Polyoxidonium®
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Clinical Pharmacology
Pharmacodynamics
Longidaza® has hyaluronidase (enzymatic) activity of prolonged action, chelating, antioxidant, immunomodulatory and moderately pronounced anti-inflammatory properties.
The prolongation of the enzyme action is achieved by covalent binding of the enzyme with a physiologically active polymeric carrier (azoxymer). Longidaza® shows anti-fibrotic properties, weakens the acute phase of inflammation, regulates (increases or decreases depending on the initial level) synthesis of inflammatory mediators (interleukin-1 and tumor necrosis factor - alpha), increases the humoral immune response and resistance of the organism to infection.
The pronounced anti-fibrotic properties of Longidaza are provided by conjugation of hyaluronidase with a carrier, which significantly increases the resistance of the enzyme to denaturing effects and to the action of inhibitors: Longididase enzymatic activity is maintained when heated to 37 ° C for 20 days, while native hyaluronidase loses its activity under the same conditions during the day. In the preparation of Longidaza, the simultaneous local presence of the enzyme hyaluronidase and a carrier is provided that is capable of binding enzyme inhibitors and stimulators of collagen synthesis (iron, copper, heparin, etc.) released during hydrolysis of the matrix components. Due to these properties, Longidase® not only has the ability to depolymerize the matrix of connective tissue in fibrous granulomatous masses, but also to suppress the reverse regulatory response, aimed at the synthesis of components of the connective tissue.
The specific substrate of 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 decreases, metal ions temporarily increase the permeability of tissue barriers, facilitates the movement of fluid in the intercellular space, increases the elasticity of connective tissue , which is manifested in a decrease in swelling of the tissue, flattening of scars, an increase in the volume of movement of the joints, a decrease in contractures and ezhdenii their formation, reduction of adhesions. Biochemical, immunological, histological and electron microscopic studies have shown that Longidase® does not damage normal connective tissue, but causes destruction of the composition and structure of the connective tissue in the area of fibrosis.
Longidis® does not have mutagenic, embryotoxic, teratogenic and carcinogenic effects.
The drug is well tolerated by patients, there are no local and general allergic reactions.
The use of Longidaza in therapeutic doses during or after surgical treatment does not cause deterioration of the postoperative period or progression of the infectious process; does not slow down the recovery of bone tissue.
Pharmacokinetics
An experimental study of pharmacokinetics has made it possible to establish that when administered rectally, the drug Longidase® is characterized by a high rate of distribution in the body, is well absorbed into the systemic circulation and reaches its maximum concentration in the blood after 1 hour. The half-distribution period is about 0.5 hours, the half-elimination period is from 42 to 84 hours. Excreted mainly by the kidneys.
The drug penetrates into all organs and tissues, including it passes through the blood-brain and blood-brain barriers. Established the absence of tissue cumulation.
The bioavailability of the drug Longidase® with rectal administration is high: about 90%.
Indications
Adults and adolescents over 12 years of age in the form of monotherapy and as part of the complex therapy of diseases involving connective tissue hyperplasia, including against the background of the inflammatory process:
- in urology: chronic prostatitis, interstitial cystitis, strictures of the urethra and ureters, Peyronie's disease, the initial stage of benign prostatic hyperplasia, prevention of scar formation and strictures after surgical interventions on the urethra, bladder, ureters;
- in gynecology: adhesions (prevention and treatment) in the small pelvis for chronic inflammatory diseases of the internal genital organs, after gynecological manipulations, including artificial abortions, previous surgical interventions on the pelvic organs; intrauterine synechia, tubal-peritoneal infertility, chronic endomyometritis;
- in dermatovenerology: limited scleroderma, prevention of fibrous complications of sexually transmitted infections;
- in surgery: prevention and treatment of adhesions after surgery on the abdominal organs; long-term non-healing wounds;
- in pulmonology and phthisiology: pneumofibrosis, siderosis, tuberculosis (cavernous-fibrous, infiltrative, tuberculoma), interstitial pneumonia, fibrosing alveolitis, pleurisy;
- to increase the bioavailability of antibiotic therapy in urology, gynecology, dermatology, surgery, pulmonology, etc.
Composition
The composition of one suppository:
Active ingredient: Bovgialuronidazozoksimer (Longidaza®) - 3000 IU
Auxiliary substance: cocoa butter - to obtain a suppository weighing 1.3 g
Description: torpedo-shaped suppositories, light yellow in color with a slight specific smell of cocoa butter, marbling staining is allowed.
Polyoxidonium® is marketed under different brands and generic names, and comes in different dosage forms:
Brand name | Manufacturer | Country | Dosage form |
---|---|---|---|
Polyoxidonium® | NPO Petrovax Farm | Russia | suppositories |
Polyoxidonium® | NPO Petrovax Farm | Russia | pills |
Polyoxidonium® | NPO Petrovax Farm | Russia | lyophilisate |
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Dosage and Administration
Use the drug only according to the indications, the method of application and in those doses that are specified in the instructions.
If there is no improvement after treatment, or symptoms become worse, or new symptoms appear, you should consult your doctor.
Orally and sublingually for 20-30 minutes before meals daily 2 times a day: for children over 10 years old and for adults - 1 tablet, for children from 3 to 10 years old - ½ tablet (6 mg).
If necessary, repeated courses of therapy are possible in 3-4 months. When you reappoint the drug its effectiveness is not reduced.
Recommended treatment regimens
Sublingual
For adult treatment:
- flu and acute respiratory infections - 1 tablet 2 times a day for 7 days;
- inflammation of the oropharynx - 1 tablet 2 times a day for 10 days;
- exacerbations of chronic diseases of the upper respiratory tract, paranasal sinuses, chronic otitis media - 1 tablet 2 times a day for 10 days;
- allergic diseases (including pollinosis, bronchial asthma), complicated by recurrent bacterial, fungal and viral infections - 1 tablet 2 times a day for 10 days.
For the treatment of children from 3 to 10 years:
- flu and acute respiratory infections - ½ tablet 2 times a day for 7 days;
- inflammation of the oropharynx - ½ tablet 2 times a day for 7 days;
- allergic diseases (including pollinosis, bronchial asthma), complicated by recurrent bacterial, fungal and viral infections - ½ tablet 2 times a day for 7 days.
For treatment of children older than 10 years:
- flu and acute respiratory infections - 1 tablet 2 times a day for 7 days;
- inflammatory processes of the oropharynx - 1 tablet 2 times a day for 7 days;
- exacerbations of chronic diseases of the upper respiratory tract, paranasal sinuses, chronic otitis media - 1 tablet 2 times a day for 7 days;
- allergic diseases (including pollinosis, bronchial asthma), complicated by recurrent bacterial, fungal and viral infections - 1 tablet 2 times a day for 7 days.
For prophylaxis for adults:
- flu and acute respiratory infections in the pre-epidemic period - 1 tablet per day for 10 days;
- recurrent herpetic infections of the nasal and labial area - 1 tablet 2 times a day for 10 days;
- exacerbations of chronic foci of infections of the oropharynx, the paranasal sinuses, the upper respiratory tract, the inner and middle ear - 1 tablet once a day for 10 days;
- secondary immunodeficiencies resulting from aging or exposure to adverse factors - 1 tablet 1 time per day for 10 days.
For prevention for children from 3 to 10 years:
- flu and acute respiratory infections in the pre-epidemic period - ½ tablet per day for 7 days;
- recurrent herpes infection of the nasal and labial area - ½ tablet 2 times a day for 7 days;
- exacerbations of chronic foci of infections of the oropharynx, the paranasal sinuses, upper respiratory tract, the inner and middle ear - ½ tablet once a day for 10 days.
For prophylaxis to children over 10 years old:
- flu and acute respiratory infections in the pre-epidemic period - 1 tablet per day for 7 days;
- recurrent herpes infection of the nasal and labial area - 1 tablet 2 times a day for 7 days;
- exacerbations of chronic foci of infections of the oropharynx, paranasal sinuses, upper respiratory tract, the inner and middle ear 1 tablet once a day for 10 days.
Orally
For adult treatment:
- diseases of the upper and lower respiratory tract - 1 tablet 2 times 10 days.
For treatment of children older than 10 years:
- diseases of the upper and lower respiratory tract - 1 tablet 2 times 10 days
Adverse reactions
No side effects reported.
Contraindications
Carefully
If you have the diseases listed in this section, consult your doctor before you start taking the medicine:
- chronic renal failure (not more often used 2 times a week).
Drug interactions
Azoximer bromide does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2D6, cytochrome P-450 isoenzymes, therefore the drug is compatible with antibiotics, antiviral, antifungal and antihistamines, glucocorticosteroids and cytostatics.
Pregnancy and Lactation
The use of the drug Polyoxidonium® is contraindicated in pregnant women and women during breastfeeding (there is no clinical experience).
In experimental use of the drug Polyoxidonium® in animals, no embryotoxic and teratogenic effects or effects on the development of the fetus were detected.
Before using Polyoxidonium®, if you are pregnant, or suggest that you might be pregnant, or are planning to become pregnant, you should consult with your doctor.
During the period of breastfeeding, before using the drug Polyoxidonium®, it is necessary to consult a doctor.
Special instructions
With the development of an allergic reaction, discontinue use of the drug Polyoxidonium® and consult a doctor.
Overdosage
Cases of overdose are not registered.
- Brand name: Polyoxidonium
- Active ingredient: Azoxymere bromide
- Dosage form: vaginal and rectal suppositories.
- Manufacturer: NPO Petrovax Farm
- Country of Origin: Russia
Studies and clinical trials of Polyoxidonium (Click to expand)
- Polyoxidonium induces adrenocorticotropic hormone secretion by peripheral blood mononuclear cells
- Study of interaction between the polyoxidonium immunomodulator and the human immune system cells
- Allergen-specific Immunotherapy Using A Highly Modified Allergen And The Immunomodulator Polyoxidonium In A Murine Model Of Allergic Asthma
- Influence of an immunopotentiator Polyoxidonium on cytokine profile and antibody production in children vaccinated with Priorix
- POLYOXIDONIUM EFFECT ON IMMUNOREACTIVITY OF PATIENTS WITH CHRONIC STAPHYLOCOCCOSIS PHARYNGITIS
- Antioxidant Effect of Polyoxidonium and Metaprot during Bronchopulmonary Inflammation in Rats
- Specifics of self-organization and properties of highly dilute aqueous solutions of polyoxidonium
- The safety profile of Polyoxidonium in daily practice: results from postauthorization safety study in Slovakia