Humulin^® Regular (Solution) Instructions for Use

ATC Code

A10AB01 (Human insulin)

Active Substance

Insulin soluble [human genetically engineered] (SP State Pharmacopoeia)

Clinical-Pharmacological Group

Short-acting human insulin

Pharmacotherapeutic Group

Short-acting insulin

Pharmacological Action

DNA-recombinant human insulin. It is a short-acting insulin preparation.

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

Pharmacokinetics

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, injection site selection, and the patient’s physical activity.

Indications

• Diabetes mellitus in the presence of indications for insulin therapy;
• Newly diagnosed diabetes mellitus;
• Pregnancy in type 2 diabetes mellitus (non-insulin-dependent).

ICD codes

Dosage Regimen

Solution

The dose is determined by the doctor individually depending on the level of glycemia.

The drug should be administered subcutaneously, intravenously, intramuscular administration is possible.

The drug is administered subcutaneously into the shoulder, thigh, buttock or abdominal area. The injection site should be alternated so that the same site is used no more than approximately once a month.

When administering subcutaneously, care must be taken to avoid entering a blood vessel. After the injection, the injection site should not be massaged. Patients should be trained in the correct use of insulin delivery devices.

Rules for preparation and administration of the drug

Humulin Regular cartridges and vials do not require resuspension and can only be used if their contents are a clear, colorless liquid without visible particles.

Cartridges and vials should be carefully checked. The drug should not be used if it contains flakes, or if solid white particles are stuck to the bottom or walls of the vial, creating a frosty pattern effect.

The design of the cartridges does not allow their contents to be mixed with other insulins directly in the cartridge itself. Cartridges are not intended for refilling.

The contents of the vial should be drawn into an insulin syringe corresponding to the concentration of the insulin being administered, and the required dose of insulin should be administered as directed by the doctor.

When using cartridges, the manufacturer’s instructions for loading the cartridge and attaching the needle should be followed. The drug should be administered in accordance with the pen injector manufacturer’s instructions.

Using the outer needle cap, immediately after administration, unscrew the needle and safely dispose of it. Removing the needle immediately after injection ensures sterility, prevents leakage, air ingress and possible needle clogging. Then put the cap on the pen.

Needles should not be reused. Needles and pen injectors should not be used by other persons. Cartridges and vials are used until they are empty, after which they should be discarded.

Humulin^® Regular can be administered in combination with Humulin NPH. For this, the short-acting insulin should be drawn into the syringe first to prevent the longer-acting insulin from entering the vial. It is advisable to administer the prepared mixture immediately after mixing. To administer an accurate amount of each type of insulin, a separate syringe for Humulin Regular and Humulin NPH can be used.

An insulin syringe corresponding to the concentration of the insulin being administered should always be used.

Adverse Reactions

Side effect associated with the main action of the drug hypoglycemia.

Severe hypoglycemia can lead to loss of consciousness and (in exceptional cases) death.

Allergic reactions local allergic reactions are possible – redness, swelling or itching at the injection site (usually stop within a period of several days to several weeks); systemic allergic reactions (occur less frequently, but are more serious) – generalized itching, difficulty breathing, shortness of breath, decreased blood pressure, increased pulse rate, increased sweating. Severe cases of systemic allergic reactions can be life-threatening.

Other the likelihood of developing lipodystrophy is minimal.

Contraindications

• Hypoglycemia;
• Increased sensitivity to insulin or to one of the components of the drug.

Use in Pregnancy and Lactation

During pregnancy, it is especially important to maintain good glycemic control in patients with diabetes mellitus. During pregnancy, the need for insulin usually decreases in the first trimester and increases in the second and third trimesters.

Patients with diabetes are advised to inform their doctor about the onset or planning of pregnancy.

In patients with diabetes during lactation (breastfeeding), adjustment of the insulin dose, diet, or both may be required.

In studies of genetic toxicity in a series of in vitro and in vivo tests, human insulin did not have a mutagenic effect.

Use in Hepatic Impairment

The need for insulin may decrease in hepatic insufficiency.

Use in Renal Impairment

The need for insulin may decrease in renal insufficiency.

Special Precautions

Transfer of a patient to another type of insulin or to an insulin preparation with a different trade name should occur under strict medical supervision. Changes in insulin potency, type (e.g., M3, NPH), species (porcine, human insulin, human insulin analogue) or manufacturing method (DNA-recombinant insulin or insulin of animal origin) may necessitate dose adjustment.

The need for dose adjustment may be required already at the first administration of a human insulin preparation after an animal insulin preparation or gradually over several weeks or months after the transfer.

The need for insulin may decrease in case of insufficient function of the adrenal glands, pituitary gland or thyroid gland, in case of renal or hepatic insufficiency.

In some diseases or during emotional stress, the need for insulin may increase.

Dose adjustment may also be required with increased physical activity or changes in the usual diet.

The warning symptoms of hypoglycemia during the administration of human insulin may be less pronounced or different from those observed during the administration of animal insulin in some patients. When blood glucose levels normalize, for example as a result of intensive insulin therapy, all or some of the warning symptoms of hypoglycemia may disappear, and patients should be informed about this.

Warning symptoms of hypoglycemia may change or be less pronounced in long-term diabetes, diabetic neuropathy, or with the simultaneous use of beta-blockers.

In some cases, local allergic reactions may be caused by reasons not related to the action of the drug, for example, skin irritation by a cleansing agent or improper injection technique.

In rare cases of systemic allergic reactions, immediate treatment is required. Sometimes it may be necessary to change insulin or perform desensitization.

Effect on ability to drive vehicles and operate machinery

During hypoglycemia, the patient’s ability to concentrate and the speed of psychomotor reactions may deteriorate. This can be dangerous in situations where these abilities are especially necessary (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 warning symptoms of hypoglycemia or with frequent hypoglycemia. In such cases, the doctor should assess the advisability of the patient driving a car.

Overdose

Symptoms hypoglycemia, accompanied by lethargy, increased sweating, tachycardia, pale skin, headache, tremors, vomiting, confusion.

Under certain conditions, such as long duration or intensive control of diabetes, the warning symptoms of hypoglycemia may change.

Treatment mild hypoglycemic conditions can usually be controlled by oral administration of glucose (dextrose) or sugar. Adjustment of the insulin dose, diet, or physical activity may be required.

Moderate hypoglycemia can be corrected by intramuscular or subcutaneous administration of glucagon followed by oral carbohydrate intake.

Severe hypoglycemic conditions accompanied by coma, convulsions or neurological disorders are stopped by intramuscular or subcutaneous administration of glucagon or intravenous administration of a concentrated glucose (dextrose) solution. After regaining consciousness, the patient should be given a carbohydrate-rich meal to avoid recurrent hypoglycemia.

Drug Interactions

The hypoglycemic effect of Humulin Regular is reduced by oral contraceptives, corticosteroids, thyroid hormone preparations, thiazide diuretics, diazoxide, tricyclic antidepressants.

The hypoglycemic effect of Humulin Regular is enhanced by oral hypoglycemic drugs, salicylates (for example, acetylsalicylic acid), sulfonamides, MAO inhibitors, beta-blockers, ethanol and ethanol-containing drugs.

Beta-blockers, clonidine, reserpine may mask the manifestation of hypoglycemia symptoms.

Pharmaceutical interaction

The effects resulting from mixing human insulin with animal insulins or human insulin produced by other manufacturers have not been studied.

Storage Conditions

The drug should be stored in a refrigerator at a temperature from 2°C (35.6°F) to 8°C (46.4°F), avoid freezing, protect from direct exposure to light.

Shelf Life

Shelf life – 2 years.

The drug in use in a vial or cartridge should be stored at room temperature (from 15°C (59°F) to 25°C (77°F)) for no more than 28 days.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.