Description
Latin name
Lantus SoloStar
Release form
Solution for subcutaneous injection
Packaging
In 1 colorless glass cartridge 3 ml solution.
In 1 SoloStar 1 syringe pen 1 cartridge.
In a pack of cardboard 5 syringe pens.
Pharmacological action
LAMIZIL – broad-spectrum antifungal, fungistatic, fungicidal.
Pharmacodynamics
Terbinafine is allylamine, which has a wide spectrum of action against fungi that cause diseases of the skin, hair and nails, including dermatophytes such as Trichophyton (e.g. T. rubrum, T. mentagrophytes, T. verrucosum, T. tonsurans, T. violaceum), Microsporum (e.g. M. canis),After 1 hour. 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 both in different patients and in the same patient.
Indications
Diabetes mellitus requiring insulin treatment in adults, adolescents, and children over 6 years of age.
Contraindications
Children under 6 years of age due to a lack of clinical data on their use.
Hypersensitivity to the drug.
Caution is advised to use the drug during pregnancy (possibility of changing insulin requirements during pregnancy and after childbirth).
Composition
active substance:
insulin glargine 3.6378 mg, which corresponds to the content of human insulin 100 IU
excipients:
m-cresol,
zinc chloride,
glycerol, srdlrd hydrochloric acid sodium
d /
Dosage and administration of
In type 1 diabetes mellitus, the drug is used as the main insulin.
In type 2 diabetes mellitus, the drug can be used both as monotherapy and in combination with other hypoglycemic drugs.
When transferring a patient from insulin of long or medium duration to Lantus, correction of the daily dose of basal insulin or a change in concomitant antidiabetic therapy (doses and regimen of administration of short-acting insulins or their analogues, as well as doses of oral hypoglycemic drugs) may be required.
When transferring a patient from a double administration of insulin-isophan to a single injection 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 doses of short-acting insulin, and at the end of the period, the dosage regimen must be individually adjusted.
As with other analogues of human insulin, patients receiving high doses of drugs due to the presence of antibodies to human insulin may experience an improvement in the response to insulin when switching to Lantus. In the process of switching 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 sensitivity to insulin, further correction of the dosage regimen may be necessary. Dose adjustment may also be required, for example, when changing the patient s body weight, lifestyle, time of day for drug administration, or when other circumstances arise that increase the 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.
Side effects
Side effects associated with effects on carbohydrate metabolism: hypoglycemia develops most often if the dose of insulin exceeds the need for it.
Attacks 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.
Neuropsychiatric disorders due to hypoglycemia (twilight consciousness or its loss, convulsive syndrome) are usually preceded by symptoms of adrenergic counter-regulation (activation of the sympathetic-adrenal system in response to hypoglycemia): hunger, irritability, cold sweat, tachycardia (the faster and more significant the development of hypoglycemia, the more pronounced symptoms of adrenergic counter-regulation).
From the side 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 refractive index of the lens of the eye.
Long-term normalization of blood glucose reduces the risk of progression of diabetic retinopathy. Against the background of insulin therapy, accompanied by sharp fluctuations in blood glucose, a temporary worsening of the course of diabetic retinopathy is possible. In patients with proliferative retinopathy, especially those not receiving photocoagulation treatment, episodes of severe hypoglycemia can lead to the development of transient vision loss.
Local reactions: as with any other insulin treatment, lipodystrophy and local delay in insulin absorption are possible. During clinical trials during insulin therapy using Lantus, lipodystrophy was observed in 1-2% of patients, while lipoatrophy was not characteristic at all. Constant change of injection sites within areas of the body, recommended for sc administration of insulin, can reduce the severity of this reaction or prevent its development.
Allergic reactions: in clinical trials during insulin therapy using Lantus, allergic reactions at the injection site were observed in 3-4% of patients – redness, pain, itching, urticaria, swelling or inflammation. In most cases, minor reactions are resolved over a period of several days to several weeks.
Rarely, immediate allergic reactions to insulin (including insulin glargine) or auxiliary components of the drug – generalized skin reactions, angioedema, bronchospasm, arterial hypotension, shock develop. These reactions can be life threatening.
Other: the use of insulin can cause the formation of antibodies to it. During clinical trials in groups of patients treated with insulin-isofan and insulin glargine, the formation of antibodies cross-reacting with human insulin was observed with the same frequency. In rare cases, the presence of such antibodies to insulin may necessitate dose adjustment in order to eliminate the tendency to the development of hypo- or hyperglycemia.
Rarely, insulin can cause a delay in sodium excretion and the formation of edema, especially if intensified insulin therapy leads to an improvement in previously insufficient regulation of metabolic processes.
Drug Interaction
Oral hypoglycemic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoxyfen, salicylates and sulfanylamide antimicrobial agents antimicrobial agents These combinations may require adjustment of the glargine dose.
ACS, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens, gestagens, phenothiazine derivatives, somatotropin, sympathomimetics (eg, epinephrine, salbutamol, terbutaline), hormones, thyroid gland, protozoan reduce the hypoglycemic action of insulin. These combinations may require adjustment of the glargine dose.
With the simultaneous use of the drug Lantus SolStar with beta-blockers, clonidine, lithium salts, ethanol, both the intensification and the attenuation of hypoglycemic action of insulin are possible.
Pentamidine in combination with insulin can cause hypoglycemia, which is sometimes replaced by hyperglycemia.
When used with sympatholytic agents such as beta-blockers, clonidine, guanfacin and reserpine, there may be a decrease or absence of signs of adrenergic counterregulation (activation of the sympathetic nervous system) in the development of hypoglycemia.
Lantus SolStar should not be mixed with other insulin preparations, with any other medicines or diluted. When mixed or diluted, its profile over time may change, in addition, mixing with other insulins may cause precipitation.
Overdose
Symptoms: moderate and severe hypoglycaemia, accompanied by coma, convulsions or neurological disorders.
Treatment: Episodes of moderate hypoglycemia are usually stopped by taking in fast-digesting carbohydrates.
It may be necessary to change the dosage regimen, diet or physical activity.
Episodes of severe hypoglycemia accompanied by coma, convulsions or neurological disorders, require in / m or n / to the introduction of glucagon, as well as / in the introduction of a concentrated solution of dextrose.
Carbohydrate intake and specialist supervision may be required as well. possible recurrence of hypoglycemia after apparent clinical improvement.
Storage conditions
Store in a dark place at a temperature of 2 ° to 8 ° C. Do not freeze.
When storing Lantus SoloStar in the refrigerator, make sure that the containers do not come in direct contact with the freezer compartment or frozen packages.
Used SoloStar disposable syringe pens should be stored in a dark place at a temperature of no higher than 25 ° C.
The pre-filled SoloStar syringe pen should not be cooled.
Before first use, the Lantus SoloStar syringe pen must be kept at room temperature for 1-2 hours.
It is recommended that the date of first administration of the drug is marked on the label.
Expiration
3 years. The Expiration of the drug in a SoloStar disposable syringe pen after the first use is 4 weeks.
Sanofi-Aventis East, Germany, Russia
