General information
Registration number P N000088/02
Trade name: Galavit®
INN or group name: Sodium aminodihydrophthalazindione.
Dosage form: powder for the preparation of a solution for intramuscular administration.
Compound:
Active ingredient: sodium aminodihydrophthalazindione - 50 mg and 100 mg.
Pharmacotherapeutic group:
Immunomodulatory and anti-inflammatory agent.
ATX code: L03, G02.
Pharmacological properties
Pharmacodynamics
The mechanism of action of the drug is associated with its ability to regulate the functional and metabolic activity of innate and adaptive immune cells (monocytes, macrophages, neutrophils, natural killer cells, etc.). The drug Galavit normalizes the phagocytic activity of monocytes/macrophages, the bactericidal activity of neutrophils and the cytotoxic activity of NK cells.
At the same time, by restoring the reduced activity of innate and adaptive immune cells, the drug increases the body’s resistance to infectious diseases.
In addition, the drug Galavit normalizes antibody formation, indirectly stimulates the production of endogenous interferons (IFN-α, IFN-γ), and increases the functional activity (affinity) of antibodies.
In inflammatory diseases, the drug reversibly inhibits for 6-8 hours the excessive synthesis of tumor necrosis factor-α, interleukin-1, interleukin-6 and other pro-inflammatory cytokines by hyperactivated macrophages, the level of which determines the degree of inflammatory reactions, their cyclicity, as well as the severity of intoxication of the body.
Galavit reduces the production of reactive oxygen species by hyperactivated macrophages, thereby reducing the level of oxidative stress and protecting tissues and organs from the destructive effects of radicals.
Normalization of excessively increased functional activity of phagocytic cells leads to the restoration of their antigen-presenting and regulatory functions, and a decrease in the level of autoaggression.
The drug has no allergenic, mutagenic, embryotoxic, teratogenic or carcinogenic effects.
Pharmacokinetics
It is excreted from the body mainly through the kidneys. After intramuscular injection, the half-life is 30-40 minutes. The main pharmacological effects are observed within 72 hours.
GALAVIT powder for the preparation of solution for intramuscular administration 100 mg bottles No. 5
The dosage regimen and duration of therapy are set individually depending on the nature, severity and duration of the disease. To prepare a solution for intramuscular injection, the drug in the form of a powder for preparing a solution for injection is diluted in 2 ml of water for injection or in 0.9% sodium chloride solution. Adults For acute intestinal infections accompanied by diarrhea, the initial single dose is 200 mg once. Then the drug is administered at a dose of 100 mg 2 times a day until the symptoms of intoxication are relieved. It is possible to subsequently continue the course of 100 mg at intervals of 72 hours. The course is 20-25 injections. For peptic ulcer of the stomach and duodenum in the acute period - 2 days, 200 mg 1 time / day, then - 100 mg with an interval of 72 hours. A course of 15-25 injections. In the chronic period - for 5 days, 100 mg 1 time / day, then - 100 mg every 72 hours. Course - 20 injections. For viral hepatitis of various etiologies in the acute period of the disease, the initial dose is 200 mg once, then 100 mg 2 times a day until the symptoms of intoxication and inflammation are relieved. Subsequent continuation of the course of therapy at a dose of 100 mg with an interval of 72 hours. The course is 20-25 injections. For chronic recurrent herpes infection, the drug is prescribed 100 mg daily for 5 injections, then 100 mg every other day for 15 injections. For diseases caused by HPV, the drug is prescribed for 5 days at 100 mg 1 time / day, then 100 mg every other day. The course is 20 injections. For urogenital infections (chlamydial and trichomonas urethritis, chlamydial prostatitis), the drug is prescribed at 100 mg 2 times a day for 1 day, then switched to administering the drug at 100 mg every other day. The course is 10-15 injections, depending on the severity of the pathological process. For salpingoophoritis and endometritis in the acute period, the drug is prescribed for 2 days at 200 mg 1 time / day, then 100 mg at intervals of 72 hours. The course is 20 injections. In the chronic period, the drug is prescribed for 5 days, 100 mg 1 time/day, then 100 mg every 72 hours. The course is 20 injections. For acute and chronic PID in the acute period, the drug is prescribed for 1 day, 200 mg 1 time/day, then for 3 days, 100 mg daily, then 100 mg every other day, 5 injections. Course - 20 injections. In the chronic period, the drug is prescribed for 5 days, 100 mg 1 time/day, then 100 mg every 72 hours. The course is 20 injections. For postoperative rehabilitation of patients with uterine fibroids and complications of the postoperative period in patients of reproductive age, the drug is prescribed for 5 days, 100 mg 1 time / day, then 100 mg every other day. The course consists of 15 injections. For the prevention and treatment of surgical complications in the preoperative and postoperative period (including in cancer patients), the drug is prescribed at a dose of 100 mg 1 time/day. Before surgery, 5 injections, after surgery, 100 mg every other day and 5 injections with an interval of 72 hours. For severe disease, the initial dose is 200 mg 1 time / day or 100 mg 2 times / day. Course - 20 injections. For chronic recurrent furunculosis and erysipelas, 100 mg of the drug is prescribed once a day for 5 days, then 100 mg every other day. Course - 20 injections. For asthenic conditions, neurotic and somatoform disorders, for mental, behavioral and post-withdrawal disorders, alcohol and drug addiction, the drug is prescribed for 5 days, 100 mg 1 time / day, then 100 mg every 72 hours. The course is 15-20 injections . To increase physical performance, the drug is prescribed 100 mg every other day for 5 injections, then 100 mg every 72 hours. The course is up to 20 injections. For inflammatory diseases of the mucous membrane of the oral cavity and pharynx, periodontal diseases, the initial dose is 100 mg daily for 5 injections, then 100 mg at intervals of 72 hours. The course is 15 injections. Children over 6 years of age For purulent surgical diseases (including burn lesions, recurrent furunculosis, chronic osteomyelitis, gangrenous appendicitis with omentitis, peritonitis, purulent pleurisy) the drug is prescribed to children aged 6 to 11 years - 1 injection of 50 mg 1 time/day for 5 days, then 1 injection of 50 mg every other day for 10-15 days. The course is 10-15 injections. Children aged 12 to 18 years are treated according to the same regimen in the form of intramuscular injections of 100 mg. When dressings, it is desirable to apply Galavit externally in the form of dressings with sterile napkins moistened with a 1% solution of Galavit in water for injection (in dressings with mash or water-soluble ointment dressings). For frequent recurrent diseases of the respiratory tract and ENT organs of bacterial and viral etiology (frequent acute respiratory viral infections, bronchitis, pneumonia, chronic tonsillitis, chronic otitis, chronic adenoiditis) for children aged 6 to 11 years, the drug is prescribed 1 injection of 50 mg 1 time / day for 5 days, then 50 mg 1 time/day every other day for 10-15 days. The course is 10-15 injections. Children aged 12 to 18 years are treated according to the same regimen in the form of intramuscular injections of 100 mg.
Galavit® (Galavit)
Intramuscularly. Before administration, the drug is diluted in 2 ml of water for injection or 0.9% sodium chloride solution. Methods of application, doses and duration of use are selected by the doctor depending on the diagnosis, severity of the disease, and age of the patient.
— For gastric and duodenal ulcers in the acute period: 2 days, 200 mg once a day, then 100 mg at intervals of 72 hours. A course of 15-25 injections. In the chronic period: 5 days, 100 mg once a day, then 100 mg every 72 hours. Course of 20 injections.
— For viral hepatitis, the initial dose is 200 mg once, then 100 mg 2 times a day until the symptoms of intoxication and inflammation subside. Subsequent continuation of the course of 100 mg at intervals of 72 hours. Course 20 -25 injections.
— For chronic recurrent diseases caused by the herpes virus: 100 mg daily for 5 injections, then 100 mg every other day for 15 injections.
— For diseases caused by the papilloma virus, 100 mg 1 time per day for 5 days, then 100 mg every other day for 15 injections. Course - 20 injections.
- For urogenital diseases - urethritis of chlamydial and trichomonas etiology, chlamydial prostatitis - 100 mg twice a day for 1 day, then 100 mg every other day. A course of 10-15 injections (depending on the severity of the pathological process).
— For salpingoophoritis, endometritis in the acute period, 200 mg 1 time per day for 2 days, then 100 mg at intervals of 72 hours, duration of use depends on the severity of the disease. There are a total of 20 injections per course. In the chronic period - 5 days, 100 mg once a day, then 100 mg every 72 hours. Course of 20 injections.
- For acute and chronic purulent diseases of the pelvic organs: in the acute period - 1 day 200 mg once, 3 days 100 mg daily, then 100 mg every other day 5 injections. Course of 10 injections. In the chronic period - 5 days, 100 mg once a day, then 100 mg every 72 hours. Course - 20 injections.
— For postoperative rehabilitation of patients with uterine fibroids and complications of the postoperative period in women of reproductive age: 5 days, 100 mg once a day, then 100 mg every other day. Course - 15 injections.
— For the prevention and treatment of postoperative infectious complications in the pre- and postoperative period (including in cancer patients), 100 mg is prescribed once a day, 5 injections before surgery, 5 after surgery, 100 mg every other day, and 5 injections of 100 mg. with an interval of 72 hours. For severe disease, the initial dose is 200 mg once or 100 mg 2 times a day. Course - 20 injections.
- For chronic recurrent furunculosis, erysipelas - 5 days, 100 mg once a day, then 100 mg every other day. Course of 20 injections.
— For asthenic conditions, neurotic and somatoform disorders, for mental, behavioral and post-abstinence disorders, in patients with alcohol and drug addiction: 5 days, 100 mg daily, then 100 mg every 72 hours. A course of 15-20 injections. To increase physical performance: 100 mg every other day - 5 injections, then 100 mg every 72 hours, course up to 20 injections.
— For inflammatory diseases of the mucous membrane of the mouth and throat, periodontal diseases: initial dose of 100 mg daily for 5 injections, then 100 mg at intervals of 72 hours. Course of 15 injections.
In adults and adolescents over 12 years of age in monotherapy:
- acute and chronic infectious and inflammatory diseases of the gastrointestinal tract, accompanied by intoxication and/or diarrhea: 200 mg once, then 100 mg 2 times a day until the symptoms of intoxication are relieved. It is possible to subsequently continue the course of 100 mg at intervals of 72 hours. A course of 20-25 injections.
— chronic urogenital infections, including when carrying out immunorehabilitation measures during the inter-relapse period in order to maintain clinical remission: 100 mg every other day for a course of 10 injections.
In children over 6 years of age:
— For purulent surgical diseases (burn lesions, recurrent furunculosis, chronic osteomyelitis, gangrenous appendicitis with omentitis, peritonitis, purulent pleurisy): children from 6 to 11 years old, one injection of 50 mg daily - 5 days, then one injection of 50 mg every other day within 10-15 days. Course 10-15 injections; children aged 12-18 years - treatment is carried out according to the same scheme in the form of intramuscular injections of 100 mg. When dressings, it is desirable to apply Galavit externally in the form of dressings with sterile napkins moistened with a 1% solution of Galavit in water for injection (in dressings with mash or water-soluble ointment dressings).
— For frequent recurrent diseases of the respiratory tract and ENT organs of bacterial and viral etiology (frequent ARVI, bronchitis, pneumonia, chronic tonsillitis, chronic otitis, chronic adenoiditis): children from 6 to 11 years old, one injection of 50 mg daily for 5 days, then 50 mg once a day every other day for 10-15 days. A course of 10-15 injections. Children aged 12-18 years - treatment according to the same regimen in the form of intramuscular injections of 100 mg.
