Apidra® [Insulin glulisine]

Brand Sanofi-aventis

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Clinical Pharmacology

Hypoglycemic drug. Insulin glulisine is a recombinant analogue of human insulin, which is equivalent to ordinary human insulin. The action of insulin glulisine comes faster, and the duration of action is shorter than that of standard human insulin. The mechanism of action of insulin glulisine is the regulation of glucose metabolism. Insulin preparations lower blood glucose by stimulating peripheral glucose intake, especially by skeletal muscle and adipose tissue, and by suppressing glucose production by the liver. Insulin inhibits lipolysis in adipocytes, inhibits proteolysis and stimulates protein synthesis. When s / c administration, the action of insulin glulisine begins much earlier and lasts shorter compared with human insulin preparations: its hypoglycemic activity begins after 10-20 minutes. The hypoglycemic effects of insulin glulisine and human insulin are equivalent when administered intravenously. One unit of insulin glulisine has the same hypoglycemic effect as one unit of human insulin.

Indications

Treatment of diabetes in adults, adolescents and children aged 6 years and older, when insulin therapy is needed.

Composition

1 ml contains insulin glulisine 100 U (3.49 mg);Excipients:metacresol (m-cresol), trometamol, sodium chloride, polysorbate 20, sodium hydroxide, hydrochloric acid, water d / and.

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Dosage and Administration

P / c, shortly (0–15 minutes) before or shortly after meals. The drug Apidra SoloStar should be used in treatment regimens that include either medium-length insulin, either long-acting insulin, or a long-acting insulin analogue. In addition, the drug Apidra SoloStar can be used in combination with oral hypoglycemic agents. The dosage regimen of the drug Apidra SoloStar is selected individually.

Adverse reactions

Hypoglycemia - The most frequent undesirable effect of insulin therapy, which can occur if you use too high doses of insulin, exceeding the need for it.
The adverse reactions associated with drug administration observed in clinical studies are listed below in organ systems and in order of decreasing incidence. When describing the frequency of occurrence, the following criteria are used: very often -> 10%; often -> 1% and <10%; sometimes -> 0.1% and <1%; rarely> 0.01% and <0.1%; very rarely - <0.01%.
Metabolism:very often - hypoglycemia. Symptoms of hypoglycemia usually occur suddenly. However, neuroglycopenia (feeling tired, unusual fatigue or weakness, decreased concentration, drowsiness, visual disturbances, headache, nausea, confusion or loss of it, convulsive syndrome) usually precedes the symptoms of adrenergic counterregulation (activation of the sympathoadrenal system in response to hypoglycemia): feeling of hunger, irritability, nervous excitement or tremor, anxiety, paleness of the skin, cold sweat, tachika pd, marked heartbeat (the faster hypoglycemia develops and the harder it is, the more pronounced the symptoms of adrenergic counter-regulation).
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, since with an increase in hypoglycemia, even fatal outcome is possible.
Local reactions:often - local hypersensitivity reactions (hyperemia, swelling and itching at the injection site). These reactions are usually transient and disappear with continued treatment; rarely - lipodystrophy (as a result of a violation of the alternation of insulin injection sites in any of the areas / administration of the drug in the same place /).
Allergic reactions: sometimes - urticaria, chest tightness, bronchospasm, allergic dermatitis, itching. Severe cases of generalized allergic reactions (including anaphylactic) can be life-threatening.

Contraindications

Hypersensitivity to insulin glulisine or to any of the components of the drug; Hypoglycemia.

Caution should be used when pregnant.

Drug interactions

No pharmacokinetic interaction studies have been performed. Based on the available empirical knowledge for other similar drugs, the occurrence of clinically significant pharmacokinetic interaction is unlikely. Some substances may affect glucose metabolism, which may require correction of insulin glulisine doses and especially careful monitoring of treatment. Substances that can increase the hypoglycemic effect of insulin and increase the susceptibility to hypoglycemia include: oral hypoglycemic agents, angiotensin-converting enzyme inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, propoxyphene, pyroxetine, monoamine oxidase inhibitors, pentoxifylline, propoxyphene, pyroxetine, monoamine oxidase inhibitors, pentoxifylline, propoxyphene, pyroxetine, monoamine oxidase inhibitors, pentoxifylline, propoxyphene, pyroxetine, monoamine oxidase inhibitors, pentoxifylline, propoxyphene, pyroxetine, monoamine oxidase inhibitors, pentoxifylline, propoxyphene, pyroxetine, monoamine oxidase inhibitors, pentoxifylline, propoxyphene; Substances capable of reducing the hypoglycemic effect of insulin include: GCS, danazol, diazoxide, diuretics, isoniazid, phenothiazine derivatives, somatropin, sympathomimetics (for example, epinephrine (adrenaline), salbutamol, terbutaline), thyroid hormones, estrogens, prostates. contraceptives), protease inhibitors and antipsychotic drugs (for example olanzapine and clozapine).

Pregnancy and Lactation

There is a lack of information on the use of insulin glulisine in pregnant women.Reproductive animal studies have not revealed any differences between insulin glulisine and human insulin regarding pregnancy, fetal / fetal development, childbirth and postnatal development. Caution should be taken when using the drug Apidra SoloStar. Required careful monitoring of blood glucose levels. Patients with pre-pregnancy or gestational diabetes need to maintain optimal metabolic control throughout pregnancy. During the first trimester of pregnancy, the need for insulin may decrease, and during the second and third trimesters, as a rule, it may increase. Immediately after delivery, the need for insulin is rapidly reduced. Nursing mothers may need a dose adjustment of insulin and diet.

Special instructions

Transferring a patient to a new type of insulin or insulin from another manufacturer should be carried out under strict medical supervision, because It may be necessary to change the dose due to changes in insulin concentration, brand (manufacturer), type of insulin (soluble, insulin-isophane, etc.), type of insulin (animal origin) and / or method of production. In addition, correction of concomitant oral hypoglycemic therapy may be required. Using inadequate doses of insulin or stopping treatment, especially in patients with type 1 diabetes, can lead to the development of hyperglycemia and diabetic ketoacidosis, conditions that are potentially life-threatening.

Overdosage

Symptoms: There are no specific data on the overdose of insulin glulisine; possible development of hypoglycemia of varying severity.
Treatment: episodes of mild hypoglycemia can be stopped by taking glucose or sugar-containing foods. Therefore, it is recommended that patients with diabetes should always carry with them pieces of sugar, candy, cookies or sweet fruit juice. Episodes of severe hypoglycemia, during which the patient loses consciousness, can be stopped by i / m or s / c by the introduction of 0.5-1 mg glucagon or / in the introduction of dextrose (glucose). If the patient does not respond to the administration of glucagon for 10-15 minutes, dextrose should also be administered iv. After recovery of consciousness, it is recommended to give the patient carbohydrates inwards to prevent the recurrence of hypoglycemia. After the introduction of glucagon to determine the cause of this severe hypoglycemia and prevent the development of other similar episodes, the patient should be observed in the hospital.