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Why is Bioparox banned in Russia? Reasons and analogues for replacement
Bioparox banned to use around the world!
Popular Aerosol Bioparox. often prescribed by doctors to treat upper respiratory tract infections, has suddenly been banned worldwide. Roszdravnazdzor has banned selling the drug since April 2016.
So why Bioparox, considered an effective antibiotic for decades, suddenly banned in Russia? The answer lies in the identified qualities of the main medicinal substance of Bioparox - physiophungine.
Bioparox - what is it and what is it used for?
Bioparox is an antibacterial aerosol used topically for bacterial damage of the upper respiratory tract. The basis of the drug - the polypeptide substance fusafungin (fusafunjin) - isolated from the fungus that infects cereals.
The discovery of Fusafunjina in 1963, which has a broad anti-bacterial spectrum against nasopharyngeal infection (streptococcus, pneumococcus, staphylococcus, Candida mushrooms, Mycoplasma pneumonia, some types of anaerobes and neuserium strains) was considered a revolutionary breakthrough in ENT practice.
The production of Bioparox by the French company Laboratories Servier quickly gained momentum, and the head of the pharmaceutical company Jacques Servier considered the drug to be his own pride.
From what used Bioparox, known to almost everyone. The drug was actively prescribed by doctors all over the world for the following diseases:
- rhinitis and sinusitis;
- pharyngitis / laryngitis;
- tonsillitis (tonsillitis), including conditions after tonsillectomy.
In the course of preliminary studies, the drug Bioparox revealed the following unique properties:
- anti-inflammatory effect develops due to a decrease in tumor necrosis factor (TNF-a); inhibition of the synthesis of toxins by macrophages is not accompanied by a decrease in the function of phagocytosis;
- pathogenic microorganisms can not adapt to fusafungin (there is no effect of resistance);
- when applied locally, the drug enters the blood in a critically low concentration (less than 1 ng / ml), which means no effect on the internal organs and systems;
- in the side effects of the manufacturer indicated only a small risk of an allergic reaction, like any other antibiotic.
Due to these properties, Bioparroks, in many cases, made it possible to cure a throat infection without systemic (oral, injectable) administration of other antibiotics. Even with severe sore throat, Bioparox reduced the length of treatment with systemic antimicrobials and accelerated recovery.
Although there have been no studies on the effects on the fetus in humans, animal studies have revealed the teratogenic and genotoxic effects of fizafungin. Therefore, Bioparox during pregnancy, as well as breastfeeding, was not recommended.
Why banned Bioparox in Russia?
Aerosol Bioparox, literally bursting into the pharmaceutical market, did not remain without further attention of scientists. Further studies of the drug raised a number of serious problems to the surface:
- Over time, Bioparox showed less and less effectiveness;
- The potential risk of developing resistance to other antibacterial substances has been identified;
- Side effects indicated by the manufacturer occur quite often and are more pronounced - from bronchospasm to anaphylactic shock.
In Russia in August 2015, the first restriction on the use of Bioparox was introduced. From now on, Bioparox in children was forbidden to use from 2.5 years, moving the age bar to 12 years. This change was immediately reflected in the instructions for the aerosol.
In the same year, the Italian organization AIFA, which regulates the circulation of medicines, appealed to the European Medical Agency in order to identify the frequent development of anaphylactic life-threatening shock.
At the same time, serious conditions developed after the use of Bioparox in both children and adult patients. One death was also reported. In 2016, in February, it was decided that Bioparox, although rare, could cause life-threatening reactions, effective measures for the prevention of which do not yet exist.
- After that, Bioparox was removed from production, and the manufacturing company officially withdrawn the aerosol from the pharmaceutical market worldwide.
How to replace Bioparox? Analogs of the drug
It is the ratio of efficiency and safety that led to the removal of Bioparox from production and the ban in Russia in particular. Although today's pharmaceuticals offer a huge amount of local antiseptics and antibiotics, no other preparation can give a fine dispersion, like in Bioparox,. However, this aerosol can be replaced. Safer and cheaper Bioparox analogues:
Faringosept is an antiseptic; when tablets are resorbed, a bacteriostatic effect develops in the mouth (stops the growth of bacteria, and does not destroy them). Faringosept is effective when used immediately after the first symptoms of inflammation appear (tickling, redness, etc.). When an infection develops, it is used as a symptomatic remedy for reducing pain and relieving the inflammatory response.
Geksoral is an antiseptic (not an antibiotic!), Therefore its effectiveness is somewhat lower, and its use is necessarily combined with the intake of an antibacterial agent. Additionally has analgesic and antifungal effects.
Grammidine is an antibiotic that has a detrimental effect on a huge number of pathogenic microorganisms. Tablets for sucking cause abundant salivation, which helps to remove bacteria and toxic products of their vital activity from the oral cavity.
Tantum Verde - anti-inflammatory agent in the form of a solution and lozenges .
Polydex - a combined drug for nasal use, used exclusively for otitis and rhinitis. Although highly effective, its use is limited, as part of the glucocorticosteroid Dexamethasone.
Isofra - by its properties replaces the drug Bioparox. It has an antiseptic and antimicrobial effect, does not develop resistance in microorganisms.
Chlorophyllite is a herbal preparation that sets it apart from other local antiseptics. Isolated from the leaves of eucalyptus, a combination of chlorophylls has anti-inflammatory and antimicrobial action.
Based on the specificity of the infection of the nasopharynx, it is possible to choose a drug that can replace Bioparox. However, it should be remembered: any use of the antibiotic should be agreed with the doctor.
Even local antiseptics have a number of contraindications and side effects, and their therapeutic effect is not always sufficient for the treatment of respiratory diseases.