Tudgeo SoloStar - Instructions For The Use Of Insulin, Price, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Tudgeo SoloStar

Tudgeo SoloStar: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Toujeo SoloStar

ATX code: A10AE04

Active ingredient: insulin glargine (Insulin glargine)

Manufacturer: Sanofi-Aventis Deutschland, GmbH (Sanofi-Aventis Deutschland, GmbH) (Germany), Sanofi-Aventis Vostok, JSC (Russia)

Description and photo updated: 2018-29-11

Prices in pharmacies: from 2727 rubles.

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Tudgeo SoloStar is a long-acting hypoglycemic drug, an analogue of human insulin.

Release form and composition

The drug is produced in the form of a solution for subcutaneous (s / c) administration: an almost colorless or colorless liquid with a transparent structure (1.5 ml each in glass cartridges without color, the cartridges are mounted in disposable syringe pens SoloStar, in a cardboard box 1, 3 or 5 cartridges and instructions for use of Tudgeo SoloStar).

1 ml of solution contains:

• active substance: insulin glargine - 10.91 mg, which corresponds to 300 units (unit of action);
• auxiliary components: glycerol 85%, zinc chloride, hydrochloric acid, m-cresol (m-cresol), sodium hydroxide, water for injection.

Pharmacological properties

Pharmacodynamics

The mechanism of action of the active substance Tudgeo SoloStar, insulin glargine, is aimed at regulating glucose metabolism by reducing its concentration in the blood by inhibiting the formation of glucose in the liver and stimulating its absorption by skeletal muscles, adipose and other peripheral tissues. Insulin glargine, by suppressing lipolysis in adipocytes and inhibiting proteolysis, increases protein synthesis.

Insulin glargine obtained by recombination of DNA (deoxyribonucleic acid) of bacteria of the species Escherichia coli (K12 strains) used as a producer strain has low solubility in a neutral medium. At pH 4 (acidic environment), insulin glargine is completely dissolved. Neutralization of the acidic reaction of the solution after the introduction of the drug into the subcutaneous fat leads to the formation of microprecipitates, which release small amounts of insulin glargine in a constant mode.

Compared to human insulin isophane, insulin glargine (100 U / ml) is characterized by a slower onset of the hypoglycemic effect after subcutaneous administration, its prolonged action is characterized by maintaining uniform constancy.

When comparing insulin Tudgeo SoloStar with insulin glargine 100 U / ml, it was found that after SC administration of the drug in clinically significant doses, its hypoglycemic effect was more constant and lasted from 24 to 36 hours. The prolonged action allows patients to change the time of administration of the drug, if necessary, performing the procedure within 3 hours before or after the usual time.

The discrepancy between the curves of hypoglycemic action of insulin glargine 100 U / ml and Tudgeo SoloStar is associated with a change in the release of insulin glargine from the precipitate. For the introduction of the same number of units of insulin glargine, the volume of the drug is required three times less than for the introduction of insulin glargine 100 U / ml, this contributes to a decrease in the surface area of the precipitate and its more gradual release from the precipitate of the drug, in comparison with the precipitate of insulin glargine 100 U / ml.

The hypoglycemic effect with intravenous (iv) administration of equal doses of insulin glargine and human insulin is the same.

As a result of biotransformation of insulin glargine, two active metabolites are formed - M1 and M2. According to in vitro studies, the affinity of insulin glargine and its active metabolites for human insulin receptors is similar to that of human insulin.

The affinity of insulin glargine for the receptor for insulin-like growth factor 1 (IGF-1) is approximately 5–8 times higher than that of human insulin, but lower than that of IGF-1 by approximately 70–80 times. The metabolites M1 and M2 are inferior in affinity for the IGF-1 receptor human insulin.

In patients with type 1 diabetes mellitus, the total therapeutic concentration of insulin glargine and its metabolites is much lower than the level required for half-maximal binding to IGF-1 receptors and subsequent activation of the mitogen-proliferative pathway. It can be activated by the physiological level of the concentration of endogenous IGF-1, but the therapeutic concentrations of insulin determined during the treatment of Tudgeo SoloStar are significantly lower than the pharmacological concentrations required for this.

The results of clinical studies of the drug, which involved patients with type 1 diabetes mellitus (546 patients) and type 2 diabetes mellitus (2474 patients), showed that, compared with the initial values of the glycosylated hemoglobin (Hb _A1c) index, its values decreased by the end of the study. not less than that when using insulin glargine 100 U / ml.

The number of patients who achieved the target Hb _A1c (below 7%) was comparable in both treatment groups.

By the end of the study, the degree of lowering blood sugar levels with the use of Tudgeo SoloStar and insulin glargine 100 U / ml was the same. At the same time, a slower decrease in the concentration of glucose in the blood plasma was noted during the period of dose selection during treatment with the drug.

Comparing the results with the administration of insulin glargine 300 U / ml in the morning or in the evening, it was found that glycemic control, including the improvement in Hb _A1c, was comparable. When the drug was administered within 3 hours before or after the usual time of administration, its effectiveness was not impaired.

With the use of Tudgeo SoloStar for six months, an increase in body weight by an average of less than 1 kg is possible.

It was found that gender, ethnicity, age or weight of the patient, duration of diabetes mellitus (less than 10 years, 10 years or more) and baseline values of this indicator did not affect the improvement of Hb _A1c.

The results of clinical studies in patients with type 2 diabetes mellitus have shown a lower incidence of severe and / or confirmed hypoglycemia, as well as hypoglycemia, occurring with clinical symptoms, than with treatment with insulin glargine 100 U / ml.

In terms of reducing the risk of developing severe and / or confirmed nocturnal hypoglycemia, the advantage of Tudgeo SoloStar over insulin glargine 100 U / ml was demonstrated during the period from the third month of therapy to the end of the study in 23% of patients who received prior oral hypoglycemic agents and in 21% of patients taking insulin with meals.

The use of Tudgeo SoloStar causes a decrease in the risk of hypoglycemia in patients who have previously received insulin therapy, and in patients who have not previously received insulin.

In patients with type 1 diabetes mellitus, the incidence of hypoglycemia during the use of Tudgeo SoloStar is comparable to that in the treatment of insulin glargine 100 U / ml. It should be noted that during the initial period of treatment, the incidence of all categories of nocturnal hypoglycemia is lower with drug treatment than with insulin glargine 100 U / ml.

The results of the studies did not indicate the presence of differences associated with the formation of antibodies to insulin, as well as in the efficacy, safety, dose of basal insulin when comparing patients treated with Tudgeo SoloStar, and patients treated with insulin glargine 100 U / ml.

An international, multicenter, randomized trial of 100 U / ml insulin glargine was conducted in 12,537 patients with impaired glucose tolerance, impaired fasting glycemia or early-stage type 2 diabetes mellitus and confirmed cardiovascular disease. One half of the study participants received insulin glargine 100 U / ml, the dose of which was titrated until a fasting plasma glucose concentration of 5.3 mmol and below was reached, the other half received standard therapy. The study lasted approximately 6.2 years.

The median Hb _A1c values, at an outcome of 6.4%, during treatment ranged from 5.9–6.4% in the insulin glargine group and 6.2–6.6% in the standard therapy group.

Comparative results of this study showed that treatment with insulin glargine 100 U / ml does not change the likelihood of developing cardiovascular complications (nonfatal myocardial infarction or nonfatal stroke, cardiovascular death), revascularization or hospitalization for the development of heart failure, microvascular complications. The combined index of microvascular complications took into account laser photocoagulation or vitrectomy, vision loss due to diabetic retinopathy, doubling of the blood creatinine concentration, progression of albuminuria, or the need for dialysis therapy. The gender and race of the patients does not affect the effectiveness and safety indicators of Tudgeo SoloStar.

In general, there are no differences in the efficacy and safety of the drug between patients with type 1 and type 2 diabetes mellitus aged 65 and older and younger patients. To avoid hypoglycemic reactions, in elderly patients, the initial and maintenance doses should be lower than usual; it is recommended to increase the dose more slowly. In older patients, it may be difficult to determine the symptoms of hypoglycemia, therefore, it is necessary to closely monitor the concentration of glucose in the blood.

There are no data on the safety and effectiveness of the use of Tudgeo SoloStar in children.

Pharmacokinetics

In comparison with insulin glargine 100 U / ml, after SC administration of Tudgeo SoloStar, serum insulin concentration is achieved as a result of slower and longer absorption, leading to a flatter concentration-time curve for up to 36 hours. C _ss (equilibrium concentration of the drug in plasma) within the therapeutic range of concentrations is achieved after 72–96 hours of regular use of Tudgeo SoloStar.

The same patient has low variability in systemic insulin exposure over 24 hours at steady state.

Insulin glargine is rapidly metabolized from the carboxyl end (C-end) of the beta-chain, as a result of biotransformation, two active metabolites are formed M1 (21 ^A- Gly-insulin) and M2 (21 ^A- Gly-des-30 ^B- Thr-insulin) … The metabolite M1 is predominantly found in blood plasma, its systemic exposure increases in proportion to the increase in the dose of insulin glargine. It has been established that the therapeutic effect of the drug is mainly due to the systemic exposure of the M1 metabolite, since insulin glargine and the M2 metabolite are not detected in the systemic circulation in the vast majority of patients. In other cases, the blood concentrations of insulin glargine and M2 metabolite did not depend on the administered dose and the dosage form of insulin glargine.

The T _½ (half-life) of the M1 metabolite, regardless of the dose of insulin glargine, is in the range of 18-19 hours.

The influence of the race or gender of the patient on the pharmacokinetics of Tudgeo SoloStar has not been established.

There is no information on the effect of age on the pharmacokinetics of the drug. To avoid hypoglycemic episodes in patients with diabetes mellitus in the elderly, it is recommended that the initial and maintenance doses be prescribed lower and the dose increase is carried out more slowly.

The pharmacokinetics of Tudgeo SoloStar in children have not been studied.

In studies with human insulin, an increase in insulin concentrations was found in patients with renal and hepatic insufficiency. A similar effect is expected with the use of insulin glargine; therefore, it is recommended to carefully monitor the blood glucose level in this category of patients.

Indications for use

The use of Tudgeo SoloStar is indicated for adult patients with diabetes mellitus requiring insulin therapy.

Contraindications

Absolute:

• age under 18 years (since there are no data from clinical studies confirming the efficacy and safety of the drug in children and adolescents);
• hypersensitivity to the components of the drug.

Insulin Tudgeo SoloStar should be prescribed with caution during pregnancy, elderly patients, with uncompensated endocrine disorders (including insufficiency of the adrenal cortex and adenohypophysis, hypothyroidism), severe stenosis of the vessels of the brain or coronary arteries, proliferative retinopathy (especially in the absence of photocoagulation), renal failure, severe liver failure, diseases accompanied by diarrhea or vomiting.

Tujeo SoloStar, instructions for use: method and dosage

The solution is intended for injection into the subcutaneous fatty tissue of the abdomen, shoulders or thighs by subcutaneous injection. The procedure is carried out once a day at a set time. For each subsequent injection, a new site must be selected within the recommended injection areas.

The content of insulin glargine units in Tudjeo SoloStar (300 units in 1 ml of solution) refers only to this drug, it is not equivalent to the content of units expressing the strength of the action of other insulin analogues.

Intravenous administration of the solution is contraindicated!

Do not use an insulin pump to deliver the solution.

The pen cartridge contains 80 units of ready-to-use solution, which should never be withdrawn into another syringe or used by multiple patients, even if the needle is replaced.

The syringe pen is equipped with a dose counter with a step of 1 unit increase. It shows the number of units of insulin glargine that will be injected.

To inject the drug, use special needles BD Micro-Fine Plus for SoloStar syringe pens. The needles are for single use only. Reuse of the needle increases the risk of needle blockage and misdosing, as well as contamination and infection.

When using the syringe pen for the first time, it is removed from the refrigerator no later than 1 hour before the injection so that insulin reaches room temperature and its introduction is not so painful.

Before each injection, you should check the name of the insulin and the expiration date on the pen label. It is recommended to indicate the date of the autopsy on it.

After removing the cap from the pen, it is necessary to visually assess the transparency of insulin. If the contents of the cartridge are cloudy, discolored or contain foreign particles, the drug should be disposed of. Air bubbles in insulin are not harmful.

After making sure that the solution looks like pure water, you can proceed with the procedure. First of all, wipe the rubber membrane on the cartridge with a cloth soaked in ethyl alcohol. Take a new needle and, after removing the protective coating, without excessive force screw it all the way to the syringe pen. Carefully remove the outer and then the inner caps from the needle.

Before each injection, it is necessary to conduct a safety test, the results of which should confirm the correct operation of the syringe pen, excluding the obstruction of the needle or the introduction of the wrong dose of insulin.

To carry out a safety test, it is required to set the pointer on the dose indicator between the numbers 2 and 4, which will correspond to a set of 3 units. If, after pressing the dose button all the way, a drop of insulin appears on the tip of the needle, then the pen is working correctly. If this does not happen, then you can repeat pressing the enter button. If there is no drop at the tip of the needle after the third attempt, the needle must be replaced and the test repeated. If the replacement of the needle did not give a positive result and the safety test was not successful, the pen needs to be replaced with a new one. It is strictly forbidden to use a syringe to draw insulin from a pen.

After the safety test, the dose indicator should be at "0". To set the prescribed dose, the pointer should be set in line with the desired dose. If the pointer is accidentally turned beyond the required dose, you need to turn it back.

If the content of the drug in the cartridge is less than the dose required for administration, two injections should be made: one from a working syringe pen, the other, containing the missing amount of insulin, from a new syringe pen. An alternative is to administer the entire required dose with a new pen.

Even numbers (number of units) in the dose indicator window are displayed opposite the dose indicator, odd numbers - on the line between the even ones.

The cartridge contains 450 units of insulin, the dose can be set from 1 to 80 units in 1 unit increments. Each pen contains more than one dose, the scale on the cartridge allows you to approximately determine the number of units of insulin remaining in it.

To carry out the injection, select a place and, holding the syringe-pen by the body, insert the needle, then, placing your thumb on the dose administration button, press it all the way and hold it in this position. You cannot press the button at an angle, you must make sure that your thumb does not block the rotation of the dose selector. It is important to keep the button pressed until "0" appears in the dose window, while slowly counting to five. Only then can the insertion button be released and the needle removed.

If there is any difficulty with the operation of the dose administration button, no force should be applied so as not to damage the pen. It is necessary to verify the patency of the needle by retesting for safety. If the button continues to work poorly, it is necessary to replace the pen.

After injection, the needle should be removed using the outer needle cap. To do this, take the wide end of the outer cap with two fingers and insert the needle into it. Press the cap tightly and, firmly grasping the wide part of the outer cap of the needle, turn the pen syringe several times with the other hand.

Dispose of the used needle in a puncture-resistant container.

After removing the needle, the syringe pen should be closed with a cap and stored in a place protected from light and heat. You cannot put the used syringe pen in the refrigerator.

If there are doubts about the serviceability of the pen or it is damaged, you should not use it, you should not try to repair it. It is recommended to handle the syringe pen with care: do not fall on hard surfaces, protect from contact with wet media, dust or dirt, do not lubricate. You can use a damp cloth to clean the outside.

It is recommended that you always have a spare pen and spare needles.

The doctor determines the dose and time of administration of Tudgeo SoloStar, taking into account the target values of the concentration of glucose in the blood individually.

Correction of the insulin dose is carried out with great care and only by a doctor, who takes into account the possible causes of insufficient glycemic control, including changes in body weight, the patient's lifestyle, and the timing of insulin administration.

Tudgeo SoloStar is not the drug of choice for diabetic ketoacidosis, for which it is preferable to use short-acting intravenous insulin.

Patients with diabetes mellitus are recommended to regularly monitor the concentration of glucose in the blood.

When prescribing a drug, a medical worker must instruct the patient in detail on the step-by-step implementation of the steps necessary for the subcutaneous administration of the drug, and then control the patient's self-administration of the procedure to make sure that insulin is administered correctly.

In the treatment of type 1 diabetes mellitus, Tudgeo SoloStar is prescribed in combination with insulin, which is administered during a meal and requires an individual dose adjustment.

For patients with type 2 diabetes mellitus, the initial daily dose of Tudgeo SoloStar is recommended to be prescribed at the rate of 0.2 U per 1 kg of the patient's weight with subsequent individual dose adjustment.

When switching from treatment with insulin glargine 100 U / ml to Tudgeo SoloStar, or vice versa, it should be borne in mind that drugs are not bioequivalent and are not directly interchangeable.

After previous therapy with insulin glargine 100 U / ml, the transition to Tudgeo SoloStar can be carried out on a unit-by-unit basis. However, a higher dose of insulin glargine of 300 U / ml may be required to achieve the target plasma glucose concentration.

When switching from Tudgeo SoloStar to insulin glargine 100 U / ml, the dose of insulin should be reduced by approximately 20%, if necessary, dose adjustment should be continued.

After switching from one of these drugs to another, close metabolic monitoring is recommended for the first 2–3 weeks.

When switching from insulin of intermediate or long duration of action to the treatment regimen with Tudgeo SoloStar, it may be necessary to change the dose of basal insulin and adjust the doses and time of simultaneously used short-acting insulins, fast-acting insulin analogues or non-insulin hypoglycemic agents.

When switching from the introduction of basal insulin once a day, the dose of Tudgeo SoloStar can be set on the basis of one unit per unit of previously administered insulin.

When switching from the introduction of basal insulin 2 times a day, the initial dose of the drug should be 80% of the total daily dose of the previous insulin.

The presence of antibodies to human insulin in patients on therapy with high doses of insulin improves the response to insulin glargine 300 U / ml.

Changing the treatment regimen should be accompanied by careful metabolic monitoring.

An increase in insulin sensitivity against a background of improved metabolic control may require additional dosage adjustments.

A single injection during the day of Tudgeo SoloStar allows the patient to have a flexible schedule of injections and, if necessary, to inject 3 hours before the usual time of the procedure or 3 hours later.

Do not dilute insulin glargine 300 U / ml or mix it with other insulin.

When treating elderly patients, careful monitoring of blood glucose concentrations is required. When choosing a dose in this category of patients, one should take into account the progressive deterioration of their renal function, which may cause the need for a constant decrease in the dose of insulin.

For the treatment of patients with renal or hepatic insufficiency, there are no special recommendations for adjusting the dosage regimen. It should be borne in mind that a slowdown in insulin metabolism in this category of patients can reduce the need for insulin, so they need to carefully monitor the concentration of glucose in the blood.

Side effects

Side effects are presented by organ system in accordance with the following gradations of frequency of occurrence recommended by WHO (World Health Organization): very often -> 10%; often -> 1% and 0.1% and 0.01% and <0.1%; very rarely - <0.01%, including isolated cases.

• from the side of metabolism: very often - hypoglycemia (the cause of the occurrence is a too high dose of insulin compared to the need for it);
• on the part of the organ of vision: temporary deterioration of vision (may occur against the background of a significant improvement in glycemic control, is the result of a temporary violation of turgor and refractive index of the lens of the eye), temporary aggravation of the course of diabetic retinopathy; in patients with proliferative retinopathy (especially in the absence of photocoagulation treatment) - episodes of severe hypoglycemia with possible transient loss of vision;
• from the musculoskeletal system: very rarely - myalgia;
• from the immune system: rarely - immediate allergic reactions, including generalized skin reactions, angioedema, Quincke's edema, bronchospasm, decreased blood pressure (BP), shock (including fatal);
• dermatological reactions: often - lipodystrophy; infrequently - lipoatrophy;
• laboratory disorders: rarely - an increase in the concentration of sodium in the body;
• reactions at the injection site: often - pain, skin redness, itching, rash, urticaria, inflammation, edema.

Overdose

Symptoms: hypoglycemia, including severe and prolonged life-threatening episodes.

For rapid relief of moderate hypoglycemia, ingestion of rapidly digestible carbohydrates is usually sufficient. It is possible to change the diet or physical activity, the dosage regimen of Tudgeo SoloStar. For the relief of more severe episodes of hypoglycemia, manifested by seizures, neurological disorders or coma, glucagon (intramuscularly or s.c.) or a concentrated solution of dextrose or glucose (i.v.) is prescribed. Long-term intake of carbohydrates and careful supervision of a specialist may be required for the timely diagnosis of possible relapses of hypoglycemia.

special instructions

Patients with diabetes mellitus should be able to independently determine the level of glucose concentration in the blood, carry out s / c injections, stop the symptoms of hypoglycemia or hyperglycemia.

Before proceeding with the correction of the dosage regimen in the absence of sufficient control of the blood glucose level, one should make sure that the prescribed treatment regimen is accurately followed, that the diet is followed, the technique and the places of subcutaneous injections. It is necessary to exclude all factors not related to the dose of the drug that can cause symptoms of hypo- or hyperglycemia.

Regular measurement of blood glucose levels can help monitor the development of episodes of hypoglycemia. Severe and frequently recurring hypoglycemia can cause neurological damage, and episodes of severe and prolonged hypoglycemia can threaten the patient's life.

Often in response to hypoglycemia, the sympathoadrenal system is activated, which is accompanied by pallor of the skin, hunger, cold sweat, palpitations, tachycardia, unreasonable anxiety, irritability, nervous excitement or tremor. The appearance of these conditions in patients with diabetes mellitus should cause alertness, since it may be evidence of a decrease in blood sugar levels, which requires immediate adoption of appropriate measures to stop them. The severity of the symptoms of adrenergic counterregulation is the stronger, the more severe the hypoglycemia, and the faster it develops. With the aggravation of disorders, many patients develop signs and symptoms of neuroglycopenia, namely weakness, headache, nausea, feeling of tiredness, drowsiness,decreased ability to concentrate, inadequate fatigue, visual disturbances, confusion or loss of consciousness, convulsive syndrome.

Caution should be observed in patients for whom episodes of hypoglycemia are of particular clinical importance. These include patients with comorbidities such as severe stenosis of the coronary arteries or cerebral vessels, proliferative retinopathy, especially in the absence of photocoagulation treatment.

It should be borne in mind that some conditions can reduce the severity of symptoms, precursors of hypoglycemia, sometimes completely eliminate them. The list of such conditions includes a noticeable improvement in glycemic control, slow development of hypoglycemia, autonomic neuropathy, a long history of diabetes mellitus, mental disorders, old age, and the simultaneous use of other drugs. The danger of such conditions is the risk of developing severe hypoglycemia, accompanied by loss of consciousness, before the patient feels its symptoms.

The patient's exit from the state of hypoglycemia may be somewhat delayed due to the prolonged action of Tudgeo SoloStar.

If the indicators of glycosylated hemoglobin are at a normal or reduced level, the likelihood of developing recurring unrecognized episodes of hypoglycemia (especially at night) increases.

The following factors affect the increase in the tendency to hypoglycemia:

• changing the place of insulin injection;
• the occurrence of hypersensitivity to insulin, including the elimination of stress factors;
• increased, prolonged or unusual physical activity;
• intercurrent diseases that are accompanied by vomiting and / or diarrhea;
• insufficient amount of food;
• alcohol consumption;
• uncompensated endocrine disorders, including hypothyroidism, adrenal cortex insufficiency, or anterior pituitary insufficiency;
• combination with drugs that affect glucose metabolism.

A significant reduction in the risk of developing hypoglycemia is facilitated by the strict adherence of patients to the treatment regimen for diabetes mellitus, including the diet, the correct administration of insulin, as well as the knowledge and ability to timely recognize the precursor symptoms of hypoglycemia. To immediately eliminate the first symptoms of a decrease in blood glucose levels, the patient should always carry at least 20 g of rapidly digestible carbohydrates (including a piece of sugar).

A sustained decrease in insulin requirements can occur with the progression of renal or hepatic failure.

Monitoring of blood glucose concentration in intercurrent diseases should be carried out more intensively. In many cases, an increase in the insulin dose may be required. An analysis is recommended for the presence of ketone bodies in the urine. Patients with type 1 diabetes should not skip insulin. They need to continue to receive carbohydrates on a regular basis, including with small meals or, if not eating, if vomiting develops.

Influence on the ability to drive vehicles and complex mechanisms

Due to the increased risk of impaired ability to concentrate and the speed of psychomotor reactions as a result of hypoglycemia, hyperglycemia or visual impairment, patients with diabetes mellitus are advised to consult a doctor about their ability to drive vehicles. Special precautions must be taken when there is a high incidence of episodes of hypoglycemia or in the absence or mild symptoms of its development.

Application during pregnancy and lactation

Patients with diabetes mellitus need to inform the attending physician about the planned or completed conception.

It is recommended to use Tudgeo SoloStar with caution during pregnancy.

It should be borne in mind that the need for the drug may decrease in the first trimester of pregnancy and increase during the next two trimesters. Immediately after childbirth, the need for insulin drops rapidly. Therefore, to reduce the risk of hypoglycemia, regular careful monitoring of blood glucose concentration is required.

Women with gestational diabetes mellitus (including history) need to maintain adequate regulation of metabolic processes during the entire period of gestation, this will minimize the likelihood of hyperglycemia.

During lactation, there may be a need to correct the diet and dosage regimen of Tudgeo SoloStar.

Pediatric use

It is contraindicated to prescribe Tudjeo SoloStar to patients under the age of 18 years due to the lack of information on the safety and efficacy of insulin glargine 300 U / ml in this age category.

With impaired renal function

Caution should be given to Tudgeo SoloStar in patients with renal insufficiency.

For violations of liver function

With caution, Tugio SoloStar should be prescribed to patients with severe hepatic impairment.

Use in the elderly

It is recommended to use Tudgeo SoloStar with caution in elderly patients. Due to age-related progression of deterioration in renal function, there may be a need to reduce the dose of insulin. Close monitoring of blood sugar levels is required.

Drug interactions

• oral hypoglycemic agents, disopyramide, salicylates, angiotensin-converting enzyme inhibitors, monoamine oxidase inhibitors, fibrates, fluoxetine, pentoxifylline, propoxyphene, sulfonamide antibiotics: an increase in the hypoglycemic effect of insulin and an increased risk of hypoglycemia;
• glucagon, glucocorticosteroids, sympathomimetics (including adrenaline, terbutaline, salbutamol), danazol, diazoxide, diuretics, isoniazid, growth hormone, estrogens and gestagens (including hormonal contraceptives), thyroid hormones, phenotypic neurozapine derivatives (including clotzapine) protease inhibitors: reducing the hypoglycemic effect of insulin;
• beta-blockers, lithium salts, clonidine, ethanol: it is possible to both increase and decrease the hypoglycemic effect of insulin;
• pentamidine: hypoglycemia may develop, which may be replaced by hyperglycemia (special care should be taken);
• pioglitazone: an increase in the likelihood of developing heart failure, especially in patients at risk (if cardiac symptoms such as weight gain, edema, or their aggravation appear, pioglitazone should be discontinued).

It should be borne in mind that sympathomimetic agents (beta-blockers, clonidine, guanethidine and reserpine) can reduce the manifestation of signs of adrenergic counterregulation or completely hide them.

Analogs

Tudgeo SoloStar analogs are: Lantus SoloStar, Apidra SoloStar, Biosulin P, Gansulin P, Gensulin P, Rosinsulin P, Vozulim-R, Humodar P, Actrapid NM, Actrapid MS, Monosuinsulin (MK, MP), Insulin-Fereyn MK, NovoRapid Penfill, Insuman Rapid GT, NovoRapid FlexPen, Humalog, etc.

Terms and conditions of storage

Keep out of the reach of children.

Store at 2–8 ° C in a dark place, keep away from freezing.

The shelf life is 2.5 years.

The used pen should be stored at a temperature not exceeding 30 ° C in a place protected from light and heat (not in a refrigerator). The drug is suitable for use within 28 days from the date indicated on the label of the syringe pen when it was opened.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Tudgeo SoloStar

Reviews about Tudgeo SoloStar are positive. Patients indicate the effectiveness of the drug and ease of use when prescribing high doses of insulin. It is reported that the introduction of Tudjeo SoloStar 1 time per day is not accompanied by sharp jumps in blood sugar levels, good tolerance, a significant decrease in the risk of nocturnal hypoglycemia.

The price of Tudgeo SoloStar in pharmacies

The price of Tudgeo SoloStar for a package containing 3 syringe pens can be from 3283 rubles, 5 syringe pens - from 5365 rubles.

Tujeo SoloStar: prices in online pharmacies

Drug name Price Pharmacy

Tudjeo SoloStar 300 IU / ml solution for subcutaneous administration 1.5 ml 3 pcs. 2727 RUB Buy

Tudzheo SoloStar 300 IU / ml solution for subcutaneous administration 1.5 ml 5 pcs. RUB 2928 Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!