Humadar P 100 Rek (Solution) Instructions for Use

Marketing Authorization Holder

Indar Private Joint Stock Company for Insulin Production (Ukraine)

ATC Code

A10AB01 (Human insulin)

Active Substance

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

Dosage Form

Humadar P 100 Rek

Injection solution 100 U/ml: 10 ml bottle, 3 ml cartridges 3 or 5 pcs.

Dosage Form, Packaging, and Composition

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

Clinical-Pharmacological Group

Short-acting human insulin

Pharmacotherapeutic Group

Short-acting insulin

Pharmacological Action

Hypoglycemic agent, short-acting insulin. By interacting with a specific receptor on the external cell membrane, it forms an insulin-receptor complex. Influencing the synthesis of cAMP (in fat cells and liver cells) or directly penetrating into the cell (muscles), the insulin-receptor complex stimulates intracellular processes, including the synthesis of a number of key enzymes (including hexokinase, pyruvate kinase, glycogen synthase).

The decrease in blood glucose concentration is due to an increase in its intracellular transport, enhanced uptake and utilization by tissues, stimulation of lipogenesis, glycogenesis, protein synthesis, and a decrease in the rate of glucose production by the liver (reduction of glycogen breakdown).

Onset of action is within 30 minutes, maximum effect is in 1-3 hours, duration of action is 8 hours.

Pharmacokinetics

The degree of absorption depends on the method of administration (subcutaneous, intramuscular), the site of administration (abdomen, thigh, buttocks), dose, and concentration of insulin in the preparation. Distribution in tissues is uneven. Does not cross the placental barrier or into breast milk. Destroyed by insulinase, mainly in the liver and kidneys. T_1/2 up to 10 minutes. Excreted by the kidneys – 30-80%.

Indications

Type 1 diabetes mellitus, Type 2 diabetes mellitus: stage of resistance to oral hypoglycemic agents; diabetic ketoacidosis, diabetic coma; diabetes mellitus occurring during pregnancy (when diet therapy is ineffective); for intermittent use in patients with diabetes mellitus in the presence of infections accompanied by high fever; during upcoming surgical operations, trauma, childbirth, in case of metabolic disorders, before switching to treatment with long-acting insulin preparations.

ICD codes

Dosage Regimen

The dose and route of administration of the drug are determined individually in each specific case based on blood glucose levels before meals and 1-2 hours after meals, as well as depending on the degree of glucosuria and the characteristics of the disease course.

It is usually administered subcutaneously 15-20 minutes before a meal. Injection sites are changed each time. If necessary, intramuscular or intravenous administration is allowed.

Can be combined with long-acting insulins.

Adverse Reactions

Allergic reactions: urticaria, angioedema, fever, shortness of breath, decreased blood pressure.

From the endocrine system: hypoglycemia with manifestations such as pallor, increased sweating, palpitations, sleep disorders, tremor; neurological disorders; immunological cross-reactions with human insulin; increase in the titer of anti-insulin antibodies with subsequent increase in glycemia.

From the organ of vision: transient visual disturbances (usually at the beginning of therapy).

Local reactions: hyperemia, itching and lipodystrophy (atrophy or hypertrophy of subcutaneous adipose tissue) at the injection site.

Other: at the beginning of treatment, edema may occur (they disappear with continued treatment).

Contraindications

Hypoglycemia, hypersensitivity to this insulin.

Use in Pregnancy and Lactation

During pregnancy, it is necessary to consider the decrease in insulin requirement in the first trimester or the increase in the second and third trimesters. During childbirth and immediately after them, the need for insulin may sharply decrease.

During breastfeeding, the patient requires daily monitoring for several months (until the insulin requirement stabilizes).

Use in Hepatic Impairment

In liver diseases, the need for insulin may change.

Use in Renal Impairment

In kidney diseases, the need for insulin may change.

Geriatric Use

Dose adjustment of insulin is required for diabetes mellitus in patients over 65 years of age.

Special Precautions

Dose selection of the drug should be carried out with caution in patients with a history of cerebral circulation disorders of the ischemic type and with severe forms of coronary artery disease.
The need for insulin may change in the following cases: when switching to another type of insulin; when changing the diet, diarrhea, vomiting; when changing the usual volume of physical activity; in diseases of the kidneys, liver, pituitary gland, thyroid gland; when changing the injection site.
Correction of the insulin dose is required in infectious diseases, thyroid dysfunction, Addison’s disease, hypopituitarism, chronic renal failure and diabetes mellitus in patients over 65 years of age.

Transferring a patient to human insulin should always be strictly justified and carried out only under medical supervision.

Causes of hypoglycemia may include: insulin overdose, drug substitution, missed meals, vomiting, diarrhea, physical exertion; diseases that reduce the need for insulin (severe kidney and liver diseases, as well as hypofunction of the adrenal cortex, pituitary gland or thyroid gland), change of injection site (e.g., skin on the abdomen, shoulder, thigh), as well as interaction with other drugs. A decrease in blood glucose concentration is possible when transferring a patient from animal insulin to human insulin.

The patient must be informed about the symptoms of a hypoglycemic state, the first signs of diabetic coma, and the need to inform the doctor about all changes in their condition.

In case of hypoglycemia, if the patient is conscious, dextrose is prescribed orally; glucagon is administered subcutaneously, intramuscularly or intravenously, or a hypertonic dextrose solution is administered intravenously. In case of hypoglycemic coma development, 20-40 ml (up to 100 ml) of a 40% dextrose solution is administered intravenously as a bolus until the patient recovers from the comatose state.

Patients with diabetes mellitus can relieve mild hypoglycemia felt by themselves by taking sugar or food high in carbohydrates (patients are recommended to always carry at least 20 g of sugar with them).

Alcohol tolerance in patients receiving insulin is reduced.

Effect on the ability to drive vehicles and operate machinery

A tendency to develop hypoglycemia may impair patients’ ability to drive vehicles and operate machinery.

Drug Interactions

The hypoglycemic effect is enhanced by sulfonamides (including oral hypoglycemic drugs, sulfonamides), MAO inhibitors (including furazolidone, procarbazine, selegiline), carbonic anhydrase inhibitors, ACE inhibitors, NSAIDs (including salicylates), anabolic steroids (including stanozolol, oxandrolone, methandienone), androgens, bromocriptine, tetracyclines, clofibrate, ketoconazole, mebendazole, theophylline, cyclophosphamide, fenfluramine, lithium preparations, pyridoxine, quinidine, quinine, chloroquine, ethanol.

The hypoglycemic effect is reduced by glucagon, corticosteroids, histamine H₁-receptor blockers, oral contraceptives, estrogens, thiazide and “loop” diuretics, slow calcium channel blockers, sympathomimetics, thyroid hormones, tricyclic antidepressants, heparin, somatropin, sulfinpyrazone, danazol, diazoxide, morphine, marijuana, nicotine, phenytoin, epinephrine.

Beta-blockers, reserpine, octreotide, pentamidine can either enhance or reduce the hypoglycemic effect of insulin.

Concomitant use of beta-blockers, clonidine, guanethidine or reserpine may mask the symptoms of hypoglycemia.

Pharmaceutically incompatible with solutions of other drugs.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.