Composition
Composition per suppository: Â
Active ingredient:
azoximer bromide – 12 mg
Excipients (for a dosage of 12 mg):
mannitol-3.6 mg;
povidone K 17-2.4 mg;
cocoa butter-1282 mg
Pharmacological action
Azoximer bromide has a complex immunomodulatory, detoxifying, antioxidant, moderate anti-inflammatory effect.
The mechanism of immunomodulatory action of azoximer bromide is based on direct action on phagocytic cells and natural killers, as well as stimulation of antibody formation, interferon-alpha and interferon-gamma synthesis.
Detoxification and antioxidant properties of azoximer bromide are largely determined by the structure and high-molecular nature of the drug.
Azoximer bromide increases the body’s resistance to local and generalized infections of bacterial, fungal and viral etiology. Restores immunity in secondary immunodeficiency conditions caused by various infections, injuries, complications after surgery, burns, autoimmune diseases, malignant neoplasms, the use of chemotherapeutic agents, cytostatics, and steroid hormones.
A characteristic feature of azoximer bromide for local (intranasal, sublingual) use is the ability to activate factors of early protection of the body against infection: the drug stimulates the bactericidal properties of neutrophils, macrophages, enhances their ability to absorb bacteria, increases the bactericidal properties of saliva and secretions of the upper respiratory tract mucosa.
Azoximer bromide blocks soluble toxic substances and microparticles, has the ability to remove toxins and heavy metal salts from the body, and inhibits lipid peroxidation, both by intercepting free radicals and by eliminating catalytically active Fe2+ions.
Azoximer bromide reduces the inflammatory response by normalizing the synthesis of pro-and anti-inflammatory cytokines.
Azoximer bromide is well tolerated, does not have mitogenic, polyclonal activity, antigenic properties, and does not have allergenic, mutagenic, embryotoxic, teratogenic, or carcinogenic effects. Azoximer bromide is odorless and tasteless, and has no local irritant effect when applied to the mucous membranes of the nose and oropharynx.
Indications
In adults and children over 6 years of age — treatment and prevention of infectious and inflammatory diseases (viral, bacterial and fungal etiology), in the stage of exacerbation and remission.
For treatment (in complex therapy):
acute exacerbation of chronic recurrent infectious and inflammatory diseases of various localization, bacterial, viral and fungal etiology;
inflammatory diseases of the urogenital tract (urethritis, cystitis, pyelonephritis, prostatitis, oophoritis, endomyometritis, colpitis, cervicitis, services, bacterial vaginosis);
various forms of pulmonary tuberculosis;
allergies (including hay fever, bronchial asthma, atopic dermatitis), complicated by recurrent bacterial, fungal and viral infection;
rheumatoid arthritis complicated by recurrent bacterial, fungal and viral infection on the background of prolonged use of immunosuppressive drugs;
to activate regenerative processes (fractures, burns, trophic ulcers);
in Oncology during and after chemo – and radiation therapy — reducing immunosuppressive, nephrotoxicity and hepatotoxicity of drugs.
For prevention (monotherapy):
recurrent herpetic infection of the urogenital tract;
exacerbations of chronic foci of infections;
influenza and other acute respiratory infections in the pre-epidemic and epidemic period in immunocompromised individuals;
secondary immunodeficiency resulting from aging or exposure to adverse factors.
Use during pregnancy and lactation
Polyoxidonium is contraindicated in pregnancy, breast-feeding and children under 6 months of age (there is no clinical experience with its use).
Recommendations for use
The drug should be used only according to the indications, the method of use and in the doses indicated in the instructions. If there is no improvement after treatment, or if the symptoms worsen or new symptoms appear, you should consult your doctor. 1 time a day, every other day, or 2 times a week.
If necessary, it is possible to conduct repeated courses of therapy in 3-4 months. With repeated use of the drug, its effectiveness does not decrease.
Recommended drug regimens
For treatment in adults:
– rectally,1 supp. 1 time a day after bowel cleansing;
– vaginally, in gynecological diseases,1 supp. 1 time a day (at night) is inserted into the vagina in the supine position.
Dosage and use for adults
– for chronic infectious and inflammatory diseases in the acute stage-suppositories 12 mg 1 time a day daily for 3 days, then every other day. Course of treatment-10 suppl. ;
– for acute infectious processes and for activation of regenerative processes (fractures, burns, trophic ulcers)Â – suppositories 12 mg 1 time a day daily. The course of treatment is 10 suppositories;
– for gynecological diseases-suppositories of 12 mg 1 time a day daily for 3 days, then-every other day. The course of treatment is 10 suppl. ;
– in case of exacerbation of urological diseases (urethritis, pyelonephritis, cystitis, prostatitis)Â – suppositories 12 mg 1 time a day daily. Course of treatment-10 suppositories;
– for pulmonary tuberculosis-suppositories 12 mg 1 time a day daily for 3 days, then-every other day. The course of treatment is 20 supp. Further, it is possible to use maintenance therapy-suppositories of 6 mg 2 times a week, with a course of up to 2-3 months;
– in the complex therapy of oncological diseases during chemo and radiation therapy-suppositories of 12 mg daily 2-3 days before the start of the course of chemo or radiation therapy. Then-12 mg 2 times a week, with a course of up to 20 suppositories;
–for allergic diseases complicated by infectious syndrome, – suppositories of 12 mg 1 time a day daily. Course of treatment-10 suppositories;
– for rheumatoid arthritis-suppositories 12 mg every other day. The course of treatment is 10 supp.
For prevention (monotherapy):
– exacerbations of chronic foci of infections-10 suppositories;
– flu and ARVI-suppositories 12 mg 1 time a day. Course — 10 suppositories;
– secondary immunodeficiency due to aging-suppositories 12 mg 2 times a week. Course — 10 suppl.,2-3 times a year.
For the treatment of children and adolescents from 6 to 18 years of age:
For children and adolescents from 6 to 18 years of age, suppositories are administered only rectally,1 supp. 6 mg 1 time a day after cleansing the intestines:
– for chronic infectious and inflammatory diseases in the acute stage-suppositories 6 mg 1 time a day daily for 3 days, then every other day. Course of treatment-10 suppl. ;
– for acute infectious processes and for activation of regenerative processes (fractures, burns, trophic ulcers)Â – suppositories 6 mg 1 time a day daily. Course of treatment-10 supp. ;
– in case of exacerbation of urological diseases (urethritis, pyelonephritis, cystitis, prostatitis)Â – suppositories 6 mg 1 time a day daily. Course of treatment-10 suppositories;
– for pulmonary tuberculosis-suppositories 6 mg 1 time a day daily for 3 days, then-every other day. The course of treatment is 20 supp. Further, it is possible to use maintenance therapy-suppositories of 6 mg 2 times a week, for a course of up to 2-3 months;
– in the complex therapy of oncological diseases during chemo and radiation therapy-suppositories of 6 mg daily 2-3 days before the start of the course of chemo or radiation therapy. Then-6 mg 2 times a week, with a course of up to 20 suppositories;
— for allergic diseases complicated by infectious syndrome, – suppositories of 6 mg 1 time a day daily. Course of treatment-10 suppositories;
– for rheumatoid arthritis-suppositories 6 mg every other day. The course of treatment is 10 supp.
For prevention (monotherapy):
– exacerbations of chronic foci of infections, recurrent herpetic infection of the urogenital tract-suppositories 6 mg every other day. Course — 10 suppositories;
– flu and ARVI-suppositories 6 mg 1 time a day. Course — 10 supp.
For patients receiving long-term immunosuppressive therapy, cancer patients who have been exposed to radiation, and those with an acquired immune system defect (HIV), long-term maintenance therapy with Polyoxidonium® is indicated from 2-3 months to 1 year (adults-12 mg, children over 6 years-6 mg 1-2 times a week).
Contraindications
increased individual sensitivity;
acute renal failure;
pregnancy (no clinical experience); lactation
period;
children under 6 years of age.
With caution
, chronic renal failure (used no more than 2 times a week).
Side effects
Very rarely — local reactions in the form of redness, swelling, itching of the perianal zone, vaginal itching (due to individual sensitivity to the components of the drug).
Interaction
No drug interaction has been established. Possible use of Polyoxidonium® with many medicinal products, includingIt is compatible with antibiotics, antivirals, antifungal and antihistamines, bronchodilators, corticosteroids, cytostatics and beta-adrenomimetics.
Azoximer bromide does not inhibit cytochrome P 450 isoenzymes CYP1A2, CYP2C9, CYP2C19, and CYP2D6, so the drug is compatible with antibiotics, antiviral, antifungal, and antihistamines, corticosteroids, and cytostatics.
If the patient is taking the above or other medications (including over-the-counter medications), consult your doctor before taking Polyoxidonium®.
Overdose
Cases of overdose of Polyoxidonium® are unknown.
Functional features
Suppositories: when administered rectally, it has a high bioavailability (at least 70%), reaching Cmax in the blood 1 h after use. The half-life is about 0.5 hours, the half — elimination period is 36.2 hours.
In the body, it is hydrolyzed to oligomers, which are mainly excreted by the kidneys. There is no cumulative effect.
Special instructions
If an allergic reaction develops, stop using Polyoxidonium® and consult a doctor.
If it is necessary to stop taking the drug Polyoxidonium® withdrawal can be carried out immediately, without gradually reducing the dose.
If you miss the next dose of the drug, its subsequent use should be carried out as usual, as indicated in these instructions or recommended by your doctor. The patient should not be given a double dose to compensate for missed doses.
Do not use the product if there are visual signs of its unsuitability (packaging defect).
Form of production
Suppositories for vaginal or rectal use
Storage conditions
Store in a dry place protected from light at a temperature of 2 to 15 ° C. Keep away from children.
Shelf
life is 2 years. Do not use the drug after the expiration date indicated on the package.
Active ingredient
Azoximer bromide
Dosage form
rectal suppositories
Purpose
For the elderly, For adults
Indications
Immunodeficiency conditions, Urethritis, Trophic ulcers, Otitis media, Pollinosis, Burns, Bone Fractures, Colds, Chronic infections, Tuberculosis, Herpes, Inflammation of the female genital organs, Cytomegalovirus infection, Sinusitis, Cancer, Fungus, Bronchial asthma, Prostatitis, Flu and cold prevention, Pharyngitis, Flu
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Side effects of Polyoxidonium suppositories vaginal and rectal 12mg, 10pcs.
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