Humalog, 100 me/ml 3 ml cartridges 5 pcs

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

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

In patients with type 1 and type 2 diabetes, insulin lispro has a greater reduction in post-meal hyperglycemia compared to soluble human insulin. For patients receiving short-acting and basal insulin, the dose of both insulins should be adjusted to achieve optimal blood glucose levels throughout the day.

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

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

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

The treatment with insulin lispro in patients with type 1 and type 2 diabetes is associated with a decrease in the number of episodes of nocturnal hypoglycemia.

The glucodynamic response to insulin lispro is independent of functional renal or hepatic impairment.

Lispro insulin has been shown to be equimolar to human insulin, but its action is more rapid and lasts for a shorter time.

Lispro has a rapid onset (approximately 15 minutes) because it is highly absorbed, so it can be injected immediately before a meal (0-15 minutes before a meal) versus regular short-acting insulin (30-45 minutes before a meal). Insulin lispro has a shorter duration of action (2 to 5 hours) compared to regular human insulin.

Pharmacokinetics

Absorption and distribution

Lispro insulin is rapidly absorbed after subcutaneous administration and reaches Cmax in blood plasma after 30-70 minutes. The Vd of insulin lispro and regular human insulin are identical and range from 0.26-0.36 L/kg.

The T1/2 of insulin lispro is about 1 hour when administered subcutaneously. Patients with renal and hepatic impairment retain a higher rate of absorption of insulin lispro compared to regular human insulin.

Indications

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

Active ingredient

Composition

1 ml of solution for intravenous and subcutaneous administration contains:

the active ingredient:

insulin lispro 100 IU,

auxiliary substances:

Glycerol (glycerin) – 16 mg,

metacresol – 3.15 mg,

Zinc oxide (q.s. for Zn2+ content 0.0197 µg),

Sodium hydrophosphate 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.

How to take, the dosage

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

The temperature of the drug administered should be at room temperature.

Humalog is administered subcutaneously as an injection or as an extended subcutaneous infusion with an insulin pump. If necessary (ketoacidosis, acute illness, period between surgeries or postoperative period) Humalog may be given intravenously.

The subcutaneous injection should be given in the shoulder, thigh, buttock, or abdomen. The injection sites should be alternated so that the same site is not used more than once a month. When injecting Humalog subcutaneously, care should be taken to avoid getting the drug into a blood vessel. The injection site should not be massaged after the injection. The patient should be trained in proper injection technique.

Humalog administration rules

Preparing for injection

The Humalog solution must be clear and colorless. A cloudy, thickened or faintly colored Humalog solution, or if solid particles are visually detectable, should not be used.

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

Injection

Intravenous Insulin

Humalog intravenous injections should be given according to normal clinical practice for intravenous injections, such as intravenous bolus or using an infusion system. Frequent monitoring of blood glucose levels is required.

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

Subcutaneous insulin infusion with an insulin pump

Minimed and Disetronic insulin infusion pumps can be used for Humalog infusions. You must strictly follow the instructions that come with the pump. The infusion system must be changed every 48 hours. Observe the rules of asepsis when connecting the infusion system.

In case of a hypoglycemic episode, the infusion should be stopped until the episode has resolved. If recurrent or very low blood glucose levels are noted, this should be reported to the physician and provision made to reduce or stop the insulin infusion. A pump malfunction or clogged infusion system can cause glucose levels to rise rapidly. If insulin supply failure is suspected, follow the instructions and inform the physician if necessary. Humalog should not be mixed with other insulins when using the pump.

Interaction

Hypoglycemic effects of Humalog are reduced by oral contraceptives, GCS, thyroid hormone preparations, danazol, beta2-adrenomimetics (including ritodrine, salbutamol, terbutaline), tricyclic antidepressants, thiazide diuretics, chlorprotixen, diazoxide, isoniazid, lithium carbonate, nicotinic acid, phenothiazine derivatives.

. The hypoglycemic effect of Humalog is increased by beta-adrenoblockers, ethanol and ethanol-containing drugs, anabolic steroids, phenfluramine, guanethidine, tetracyclines, oral hypoglycemic drugs, salicylates (e.g., acetylsalicylic acid), sulfonamides, MAO inhibitors, ACE inhibitors (captopril, enalapril), octreotide, angiotensin II receptor antagonists.

Humalog should not be mixed with animal insulin preparations.

Humalog may be used (under a physician’s supervision) in combination with longer-acting human insulin or in combination with oral hypoglycemic sulfonylurea derivatives.

Special Instructions

Transfer of a patient to a different type or brand of insulin should be done under strict medical supervision. Changes in activity, brand (manufacturer), type (e.g. Regulare, NPH, Lente), species (animal, human, human insulin analogues) and/or method of production (DNA recombinant insulin or animal insulin) may necessitate changes in dose.

Conditions in which early precursory symptoms of hypoglycemia may be nonspecific and less pronounced include long-standing diabetes, intensive insulin therapy, diabetic nervous system disorders, or taking medications such as beta-adrenoblockers.

In patients with hypoglycemic reactions after switching from animal insulin to human insulin, early symptoms of hypoglycemia may be less severe or different from those they experienced when treated with their previous insulin. Uncorrected hypoglycemic or hyperglycemic reactions can cause loss of consciousness, coma, or death.

The use at inadequate doses or discontinuation of treatment, especially in insulin-dependent diabetes, 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 decrease in gluconeogenesis and insulin metabolism. However, in patients with chronic hepatic insufficiency, increased insulin resistance may lead to increased insulin requirement.

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

The dose may also need to be adjusted if the patient’s physical activity increases or the usual diet changes. Physical activity immediately after a meal contributes to the risk of hypoglycemia. A consequence of the pharmacodynamics of rapid-acting insulin analogues is that if hypoglycemia develops, it may occur sooner after injection than when soluble human insulin is injected.

The patient should be cautioned that if the physician has prescribed an insulin product with a 40 IU/ml concentration in the vial, the patient should not draw insulin from the 100 IU/ml insulin cartridge using a 40 IU/ml insulin syringe.

If other medications need to be taken at the same time as Humalog, the patient should consult a physician.

Impact on driving and operating ability

In hypoglycemia or hyperglycemia associated with inadequate dosing regimen, impairment of ability to concentrate and speed of psychomotor reactions may occur. This may be a risk factor for potentially hazardous activities (including driving or operating machinery).

Patients should be careful to avoid hypolcaemia while driving. This is particularly important for patients who have a reduced or absent sense of the symptom precursors of hypoglycemia, or who have frequent episodes of hypoglycemia. In these circumstances, the appropriateness of driving should be evaluated. Patients with diabetes mellitus can self-limit sensible mild hypoglycemia with glucose or high carbohydrate foods (it is always recommended to have at least 20 g of glucose with you). The patient should inform the attending physician about the hypoglycemia.

Contraindications

Hypoglycemia; hypersensitivity to components of the drug.

Side effects

A side effect associated with the main effect of the drug: hypoglycemia. Severe hypoglycemia may lead to loss of consciousness (hypoglycemic coma) and, in exceptional cases, to death.

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

Local reactions: lipodystrophy at the injection site.

Overdose

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

Treatment: mild states of hypoglycemia are usually controlled by oral administration of glucose or other sugar, or products containing sugar.

Moderately severe hypoglycemia can be corrected by intramuscular or subcutaneous injection of glucagon, followed by ingestion of carbohydrates after the patient has stabilized. Patients who do not respond to glucagon are given intravenous dextrose (glucose) solution.

If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously. If glucagon is not available or if there is no response to its administration, intravenous dextrose (glucose) solution should be administered. Immediately after recovery of consciousness, the patient should be given food rich in carbohydrates.

Further maintenance of carbohydrate intake and monitoring of the patient may be necessary, as a recurrence of hypoglycemia may occur.

Pregnancy use

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

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

Women of childbearing age with diabetes should inform their physician of an existing or planned pregnancy. During pregnancy, patients with diabetes require close monitoring of blood glucose levels, as well as general clinical monitoring.

In diabetic patients during breastfeeding it may be necessary to adjust the insulin dose and/or diet.