Description
One suppository contains
- Active ingredient – sodium aminodihydrophthalazinedione (Galavit®) 100 mg,
- excipients: witepsol W-35 (fatty acid glycerides, witepsol H-15 (fatty acid glycerides)
Pharmacological properties
Pharmacokinetics
Galavit® is quickly absorbed, penetrates into organs, tissues and biological fluids. The maximum plasma concentration after rectal administration is reached after 23 minutes. Communication with plasma proteins – 6%. The maximum concentration of the drug is in the kidneys, the minimum in the muscles and brain tissues. The absolute bioavailability of Galavit® with rectal administration is 61%. The drug penetrates the blood-brain and placental barrier. It is excreted from the body mainly through the kidneys. After rectal administration, the half-life of the drug is 40-60 minutes.
Pharmacodynamics
Galavit® is used as an immunomodulatory and anti-inflammatory agent in the complex therapy of immunodeficiency states. The mechanism of action of the drug is associated with its ability to affect the functional and metabolic activity of phagocytic cells (monocytes / macrophages, neutrophils, natural killers). In addition, Galavit® normalizes antibody formation, indirectly stimulates the production of endogenous interferons (IFN-α, IFN-γ).
In inflammatory diseases, the drug reversibly inhibits for 6-8 hours the excessive synthesis of hyperactivated macrophages of tumor necrosis factor-α, interleukin-1, interleukin-6 and other pro-inflammatory cytokines, reactive oxygen species, the level of which determines the degree of inflammatory reactions, their cyclicity, as well as the severity intoxication and the level of oxidative stress. Normalization of the functional state of macrophages leads to the restoration of the antigen presenting and regulatory functions of macrophages, and a decrease in the level of autoaggression. Stimulates the bactericidal activity of neutrophilic granulocytes, enhancing phagocytosis and increasing the body’s nonspecific resistance to infectious diseases. The main pharmacological effects (immunomodulatory and anti-inflammatory) are observed within 72 hours.
Indications for use
As an immunomodulating and anti-inflammatory agent in the complex therapy of immunodeficiency conditions in adults and adolescents over 12 years of age:
- infectious and inflammatory urogenital diseases (urethritis of chlamydial and trichomonas etiology, chlamydial prostatitis, acute and chronic salpingo-oophoritis, endometritis);
- purulent-inflammatory diseases of the pelvic organs;
- chronic recurrent diseases caused by the herpes virus;
- diseases caused by the papilloma virus;
- postoperative rehabilitation of patients with uterine myoma;
- complications of the postoperative period in women of reproductive age;
- postoperative purulent-septic complications and their prevention (including in cancer patients);
- chronic recurrent furunculosis, erysipelas;
- nonspecific prevention and treatment of influenza and acute respiratory infections.
- inflammatory diseases of the mucous membrane of the mouth and throat, periodontal disease;
- viral hepatitis;
- infectious intestinal diseases accompanied by intoxication and / or diarrhea;
- peptic ulcer of the stomach and duodenum;
- asthenic conditions, neurotic and somatoform disorders, decreased physical performance (including in athletes); mental, behavioral and post-withdrawal disorders in alcohol and drug addiction;
Dosage and administration
Adults and children over 12 years old.
Rectally. The suppository is released from the contour packaging and then injected into the rectum. It is preliminary recommended to empty the intestines.
The dose and duration of the drug depends on the nature, severity and duration of the disease.
– In chronic recurrent diseases caused by the herpes virus type 1 and 2 for 5 days, 1 suppository 1 time per day, then 1 suppository every other day. The duration of treatment is up to 5 weeks.
– In diseases caused by the human papillomavirus: 5 days, 1 suppository 1 time per day, then 1 suppository every other day. Course duration up to 5 weeks.
– In urogenital diseases – urethritis of chlamydial and trichomonas etiology, chlamydial prostatitis: 1 day, 1 suppository twice, then 1 suppository every other day. The course is up to 4 weeks (depending on the severity of the pathological process).
With salpingoophoritis, endometritis in the acute period: 2 days, 2 suppositories once (enter sequentially one after the other), then one at a time with an interval of 72 hours. In the chronic period: 5 days, 1 suppository 1 time per day, then one every 72 hours. The course of treatment is up to 7 weeks.
– In acute and chronic purulent diseases of the pelvic organs – in the acute period: on the 1st day, 2 suppositories once (successively one after the other), then for the next 3 days, one suppository daily, then one suppository every other day – 5 days. The course is up to 2 weeks. In the chronic period: 5 days, 1 suppository 1 time per day, then one every 72 hours. Course up to 7 weeks.
– For postoperative rehabilitation of patients with uterine myoma and complications of the postoperative period in women of reproductive age: 5 days, 1 suppository 1 time per day, then one suppository every other day. The course is up to 4 weeks.
– For the prevention and treatment of surgical complications in the pre- and postoperative period (including in cancer patients): appoint 1 suppository 1 time per day – 5 suppositories before surgery, 5 after surgery, one every other day and 5 suppositories – c interval of 72 hours. In severe cases of the disease, the initial dose is 2 suppositories once or 2 times a day, one at a time. The course is up to 4 weeks.
– In chronic recurrent furunculosis, erysipelas: 5 days, one suppository 1 time per day, then one suppository every other day. Course up to 5 weeks.
– With asthenic conditions, neurotic and somatoform disorders, with mental, behavioral and post-abstinence disorders, in patients with alcohol and drug addiction: 5 days, one suppository daily, then one suppository every 72 hours. Course up to 7 weeks. To increase physical performance: 1 suppository every other day – 5 suppositories, then one at a time – after 72 hours, the course – up to 8 weeks.
– For non-specific prevention and treatment of influenza and acute respiratory infections, one suppository 1 time per day. Course 5 days.
For elderly patients, doses are not adjusted.
Side effects
Rarely (from 0.01% to 0.1%)
– allergic reactions from the skin and subcutaneous tissues: skin rash, itching, urticaria
Contraindications
– individual sensitivity to the drug
– pregnancy and lactation
– children’s age up to 12 years
Drug Interactions
With simultaneous use, it is possible to reduce the course doses of antibiotics. Cases of incompatibility with other drugs have not been noted.
Special instructions
Application in pediatrics
The drug is not prescribed to children under 12 years of age.
Pregnancy and lactation
The drug is not prescribed to pregnant women, women during breastfeeding
Features of the effect of the drug on the ability to drive a vehicle and potentially dangerous mechanisms
Does not affect.
Overdose
There are no data on cases of overdose of Galavit®.
Storage conditions
Store in a dry, dark place at a temperature not exceeding 25°C.
Keep out of the reach of children!
Shelf life – 3 years
Do not use after the expiration date.
Additional information
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