GALAVIT is a new immunomodulator in the treatment of patients with urogenital infections

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.

General information

Registration number P N000088/03
Trade name Galavit®

INN or group name Aminodihydrophthalazindione sodium

Chemical name: 5-amino-1,2,3,4-tetrahydrophthalazine-1,4-dione sodium salt

Dosage form: Rectal suppositories

Compound

Active ingredient – ​​sodium aminodihydrophthalazindione (Galavit®) 100 mg; excipients - vitepsol W-35 (fatty acid glycerides) - 575 mg, vitepsol H-15 (fatty acid glycerides) - 575 mg.

Description

Suppositories are white to white with a yellowish tint, torpedo-shaped without visible inclusions on the longitudinal section.

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.).

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, Galavit normalizes antibody formation 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 rectal administration, the half-life is 40-60 minutes. The main pharmacological effects are observed within 72 hours. Aminodihydrophthalazindione sodium in suppositories when administered rectally has high bioavailability, and therefore both local and pronounced systemic effects are achieved.

Indications for use

In adults and adolescents over 12 years of age (including those with secondary immune deficiency) as an immunomodulatory and anti-inflammatory agent in complex therapy:

• infectious and inflammatory urogenital diseases (urethritis of chlamydial and trichomonas etiology, chlamydial prostatitis, acute and chronic salpingoophoritis, 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 fibroids;
• 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 diseases;
• 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.

Directions for use and doses

Rectally. The suppository is released from the contour packaging and then inserted into the rectum. It is recommended to empty the intestines first. The dose and duration of use of the drug depends on the nature, severity and duration of the disease.

• For urogenital diseases - urethritis of chlamydial and trichomonas etiology, chlamydial prostatitis: 1 day, 1 suppository twice, then one suppository every other day. A course of 10-15 suppositories (depending on the severity of the pathological process).
• For salpingoophoritis, endometritis in the acute period: 2 days, 2 suppositories once a day, then one at an interval of 72 hours. In the chronic period: 5 days, 1 suppository once a day, then one every 72 hours. Course - 20 suppositories.
• For acute and chronic purulent diseases of the pelvic organs - in the acute period: 1 day, 2 suppositories once, 3 days, one suppository daily, then one every other day for 5 days. Course - 10 suppositories. In the chronic period: 5 days, 1 suppository once a day, then one every 72 hours. Course – 20 suppositories
• For chronic recurrent diseases caused by the herpes virus: 1 suppository daily - 5 suppositories, then one every other day - 15 suppositories.
• For diseases caused by the papilloma virus: 5 days, 1 suppository once a day, then one suppository every other day. Course - 20 suppositories.
• For postoperative rehabilitation of patients with uterine fibroids and complications of the postoperative period in women of reproductive age: 5 days, 1 suppository once a day, then one suppository every other day. Course - 15 suppositories.
• For the prevention and treatment of surgical complications in the pre- and postoperative period (including in cancer patients): 1 suppository is prescribed once a day - 5 suppositories before surgery, 5 after surgery, one every other day and 5 suppositories at intervals 72 hours. In severe cases of the disease, the initial dose is 2 suppositories once or 2 times a day, one at a time. Course - 20 suppositories.
• For chronic recurrent furunculosis, erysipelas: 5 days, one suppository once a day, then one suppository every other day. Course - 20 suppositories.
• For nonspecific prevention and treatment of influenza and acute respiratory infections: one suppository 1 time per day. Course 5 days.
• For inflammatory diseases of the mucous membrane of the mouth and throat, periodontal diseases: initial dose of 1 suppository daily - 5 suppositories, then one at an interval of 72 hours. Course 15 suppositories.
• For viral hepatitis: the initial dose is 2 suppositories once, then one suppository 2 times a day until the symptoms of intoxication and inflammation subside. Subsequent continuation of the course of 1 suppository with an interval of 72 hours. Course 20 -25 suppositories.
• For acute infectious intestinal diseases accompanied by diarrhea syndrome: the initial dose is 2 suppositories once, then 1 suppository 2 times a day until the symptoms of intoxication are relieved. It is possible to subsequently continue the course of 1 suppository with an interval of 72 hours. A course of 20-25 suppositories.
• For gastric and duodenal ulcers in the acute period: 2 days, 2 suppositories once a day, then 1 suppository at intervals of 72 hours. A course of 15-25 suppositories. In the chronic period: 5 days, 1 suppository once a day, then one suppository every 72 hours. Course of 20 suppositories.
• For asthenic conditions, neurotic and somatoform disorders, for mental, behavioral and post-abstinence disorders, in patients with alcohol and drug addiction: 5 days, one suppository daily, then one suppository every 72 hours. A course of 15-20 suppositories. To increase physical performance: 1 suppository every other day – 5 suppositories, then one suppository after 72 hours, course – up to 20 suppositories.

Precautionary measures

Contraindications

Hypersensitivity to Galavit and other components of the drug, pregnancy and breastfeeding, children under 12 years of age.

Use during pregnancy and breastfeeding:

The use of the drug is contraindicated during pregnancy and breastfeeding.

Side effects

In rare cases, allergic reactions are possible. If you experience the side effects listed in the instructions or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

No cases of overdose have been reported.

Interaction with other drugs

With simultaneous use, it is possible to reduce the course doses of antibiotics. There are no cases of incompatibility with other drugs.

Impact on the ability to drive vehicles and machinery:

Not studied

Special instructions:

To prevent urogenital infection, it is recommended to consider simultaneous treatment of the sexual partner.

Shelf life, storage conditions

Release form

Rectal suppositories 100 mg. 5 pieces in a blister pack, 1 or 2 blister packs with instructions for use in a cardboard box.

Best before date

3 years. Do not use after the expiration date indicated on the carton.

Storage conditions:

Store in a dry place, protected from light, out of reach of children, at a temperature not exceeding 25 °C.

Vacation conditions:

Over the counter.

Name, address of the manufacturer of the medicinal product and address of the place of production of the medicinal product.

, address: 123290, Russia, Moscow, Magistralny 1st dead end, 5A, room. 91.

Tel. 8-800-707-71-81.

Email; https://www.galavit.ru

Address of production place: 308013, Belgorod, st. Rabochaya, 14.

Send claims to the address: 123290, Moscow, Magistralny 1st dead end, 5A, room. 91. Tel. 8-800-707-71-81.

Drugs with complex action for the treatment of prostatitis

A universal remedy for the treatment of diseases of the urogenital tract is the drug Galavit. It affects many parts of the mechanism of development of diseases of the genitourinary system, including being used for prostatitis.

Suppositories for prostatitis Galavit have the following types of action:

• Anti-inflammatory.
  Galavit controls the inflammation process by modulating an adequate response of the immune system, reducing the severity and severity of symptoms such as pain, swelling and temperature.
• Restorative (regenerative).
  At the site of inflammation, Galavit reduces the production of reactive oxygen species, protecting tissues and organs from the destructive effects of radicals. The use of Galavit accelerates the process of physiological recovery and reduces the likelihood of the formation of rough scar tissue.
• Immunomodulatory.
  By restoring the reduced activity of innate and adaptive immune cells, Galavit increases the body’s resistance to infectious diseases and promotes faster elimination of pathogens from the body.
• Antioxidant.
  Due to its antioxidant effect, Galavit reduces the severity of intoxication in the body and improves well-being.

The complex action of Galavit speeds up recovery and reduces the risk of chronicity and complications. In addition, Galavit candles are indicated for the following conditions:

• Infectious and inflammatory urogenital diseases caused by chlamydia or trichomonas
• Prostatitis
• Urethritis
• Chronic recurrent diseases caused by the herpes virus
• Diseases caused by human papillomavirus (HPV)
• Prevention and treatment of postoperative purulent-septic complications, including in cancer patients

When to use suppositories to treat prostatitis in men?

Diseases of the genitourinary system bring a lot of trouble: they worsen the functions of the reproductive system, reduce productivity, affect self-esteem, and sometimes lead to divorce. They can be asymptomatic and cause irreversible changes in organs and tissues. To cure prostatitis and prevent relapse, treatment must be approached comprehensively. That is, it is necessary not only to reduce the severity of symptoms, but also to influence the cause and mechanism of development of the pathology.

Suppositories for prostatitis, unlike other drugs used orally, begin to act faster. This is due to the characteristics of absorption, distribution and transformation of the drug. When using suppositories, interactions in the stomach and intestines with other drugs used orally are eliminated, and the risk of adverse side reactions is reduced. It is important that in the treatment of urogenital diseases, suppositories have not only a general effect, but also a local one.

GALAVIT is a new immunomodulator in the treatment of patients with urogenital infections

We prescribed GALAVIT to patients with urogenital infections (chlamydial urethritis and prostatitis) in injection form and in the form of rectal suppositories. GALAVIT was included in the complex therapy of patients (17 people) with chlamydial urethritis and prostatitis. The course of treatment consisted of 7 injections of the drug intramuscularly at a dose of 0.1 g: daily in the first 2 days, then 2 times a week. During a control microbiological examination of patients a month after the end of treatment, chlamydia was not detected in 15 people. Antibacterial-sensitive forms of Chlamydia trachomatis were found in 2 patients.

An immunological study after treatment with GALAVIT noted an increase in the number of CD4+ lymphocytes and NK cells (natural killer cells), as well as an increase in the level of interferons to subnormal values. An increase in the level of immunoglobulins IgA and IgM was also observed. Let us recall that IgA plays an important role in protecting mucous membranes from infectious agents.

The use of GALAVIT in the form of suppositories as part of complex therapy for chlamydial urethritis and prostatitis is promising. The dose of the active substance in this dosage form is 0.1 g. Rectal suppositories were prescribed according to two different regimens. The first group of patients with chlamydial urethritis and prostatitis (30 people) used the drug once a day. 2 months after completion of the course of treatment, direct immunofluorescence revealed complete elimination of the pathogen in 96% of cases. An immunological study revealed an increase in the number of T-helper cells and IgA in the peripheral blood. The microscopic picture of prostate secretion also normalized and the laboratory parameters of the ejaculate improved. Ultrasound examination of the prostate showed an improvement in its structure.

Rectal suppositories were also used daily 2 times a day (morning and evening) for 10 days in the treatment regimen of 15 patients with chronic chlamydial urethritis and prostatitis. In all patients, after the course of treatment, the clinical manifestations of the disease (pain in the urethra, pain and discomfort in the perineum, pathological discharge from the urethra) completely disappeared, and the erection improved. In a control study using polymerase chain reaction (PCR), after 1 month, chlamydia disappeared in 13 patients and persisted in only 2 patients. These results allow us to conclude that GALAVIT is highly effective in the complex treatment of chlamydial urogenital infections.

As noted, in addition to chlamydia, protozoa (Trichomonas) are common causative agents of urogenital infections. We have accumulated experience in using GALAVIT in the treatment of men with Trichomonas urethritis without symptoms of prostatitis. We observed 25 patients who were diagnosed based on a morphological examination of scrapings from the urethra using a microscopic method and the PCR method. 13 patients (Group I) received etiotropic chemotherapy drugs (metronidazole, ornidazole or nimorozole) in combination with GALAVIT (3 times a week intramuscularly, 0.1 g), 12 patients (Group II) were prescribed only chemotherapy drugs. After completing the course of treatment, Trichomonas was not detected in scrapings from the urethra in all patients of group I. In group II, after the course of treatment, it was possible to achieve elimination of the pathogen in only 6 patients.

Thus, the use of GALAVIT has shown its high effectiveness in the complex treatment of patients with urogenital diseases of chlamydial and trichomonas etiology. Complete clinical recovery and disappearance of pathogens were noted in the majority of patients who were prescribed GALAVIT, in contrast to patients from the control groups. In addition, the use of GALAVIT in complex therapy made it possible to significantly shorten the treatment period, significantly reduce the dose of antibacterial drugs, and reduce the frequency of distant relapses of the disease.

Assessing the results of treatment of patients with urogenital diseases of chlamydial and trichomonas etiology, it can be noted that GALAVIT, used in complex therapy, has a number of positive properties. High efficiency and good tolerability make it possible to recommend GALAVIT as an immunomodulator as part of complex therapy for the treatment and prevention of sexually transmitted infections. o

BASIC SCHEMES AND TACTICS OF USING GALAVIT

The route of administration and dosage may vary depending on the disease. When treating urogenital infections, GALAVIT is prescribed according to the following regimen: 10 injections of 0.1 g intramuscularly every other day. Depending on the severity of the pathological process, the number of injections can be increased to 15 –

25. In order to quickly stop the pathological process during exacerbations and septic conditions, GALAVIT can be prescribed in the first 2 days, 0.1 g daily. GALAVIT has the ability to enhance the effect of the main etiotropic agents of basic therapy: antimicrobial drugs, interferons and their inducers. Therefore, in case of secondary immunodeficiency states, it is advisable to prescribe it, according to indications, simultaneously with chemotherapeutic drugs: antibacterial, antifungal or antiviral agents (Ovchinnikov A.A., 1998; Stanulis A.I., Grishina T.I., 2002; Latysheva T.V., Shcherbakova O.A., 2004; Khaitov R.M., 2004). GALAVIT increases the functional activity of cells of the phagocytic system, stimulating their ability to absorb and destroy extracellular pathogens (microbicidal activity), as well as NK cells and T lymphocytes, helping them destroy cells infected with intracellular pathogens. In turn, antimicrobial chemotherapeutic drugs, exhibiting microbicidal or microbostatic activity, make pathogens more sensitive to the action of nonspecific resistance factors of the body: macrophages, NK cells and T lymphocytes.

I.A. Usovetsky, Candidate of Medical Sciences, Dermatovenerologic Dispensary No. 10, Moscow