Lewemir - instructions for use, reviews, analogues and forms of release (injections in ampoules for hypodermic injections Penfill and cartridges in the syringe handle Flexple 100 ED) drug for the treatment of diabetes in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Levemir. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Leveemir in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Lewemer in the presence of existing structural analogs.Use for the treatment of diabetes in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

Levemir - long-acting insulin, soluble analog of human insulin. Levemir Penfill and Lewemir FlexPen are produced by the method of biotechnology of recombinant DNA using the strain Saccharomyces cerevisiae.

The prolonged effect of drugs Levemir Penfill and Leveemir FlexPen is due to the pronounced self-association of insulin detemir molecules at the injection site and the binding of the drug molecules to albumin by bonding with the fatty acid side chain. Insulin detemir is slower than isophane-insulin to peripheral target tissues. These combined delayed distribution mechanisms provide a more reproducible absorption profile and the effects of Levemir Penfill and Leveemer FlexPen versus isophane-insulin.

It interacts with a specific receptor of the external cytoplasmic cell membrane and forms an insulin-receptor complex that stimulates intracellular processes, incl. synthesis of a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthetase).

Reducing blood glucose is due to increased intracellular transport, increased tissue absorption, lipogenesis stimulation, glycogenogenesis, and a decrease in the rate of glucose production by the liver.

After subcutaneous administration, a pharmacodynamic response is observed, proportional to the administered dose (maximum effect, duration of action, total effect).

The profile of night glucose monitoring is more flat and even in insulin detemir, compared with insulin isophane, which is reflected in a lower risk of developing nocturnal hypoglycemia.

Composition

Insulin Detemir + auxiliary substances.

Pharmacokinetics

Cmax in the blood plasma is achieved 6-8 hours after administration. With a double daily regimen of Css injection in the blood plasma is achieved after 2-3 injections.

The intra-individual variability of absorption is lower in the drug Levemir Penfill and Levemir FlexPen compared with other preparations of basal insulin.

Clinically significant inter-sex differences in the pharmacokinetics of the drug Levemir Penfill / Leveemir FlexPhen was not revealed.

Inactivation of the drug Levemir Penfill and Leveemir FlexPen is similar to that of human insulin preparations; all formed metabolites are inactive.

The results of studies of protein binding indicate the absence of clinically significant interactions between insulin detemir and fatty acids or other preparations that bind to proteins.

The terminal elimination half-life after subcutaneous injection is determined by the degree of absorption from the subcutaneous tissue and is 5-7 hours, depending on the dose.

Indications

• insulin-dependent diabetes mellitus (type 1 diabetes mellitus);
• non-insulin-dependent diabetes mellitus (type 2 diabetes mellitus).

Forms of release

Solution for subcutaneous administration Levemir Penfill in glass cartridges of 300 units (3 ml) (injections in ampoules for injection).

Solution for subcutaneous administration Левемир ФлексПен glass cartridges of 300 units (3 ml) in the syringe handles multi-dose disposable for multiple injections of 100 units per 1 ml.

Instructions for use, dosage and technique of injection

Enter subcutaneously into the thigh, front abdominal wall or shoulder area. It is necessary to change the injection site within the anatomical area to prevent the development of lipodystrophy. Insulin will act faster if it is injected into the anterior abdominal wall.

Enter 1 or 2 times a day based on the needs of the patient. Patients who require the use of the drug 2 times a day for optimal glycemic control can enter the evening dose either during supper, either at bedtime or 12 hours after the morning dose.

In elderly patients, as well as in cases of violations of the liver and kidneys, blood glucose should be monitored more carefully and insulin dose adjustment should be performed.

Dose adjustment may also be required if the patient's physical activity is increased, his usual diet changes, or with an accompanying disease.

When transferring from insulin of average duration of action and prolonged insulin to insulin detemir, a dose adjustment and time of administration may be required. It is recommended to carefully monitor blood glucose levels during the transfer and in the first weeks of insulin detemir treatment. It may be necessary to correct concomitant hypoglycemic therapy (dose and time of administration of short-acting insulin preparations or a dose of oral hypoglycemic drugs).

Side effect

• hypoglycemia,the symptoms of which usually develop suddenly and may include pale skin, cold sweat, increased fatigue, nervousness, tremor, anxiety, unusual fatigue or weakness, impaired orientation, impaired concentration, drowsiness, severe hunger, visual impairment, headache, nausea, palpitations. Pronounced hypoglycemia can lead to loss of consciousness and / or convulsions, temporary or irreversible impairment of brain function up to a lethal outcome;
• reactions of local hypersensitivity (redness, swelling and itching at the injection site), as a rule, are of a temporary nature, i.e. disappear when continuing treatment;
• lipodystrophy (as a result of non-compliance with the rule of changing the injection site within the same area);
• hives;
• skin rash;
• itching;
• increased sweating;
• disorders of the gastrointestinal tract;
• angioedema;
• difficulty breathing;
• tachycardia;
• a decrease in blood pressure;
• violation of refraction (usually temporary and observed at the beginning of insulin treatment);
• diabetic retinopathy (prolonged improvement in glycemic control reduces the risk of progression of diabeticretinopathy; However, the intensification of insulin therapy with a sharp improvement in the control of carbohydrate metabolism can lead to a temporary deterioration in the state of diabetic retinopathy);
• peripheral neuropathy, which is usually reversible;
• edema.

Contraindications

• increased individual sensitivity to insulin detemir.

Application in pregnancy and lactation

Currently, there are no data on the clinical use of drugs Levemir Penfill and Leveemir FlexPen during pregnancy and lactation.

During the period of possible onset and during the entire pregnancy period, it is necessary to carefully monitor the condition of patients with diabetes mellitus and to monitor the level of glucose in the blood plasma. The need for insulin, as a rule, decreases in 1 trimester and gradually rises in 2 and in 3 trimesters of pregnancy. Shortly after birth, the need for insulin quickly returns to the level that was before pregnancy.

During breastfeeding, it may be necessary to adjust the dose of the drug and diet.

In experimental animal studies, there was no difference between the embryotoxic and teratogenic effects of insulin detemir and human insulin.

Use in children

It is not recommended to use insulin Levemir Penfill and Levemir FlexPen in children under 6 years of age.

Application in elderly patients

In elderly patients, blood glucose levels should be monitored more carefully and insulin dosage adjustment should be performed.

special instructions

It is believed that intensive insulin therapy detemir does not lead to an increase in body weight.

The lower risk of nocturnal hypoglycemia compared with other insulin allows more intensive selection of the dose in order to achieve the target blood glucose level.

Insulin Detemir provides better glycemic control (based on fasting plasma glucose measurement) compared to the use of insulin isophane. Insufficient dose of the drug or discontinuation of treatment, especially in type 1 diabetes, can lead to the development of hyperglycemia or diabetic ketoacidosis. Typically, the first symptoms of hyperglycemia appear gradually, within a few hours or days. These symptoms include thirst, frequent urination, nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, loss of appetite, odor of acetone in the exhaled air.In type 1 diabetes mellitus, without appropriate treatment, hyperglycemia leads to the development of diabetic ketoacidosis and can end fatal.

Hypoglycemia can develop if the dose of insulin is too high in relation to the need for insulin.

Skipping meals or unplanned heavy exercise can lead to hypoglycemia.

After compensating for carbohydrate metabolism, for example, with intensified insulin therapy, the symptoms typical for them, precursors of hypoglycemia, can change in patients, which patients should be informed about. Common symptoms-precursors can disappear with prolonged course of diabetes.

Concomitant diseases, especially infectious and accompanied by fever, usually increase the body's need for insulin.

The transfer of a patient to a new type or preparation of another manufacturer's insulin should be carried out under strict medical supervision. If the concentration, producer, type, species (animal, human, analogues of human insulin) and / or its production method (genetically engineered or insulin of animal origin) changes, a dose adjustment may be required.

Insulin detemir should not be administered intravenously, because it can lead to severe hypoglycemia.

Mixing Insulin Levemir Penfill and Lewemir FlexPen with a fast-acting insulin analog such as insulin aspart leads to an action profile with a reduced and delayed maximum effect compared to their separate administration.

Impact on the ability to drive vehicles and manage mechanisms

The ability of patients to concentrate and respond quickly to hypoglycemia and hyperglycemia, which can be dangerous in situations where these abilities are particularly necessary (for example, when driving or working with machinery and mechanisms). Patients should be advised to take measures to prevent the development of hypoglycemia and hyperglycemia when driving a car and working with mechanisms. This is especially important for patients with a lack or decrease in the severity of symptoms-precursors of developing hypoglycemia or suffering from frequent episodes of hypoglycemia. In these cases, you should consider the feasibility of doing such work.

Drug Interactions

Hypoglycemic action of insulin enhances oral hypoglycemic drugs, MAO inhibitors, ACE inhibitors, carbonic anhydrase inhibitors, nonselective beta adrenoblockers, bromocriptine, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium preparations, containing ethanol. The hypoglycemic effect of insulin is weakened by oral contraceptives, GCS, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, slow calcium channel blockers, diazoxide, morphine, phenytoin, nicotine.

Under the influence of reserpine and salicylates, both weakening and enhancement of the action of insulin detemir are possible.

Octreotide / lanreotide can both increase and decrease the body's need for insulin.

Beta-blockers can mask symptoms of hypoglycemia and delay recovery after hypoglycemia.

Ethanol (alcohol) can enhance and prolong the hypoglycemic effect of insulin.

Pharmaceutical interaction

Some medicines, for example, containing thiol or sulfite, when detemir is added to insulin, can cause destruction of insulin detemir.

Analogues of Levemir

Structural analogs for the active substance:

• Insulin Detemir;
• Levemir Penfill;
• Levemir FlexPhen.

Analogues for the pharmacological group (insulin):

• Actrapid;
• Apidra;
• Apidra SoloStar;
• Berselsulin;
• Bersulsulin N. Basal;
• Berlinersulin N Normal;
• Biosulin;
• Brinsulmidi;
• Brinsulrapi;
• Vozulim 30/70;
• Gensulin;
• Depo insulin C;
• Isofan Insulin World Cup;
• Iletin 2;
• Insulin aspart;
• Insulin glargine;
• Insulin glulisine;
• Insulin Detemir;
• Insulin Isophanycum;
• Insulin Lente;
• Insulin lyspro;
• Insulin Maxiprapid;
• Insulin is a soluble neutral;
• Insulin C;
• Insulin pork high-purity MK;
• Insulin Semilente;
• Insulin Ultralente;
• Human insulin;
• Human genetically insulin insulin;
• Human insulin is semisynthetic;
• Human insulin is recombinant;
• Insulin Long QMS;
• Insulin Ultralong SMK;
• Insulong SPP;
• Insulrape SPP;
• Insuman Bazal;
• Insuman Comb;
• Insuman Rapid;
• Insuran;
• Inutral;
• Combinsulin C;
• Lantus;
• Lantus SoloStar;
• Levemir Penfill;
• Levemir FlexPen;
• Mixtard;
• Monoinsulin;
• Monotard;
• NovoMiks;
• NovoRapid;
• Pensulin;
• Protamine insulin;
• Protafan;
• Raizodeg Penfill;
• Raizodeg FlexTach;
• Recombinant human insulin;
• Rinsulin;
• Rosinsulin;
• Sultofay;
• Tresib;
• Tudzheo SoloStar;
• Ultradard NM;
• Homolong 40;
• Homorap 40;
• Humalog;
• Humalog Mix;
• Humodar;
• Humulin;
• Humulin Regular.

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