat to the life of the patient.

Many patients before the appearance of clinical manifestations neyroglikopenii   often with symptoms of so-called adrenergic counterregulation . The greater and faster level decreases Glucose   in the blood, the more pronounced the phenomenon counterregulation and accompanying manifestations.

Depending on the frequency of occurrence of side reactions is divided into:

• frequent;
• infrequent;
• rare;
• very rare.

It often refers:

• Manifestations lipohypertrophy . The consequences of any insulin may be of lipodystrophy   at the injection site, and local absorption slowing insulin . To prevent such a phenomenon, or at least reduce it to a minimum recommended manifestations constantly alternate injection sites Lantus ® within the injection zone.
• Local reactions, which are expressed in the form redness, itching, pain, hives, swelling   or signs inflammation   at the injection site. As a rule, most of the weakly expressed on Lantus local reactions usually disappear after a few days or weeks after the start of treatment.

The category infrequent side effects of treatment include Lantus lipoatrophy   subcutaneous fat.

In rare cases can develop:

• Immediate allergic reactions Representing a danger for the life of the patient. These include reactions anaphylactic . cytotoxic   type, as well as related disorders immune complex . This can be generalized type skin reactions, development angioedema   ( angioedema   or angioedema ), Symptoms bronchospasm . anaphylactic shock . hypotension   etc..
• Blurred vision, retinopathy . Wearing a pronounced change in the level of glycemic control can cause a temporary dysfunction of which is explained by a change in tissue turgor and refractive index lens (which also are temporary). Increased control glycemia   for an extended period of time reduces the risk of progression diabetic retinopathy . However, intensive therapy with Lantus, accompanied by dramatic improvements in glycemic control may cause temporary worsening retinopathy . In cases where the patient develops diabetic retinopathy III   (proliferative retinopathy type), particularly if the patient does not appoint treatment method photocoagulation , Severe hypoglycaemic attacks may cause temporary blindness .
• Puffiness . In some situations, treatment Lantus may cause sodium retention and appearance edema . It is mainly observed in situations where previously conducted by control metabolism , Assessed as unsatisfactory, significantly improved against the background of intensive treatment with insulin.

In rare cases, the body can also react to the introduction of Lantus ® elaboration antibodies   to him.

Results of clinical studies conducted have shown that antibodies Provoking cross-reaction with insulin glargine   and human insulin With the same frequency were observed in groups where the treatment was carried out using insulin glargine And in groups, where the treatment of patients prescribed drugs   NPH-insulin .

In some cases, when the patient begins to produce Antibodies to insulin In order to avoid the development of hyper-   or hypoglycemia   It requires correct dose.

It is very rare occurring side effects include:

• dysplasia Which represents the subjective taste disorder;
• myalgia Characteristic feature of which is pain in the muscle, resulting from an increased tone muscle cells   (both at rest and under stress).

As a rule, the safety profile of Lantus ® in patients child and adolescent safety profile similar to that observed in adults.

Statistics collected during the post-marketing use of the drug, revealed that in the child and adolescent population, local reactions to injections of Lantus ® rated as relatively more frequent.

In particular, the pain at the injection insulin . hives   and skin rash   children are observed more frequently than in adults.

Data on the safety of the drug in pediatric patients for the treatment of children under six years of age are not available.

Instructions for use Lantus ®

The preparation includes insulin glargine   - An analog of the human insulin Characterized prolonged effect.

A solution for injection into the subcutaneous adipose tissue, to the patient intravenously infuse prohibited.

This is because the prolonged mechanism of action is determined by subcutaneous injection of the drug, if it enter intravenously, can provoke hypoglycemic attack   severe.

Any significant difference in terms of the concentration insulin   level or Glucose   in blood after subcutaneous injection in the abdominal wall, or the deltoid muscle of the thigh was identified.

Insulin Lantus SoloSTAR   It is placed in the pen cartridge system, immediately usable. When insulin   in the cartridge runs out, handle discarded and replaced with a new one.

Systems OptiKlik   intended for repeated use. When insulin   in the handle comes to an end, the patient should buy a new cartridge, and set it to an empty place.

Before the introduction of a layer of subcutaneous fat Lantus must not be diluted or combined with other drugs insulin

insulin .

insulin   kidney .

insulin  

Patients with   insulin   Glucose     insulin .

insulin insulin    

insulin   Hormone  

     

 

Lantus SoloSTAR . insulin

Overdose

hypoglycemia  

hypoglycemia carbohydrates  

convulsions whom glucagon Which is a Glucose .

carbohydrates .   .

Cooperation

Glucose

hypoglycemia

• Dizopiramid ;
• ;
• Fluoxetine ;
• Pentoxifylline ;
• ;
• salicylates ;
• sulfonamides  

• ;
•   ;
• ;
• estrogen - And progestogen
• phenothiazines ;
• sympathomimetic ;
• preparations hormones ;
• ;
• .

Clonidine . lithium salt

The simultaneous use   from Pentamidine   can provoke hyperglycemia .

b   or reserpine

Terms of sale

Storage conditions

Shelf life

  and  

  amino acid     .   binds  

. .

  from Lantus SoloSTAR  

• Shelf life  
•  

In Ukraine, the price  

Get the best price and buy