Derinat^® (Solution) Instructions for Use

ATC Code

L03AX (Other immunostimulants)

Active Substance

Sodium desoxyribonucleate

Clinical-Pharmacological Group

Immunomodulator

Pharmacotherapeutic Group

Immunostimulants; other immunostimulants

Pharmacological Action

An immunomodulator affecting cellular and humoral immunity. The immunomodulatory effect of Derinat^® is due to the stimulation of B-lymphocytes and activation of T-helpers.

Derinat^® activates the nonspecific resistance of the body, optimizing inflammatory responses and the immune response to bacterial, viral, and fungal antigens. Derinat^® stimulates reparative and regenerative processes.

It increases the body’s resistance to infections. It regulates hematopoiesis (normalizing the number of leukocytes, lymphocytes, granulocytes, phagocytes, platelets). Possessing pronounced lymphotropism, Derinat^® stimulates the drainage-detoxification function of the lymphatic system.

Derinat^® significantly reduces cell sensitivity to the damaging effects of chemotherapeutic drugs and radiation therapy.

Pharmacokinetics

Absorption and Distribution

It is rapidly absorbed from the injection site after intramuscular administration and distributed via lymphatic pathways to organs and tissues.

Sodium desoxyribonucleate has high tropism to hematopoietic organs, actively participates in cellular metabolism, integrating into cellular structures. It accumulates maximally in the bone marrow, lymph nodes, thymus, spleen, and to a lesser extent in the liver, brain, stomach, small and large intestine.

During the phase of intensive drug entry into the blood, redistribution occurs between plasma and blood cells, parallel with metabolism and excretion.

After a single injection, all pharmacokinetic curves describing the change in drug concentration in the studied organs and tissues are characterized by a rapid phase of increase and a rapid phase of decrease in concentration within the interval of 5-24 hours.

After intramuscular administration, C_max is reached after 5 hours. The drug penetrates the blood-brain barrier. C_max of the drug in the brain is reached after 30 minutes.

Metabolism and Excretion

Sodium desoxyribonucleate is metabolized in the body. It is excreted mainly by the kidneys and partially with feces. T_1/2 after intramuscular administration is 72.3 hours.

Indications

• Radiation injuries;
• Impaired hematopoiesis;
• Myelodepression and resistance to cytostatics in cancer patients, developed against the background of cytostatic and/or radiation therapy (stabilization of hematopoiesis, reduction of cardio- and myelotoxicity of chemotherapeutic drugs);
• Stomatitis induced by cytostatic therapy;
• Gastric and duodenal ulcer, erosive gastroduodenitis;
• Coronary artery disease;
• Obliterating diseases of the vessels of the lower extremities stages II-III;
• Trophic ulcers, long-term non-healing wounds;
• Odontogenic sepsis, purulent-septic complications;
• Rheumatoid arthritis;
• Burn disease;
• Preoperative and postoperative periods (in surgical practice);
• Chlamydia, ureaplasmosis, mycoplasmosis;
• Endometritis, salpingo-oophoritis, endometriosis, fibroids;
• Prostatitis, benign prostatic hyperplasia;
• Chronic obstructive pulmonary diseases;
• Pulmonary tuberculosis, inflammatory diseases of the respiratory tract.

ICD codes

Dosage Regimen

Solution

Derinat^® in the form of a solution for topical and external use is prescribed depending on the localization of the pathological process.

The drug is prescribed to children from the first day of life and adults.

For the prevention of acute respiratory viral infections (ARVI), instill 2 drops into each nasal passage 2-4 times/day for 1-2 weeks. When symptoms of a respiratory disease appear, instill 2-3 drops into each nasal passage every 1-1.5 hours during the first day, then 2-3 drops into each nasal passage 3-4 times/day. The duration of the course of therapy is from 5 days to 1 month.

For inflammatory diseases of the nasal cavity and paranasal sinuses, instill 3-5 drops into each nasal passage 4-6 times/day; the duration of the course is 7-15 days.

For inflammatory diseases of the oral cavity, rinse the mouth with the drug solution 4-6 times/day (1 bottle for 2-3 rinses). The duration of the course of therapy is 5-10 days.

For chronic inflammatory diseases, fungal, bacterial and other infections in gynecological practice – intravaginal administration of tampons with the drug or irrigation of the vagina and cervix with 5 ml per procedure 1-2 times/day for 10-14 days.

For hemorrhoids, the drug is administered rectally using microenemas of 15-40 ml. The duration of the course of treatment is 4-10 days.

In ophthalmological practice for severe inflammatory and dystrophic processes, Derinat^® is instilled into the eyes, 1-2 drops 2-3 times/day for 14-45 days.

For obliterating diseases of the lower extremities to achieve a systemic effect, instill 1-2 drops into each nasal passage 6 times/day, the duration of the course is up to 6 months.

For post-radiation necrosis of the skin and mucous membranes, for long-term non-healing wounds, burns, frostbite, trophic ulcers of various etiologies, gangrene, it is recommended to apply application dressings (gauze in 2 layers) with the drug applied 3-4 times/day or treat the affected surface with the drug from a sprayer 10-40 ml 4-5 times/day. The course of treatment is 1-3 months.

Adverse Reactions

Possibly, in patients with diabetes mellitus, a hypoglycemic effect is noted, which should be taken into account by monitoring blood glucose levels.

Contraindications

• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The patient should be warned that before using the drug during pregnancy and lactation, a doctor’s consultation is necessary. If it is necessary to prescribe the drug during pregnancy, the expected benefit for the mother and the potential risk to the fetus should be assessed.

Pediatric Use

For children, the frequency of intramuscular administration of the drug is the same as for adults. For children under 2 years of age, the drug is prescribed at an average single dose of 7.5 mg (0.5 ml of solution for intramuscular injection 15 mg/ml), for children aged 2 to 10 years, the single dose is determined at the rate of 0.5 ml of the drug per year of life. For children over 10 years of age, the average single dose is 75 mg (5 ml of solution for intramuscular injection 15 mg/ml), the course dose is up to 5 injections of the drug.

Special Precautions

The drug does not have embryotoxic, teratogenic, or carcinogenic effects.

Subcutaneous administration of the drug is possible.

The drug potentiates the therapeutic effect of basic therapy for gastric and duodenal ulcers.

Derinat^® reduces the iatrogenicity of basic drugs in the treatment of rheumatoid arthritis, achieving 50% and 70% improvement according to a number of complex indicators of disease activity.

In surgical sepsis, the inclusion of Derinat^® in complex therapy causes a decrease in the level of intoxication, activation of immunity, normalization of hematopoiesis, and improves the function of organs responsible for the processes of detoxification of the internal environment of the body (including lymph nodes, spleen).

According to recent clinical studies, the efficacy of Derinat^® has been proven in patients with exacerbation of COPD of varying severity against the background of standard therapy. It is prescribed intramuscularly 5 ml of a 15 mg/ml solution every 24-48 hours, the course of treatment is 5-10 injections.

Overdose

No symptoms of overdose have been observed.

Drug Interactions

The use of Derinat^® in complex therapy allows increasing the effectiveness and reducing the duration of therapy, with a significant reduction in the doses of antibiotics and antiviral agents and an increase in remission periods.

Derinat^® increases the effectiveness of anthracycline antitumor antibiotics and cytostatics.

Storage Conditions

The drug should be stored out of the reach of children, protected from light, at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 5 years.

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.