Humalog, 100 me/ml cartridges, 3 ml, 5 pcs.

Composition

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1 ml of solution for intravenous and subcutaneous administration contains:

Active ingredient:

insulin lispro 100 IU,

excipients:

glycerol (glycerin) – 16 mg,

metacresol – 3.15 mg,

zinc oxide (q. s. for the content of Zn2+ 0.0197 mg),

sodium hydrogen phosphate, heptahydrate – 1.88 mg,

hydrochloric acid solution 10% and/or sodium hydroxide solution 10% – q. s. to pH 7.0-8.0,

water for injection q. s. to 1 ml of

Pharmacological action of

Humalog – DNA-recombinant analogue of human insulin. It differs from the latter by the reverse sequence of amino acids in positions 28 and 29 of the insulin B-chain.

The main effect of the drug is the regulation of glucose metabolism. In addition, it has an anabolic effect. In muscle tissue, there is an increase in the content of glycogen, fatty acids, glycerol, increased protein synthesis and increased consumption of amino acids, but there is a decrease in glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein catabolism and amino acid release.

In patients with type 1 and 2 diabetes mellitus, the use of insulin lispro significantly reduces hyperglycemia that occurs after food intake, compared with soluble human insulin. For patients receiving short-acting and basal insulins, it is necessary to adjust the dose of both insulins to achieve optimal blood glucose levels throughout the day.

As with all insulin preparations, the duration of action of lispro insulin can vary between patients or at different time periods in the same patient and depends on the dose, injection site, blood supply, body temperature and physical activity.

The pharmacodynamic characteristics of insulin lispro in children and adolescents are similar to those observed in adults.

In patients with type 2 diabetes mellitus receiving maximum doses of sulfonylurea derivatives, the addition of insulin lispro leads to a significant decrease in glycated hemoglobin.

Treatment with lispro insulin in patients with type 1 and 2 diabetes mellitus is accompanied by a decrease in the number of episodes of nocturnal hypoglycemia.

The glucodynamic response to insulin lispro does not depend on functional insufficiency of the kidneys or liver.

It has been shown that insulin lispro is equimolar to human insulin, but its action occurs more quickly and lasts for a shorter time.

Lispro insulin is characterized by a rapid onset of action (about 15 minutes), because it has a high absorption rate, and this allows it to be administered immediately before a meal (0-15 minutes before a meal), unlike conventional short-acting insulin (30-45 minutes before a meal). Lispro insulin has a shorter duration of action (from 2 to 5 hours) compared to regular human insulin.

Pharmacokinetics

Suction and distribution

After subcutaneous administration, insulin lispro is rapidly absorbed and reaches Cmax in the blood plasma in 30-70 minutes. The Vd of lispro insulin and normal human insulin are identical and are in the range of 0.26-0.36 l / kg.

Deduction

With subcutaneous administration, the T1 / 2 of insulin lispro is about 1 hour. Patients with renal and hepatic insufficiency maintain a higher rate of absorption of lispro insulin compared to conventional human insulin.

Indications

Diabetes mellitus in adults and children, requiring insulin therapy to maintain normal glucose levels.

Use during pregnancy and lactation

To date, no adverse effects of lispro insulin on pregnancy or fetal/newborn health have been identified. No relevant epidemiological studies have been conducted.

The goal of insulin therapy during pregnancy is to maintain adequate glucose control in patients with insulin-dependent diabetes mellitus or gestational diabetes. The need for insulin usually decreases in the first trimester and increases in the second and third trimesters of pregnancy. During labor and immediately after it, the need for insulin may decrease dramatically.

Women of childbearing age who suffer from diabetes should inform the doctor about the upcoming or planned pregnancy. During pregnancy, patients with diabetes mellitus require careful monitoring of blood glucose levels, as well as general clinical monitoring.

Patients with diabetes mellitus who are breastfed may need to adjust their insulin dose and / or diet.

Contraindications

Hypoglycemia; hypersensitivity to the components of the drug.

Side effects

Side effect associated with the main action of the drug: hypoglycemia. Severe hypoglycemia can lead to unconsciousness (hypoglycemic coma) and, in exceptional cases, death.

Allergic reactions: local allergic reactions are possible – redness, swelling or itching at the injection site (usually disappear within a few days or weeks); systemic allergic reactions (occur less frequently, but are more serious) – generalized itching, urticaria, angioedema, fever, shortness of breath, decreased blood pressure, tachycardia, increased sweating. Severe cases of systemic allergic reactions can be life-threatening.

Local reactions: lipodystrophy at the injection site.

Interaction

The hypoglycemic effect of Humalog is reduced by oral contraceptives, corticosteroids, thyroid hormone preparations, danazol, beta-2-adrenomimetics (including ritodrin, salbutamol, terbutaline), tricyclic antidepressants, thiazide diuretics, Chlorprothixen, diazoxide, isoniazid, lithium carbonate, nicotinic acid, phenothiazine derivatives.

The hypoglycemic action of Humalog increase beta-blockers, ethanol and etanolsodergaszczye drugs, anabolic steroids, fenfluramine, guanetidin, tetracyclines, oral hypoglycemic drugs, salicylates (eg, aspirin), sulfonamides, inhibitors of MAO, ACE inhibitors (captopril, enalapril), octreotide, antagonists of angiotensin II receptors.

Humalog should not be mixed with animal insulin preparations.

Humalog can be used (under the supervision of a doctor) in combination with longer-acting human insulin or in combination with oral hypoglycemic agents with sulfonylureas.

How to take, course of administration and dosage

The doctor determines the dose individually, depending on the patient’s needs. Humalog can be administered shortly before a meal, and if necessary, immediately after a meal.

The temperature of the administered drug should correspond to room temperature.

Humalog is administered subcutaneously as an injection or as an extended subcutaneous infusion using an insulin pump. If necessary (ketoacidosis, acute diseases, the period between operations or the postoperative period), Humalog can be administered intravenously.

Subcutaneously, it should be injected into the shoulder, thigh, buttock, or abdomen. Injection sites should be alternated so that the same place is used no more than once a month. When injecting Humalog subcutaneously, care should be taken to avoid getting the drug into a blood vessel. After the injection, do not massage the injection site. The patient should be trained in the correct injection technique.

Rules of administration of the drug Humalog

Preparing for the introduction

The solution of Humalog should be clear and colorless. Do not use a cloudy, thickened or slightly colored solution of the drug, or if solid particles are visually detected in it.

When inserting the cartridge into the pen (pen-injector), attaching the needle, and injecting insulin, follow the manufacturer’s instructions that come with each pen.

Introduction

Intravenous administration of insulin

Intravenous injections of Humalog should be carried out in accordance with the usual clinical practice of intravenous injections, for example, intravenous bolus administration or using an infusion system. At the same time, it is often necessary to monitor the level of glucose in the blood.

Infusion systems with concentrations from 0.1 IU/ml to 1.0 IU/ml of lispro insulin in 0.9% sodium chloride solution or 5% dextrose solution are stable at room temperature for 48 hours.

Subcutaneous insulin infusion with an insulin pump

The Minimed and Disetronic pumps for insulin infusion can be used to infuse Humalog. You must strictly follow the instructions provided with the pump. The infusion system is changed every 48 hours. When connecting the infusion system, observe the rules of asepsis.

In the case of a hypoglycemic episode, the infusion is stopped until the episode resolves. If repeated or very low blood glucose levels are observed, then the doctor should be informed about this and consider reducing or stopping the insulin infusion. A pump malfunction or a clogged infusion system can lead to a rapid rise in glucose levels.If you suspect a violation of the insulin supply, follow the instructions and inform your doctor if necessary. When using the pump, Humalog should not be mixed with other insulins.

Overdose

Symptoms: hypoglycemia, accompanied by the following symptoms: lethargy, increased sweating, tachycardia, headache, vomiting, confusion.

Treatment: Mild conditions of hypoglycemia are usually relieved by ingestion of glucose or other sugar, or by foods containing sugar.

Correction of moderately severe hypoglycemia can be performed by intramuscular or subcutaneous administration of glucagon, followed by ingestion of carbohydrates after stabilization of the patient’s condition. Patients who do not respond to glucagon are given an intravenous dextrose (glucose) solution.

If the patient is in a comatose state, then glucagon should be administered intramuscularly or subcutaneously. In the absence of glucagon or if there is no reaction to its administration, it is necessary to introduce intravenous dextrose (glucose) solution. Immediately after regaining consciousness, the patient should be given food rich in carbohydrates.

It may be necessary to continue carbohydrate maintenance and monitor the patient, as a relapse of hypoglycemia may occur.

Special instructions

The transfer of a patient to another type or brand of insulin should be carried out under strict medical supervision. A change in activity, brand (manufacturer), type (e. g., Regular, NPH, Lente), species (animal, human, human insulin analog), and/or method of production (DNA-recombinant insulin or animal-derived insulin) may result in the need to change the dose.

Conditions in which the early warning symptoms of hypoglycemia may be non-specific and less pronounced include long-term diabetes, intensive insulin therapy, diseases of the nervous system in diabetes mellitus, or taking medications, such as beta-blockers.

In patients with hypoglycemic reactions after switching from animal-derived insulin to human-derived insulin, the early symptoms of hypoglycemia may be less pronounced or different from those experienced during treatment with their previous insulin. Unadjusted hypoglycemic or hyperglycemic reactions can cause unconsciousness, coma, or death.

Inadequate dosage or discontinuation of treatment, especially in patients with insulin-dependent diabetes mellitus, can lead to hyperglycemia and diabetic ketoacidosis, potentially life-threatening conditions.

The need for insulin may decrease in patients with renal insufficiency, as well as in patients with hepatic insufficiency, as a result of a decrease in the processes of gluconeogenesis and insulin metabolism. However, in patients with chronic hepatic insufficiency, increased insulin resistance can lead to an increased need for insulin.

The need for insulin can increase with infectious diseases, emotional stress, with an increase in the amount of carbohydrates in the diet.

Dose adjustment may also be necessary if the patient increases physical activity or changes the usual diet. Exercise immediately after a meal increases the risk of hypoglycemia. A consequence of the pharmacodynamics of rapid-acting insulin analogues is that if hypoglycemia develops, it may develop after injection earlier than with the injection of soluble human insulin.

The patient should be warned that if the doctor has prescribed an insulin preparation with a concentration of 40 IU / ml in the vial, then do not draw insulin from the 100 IU/ml insulin cartridge using a 40 IU/ml insulin injection syringe.

If it is necessary to take other medications at the same time as Humalog, the patient should consult a doctor.

Influence on the ability to drive motor vehicles and manage mechanisms

With hypoglycemia or hyperglycemia associated with an inadequate dosage regimen, the ability to concentrate attention and the speed of psychomotor reactions may be impaired. This can become a risk factor for potentially dangerous activities (including driving vehicles or working with mechanisms).

Patients should be careful to avoid hypolycemia while driving vehicles. This is especially important for patients who have reduced or no perception of symptoms that are harbingers of hypoglycemia, or who have frequent episodes of hypoglycemia. In these circumstances, it is necessary to evaluate the feasibility of driving vehicles. Patients with diabetes can independently stop the perceived mild hypoglycemia by taking glucose or food with a high carbohydrate content (it is recommended to always have at least 20 g of glucose with you). The patient should inform the attending physician about the history of hypoglycemia.

Form of production

Suspension for injection

Storage conditions

At a temperature of 2-8 °C (do not freeze)

Shelf life

2 years

Active ingredient

Lispro Insulin

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Purpose

For adults as directed by your doctor

Indications

Type 2 Diabetes, Type 1 Diabetes

Weight

Weight: 62 gr.