Insulin glargine

Brand Sanofi-aventis

In stock 18 Items

Available since: 2019-09-19

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Clinical Pharmacology

Insulin glargine is an analogue of human insulin, obtained by recombination of DNA of bacteria of the species Escherichia coli (strains K12). Differs in low solubility in the neutral environment. It is completely soluble in the composition of the drug Lantus SoloStar, which is provided by the acidic medium for injection (pH = 4). After injection into the subcutaneous fatty tissue, the solution, due to its acidity, enters into a neutralization reaction with the formation of micro-precipitates, from which small amounts of insulin glargine are constantly released, ensuring a smooth (no peak) profile of the concentration-time curve, as well as a prolonged effect of the drug.

The parameters for binding to insulin receptors of insulin glargine and human insulin are very close, so 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 by stimulating glucose uptake by peripheral tissues (especially skeletal muscle and adipose tissue), as well as inhibiting glucose formation in the liver (gluconeogenesis). Insulin inhibits lipolysis in adipocytes and proteolysis, while simultaneously enhancing protein synthesis.

The prolonged action of insulin glargine is directly caused by the reduced rate of its absorption, which allows the use of the drug 1 time / day. After s / c administration, the onset of its action is observed, on average, after 1 h. The average duration of action is 24 hours, the maximum is 29 hours. The duration of action of insulin and its analogues (for example, insulin glargine) can vary significantly from one patient to another. and in the same patient.

Indications

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

Insulin glargine is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Tujeo SoloStar	Sanofi-aventis	France	solution
Lantus	Sanofi-Aventis East RU	Germany, Germany, Russia	pen

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Dosage and Administration

Withtype 1 diabetes The drug is used as the main insulin.

Withtype 2 diabetes the drug can be used both as monotherapy and in combination with other hypoglycemic drugs.

When transferring a patient from long-term or medium-length insulin to Lantus, it may be necessary to adjust the daily dose of basal insulin or change the 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 double 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 reduction in the dose of Lantus should be compensated for by increasing the dose of short-acting insulin, and at the end of the period the dosing regimen should be adjusted individually.

As with the use of other human insulin analogues, patients receiving high doses of drugs due to the presence of antibodies to human insulin, when switching to Lantus, an improvement in the response to insulin administration can be observed. During the transition to Lantus and in the first weeks after it, careful monitoring of blood glucose is required.

In the case of improved regulation of metabolism and the resulting increase in insulin sensitivity, further correction of the dosing regimen may be necessary. Dose adjustment may also be required, for example, when the patient's body weight, lifestyle, time of day for administration of the drug or other circumstances that increase the susceptibility to the development of hypo-or hyperglycemia.

The drug should not be administered in /. IV the introduction of the usual dose, intended for s / to the introduction, can cause the development of severe hypoglycemia.

Adverse reactions

Side effects associated with the effect on carbohydrate metabolism:hypoglycemia develops most often if the insulin dose exceeds the need for it.
Seizures of severe hypoglycemia, especially recurring, can lead to damage to the nervous system. Episodes of prolonged and severe hypoglycemia can threaten the lives of patients.
Symptoms of adrenergic counter-regulation (activation of the sympathetic-adrenal system in response to hypoglycemia) usually precede psycho-neurological disorders against the background of hypoglycemia (twilight consciousness or its loss, convulsive syndrome): hunger, irritability, cold sweat, tachycardia the more pronounced the symptoms of adrenergic counter-regulation).

On the part of the organ of vision: significant changes in the regulation of glucose in the blood can cause temporary visual impairment due to changes in tissue turgor and the index of refraction of the lens of the eye.
Long-term normalization of blood glucose reduces the risk of progression of diabetic retinopathy. On the background 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 vision loss.

Contraindications

Children's age up to 6 years, due to the lack of clinical data on the application.
Hypersensitivity to the drug.

With caution should use the drug during pregnancy (the possibility of changing the need for insulin during pregnancy and after childbirth).

Drug interactions

Oral hypoglycemic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoxyphene, salicylates, and sulfanilamide antimicrobial agents can enhance the hypoglycemic effect of insulin and increase the susceptibility to the development of hypoglycemia. With these combinations, you may need a dose adjustment of insulin glargine.

GCS, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens, gestagens, phenothiazine derivatives, somatotropin, sympathomimetics (for example, epinephrine, salbutamol, terbutaline), thyroid hormones, protease inhibitors, some neuroleptics (for example, olanans, olanthans, olantamines) hypoglycemic effect of insulin. With these combinations, you may need a dose adjustment of insulin glargine.

With the simultaneous use of the drug Lantus SoloStar with beta-blockers, clonidine, lithium salts, ethanol, it is possible to both strengthen and weaken the hypoglycemic effect of insulin.

Pentamidine when combined with insulin can cause hypoglycemia, which is sometimes replaced by hyperglycemia.

With simultaneous use with drugs that have a sympatolytic effect, such as beta-blockers, clonidine, guanfacin and reserpine, it is possible to reduce or absence of signs of adrenergic counter-regulation (activation of the sympathetic nervous system) with the development of hypoglycemia.

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

Pregnancy and Lactation

Caution should be used Lantus SoloStar during pregnancy. Required careful monitoring of blood glucose levels.

For patients with previous or gestational diabetes, it is important to maintain glycemic control 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 birth, the need for insulin is reduced, and therefore the risk of hypoglycemia increases. Under these conditions, careful monitoring of blood glucose is essential.

In experimental animal studies, no direct or indirect data were obtained on the embryotoxic or fetotoxic effect of insulin glargine.

Controlled clinical studies on the safety of the drug Lantus SoloStar during pregnancy have not yet been conducted. There is evidence of the use of Lantus SoloStar 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 who received other insulin preparations.

In women during breastfeeding, it may be necessary to adjust the insulin dosage regimen and diet.

Special instructions

Lantus SoloStar is not the drug of choice for the treatment of diabetic ketoacidosis. In such cases, recommended IV the introduction of short-acting insulin.

Due to the limited experience with Lantus SoloStar, it was not possible to evaluate its efficacy and safety in treating patients with impaired liver function or patients with moderate or severe renal insufficiency.

In the case of ineffective control over blood glucose levels, as well as if there is a tendency to develop hypo- or hyperglycemia, before proceeding with the correction of the dosing regimen, you should check the accuracy of compliance with the prescribed treatment regimen, injection sites and proper injection technique. , considering all factors affecting it.

Hypoglycemia: The time of development of hypoglycemia depends on the action profile of the insulin used and can, therefore, change when the treatment regimen changes. Due to the prolonged intake of long-acting insulin when using the drug Lantus SoloStar, we should expect less chance of developing nighttime hypoglycemia, whereas in the early morning hours this probability is higher. If hypoglycemia occurs in patients receiving Lantus Solostar, consider the possibility of slowing the release of hypoglycemia due to the prolonged action of insulin glargine. In patients in whom episodes of hypoglycemia may have particular clinical significance, including with severe stenosis of the coronary arteries or cerebral vessels (risk of cardiac and cerebral complications of hypoglycemia), as well as patients with proliferative retinopathy, especially if they do not receive photocoagulation treatment (risk of transient vision loss due to hypoglycemia), special precautions should be observed and carefully monitored blood glucose. Patients should be warned about conditions in which symptoms-precursors of hypoglycemia may decrease, become less pronounced or be absent in certain risk groups, which include: patients who have markedly improved blood glucose regulation; patients in whom hypoglycemia develops gradually; elderly patients; patients transferred from animal insulin to human insulin; patients with neuropathy; patients with a long course of diabetes; patients with mental disorders; patients receiving concomitant treatment with other drugs.

Such situations can lead to the development of severe hypoglycemia (with possible loss of consciousness) before the patient realizes that he develops hypoglycemia.

If normal or reduced glycated hemoglobin levels are noted, the possibility of recurring unrecognized episodes of hypoglycemia (especially at night) must be considered.

Patient adherence to the dosing regimen, diet and diet, proper use of insulin, and control of the onset of symptoms of hypoglycemia contribute to a significant reduction in the risk of hypoglycemia. In the presence of factors that increase the predisposition to hypoglycemia, especially careful observation is necessary, since may require a dose adjustment of insulin. These factors include: changing the place of administration of insulin; increased insulin sensitivity (for example, while eliminating stress factors); unusual, increased, or prolonged physical activity; intercurrent diseases accompanied by vomiting, diarrhea; violation of diet and diet; skipped meals; alcohol consumption; some uncompensated endocrine disorders (for example, hypothyroidism, insufficiency of the adenohypophysis or the adrenal cortex); concomitant treatment with certain other drugs.

When intercurrent diseases require more intensive control of blood glucose. In many cases, analysis of the presence of ketone bodies in the urine is shown, and correction of the insulin dosing regimen is also often required. The need for insulin often increases. Patients with diabetes mellitus type 1 should continue to regularly consume at least a small amount of carbohydrates, even when eating only in small amounts or when there is no possibility to eat food, as well as vomiting. These patients should never completely stop administering insulin.

In patients with severe hepatic insufficiency, the need for insulin may be reduced due to a decrease in gluconeogenesis ability and a slower biotransformation of insulin.

In patients with impaired renal function, the need for insulin may decrease due to the weakening of its elimination processes.

In elderly patients, progressive deterioration in renal function may lead to a persistent decrease in insulin requirements.

Overdosage

Symptoms: moderate and severe hypoglycemia, accompanied by coma, convulsions or neurological disorders.
Treatment: episodes of moderate hypoglycemia are usually stopped by ingesting fast-absorbing carbohydrates. It may be necessary to change the dosage regimen of the drug, diet or physical activity. Episodes of more severe hypoglycemia, accompanied by coma, convulsions or neurological disorders, require IM or GI administration of glucagon, as well as / in the introduction of a concentrated dextrose. May require long-term carbohydrate intake and specialist supervision, as possible recurrence of hypoglycemia after apparent clinical improvement.