Polyoxidonium suppositories vaginal and rectal 6 mg 10 pcs. (Azoksymera bromide)

Latin name

bovgyaluronidase azoximer (bovhyaluronidasum azoximerum)

release form

vaginal and rectal suppositories.

Pharmacological action

Pharmacodynamics

Longidaza® has prolonged-acting hyaluronidase (enzymatic) activity, chelating, antioxidant, immunomodulating and moderately pronounced anti-inflammatory properties.

The prolongation of the action of the enzyme is achieved by covalent binding of the enzyme to a physiologically active polymer carrier (azoximer). Longidaza® exhibits antifibrotic properties, weakens the course of the acute phase of inflammation, regulates (increases or decreases depending on the initial level) the synthesis of inflammatory mediators (interleukin-1 and tumor necrosis factor-alpha), increases the humoral immune response and the body's resistance to infection.

The pronounced antifibrotic properties of Longidases are provided by conjugation of hyaluronidase with a carrier, which significantly increases the enzyme's resistance to denaturing and inhibitory effects: the enzymatic activity of Longidase is preserved by heating to 37 ° C for 20 days, while native hyaluronidase loses under these conditions activity during the day.

The Longidaza® preparation provides simultaneous local presence of the hyaluronidase enzyme and carrier, able to bind enzyme inhibitors and stimulants of collagen synthesis (iron, copper, heparin, etc.) released during the hydrolysis of matrix components. Due to these properties, Longidaza® possesses not only the ability to depolymerize the connective tissue matrix in fibro-granulomatous formations, but also suppress the reverse regulatory reaction aimed at the synthesis of connective tissue components.

A specific substrate for testicular hyaluronidase is glycosaminoglycans (hyaluronic acid, chondroitin, chondroitin-4-sulfate, chondroitin-6-sulfate), which form the basis of the connective tissue matrix.

As a result of depolymerization (breaking the bond between C1 acetylglucosamine and C4 glucuronic or induronic acids) glycosaminoglycans change their basic properties: viscosity decreases, the ability to bind water, metal ions decreases, the permeability of tissue barriers increases temporarily, fluid movement in the intercellular space is facilitated, connective tissue elasticity increases, which manifests itself in a decrease in tissue swelling, flattening of scars, an increase in the volume of movement of joints, a decrease in contractures and prevention of their formation, a decrease in adhesions process.

Biochemical, immunological, histological and electron microscopic studies have proved that Longidaza® does not damage normal connective tissue, but causes destruction of the connective tissue, which has been changed in composition and structure, in the area of ​​fibrosis.

Longidaza® does not have mutagenic, embryotoxic, teratogenic and carcinogenic effects.

The drug is well tolerated by patients, no local and general allergic reactions have been noted.

The use of Longidase in therapeutic doses during or after surgical treatment does not cause a deterioration in the postoperative period or the progression of the infectious process does not slow down bone restoration.

Pharmacokinetics

An experimental study of pharmacokinetics revealed that with rectal administration, Longidaza® is characterized by a high distribution rate in the body, is well absorbed into the systemic circulation and reaches a maximum concentration in the blood after 1 hour. The half-life is about 0.5 hours, the half-elimination period is from 42 to 84 hours. It is excreted mainly by the kidneys.

The drug penetrates into all organs and tissues, including passing through the blood-brain and blood-brain barrier. The absence of tissue cumulation was established.

The bioavailability of the drug Longidaza® with rectal administration is high: about 90%.

Indications

It is used in adults and children over 6 years of age for the 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 and 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, salpingomyophoritis cervicitis, cervicosis, bacterial vaginosis)

• various forms of pulmonary tuberculosis

• allergic diseases (including hay fever, bronchial asthma, atopic dermatitis), oslo nennyh recurrent bacterial, fungal and viral infection

• rheumatoid arthritis, complicated by recurrent bacterial, fungal and viral infections, against long-term use of immunosuppressants

• activation of regenerative processes (fractures, burns, trophic ulcers)

• in the complex therapy of oncological diseases during chemo- and radiation therapy, to reduce the nephro- and hepatotoxic effects of drugs.

For prophylaxis (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 of immunocompromised persons with old or secondary immunodeficiencies •.

Contraindications

Increased individual sensitivity

pregnancy, lactation

children under 6 years old

acute renal failure.

Caution

If you have the medical conditions described in this section, consult your doctor before taking the medication:

chronic renal failure (prescribed no more than 2 times a week).

Pregnancy and lactation

Pregnancy and lactation are contraindicated (there is no clinical experience with this).

During the experimental use of the drug Polyoxidonium® in animals, no embryotoxic and teratogenic effects or effects on the development of the fetus were revealed.

Before using Polyoxidonium®, if you are pregnant, or suspect that you might be pregnant, or are planning a pregnancy, you should consult your doctor.

Consult a physician before breastfeeding before using Polyoxidonium®.

Special instructions

If an allergic reaction develops, stop using PolyoxidoniumВ® and consult a doctor.

If it is necessary to discontinue therapy with the drug, cancellation can be carried out immediately. If you miss a single dose of the drug, you must take it as soon as possible, but if it is time to take the next dose, do not increase the dose.

Do not use the drug if there are visual signs of its unsuitability (packaging defect, suppository color change).

Influence on the ability to drive vehicles and mechanisms

The use of the drug PolyoxidoniumВ® does not affect the ability to drive vehicles, maintenance of machinery and other types of work requiring increased concentration of attention and speed of psychomotor reactions.

Composition

Composition on one suppository:

Active ingredient:

Azoximera bromide - 6 mg

Excipients:

mannitol - 1.8 mg,

povidone K 17 - 1.2 mg,

cocoa butter - 1291.0 mg (for a dosage of 6 mg).

Dosage and administration

Use the product only according to the indications, the method of use and the doses indicated in the instructions.

If, after treatment, improvement does not occur or the symptoms worsen, or new symptoms appear, consult a doctor.

Rectally and vaginally 1 time per day daily, every other day or 2 times a week.

If necessary, repeated courses of therapy are possible after 3-4 months. With a repeated prescription of the drug, its effectiveness does not decrease.

Recommended regimens for the use of the drug

For adults:

- rectally 1 suppository once a day after bowel cleansing

- vaginally for gynecological diseases 1 suppository once a day (at night) is injected into the vagina in the supine position.

for chronic infectious and inflammatory diseases in the acute stage - suppositories 12 mg once a day every day for 3 days, then every other day. The course of treatment is 10

suppositories for acute infectious processes and for activation of regenerative processes (fractures, burns, trophic ulcers) - suppositories 12 mg once a day daily. The course of treatment is 10

suppositories for gynecological diseases - 12 mg suppositories once a day every day for 3 days, then every other day. The course of treatment of 10

suppositories with exacerbation of urological diseases (urethritis, pyelonephritis, cystitis, prostatitis) –suppositories 12 mg once a day daily. The course of treatment is 10

suppositories for pulmonary tuberculosis - suppositories 12 mg once a day daily for 3 days, then every other day. The course of treatment is 20 suppositories. Further, it is possible to use maintenance therapy with 6 mg suppositories 2 times a week, with a course of up to 2-3 months

in the complex treatment of oncological diseases during chemotherapy and radiation therapy - 12 mg suppositories daily 2-3 days before chemotherapy or radiation therapy. Then 12 mg 2 times a week, with a course of up to 20

suppositories for allergic diseases complicated by an infectious syndrome - 12 mg suppositories once a day daily. The course of treatment is 10

suppositories for rheumatoid arthritis - 12 mg suppositories every other day. The course of treatment is 10 suppositories.

For prophylaxis (monotherapy):

of exacerbations of chronic foci of infection, recurrent herpetic infection of the urogenital tract – suppositories 12 mg every other day. Course - 10 suppositories of

influenza and ARVI - suppositories 12 mg once a day. A course of 10

suppositories of secondary immunodeficiencies resulting from aging - suppositories 12 mg 2 times a week. The course is 10 suppositories, 2-3 times a year.

For treatment for children and adolescents from 6 to 18 years:

For children and adolescents from 6 to 18 years, suppositories are administered only rectally, 1 suppository 6 mg once a day after bowel cleansing.

for chronic infectious and inflammatory diseases in the acute stage - suppositories 6 mg once a day daily for 3 days, then every other day. The course of treatment is 10

suppositories for acute infectious processes and for activation of regenerative processes (fractures, burns, trophic ulcers) - suppositories 6 mg once a day daily. The course of treatment is 10

suppositories for exacerbation of urological diseases (urethritis, pyelonephritis, cystitis, prostatitis) –suppositories 6 mg once a day daily. The course of treatment is 10

suppositories for pulmonary tuberculosis - suppositories 6 mg once a day every day for 3 days, then every other day. The course of treatment is 20 suppositories. Further, it is possible to use maintenance therapy of suppositories 6 mg2 times a week, with a course of up to 2-3 months

in the complex treatment of cancer with chemotherapy and radiation therapy - suppositories 6 mg daily 2-3 days before the start of chemotherapy or radiation therapy. Then, 6 mg 2 times a week, with a course of up to 20

suppositories for allergic diseases complicated by an infectious syndrome, 6 mg suppositories once a day daily. The course of treatment is 10

suppositories for rheumatoid arthritis - 6 mg suppositories every other day. The course of treatment is 10 suppositories.

For prophylaxis (monotherapy):

of exacerbations of chronic foci of infection, recurrent herpetic infection of the urogenital tract – suppositories 6 mg every other day.

Course - 10 suppositories

influenza and ARVI - suppositories 6 mg once a day, Course 10 suppositories.

For patients who are receiving immunosuppressive therapy for a long time, who are exposed to radiation, who have acquired an acquired immune system defect - HIV, maintenance therapy with Polyoxidonium is indicated for 2-3 months to 1 year (for adults 12 mg, children over 6 years old for 6 mg 1 -Two times per week).

Side effects

Very rare: 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.

If you notice any side effects not listed in the instructions, notify your doctor.

Drug interaction

Azoximera bromide does not inhibit the isoenzymes CYP1A2, CYP2C9, CYP2C19, CYP2D6, cytochrome P-450, therefore the drug is compatible with many drugs, including antibiotics, antiviral, antifungal and antihistamines glucocorticosteroids and cytostatics.

If you are taking the above or other medications (including over-the-counter), consult your doctor before taking Polyoxidonium.

Overdose

Overdose has not been reported.

Storage conditions

In a dry, dark place at 2 to 15 ° C. Keep away from children.

Shelf life

2 years. Do not use the drug after the expiration date indicated on the package.

Deystvuyushtee substance

Azoksimera bromide

dosage form

rectal suppositories

Possible product names

POLYOXIDONIUM 0, 006 N10 SUPP

Polyoxidonium 6mg vag. and rect. supp. X10 (R)

Polyoxidonium 6mg vag. and rect. supp. X10 (R) /! Until 10.12g /

Polyoxidonium 6mg No. 10 supp

POLIOXIDONIUM 6MG. No. 10 SUPP.



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