Rinsulin R, 100 me/ml 10 ml

Geropharm, Russia

Indications

Diabetes mellitus type 1
Type 2 diabetes mellitus: stage of resistance to oral hypoglycemic agents, partial resistance to these drugs (with combination therapy), intercurrent diseases
Type 2 diabetes mellitus in pregnant women
Emergency conditions in patients with diabetes mellitus, accompanied by decompensation of carbohydrate metabolism

Pharmacological effect

Pharmacodynamics

Rinsulin R is a human insulin produced using recombinant DNA technology. Short-acting insulin. 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, etc.). The decrease in glucose content in the blood is due to an increase in its intracellular transport, increased absorption and assimilation by tissues, stimulation of lipogenesis, glycogenogenesis, a decrease in the rate of glucose production by the liver, etc. The duration of action of insulin preparations is mainly determined by the rate of absorption, which depends on several factors (for example, on the dose, route and place of administration), and therefore the profile of insulin action is subject to significant fluctuations, both in different people and in the same person. On average, after subcutaneous administration, Rinsulin R begins to act within 30 minutes, the maximum effect develops between 1 and 3 hours, the duration of action is 8 hours.

Pharmacokinetics:

The completeness of absorption and the onset of the effect of insulin depends on the method of administration (subcutaneous, intramuscular, intravenous), injection site (abdomen, thigh, buttocks), dose (volume of insulin administered), insulin concentration in the drug, etc. It is distributed unevenly throughout the tissues; does not penetrate the placental barrier and into breast milk. It is destroyed by insulinase mainly in the liver and kidneys. The half-life is several minutes. Excreted by the kidneys (30-80%).

Special instructions

Do not use the drug if a precipitate appears in the solution. During insulin therapy, constant monitoring of blood glucose concentration is necessary. In addition to insulin overdose, the causes of hypoglycemia can be: drug replacement, skipping meals, 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), change of injection site, as well as interactions with other drugs. Incorrect dosing or interruptions in insulin administration, especially in patients with type 1 diabetes, can lead to hyperglycemia. Typically, 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, and the smell of acetone in the exhaled air. If left untreated, hyperglycemia in type 1 diabetes can lead to life-threatening diabetic ketoacidosis. The dose of insulin must be adjusted in cases of thyroid dysfunction, Addison’s disease, hypopituitarism, impaired liver and kidney function, and diabetes mellitus in persons over 65 years of age.

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. The transition from one type of insulin to another should be carried out under the control of blood glucose concentrations. The drug reduces tolerance to alcohol. Due to the possibility of precipitation in some catheters, the use of the drug in insulin pumps is not recommended.

Impact on the ability to drive vehicles and operate machinery

In connection with the primary prescription of insulin, a change in its type, or in the presence of significant physical or mental stress, the ability to drive vehicles or operate various mechanisms, as well as engage in other potentially hazardous activities that require increased attention and speed of mental and motor reactions, may be impaired.

Active ingredient

Insulin soluble human genetically engineered

Composition

1 ml of the drug contains:

active substance: human insulin 100 IU;

excipients: metacresol, glycerol, water for injection.

Pregnancy

There are no restrictions on the treatment of diabetes mellitus with insulin during pregnancy, since insulin does not penetrate 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 and immediately after childbirth, the need for insulin may decrease dramatically. Shortly after birth, insulin requirements quickly return to pre-pregnancy levels. There are no restrictions on the treatment of diabetes mellitus with insulin during breastfeeding.

However, a reduction in the insulin dose may be necessary, so careful monitoring is necessary for several months until insulin requirements stabilize.

Contraindications

Hypoglycemia; increased sensitivity to insulin.

Side Effects

Caused by the effect on carbohydrate metabolism: hypoglycemic conditions (pallor of the skin, increased sweating, palpitations, tremors, chills, hunger, agitation, paresthesia, aesthesia of the oral mucosa, weakness, headache, dizziness, decreased visual acuity).

Severe hypoglycemia can lead to the development of hypoglycemic coma. Allergic reactions: skin rash, angioedema, anaphylactic shock.

Local reactions: hyperemia, swelling and itching at the injection site, with long-term use – lipodystrophy at the injection site.

*Other: edema, transient decrease in visual acuity (usually at the beginning of therapy). If the patient has noticed the development of hypoglycemia or has had an episode of loss of consciousness, he must immediately inform the doctor. If any other side effects not described above are detected, the patient should also consult a doctor.

Interaction

Pharmaceutically incompatible with solutions of other drugs. There are a number of medications that affect the need for insulin.

The hypoglycemic effect of insulin is enhanced by oral hypoglycemic drugs, monoamine oxidase inhibitors, angiotensin-converting enzyme inhibitors, carbonic anhydrase inhibitors, non-selective beta-blockers, – bromocriptine, octreotide, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium preparations, preparations containing ethanol.

The hypoglycemic effect of insulin is weakened by glucagon, somatropin, estrogens, oral contraceptives, glucocorticosteroids, iodine-containing thyroid hormones, thiazide diuretics, loop diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, epinephrine, H1-histamine blockers receptors, blockers of “slow” calcium channels, diazoxide, . morphine, phenytoin, nicotine.

Under the influence of reserpine and salicylates, it is possible to both weaken and enhance the effect of the drug.

Overdose

In case of overdose, hypoglycemia may develop.

Treatment: the patient can eliminate mild hypoglycemia himself by ingesting sugar or carbohydrate-rich foods.

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, a 40% dextrose (glucose) solution is administered intravenously; intramuscular, subcutaneous, intravenous glucagon. After regaining consciousness, the patient is advised to eat a meal rich in carbohydrates to prevent the recurrence of hypoglycemia.

Storage conditions

In a place protected from light at a temperature of 2 °C to 8 °C. Avoid freezing. The drug should be stored out of the reach of children.

Shelf life

2 years.

Manufacturer

Geropharm LLC, Russia