Humulin Regular, 100 me/ml 3 ml cartridges 5 pcs.

Humulin Regular is a DNA recombinant human insulin. It is a medium-acting insulin preparation. The main action of the drug is regulation of glucose metabolism.

In addition, it has an anabolic effect. In muscle and other tissues (except brain) insulin causes rapid intracellular transport of glucose and amino acids, accelerates protein anabolism. Insulin promotes conversion of glucose into glycogen in the liver, inhibits gluconeogenesis and stimulates conversion of excess glucose into fat.

Pharmacokinetics

Humulin Regular is a short-acting insulin drug.

The onset of action of the drug is 30 minutes after administration, the maximum effect of action is between 1 and 3 hours, the duration of action is 5-7 hours.

Individual differences in insulin activity depend on factors such as the dose, choice of injection site, physical activity of the patient.

Indications

Diabetes mellitus requiring insulin therapy.
Pregnancy in patients with diabetes mellitus.

Pharmacological effect

Pharmacotherapeutic group
Hypoglycemic agent – short-acting insulin.

ATX code [A10AB01].

Pharmacological properties
Pharmacodynamics
Humulin® Regular is a DNA recombinant human insulin. The main effect of 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 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.
Humulin® Regular is a short-acting insulin preparation. The onset of action of the drug is 30 minutes after administration, the maximum effect is between 1 and 3 hours, the duration of action is 5-7 hours. Individual differences in insulin activity depend on factors such as dose, choice of injection site, physical activity of the patient, etc.

Pharmacokinetics
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), insulin concentration in the drug, etc. It is unevenly distributed throughout the tissues; does not penetrate the placental barrier and into breast milk. It is destroyed by insulinase mainly in the liver and kidneys. Excreted by the kidneys (30-80%).

Special instructions

Impact on the ability to drive vehicles and operate machinery
During hypoglycemia, the patient’s concentration and speed of psychomotor reactions may decrease. This can be dangerous in situations where these abilities are particularly needed (for example, driving a car or operating machinery). Patients should be advised to take precautions to avoid hypoglycemia while driving. This is especially important for patients with mild or absent symptoms – precursors of hypoglycemia or with frequent development of hypoglycemia. In such cases, the doctor should evaluate the advisability of the patient driving a car.

Active ingredient

Insulin soluble human genetically engineered

Composition

1 ml contains:
active substance – human insulin 100 IU/ml;
excipients: metacresol, glycerol (glycerol), water for injection, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% can be used during the production process to establish pH.

Pregnancy

During pregnancy, it is especially important to maintain good control in patients receiving insulin therapy (insulin-dependent diabetes or gestational diabetes). Insulin requirements usually decrease during the first trimester and increase during the second and third trimesters. During and immediately after childbirth, the need for insulin may decrease dramatically. Patients with diabetes are advised to inform their doctor if they are pregnant or planning a pregnancy. In patients with diabetes mellitus, adjustments in insulin dosage, diet, or both may be necessary during breastfeeding.

Contraindications

Hypersensitivity to insulin or to one of the components of the drug.
Hypoglycemia.

Side Effects

Hypoglycemia is the most common side effect that occurs with the administration of insulin drugs, including Humulin® Regular. Severe hypoglycemia can lead to loss of consciousness and, in exceptional cases, death.
Allergic reactions: Patients may experience local allergic reactions in the form of redness, swelling or itching at the injection site. These reactions usually subside within a few days to several weeks. In some cases, these reactions may be due to causes unrelated to insulin, such as skin irritation from the cleansing agent or improper injection procedures.
Systemic allergic reactions caused by insulin occur less frequently but are more severe. They can manifest as generalized itching, difficulty breathing, shortness of breath, decreased blood pressure, increased heart rate, and increased sweating. Severe cases of systemic allergic reactions can be life-threatening. In rare cases of severe allergy to Humulin® Regular, immediate treatment is required. You may need to change your insulin or undergo desensitization.
With long-term use, lipodystrophy may develop at the injection site.

Interaction

An increase in insulin dosage may be required if drugs that increase blood glucose levels are prescribed, such as: oral contraceptives, glucocorticosteroids, thyroid hormones, danazol, beta2-agonists (for example, ritodrine, salbutamol, terbutaline), thiazide diuretics, chlorprothixene, diazoxide, isoniazid, lithium carbonate, nicotinic acid, phenothiazine derivatives. A reduction in insulin dosage may be necessary when prescribing drugs that lower blood glucose levels, such as: beta-blockers, ethanol and ethanol-containing drugs, anabolic steroids, fenfluramine, guanethidine, tetracyclines, oral hypoglycemic drugs, salicylates (for example, acetylsalicylic acid), sulfonamide antibiotics, some antidepressants (inhibitors). monoamine oxidase), angiotensin-converting enzyme inhibitors (captopril, enapril), octreotide, angiotensin II receptor antagonists. Beta-blockers, clonidine, reserpine can mask the symptoms of hypoglycemia.
Incompatibility. The effects of mixing human insulin with animal insulin or human insulin from other manufacturers have not been studied.
Incompatibility. The effects of mixing human insulin with animal insulin or human insulin from other manufacturers have not been studied. Special instructions
Transferring a patient to another type or insulin preparation with a different trade name should occur under strict medical supervision. Changes in potency, brand (manufacturer), type (NPH, MZ, animal insulin) may require dose adjustment.
For some patients, when switching from animal insulin to human insulin, it may be necessary to adjust the dose. This may occur already with the first administration of human insulin or gradually over several weeks or months after the transfer.
Symptoms – precursors of 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 symptoms may disappear – precursors of hypoglycemia, about which patients should be informed. Symptoms that are warning signs of hypoglycemia may change or be less pronounced with prolonged diabetes mellitus, diabetic neuropathy, or treatment with drugs such as beta-blockers. The use of inappropriate 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 glands, pituitary gland or thyroid gland, or with 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.

Overdose

An overdose of insulin causes hypoglycemia, accompanied by the following symptoms: lethargy, increased sweating, tachycardia, pale skin, headache, trembling, vomiting, confusion. Under certain conditions, such as long-term diabetes or intensive control of diabetes, the warning signs of hypoglycemia may change.
Mild hypoglycemia can usually be treated with oral glucose or sugar. Adjustments to your insulin dose, diet, or physical activity may be necessary. Correction of moderate hypoglycemia can be carried out using intramuscular or subcutaneous administration of glucagon, followed by oral carbohydrates. Severe conditions of hypoglycemia, accompanied by coma, convulsions or neurological disorders, are treated with intramuscular/subcutaneous administration of glucagon or intravenous administration of a concentrated glucose solution. After regaining consciousness, the patient must be given food rich in carbohydrates to avoid re-development of hypoglycemia.

Storage conditions

Store at a temperature of 2°-8°C out of the reach of children.
Protect from direct sunlight and heat. Do not allow to freeze.
The drug in use in a 3 ml cartridge should be stored at room temperature 15°-25°C for no more than 28 days.

Shelf life

2 years.
Do not use after expiration date.

Manufacturer

Lilly France, France