Humalog Mix 25, 100 me/ml suspension 3 ml cartridges 5 pcs

Humalog Mix 25 is a DNA recombinant human insulin analog and is a pre-mix consisting of a solution of insulin lispro (a fast-acting human insulin analog) and an insulin lispro protamine suspension (a medium-acting human insulin analog).

The main action of lispro insulin is to regulate glucose metabolism. In addition, it has anabolic and anti-catabolic effects on various tissues of the body. In muscle tissue there is an increase of glycogen, fatty acids, glycerol, 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.

Lispro insulin has been shown to be equimolar to human insulin, but its action is faster and lasts for a shorter time. It has an onset of action of about 15 minutes, allowing it to be injected immediately before a meal (up to 15 minutes before a meal), compared to regular human insulin. After a subcutaneous injection of Humalog Mix 25, there is a rapid onset of action and an early peak of activity of insulin lispro. The action profile of insulin lispro protamine is similar to that of regular isophan insulin with a duration of action of approximately 15 hours.

Pharmacokinetics

Absorption and distribution. Completeness of absorption and onset of effect of insulin depends on the place of administration (stomach, thigh, buttocks), the dose (volume of insulin administered), the concentration of insulin in the drug. Distributed in tissues irregularly. It does not penetrate through the placental barrier and into the breast milk.

Metabolism and excretion. Is broken down by insulinase mainly in the liver and kidneys. Excreted by the kidneys – 30-80%.

Indications

Diabetes mellitus requiring insulin therapy.

Pharmacological effect

Humalog Mix 25 is a DNA recombinant analogue of human insulin and is a ready-made mixture consisting of a solution of insulin lispro (a fast-acting analogue of human insulin) and a suspension of insulin lispro protamine (an analogue of medium-acting human insulin).

The main effect of insulin lispro is the regulation of glucose metabolism. In addition, it has anabolic and anti-catabolic effects on various tissues of the body. In muscle tissue, there is an increase in the content of glycogen, fatty acids, glycerol, increased protein synthesis and an increase in amino acid consumption, but at the same time there is a decrease in glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein catabolism and amino acid release.

Insulin lispro has been shown to be equimolar to human insulin, but its action is faster and lasts for a shorter time. The onset of action of the drug is approximately 15 minutes, which allows it to be administered immediately before meals (up to 15 minutes before meals), compared to regular human insulin. After subcutaneous injection of Humalog Mix 25, a rapid onset of action and early peak activity of insulin lispro are observed. The action profile of insulin lispro protamine is similar to that of regular isophane insulin, with a duration of action of approximately 15 hours.

Pharmacokinetics

Absorption and distribution. The completeness of absorption and the onset of the effect of insulin depends on the injection site (abdomen, thigh, buttocks), dose (volume of insulin administered), and insulin concentration in the drug. Distributed unevenly in tissues. Does not penetrate the placental barrier and into breast milk.

Metabolism and excretion. It is destroyed by insulinase mainly in the liver and kidneys. Excreted by the kidneys – 30–80%.

Special instructions

Transferring a patient to another type or drug of insulin with a different trade name should occur under strict medical supervision. Changes in potency, brand (manufacturer), type (eg Regular, NPH), species (animal, human, human insulin analog) and/or production method (DNA recombinant insulin or animal insulin) may require dosage adjustments.

For some patients, dosage adjustments may be necessary when switching from animal insulin to human insulin. This may occur as early as the first injection of human insulin or gradually over several weeks or months after the transfer.

Symptoms that are precursors to hypoglycemia during the administration of human insulin in some patients may be less pronounced or different from those observed during the administration of animal insulin. When blood glucose levels are normalized, for example as a result of intensive insulin therapy, all or some of the warning symptoms of hypoglycemia may disappear, of which patients should be informed. Precursor symptoms of hypoglycemia may change or be less severe with long-term diabetes mellitus, diabetic neuropathy, or treatment with drugs such as beta-blockers.

The use of inadequate doses or discontinuation of treatment, especially in patients with insulin-dependent diabetes mellitus, can lead to hyperglycemia and diabetic ketoacidosis (conditions that are potentially life-threatening for the patient).

The need for insulin may be reduced if there is insufficiency of the adrenal gland, pituitary gland or thyroid gland due to renal or liver failure. With some illnesses or emotional stress, the need for insulin may increase. Insulin dosage adjustments may also be necessary if you increase your physical activity or change your usual diet.

Impact on the ability to drive vehicles and operate machinery

During hypoglycemia, the patient may experience a decrease in concentration and speed of psychomotor reactions. This can be dangerous in situations where these abilities are especially needed (for example, driving a car or operating machinery).

Patients should be advised to take precautions to avoid hypoglycemia while driving vehicles and operating machinery. This is especially important for patients with mild or absent warning signs of hypoglycemia or those with frequent hypoglycemia. In such cases, the doctor must evaluate the appropriateness of the patient driving a car and operating machinery.

Active ingredient

Insulin lispro biphasic

Composition

1 ml of suspension for subcutaneous administration contains:

active ingredient:

insulin lispro biphasic 100 IU (mixture of insulin lispro solution – 25%; insulin lispro protamine suspension – 75%)

excipients:

sodium phosphate dibasic,

glycerol (glycerin),

phenol,

metacresol,

protamine sulfate,

zinc oxide,

water for injections,

hydrochloric acid solution 10% and/or sodium hydroxide solution 10% – until the required pH level is created.

Pregnancy

To date, no adverse effects of insulin lispro on pregnancy or the condition of the fetus and newborn have been identified.

The goal of insulin therapy during pregnancy is to maintain adequate glucose control. Insulin requirements usually decrease in the first trimester and increase in the second and third trimesters of pregnancy. During and immediately after childbirth, the need for insulin may decrease dramatically.

Women of childbearing age with diabetes should inform their doctor about an existing or planned pregnancy.

In patients with diabetes mellitus, adjustment of the insulin dose and/or diet may be required during breastfeeding.

Use for liver and kidney dysfunctions. Insulin requirements may be reduced if you have liver or kidney failure.

Contraindications

Hypersensitivity to the components of the drug; hypoglycemia.

Side Effects

Side effect associated with the main effect of the drug: the most common is hypoglycemia. Severe hypoglycemia can lead to loss of consciousness and, in extreme 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; in some cases, these reactions may be caused by reasons not related to insulin, such as skin irritation with an antiseptic or improper injection); systemic allergic reactions (occur less frequently, but are more serious) – generalized itching, shortness of breath, decreased blood pressure, tachycardia, increased sweating. Severe cases of systemic allergic reactions can be life-threatening.

In rare cases of severe allergy to Humalog Mix 25, immediate treatment is required. A change in insulin or desensitization may be required.

Other: with long-term use, lipodystrophy may develop at the injection site.

Interaction

The hypoglycemic effect of Humalog Mix 25 is reduced when administered simultaneously with the following drugs: oral contraceptives, corticosteroids, thyroid hormone preparations, danazol, β2-adrenergic agonists (including ritodrine, salbutamol, terbutaline), thiazide diuretics, lithium preparations, chlorprothixene, diazoxide, isoniazid, nicotinic acid, phenothiazine derivatives.

The hypoglycemic effect of Humalog Mix 25 is enhanced by β-blockers, ethanol and ethanol-containing drugs, anabolic steroids, fenfluramine, guanethidine, tetracyclines, oral hypoglycemic drugs, salicylates (for example, acetylsalicylic acid), sulfonamides, MAO inhibitors, ACE inhibitors (captopril, enalapril), octreotide, angiotensin II receptor antagonists.

β-blockers, clonidine, reserpine can mask the manifestation of symptoms of hypoglycemia.

The interaction of Humalog Mix 25 with other insulin preparations has not been studied.

Overdose

Symptoms: hypoglycemia, accompanied by the following symptoms: lethargy, increased sweating, tachycardia, headache, vomiting, confusion. Under certain conditions, such as long-term or intensively controlled diabetes, the warning signs of hypoglycemia may change.

Treatment: Mild hypoglycemia is usually treated by ingesting glucose or other sugars or eating sugar-containing foods. Adjustments to your insulin dose, diet, or physical activity may be necessary.

Correction of moderately severe hypoglycemia can be achieved with intramuscular or subcutaneous administration of glucagon followed by oral carbohydrate.

Severe conditions of hypoglycemia accompanied by coma, convulsions or neurological disorders are treated with intramuscular or subcutaneous administration of glucagon or intravenous administration of a concentrated solution of dextrose (glucose). After regaining consciousness, the patient should be given food rich in carbohydrates to avoid the recurrence of hypoglycemia.

Further carbohydrate intake and patient monitoring may be required as… a relapse of hypoglycemia may occur.

Storage conditions

In a place protected from direct sunlight, at a temperature of 2–8 °C

Shelf life

2 years

Manufacturer

Lilly France, France