Humodar K25-100 (Suspension) Instructions for Use

Marketing Authorization Holder

Indar Private Joint Stock Company for Insulin Production (Ukraine)

ATC Code

A10AD01 (Insulin human)

Active Substance

Insulin human (Rec.INN registered by WHO)

Dosage Form

Humodar K25-100

Subcutaneous administration suspension 100 IU/1 ml: cartridges 3 ml 5 pcs., fl. 10 ml 1 pc.

Dosage Form, Packaging, and Composition

3 ml – cartridges (3) – cardboard packs.
3 ml – cartridges (5) – cardboard packs.
10 ml – “insulin” vials (1) – cardboard packs.

Clinical-Pharmacological Group

Intermediate-acting human insulin with rapid onset of action

Pharmacotherapeutic Group

Hypoglycemic agent – combination of short- and intermediate-acting insulins

Pharmacological Action

Humodar K25-100 is a medium-acting human semisynthetic insulin preparation. The drug contains soluble insulin (25%) and isophane insulin (75%). It interacts with a specific receptor on the outer cytoplasmic membrane of cells and forms an insulin-receptor complex that stimulates intracellular processes, including the synthesis of a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthase, and others). The decrease in blood glucose is due to increased intracellular transport, enhanced uptake and utilization by tissues, stimulation of lipogenesis, glycogenesis, and a decrease in the rate of glucose production by the liver. The duration of action of insulin preparations is mainly determined by the rate of absorption, which depends on several factors (for example, dose, method and site of administration), which is why the action profile of insulin is subject to significant fluctuations, both in different people and in the same person. On average, the onset of action of the drug after subcutaneous administration occurs within 30 minutes, the maximum effect is within 1-3 hours, and the duration of action is 12-16 hours.

Pharmacokinetics

The completeness of absorption and the onset of the effect of insulin depend on the method of administration (subcutaneous, intramuscular), the site of administration (abdomen, thigh, buttocks), the dose (volume of insulin administered), the concentration of insulin in the preparation, etc. It is distributed unevenly in tissues; does not cross the placental barrier and into breast milk. It is destroyed by insulinase mainly in the liver and kidneys. It is excreted by the kidneys (30-80%).

Indications

• Diabetes mellitus in adults.

ICD codes

Dosage Regimen

The drug is intended for subcutaneous administration. The dose and time of administration of the drug are determined by the doctor individually in each specific case based on the blood glucose level. On average, the daily dose of the drug ranges from 0.5 to 1 IU/kg of body weight (depends on the individual characteristics of the patient and the blood glucose level). The temperature of the administered insulin should be at room temperature. The drug is usually administered subcutaneously into the thigh. Injections can also be made into the anterior abdominal wall, buttock, or the area of the deltoid muscle of the shoulder. It is necessary to change injection sites within the anatomical area to prevent the development of lipodystrophies.

Patients with type 2 diabetes mellitus can receive both monotherapy with Humodar K25-100 (administered twice a day) and combination therapy with oral hypoglycemic agents.

Instructions to be given to the patient

Injection technique when using insulin in vials

1. Disinfect the rubber membrane on the vial
2. Draw air into the syringe in an amount corresponding to the required dose of insulin. Inject the air into the insulin vial.
3. Turn the vial with the syringe upside down and draw the required dose of insulin into the syringe. Remove the needle from the vial and remove air from the syringe. Check the correctness of the insulin dose set.
4. Immediately give the injection.

Injection technique when using insulin in cartridges

The cartridge with Humodar K25-100 is intended for use only in pen injectors. It is necessary to carefully follow the instructions in the user manual for the pen injector for insulin administration.

Before use, make sure that the cartridge with Humodar K25-100 has no damage (e.g., cracks). Do not use the cartridge if there are any visible damages. After the cartridge is inserted into the pen injector, a colored stripe should be visible through the cartridge holder window.

Before placing the cartridge into the pen injector, turn the cartridge upside down so that the glass ball moves from one end of the cartridge to the other. This procedure should be repeated at least 10 times until the entire liquid becomes white and uniformly cloudy. Immediately after this, the injection should be given.

If the cartridge is already inside the pen injector, turn it with the cartridge inside upside down at least 10 times. This procedure must be repeated before each injection.

After the injection, the needle should remain under the skin for at least 6 seconds. Hold the button pressed until the needle is completely removed from under the skin, thus ensuring the correct administration of the dose and limiting the possibility of blood or lymph entering the needle or the insulin cartridge.

The cartridge with Humodar K25-100 is intended for individual use only and is not refillable.

Injection procedure

1. With two fingers, take a fold of skin, insert the needle into the base of the fold at an angle of about 45°C (113°F) and inject the insulin under the skin.

2. After the injection, the needle should remain under the skin for at least 6 seconds to ensure that the insulin is completely injected.

3. If blood appears at the injection site after removing the needle, press the injection site lightly with your finger.

4. It is necessary to change injection sites.

Adverse Reactions

Due to the effect on carbohydrate metabolism: hypoglycemic conditions (pallor of the skin, increased sweating, palpitations, tremor, feeling of hunger, agitation, paresthesia in the mouth area, headache). Severe hypoglycemia can lead to the development of hypoglycemic coma.

Allergic reactions rarely – skin rash, angioedema, extremely rarely – anaphylactic shock.

Local reactions hyperemia, swelling and itching at the injection site, with prolonged use – lipodystrophy at the injection site.

Other edema, transient refraction disorders (usually at the beginning of therapy).

Contraindications

• Hypoglycemia;
• Hypersensitivity to insulin or other components of the drug.

Use in Pregnancy and Lactation

There are no restrictions on the treatment of diabetes mellitus with insulin during pregnancy, since insulin does not cross the placental barrier. When planning pregnancy and during it, it is necessary to intensify the treatment of diabetes mellitus. The need for insulin usually decreases in the first trimester of pregnancy and gradually increases in the second and third trimesters. During childbirth and immediately after them, the need for insulin may sharply decrease. Soon after childbirth, the need for insulin quickly returns to the level that was before pregnancy. There are no restrictions on the treatment of diabetes mellitus with insulin during lactation. However, a reduction in the insulin dose may be required, so careful monitoring is necessary until the insulin requirement stabilizes.

Special Precautions

During insulin therapy, constant monitoring of blood glucose levels is necessary. Causes of hypoglycemia, in addition to insulin overdose, may be: changing the drug, skipping a meal, vomiting, diarrhea, increased physical activity, diseases that reduce the need for insulin (impaired liver and kidney function, hypofunction of the adrenal cortex, pituitary gland or thyroid gland), changing the injection site, as well as interaction with other drugs.

Incorrect dosing or interruptions in insulin administration can lead to hyperglycemia. Usually, the first symptoms of hyperglycemia develop gradually, over several hours or days. They include the appearance of thirst, increased urination, nausea, vomiting, dizziness, redness and dryness of the skin, dry mouth, loss of appetite.

The insulin dose must be adjusted in case of thyroid dysfunction, Addison’s disease, hypopituitarism, impaired liver and kidney function, and diabetes in persons over 65 years of age.

Do not use the drug if, after shaking, the suspension does not become white or uniformly cloudy.

Adjustment of the insulin dose may also be required if the patient increases the intensity of physical activity or changes the usual diet. Concomitant diseases, especially infections and conditions accompanied by fever, increase the need for insulin.

Switching from one type of insulin to another should be carried out under the control of blood glucose levels.

The drug reduces tolerance to alcohol.

Effect on the ability to drive vehicles and mechanisms

Due to the initial prescription of insulin, a change in its type, or in the presence of significant physical or mental stress, it is possible to reduce the ability to drive a car or operate various mechanisms, as well as engage in other potentially hazardous activities that require increased attention and speed of mental and motor reactions.

Overdose

Symptoms overdose may lead to the development of hypoglycemia.

Treatment mild hypoglycemia can be eliminated by the patient himself by taking sugar or carbohydrate-rich foods orally, therefore patients with diabetes are recommended to constantly carry sugar, sweets, cookies or sweet fruit juice with them.

In severe cases, when the patient loses consciousness, 40% dextrose (glucose) solution is administered intravenously; glucagon is administered intramuscularly, subcutaneously, or intravenously. After regaining consciousness, the patient is recommended to take food rich in carbohydrates to prevent the re-development of hypoglycemia.

Drug Interactions

There are a number of drugs that affect the need for insulin.

The hypoglycemic effect of Humodar K25-100 is enhanced by oral hypoglycemic drugs, MAO inhibitors, ACE inhibitors, carbonic anhydrase inhibitors, non-selective beta-blockers, bromocriptine, octreotide, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium preparations, quinidine, quinine, chloroquine, preparations containing ethanol.

The hypoglycemic effect of the drug is weakened by oral contraceptives, corticosteroids, thyroid hormones, loop and thiazide diuretics, heparin, glucagon, somatotropin, estrogens, sulfinpyrazone, marijuana, epinephrine, histamine H₁-receptor blockers, tricyclic antidepressants, sympathomimetics, danazol, clonidine, slow calcium channel blockers, diazoxide, morphine, phenytoin, nicotine.

Under the influence of reserpine and salicylates, both weakening and enhancement of the drug’s effect are possible.

Pentamidine can both enhance and weaken the hypoglycemic effect of insulin.

While taking alcohol, the need for insulin decreases, which requires adjustment of the drug dose.

Storage Conditions

The drug should be stored at a temperature from +2°C (35.6°F) to + 8°C (46.4°F). Do not allow freezing.

The insulin vial in use can be stored for 6 weeks, and the insulin cartridge for 3 weeks at room temperature (not higher than 25°C (77°F)), provided it is protected from direct heat and light. Keep out of reach of children.

Shelf Life

The shelf life of the drug is 2 years. Do not use after the expiration date printed on the package.

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.