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Препарат Полиоксидоний. «НПО Петровакс Фарм» Россия


Producer: "NPO Petrovax Pharm" Russia

Code of automatic telephone exchange: L03

Release form: Firm dosage forms. Tablets.

Indications to use: Secondary immunodeficiency. Prevention of flu. Prevention of a herpes infection. Bronchial asthma. Pollinosis. Allergic reactions (Allergy). Upper respiratory tract infections.


General characteristics. Structure:

Active agent: полиоксидоний® (Azoksimera bromide) - 12 mg in mix with excipients: Mannitolum, povidone, бетакаротен – to 18 mg;

Excipients: Lactose monohydrate of 185 mg, starch of potato 45 mg, stearic acid of 2 mg.




Pharmacological properties:

Полиоксидоний® tablets of 12 mg possesses immunomodulatory action. Drug increases resistance of an organism concerning bacterial, fungal and viral infections. A basis of the mechanism of immunomodulatory action of Polioksidoniya® is increase in ability of leukocytes to englobe microbes, to stimulate products of the cytokines activating immunity at initially lowered indicators to strengthen antibodyformation to infectious agents.
Полиоксидоний® activates phagocytes of peripheral blood and fabric macrophages that promotes more bystry elimination of the activator from an organism in the presence of the infection center. Besides, Polioksidoniy® activates the lymphoid cells which are in regional lymph nodes namely the V-cells producing secretory IgA.
At sublingual use of Polioksidoniy® activates the lymphoid cells which are in a nasal cavity, Eustachian tubes, a stomatopharynx, bronchial tubes. Besides, Polioksidoniy® activates bactericidal properties of saliva.

At oral administration of Polioksidoniy® activates also lymphoid cells which are in lymph nodes of intestines.
Increase in stability respiratory, digestive tract and ENT organs to infectious agents is a consequence of it.
Along with immunomodulatory action, Polioksidoniy® has the expressed disintoxication and antioxidant activity, has ability to bring toxins, salts of heavy metals out of an organism, inhibits peroxide oxidation of lipids. The specified properties are defined by structure and the high-molecular nature of Polioksidoniya®.
Use of Polioksidoniya® against the background of secondary immunodeficiency allows to increase efficiency and to reduce treatment duration, to considerably reduce use of antibiotics, bronchial spasmolytics, glucocorticosteroids, to extend remission term.

Drug is well transferred, has no mitogenetic, polyclonal activity, antigenic properties, does not render allergenic, mutagen, embriotoksichesky, teratogenic and cancerogenic action.

PHARMACOKINETICS. Полиоксидоний® tablets of 12 mg after intake it is quickly soaked up from a GIT, bioavailability makes about 50%. The maximum concentration in a blood plasma is reached in 3 hours after intake. The pharmacokinetics of Polioksidoniya® is linear (concentration in a blood plasma is proportional to the accepted dose).

Полиоксидоний® is hydrophilic connection. The seeming volume of distribution makes about 0,5 l/kg that says that drug is distributed generally in intercellular liquid. The semi-absorption period – 35 minutes, an elimination half-life – 18 hours. In an organism it is hydrolyzed to oligomers which are removed preferential by kidneys. The cumulative effect is absent.


Indications to use:

Полиоксидоний® tablets of 12 mg it is applied at adults and teenagers 12 years for treatment and prevention of the infectious and inflammatory diseases (a virus, bacterial and fungal etiology) which are not giving in to standard therapy are more senior. Полиоксидоний® it is used both in an aggravation stage, and in a remission stage:
in complex therapy:
• acute and chronic recurrent infectious and inflammatory diseases of a stomatopharynx, okolonosovy bosoms, upper respiratory tracts, inner and middle ear;
• the allergic diseases complicated by a recurrent bacterial, fungal and viral infection (including a pollinosis, bronchial asthma);

• for rehabilitation it is frequent and long (more than 4-5 times a year) the ill persons;
in the form of monotherapy:

• for prevention of a recurrent herpes infection;
• for seasonal prevention of aggravations of the chronic centers of infections of a stomatopharynx, okolonosovy bosoms, upper respiratory tracts, an inner and middle ear;
• at immunokomprometirovanny persons for prevention of flu and other acute respiratory infections during the preepidemic period;
• for correction of the secondary immunodeficiences arising owing to aging or influence of adverse factors.


Route of administration and doses:

Полиоксидоний® tablets of 12 mg are applied orally and sublingual in 20-30 min. prior to food daily 1, 2 or 3 times a day: adults - in doses of 12 mg or 24 mg, teenagers of 12 years - in a dose of 12 mg. The way and the mode of dosing is defined by the doctor depending on the diagnosis, sharpness and weight of process.

THE RECOMMENDED SCHEMES OF TREATMENT
Sublingual:

• At inflammatory processes of a stomatopharynx (the bacterial, virus and fungal nature) - on 1 tablet 2 times a day in 12 hours within 10-14 days. At severe forms of a herpes and fungal infection of an oral cavity - on 1 tablet 3 times a day in 8 hours within 15 days.
• At chronic diseases of okolonosovy adnexal bosoms and chronic otitises - on 1 tablet 2 times a day in 12 hours within 5-10 days.
• At an adenoid disease - on 1 tablet 3 times a day in 8 hours in techeniye10-15 days.
• At chronic diseases of upper respiratory tracts - the adult on 2 tablets 2 times a day, to teenagers on 1 tablet of 12 mg 2 times a day in 12 hours within 10-14 days.
• For prevention of flu and acute respiratory infections - to the immunokomprometirovanny persons who are ill ORZ more than 4 times a year, during the preepidemic period the adult on 2 tablets, to teenagers on 1 tablet 2 times a day in 12 hours within 10-15 days.
Orally

• At chronic diseases of upper respiratory tracts – the adult on 2 tablets 2 times a day in 12 hours, to teenagers on 1 tablet 2 times a day in 12 hours, within 10-14 days.


Features of use:

It is not necessary to exceed the specified doses and duration of a course of treatment.
Does not exert impact on ability to driving of the car and to control of mechanisms.


Side effects:

About side effect of Polioksidoniya® it was not reported.


Interaction with other medicines:

Medicinal interaction is not established. Use of Polioksidoniya® with many medicines is possible, including it is compatible to antibiotics, antiviral, antifungal and antihistaminic drugs, bronchial spasmolytics, glucocorticosteroids, cytostatics, b-adrenomimetikami.


Contraindications:

Individual hypersensitivity. Children's age up to 12 years.

WITH CARE.
With care to apply at an acute renal failure, and also at a lactose intolerance, deficit of lactase, glyukozogalaktozny malabsorption.

USE AT PREGNANCY AND FEEDING BY THE BREAST
Use at pregnancy and a lactation is contraindicated (clinical experience of use is absent). Excretion of Polioksidoniya® with breast milk was not studied.


Overdose:

Cases of overdose of Polioksidoniya® are not known.


Storage conditions:

In the dry place protected from light at a temperature from 4 to 25 °C.
To protect from children.


Issue conditions:

Without recipe


Packaging:

The tablets containing 12 mg of Polioksidoniya® on 10 pieces in a blister strip packaging from a film of polyvinyl chloride and aluminum foil in a cardboard pack with the application instruction, on 1 or 2 packagings in a pack.



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