Medicine Bioparox instructions for use

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Bioparox

Description current as of 10/16/2015

  • Latin name: Bioparox
  • ATX code: R02AB03
  • Active ingredient: Fusafungin (Fusafunginum)
  • Manufacturer: Les Laboratoires Servier, France

Compound

The drug contains fusafungin (the concentration of the substance in one dose is 0.125 mg), as well as flavoring (additive 14868), anhydrous ethanol, saccharin, isopropyl myristate, and norflurane (propellant).

Table of contents:

Aroma additive composition: ethanol 96%, anise alcohol; oils (anise, tarragon and wormwood); extracts of caraway fruits, clove buds, coriander seeds, field mint, peel of sweet orange fruits, bitter orange, allspice fruits, pharmaceutical rosemary flowers; vanilla resinoid, methyl anthranilate, ethyl vanillin, propylene glycol, phenylethanol, heliotropin, geraniol, lignin-based vanillin, linalol, indole, isopropyl myristate, terpineol.

Release form

Aerosol for inhalation dosed.

One cylinder contains 400 releases, one dose per release. Each release corresponds to 0.125 mg of active substance.

The drug is a characteristically smelling, transparent, oily liquid of pale yellow color. It is produced in aluminum containers with a volume of 20 ml (package No. 1). Each container is equipped with a dosing valve and has three replaceable nozzles: yellow - for nasal use, white - for inhalation through the mouth, transparent - for nasal use in children.

pharmachologic effect

Pharmacodynamics and pharmacokinetics

Is fusafungin an antibiotic or not?

Wikipedia to the question “Fuzafungin - what is it?” answers that the substance is a local polypeptide antibiotic with anti-inflammatory activity. It is obtained from strain 437 of the Fusarium lateritium fungus culture.

The drug is effective against Gram (+) bacteria (group A streptococci (Str. pyogenes), Str. pneumoniae, Staphylococcus spp.); Gram (-) bacteria (including certain strains of Neisseria, Legionella pneumophila, Moraxella catarrhalis, Haemophilus influenzae); some anaerobes, fungi of the genus Candida, mycoplasmas (Mycoplasma spp.).

Pharmacodynamics

When administered by inhalation, fusafungine settles on the surface of the mucous membrane of the external respiratory system; the substance is not detected in the blood plasma. The aerosol form provides complete coverage of the mucous membrane of the respiratory tract and penetration into the bronchioles and sinuses.

After four times inhalation through each nasal passage or through the mouth, the concentration of fusafungine in the bronchi and trachea reaches 0.04, in the nasal cavity - 0.06, and in the lungs - 0.08 mg/ml.

The drug reduces exudation, relieves swelling and inflammation of the mucous membrane of the respiratory system, improves nasal breathing. Practical experience shows that the effectiveness of therapy is higher if treatment with Bioparox is started early.

Fusafungine does not reduce the effectiveness of antimicrobials for systemic use. There are no reports of cross-resistance or acquired resistance.

Pharmacokinetics

After use in the form of inhalation, the drug is distributed mainly on the surface of the mucous membrane in the nose, oral cavity and pharynx. The concentration of the substance in the blood plasma does not exceed 1 ng/ml and does not affect the safety of Bioparox.

Indications for use

The feasibility of using Bioparox for angina

For angina, Bioparox is not always used. Sore throat (or acute tonsillitis) is an infectious disease with local manifestations of inflammation in the area of ​​the 1st and 2nd tonsils.

Reviews about Bioparosk for sore throat are good. However, the drug can only be used at the catarrhal stage of inflammation - with redness and swelling of the palatine tonsils, that is, when the inflammatory process has just begun.

In addition, Bioparox is widely used to treat exacerbations of chronic tonsillitis, which in most cases are not as severe as tonsillitis.

If acute tonsillitis is complicated by the appearance of pustules, the use of topical antibiotics does not make sense. If there is no improvement after three days of treatment or the patient’s condition worsens, the drug is discontinued and the patient is prescribed systemic antibiotics.

Using Bioparox spray for sinusitis

For sinusitis, the spray is effective only in the initial stages of the disease. Sinusitis is an acute or chronic inflammation of the paranasal sinuses. Acute sinusitis usually develops against the background of acute respiratory viral infection, complicated by a bacterial infection.

The first symptoms of the disease are persistent long-term nasal congestion, headache and high fever. Acute sinusitis, like acute tonsillitis, cannot be cured with Bioparox alone. The effect of using the drug is possible only in the very early stages of inflammation.

If after 2-3 days of treatment the patient does not feel improvement, systemic antibiotics will most likely be required.

Contraindications

The drug has virtually no contraindications. Limitations to its use are intolerance to fusafungin or any of the auxiliary components of the spray, as well as early childhood (up to 2.5 years).

The spray should be used with caution in patients prone to bronchospasm and allergies.

Side effects

Sometimes (very rarely) side effects may occur, such as increased dryness in the nose/throat, dysgeusia, sneezing, throat irritation, nausea, and cough.

These reactions are transient and do not require cessation of treatment.

Sometimes, especially in patients prone to allergies, local reactions of the skin and subcutaneous tissue, reactions of the mucous membrane (redness, swelling), bronchospasm, and superinfection may occur. In such cases, treatment with Bioparox should be discontinued.

If symptoms appear in the respiratory system, skin or larynx, due to the risk of anaphylactic shock, it may be necessary to urgently administer epinephrine (adrenaline) at a dose of 0.01 mg/kg. Method of administration: intramuscular injection. In some situations, repeated administration of adrenaline may be necessary. The drug is administered in the same dose after about 20 minutes.

Spray Bioparox: instructions for use

Instructions for use of Bioparox in adults

The standard dose of the drug for infectious and inflammatory diseases of the respiratory system (bronchitis, pharyngitis, tracheitis, etc.) for adult patients (including adolescents and the elderly) is four injections through the mouth and/or two injections into each nasal passage 4 r ./day

Spray Bioparox: instructions for use for children

Due to the risk of developing laryngospasm, Bioparox for children can only be used from 2.5 years.

A single dose of Bioparox for children from 2.5 to 11 years old - one injection into each nasal passage or two injections into the mouth. Frequency of applications - 4 rubles/day.

Many mothers leave good reviews about Bioparox spray. In their opinion, the drug very quickly helps with pharyngitis and sore throat, but can cause adverse reactions in the form of a burning sensation in the throat and allergic stomatitis.

Some are afraid to use Bioparox for children, remembering the inappropriateness of topical use of antibiotics.

Dr. Komarovsky gives an explanation on this matter in his blog: it is forbidden to instill antibiotics that are intended for systemic use into the nose, but fusafungin contained in Bioparox is not systemic, therefore, it can definitely be used topically, and doctors who prescribe a spray for children in no way violate pharmacological principles and norms of modern medicine.

Overdose

No overdose was observed with topical use of fusafungin.

Interaction

Drug interactions of fusafungin (including with other antibiotics) have not been studied.

Terms of sale

Storage conditions

The aerosol container must not be exposed to temperatures above 50°C. Avoid leaking the container and storing the drug near intensely emitting heat sources.

Best before date

special instructions

Due to the possibility of relapse, it is not recommended to stop using Bioparox immediately after the first signs of improvement appear.

Long-term use of the drug can cause an imbalance in microflora and the spread of superinfection.

Lack of improvement after a week of treatment is a reason to consider alternative therapy.

The fragrance contains propylene glycol, which may cause skin irritation.

The spray contains a small amount of ethanol (less than 0.1 g/dose).

Features of using an aerosol can

Before using Bioparox for the first time, to fill the dosing mechanism, press the main nozzle 4 times. After this, the nozzle on the container is replaced with the desired one: white - for the mouth, yellow - for the nose, transparent - children's for the nose.

Before using the spray, you need to clean your nasal passages. Holding the container in a vertical position, insert the nozzle into each nasal passage one by one and make the required number of injections. In this case, the mouth and other nasal passage should be closed.

In case of use through the mouth, a white nozzle is inserted into the mouth, lips are compressed around it and, lightly pressing on the bottom of the can, an injection is made (you need to breathe as usual during injection).

The container must be disinfected daily. The treatment is carried out once a day, using cotton wool soaked in a solution of ethyl alcohol (90%).

Analogues of Bioparox

Price of Bioparox analogues

Almost all analogues are cheaper than Bioparox. Grimicidin tablets (No. 20) cost an average of rubles, Isofra nasal spray - from 240 rubles, Grammidin - from 165 rubles.

Bioparox and alcohol - compatible or not?

During treatment with the drug, alcohol is contraindicated.

Bioparox during pregnancy and breastfeeding

Is it possible to use Bioparox during pregnancy?

The spray contains the antibiotic fusafungin, which is not detectable in blood plasma when administered inhaled.

The manufacturer, in the annotation for the drug, when asked whether pregnant women can take inhalations with Bioparox, answers that during pregnancy the drug can be used, but only with the approval of the attending physician and if there are indications.

Animal studies did not reveal any negative effects (direct or indirect) on the course of pregnancy/childbirth, as well as on the development of the child in the prenatal period and during infancy. The use of the drug did not reduce fertility in female and male rats.

Please remember that taking any medications during pregnancy carries certain risks. As for the spray, there are no clinical data that would confirm the safety of its use in pregnant women.

Why is Biparox prescribed during pregnancy?

Due to the extremely low absorption of fusafungin, the likelihood that the drug will cause fetal developmental disorders is extremely low, even if Bioparox is used in early pregnancy.

In this case, the spray can cause much less harm than an infection, since the most common acute respiratory viral infection suffered by the mother in the first weeks of pregnancy often leads to a miscarriage or the development of defects incompatible with life.

However, if it is necessary to use it in the 1st trimester (especially in the first 8-9 weeks), after completion of treatment it is recommended to check how correctly the fetus is developing.

In the 2nd trimester, colds are not so scary for a child. By this time, the child has already formed all the vital organs, so viruses no longer have a fatal effect. However, a cold that is not treated in time can cause fetal hypoxia and damage to the nervous system.

Oxygen starvation can lead to both a slight slowdown in development and cerebral palsy or dangerous underdevelopment of the brain.

In the 3rd trimester, a cold can trigger premature labor. Timely use of Bioparox allows you to minimize this risk and also prevents the risk of hypoxia.

Reviews of Bioparox during pregnancy are good: the drug very quickly eliminates inflammation, makes breathing easier and relieves sore throat. Mothers who used it at different stages of pregnancy note that the treatment did not affect the health of their children in any way - their babies were born strong and healthy. However, despite all the safety of fusafungin, it is still not worth using it uncontrolled.

Use during lactation

When feeding, the use of Bioparox is possible if indicated.

It is unknown whether the active substance of the drug penetrates milk during breastfeeding. The decision to stop or continue breastfeeding/therapy is made taking into account the benefits of the first for the child and the second for the mother.

The ability of fusafungine to pass into breast milk has not been studied in animal studies.

Reviews about Bioparox

Many people evaluate Bioparox as a fast-acting and very effective remedy for infectious and inflammatory diseases of the respiratory system. The active substance of the drug acts only on the surface of the mucous membrane of the ENT organs and respiratory tract, which allows the spray to be used during pregnancy and in pediatric practice.

The drug is effective against bacterial pharyngitis, bronchitis and rhinitis. However, only if used correctly: for sore throat and sinusitis, Bioparox can only help if it is started to be used immediately after the first symptoms of the disease appear.

Reviews about Bioparox for children are quite contradictory. Some mothers praise the medicine for the fact that it quickly copes with cough, runny nose, redness and sore throat. Others call it completely useless.

The disadvantages of the spray, in their opinion, are also its specific taste and pungent smell, which children often do not like, the presence of side effects (burning and dry throat), and high price.

Based on patient reviews, we can draw the following conclusion that the drug can act completely differently on different people, so it should be used only with the approval of the attending physician and taking into account the patient’s response to the prescribed treatment.

How much does Bioparox cost? The cost of the spray in Russian and Ukrainian pharmacies

Bioparox price in Ukraine

The price for Bioparox spray in Ukrainian pharmacies varies from 83 to 112 UAH.

Price of Bioparox in Russian pharmacies

In Russian pharmacies the drug can be bought for an average of 465 rubles.

  • Online pharmacies in Russia Russia
  • Online pharmacies in Ukraine Ukraine
  • Online pharmacies in Kazakhstan Kazakhstan

ZdravZone

Pharmacy24

PaniPharmacy

BIOSPHERE

This is the best drug. Now without him I will have to be sick for a long time.

What idiot banned the release of bioparox, I was only saved by it, now I don’t know what to do.

The drug Bioparox, in Russia, has long been recalled by the manufacturer. Possible(!) serious side effect.

I recently had a bad cold. My throat hurt terribly, it was painful to eat and even talk. At the appointment, the doctor prescribed Bioparox 3 sprays 3 times a day. After 3 days, my throat didn’t seem to hurt at all.

Inna: Usually, insomnia occurs for me due to some kind of experience and when you lie down, it’s not.

Olesya: I tried glycine forte, which is more expensive in the price category, but the dosage is the same.

Andrey: Not a word is said about choosing the size of stockings according to a person’s parameters: height, leg size, etc.

Olga: For coxarthrosis of the 2nd degree, I have been injecting for 4 years at the rate (after 6 months), there is no improvement.

All materials presented on the site are for reference and informational purposes only and cannot be considered a treatment method prescribed by a doctor or sufficient advice.

The site administration and the authors of the articles are not responsible for any losses and consequences that may arise when using the site materials.

Source: http://medside.ru/bioparoks

Bioparox - instructions for use, reviews, analogs and release forms (aerosol for inhalation through the mouth or nose) of a drug for the treatment of sore throat, sinusitis, tonsillitis in adults, children and pregnancy

In this article you can read the instructions for use of the drug Bioparox. Reviews of site visitors - consumers of this medicine, as well as the opinions of specialist doctors on the use of Bioparox in their practice are presented. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not stated by the manufacturer in the annotation. Analogues of Bioparox in the presence of existing structural analogues. Use for the treatment of sore throat, sinusitis, tonsillitis and other diseases of the nasopharynx and oropharynx in adults, children, as well as during pregnancy and lactation.

Bioparox is an antibiotic for topical use. Has a bacteriostatic effect. Has anti-inflammatory activity. Reduces swelling and other manifestations of inflammation of the mucous membrane of the respiratory tract.

Bioparox is active against: Streptococcus spp. group A, Streptococcus pneumoniae (old name - Pneumococcus), Staphylococcus spp., some strains of Neisseria spp., some anaerobes, as well as Mycoplasma spp., fungi of the genus Candida. Fusafungin is believed to have similar activity in vivo.

Fusafungin (the active ingredient of the drug Bioparox) has a pronounced anti-inflammatory effect by reducing the concentration of tumor necrosis factor (TNF-a) and suppressing the synthesis of free radicals by macrophages while maintaining phagocytosis.

After inhalation use of the drug Bioparox, fusafungin is mainly distributed on the surface of the mucous membrane of the oropharynx and nasal cavity. Fusafungin can be detected in blood plasma in very low concentrations (no more than 1 ng/ml), which does not affect the safety of the drug.

  • treatment of infectious and inflammatory diseases of the respiratory tract (rhinitis, nasopharyngitis, pharyngitis, laryngitis, tracheitis, tonsillitis, sore throat, conditions after tonsillectomy, sinusitis (sinusitis)).

Aerosol for inhalation dosed 50 mg.

Instructions for use and dosage regimen

The drug is used in the form of inhalation (through the mouth and/or nose).

Adults are prescribed 4 inhalations through the mouth and/or 2 inhalations into each nasal passage 4 times a day.

Children over 2.5 years old are prescribed 2-4 inhalations through the mouth and/or 1-2 inhalations into each nasal passage 4 times a day.

To make maximum use of the activity of the Bioparox drug, it is necessary to follow the prescribed doses and follow the rules for using the attached attachments.

To obtain a lasting therapeutic effect, it is necessary to observe the duration of the prescribed treatment: it is not recommended to stop treatment when the first signs of improvement appear, because premature cessation of therapy may lead to relapse.

You should always have the drug with you, placing it in the attached portable carrying case.

The duration of treatment, as a rule, does not exceed 7 days.

After completing the 7-day course of treatment, the patient should consult a doctor to assess the effectiveness of therapy.

If symptoms of the disease and/or elevated temperature persist during therapy with Bioparox, the patient should inform the attending physician.

In the case of pronounced clinical manifestations of a bacterial infection, treatment with Bioparox in combination with systemic antibiotics is possible.

Rules for using the drug

Before using the canister for the first time, press its base 4 times to activate it.

Inhalations through the nose should be carried out for rhinitis, nasopharyngitis, and sinusitis. Before inhalation, you should clean your nose. The container with the drug must be held vertically with the nozzle upward, holding it between the thumb and forefinger. To carry out inhalation through the nose, attach the nozzle to the balloon (yellow for adults or transparent for children) and insert it into the nasal passage (while holding the opposite nasal passage and closing the mouth). While inhaling deeply through your nose, press the base of the balloon vigorously and all the way.

Inhalation through the mouth. Place the white nozzle on the balloon, insert it into your mouth, pressing it tightly with your lips, while holding the balloon vertically and slightly tilted.

For pharyngitis, tonsillitis, conditions after tonsillectomy, laryngitis, you should press firmly and for a long time on the bottom of the balloon and take a deep breath to completely irrigate the tonsils and pharynx.

For tracheitis, before inhalation it is necessary to cough, then deeply inhale the aerosol mixture and hold your breath for a few seconds to completely irrigate the trachea.

The attachments should be disinfected every other day using a cotton swab soaked in ethanol (90%).

  • dryness of the mucous membranes of the nose or oropharynx;
  • tingling sensation in the nose, mouth and throat;
  • sneeze;
  • cough;
  • nausea;
  • unpleasant taste in the mouth;
  • swelling of the eyes;
  • rash;
  • itching;
  • hives;
  • Quincke's edema, mainly in patients predisposed to allergies;
  • asthmatic attack;
  • bronchospasm attack;
  • dyspnea;
  • spasm of the larynx;
  • angioedema;
  • anaphylactic shock.
  • children under 2.5 years of age (risk of developing laryngospasm);
  • hypersensitivity to the components of the drug.

Use during pregnancy and breastfeeding

There are no clinical data on the use of the drug during pregnancy. The drug should be prescribed with caution during pregnancy.

Due to the lack of data on excretion in breast milk, the use of Bioparox in nursing women is not recommended.

Long-term studies on laboratory animals did not reveal embryo-, genotoxic effects or teratogenic effects on the fetus.

It is not recommended to exceed the duration of the standard 7-day course of treatment in accordance with the general rules for the use of antibiotics.

At the end of the 7-day course of treatment, the patient should consult a doctor to assess the effectiveness of therapy.

Do not spray the drug into the eyes.

Do not store the drug near strong heat sources. Do not expose to temperatures above 50°C.

Avoid breaking the seal of the canister body and burning it, even after the drug has been completely used.

Impact on the ability to drive vehicles and operate machinery

Bioparox does not affect the ability to drive vehicles and the speed of psychomotor reactions.

Data on drug interactions of Bioparox with other drugs, incl. and with other antibiotics is not available.

Analogues of the drug Bioparox

The drug Bioparox has no structural analogues for the active substance.

Source: http://instrukciya-otzyvy.ru/137-bioparoks-po-primeneniyu-analogi-aerozol-dlya-ingalyaciy-cherez-rot-ili-nos-angina-gaymorit-tonzillit.html

BIOPAROX

◊ Aerosol for inhalation, dosed in the form of a yellow solution with a specific odor.

Excipients: aromatic additive 80 mg, anhydrous ethanol mg, saccharin - 1.25 mg, isopropyl myristate - 85.32 mg, propellant 1,1,1,2-tetrafluoroethane (HFA 134a) mg.

10 ml (400 inhalations) - aluminum aerosol cans with a dosing valve (1) complete with spray nozzles and activator cap - contour cell packaging (1) with a case for portable carrying - cardboard packs.

Antibiotic for local use. Has antibacterial and anti-inflammatory activity.

In vitro, Bioparox is active against: Streptococcus spp. group A, Streptococcus pneumoniae (old name - Pneumococcus), Staphylococcus spp., some strains of Neisseria spp., some anaerobes, as well as Mycoplasma spp., fungi of the genus Candida. Fusafungin is believed to have similar activity in vivo.

Fusafungin has a pronounced anti-inflammatory effect by reducing the concentration of tumor necrosis factor (TNFα) and suppressing the synthesis of free radicals by macrophages while maintaining phagocytosis.

After inhalation use of the drug Bioparox, fusafungin is mainly distributed on the surface of the mucous membrane of the oropharynx and nasal cavity. Fusafungin can be detected in blood plasma in very low concentrations (no more than 1 ng/ml), which does not affect the safety of the drug.

- treatment of infectious and inflammatory diseases of the respiratory tract (rhinitis, nasopharyngitis, pharyngitis, laryngitis, tracheitis, tonsillitis, conditions after tonsillectomy, sinusitis).

- children under 2.5 years of age (risk of developing laryngospasm);

- hypersensitivity to the active substance or to the excipients included in the drug.

with caution in patients prone to allergic reactions and bronchospasm.

The drug is used in the form of inhalation (through the mouth and/or nose).

Adults are prescribed 4 inhalations through the mouth and/or 2 inhalations into each nasal passage 4 times a day.

Children over 2.5 years old are prescribed 2-4 inhalations through the mouth and/or 1-2 inhalations into each nasal passage 4 times a day.

To make maximum use of the activity of the Bioparox drug, it is necessary to follow the prescribed doses and follow the rules for using the attached attachments.

To obtain a lasting therapeutic effect, it is necessary to observe the duration of the prescribed treatment: it is not recommended to stop treatment when the first signs of improvement appear, because premature cessation of therapy may lead to relapse.

You should always have the drug with you, placing it in the attached portable carrying case.

The duration of treatment, as a rule, does not exceed 7 days.

After completing the 7-day course of treatment, the patient should consult a doctor to assess the effectiveness of therapy.

If symptoms of the disease and/or elevated temperature persist during therapy with Bioparox, the patient should inform the attending physician.

In the case of pronounced clinical manifestations of a bacterial infection, treatment with Bioparox in combination with systemic antibiotics is possible.

Rules for using the drug

Before using the canister for the first time, press its base 4 times to activate it.

Inhalations through the nose should be carried out for rhinitis, nasopharyngitis, and sinusitis . Before inhalation, you should clean your nose. The container with the drug must be held vertically with the nozzle upward, holding it between the thumb and forefinger. To carry out inhalation through the nose, attach the nozzle to the balloon (yellow for adults or transparent for children) and insert it into the nasal passage (while holding the opposite nasal passage and closing the mouth). While inhaling deeply through your nose, press the base of the balloon vigorously and all the way.

Oral inhalation . Place the white nozzle on the balloon, insert it into your mouth, pressing it tightly with your lips, while holding the balloon vertically and slightly tilted.

For pharyngitis, tonsillitis, conditions after tonsillectomy, laryngitis, you should press firmly and for a long time on the bottom of the balloon and take a deep breath to completely irrigate the tonsils and pharynx.

For tracheitis , before inhalation it is necessary to cough, then deeply inhale the aerosol mixture and hold your breath for a few seconds to completely irrigate the trachea.

The attachments should be disinfected every other day using a cotton swab soaked in ethanol (90%).

The following side effects were observed while taking fusafungin with the following frequency: very often (≥1/10), often (≥1/100, <1/10), infrequently (≥1/1000, <1/100), rarely ( ≥1/10,000, <1/1000), very rare (<1/10,000) and unknown frequency (frequency cannot be calculated from available data).

Allergic reactions are very rare. It is possible to develop local, quickly passing reactions, mainly in patients predisposed to allergies.

General disorders and symptoms: very often - sneezing, unpleasant taste in the mouth, redness of the mucous membrane of the eyes; often - dry mucous membranes of the respiratory tract, irritation in the throat, cough, nausea; unknown frequency - vomiting. There is usually no need to stop treatment.

From the immune system: very rarely - anaphylactic shock.

From the respiratory system: very rarely - asthmatic attacks, attacks of bronchial asthma, shortness of breath, laryngospasm, Quincke's edema, incl. swelling of the larynx.

From the skin: very rarely - rash, itching, urticaria.

If allergic reactions develop, the drug should be discontinued and the drug should not be resumed. Due to the risk of developing anaphylactic shock, in the event of the appearance of respiratory, laryngeal symptoms or skin (itching, generalized erythema) symptoms, immediate intramuscular injection of epinephrine (adrenaline) at a dose of 0.01 mg/kg is recommended. If necessary, repeat IM injection after a minute.

There is limited information on fusafungine overdose.

Symptoms: poor circulation, numbness in the mouth, dizziness, increased sore throat, burning sensation in the throat.

Treatment: In case of overdose, treatment should be symptomatic with subsequent observation.

No specific studies on interactions with other drugs have been conducted.

It is not recommended to exceed the duration of the standard 7-day course of treatment in accordance with the general rules for the use of antibiotics. At the end of the 7-day course of treatment, the patient should consult a doctor to assess the effectiveness of therapy.

May cause skin irritation.

The drug contains a small amount of ethanol, less than 100 mg/dose.

Do not spray the drug into the eyes.

Do not store the drug near strong heat sources.

Do not expose to temperatures above 50°C.

Avoid breaking the seal of the cylinder body and burning it, even after the drug has been completely used.

Impact on the ability to drive vehicles and operate machinery

Bioparox does not affect the ability to drive vehicles and the speed of psychomotor reactions.

There are no clinical data on the use of the drug during pregnancy. The drug should be prescribed with caution during pregnancy.

Due to the lack of data on excretion in breast milk, the use of Bioparox in nursing women is not recommended.

Long -term studies on laboratory animals did not reveal embryo-, genotoxic effects or teratogenic effects on the fetus.

Contraindicated in children under 2.5 years of age.

The drug is approved for use as a means of OTC.

No special storage conditions are required. Shelf life: 2 years. Do not use after the expiration date stated on the package.

To ask a question about the project or contact the editors, use this form.

Source: http://health.mail.ru/drug/bioparox/

Bioparox: instructions for use

The drug Bioparox is a remedy for the local treatment of inflammatory processes in the oropharynx and upper respiratory tract, which has a detrimental effect on pathogenic microorganisms and viruses.

Release form of the drug and composition

The drug Bioparox is available in the form of an aerosol with 2 dispenser sprays of transparent and white color, each with a volume of 20 ml in an aluminum can. This one canister contains about 400 doses of the drug.

The main active ingredient of the aerosol is fusafungin, as well as auxiliary components and ethanol 96%.

Pharmacological properties of the drug

Aerosol Bioparox is a local antibiotic. The active substance of the drug exhibits high therapeutic efficacy against gram-positive and gram-negative microflora, as well as some anaerobes and fungi of the genus Candida. The highest therapeutic activity of the drug is observed in the early stages of the disease, that is, literally in the first 2 days, while the inflammatory process is not yet so advanced. When using the aerosol for medicinal purposes, patients noted a decrease in pain when swallowing, a decrease in swelling of the palatine and pharyngeal tonsils, and some improvement in their general condition.

Indications for use

This drug is prescribed to patients for the prevention and treatment of the following conditions:

  • Acute and chronic inflammatory diseases of the ENT organs - as part of complex therapy for runny nose of infectious or viral origin, sinusitis, pharyngitis, inflammatory processes of the larynx;
  • Laryngotracheitis as part of complex therapy - with timely initiation of drug therapy, the active ingredient in the aerosol significantly reduces the risk of developing laryngeal stenosis;
  • Inflammatory processes in the oral cavity caused by pathological reproduction and activity of fungi of the genus Candida as part of complex therapy;
  • Inflammatory processes of the upper respiratory tract as part of complex treatment - bronchitis, tracheitis;
  • Chronic tonsillitis during exacerbation of the disease;
  • For prophylactic purposes after surgical removal of the tonsils.

Contraindications for use

This aerosol cannot be used for treatment if the patient has the following conditions:

  • Individual intolerance to the components of the drug;
  • Children under 3 years of age, which is due to a high risk of developing false croup when inhaling microparticles of the drug orally;
  • Bronchial asthma or chronic obstructive pulmonary disease;
  • Patients with a burdened allergic history, in particular those suffering from atopic dermatitis or frequent bronchial obstruction.

Method of administration and dosage of the drug

This medicine is intended for inhalation through the mouth or nasal cavity. The new bottle must be sprayed into the air a couple of times so that in the future the patient receives the correct single dose.

In the presence of inflammatory processes in the nasal cavity (rhinitis, complicated sinusitis, sinusitis), the aerosol is sprayed through the nasal cavity, which must first be cleared of accumulated mucus and crusts. A balloon with a transparent nozzle is first inserted into one nasal passage, closing the second one with a finger, and sprayed once, while inhaling deeply. The mouth must be closed. The same procedure is done with the second nasal passage.

If it is necessary to treat inflammatory processes in the oropharynx and upper respiratory tract, the drug is administered through the mouth. To do this, the patient places a yellow nozzle on the bottle. The patient tightly clamps the nozzle with his lips, takes a deep breath and at this moment sprays the medicine. In order for the drug to be evenly distributed throughout the mucous membranes of the trachea and bronchi after spraying the dose, it is recommended to hold your breath for a couple of seconds.

The cylinder nozzles must be thoroughly rinsed with running water after each use, and then wiped with a cotton swab moistened with alcohol. The number of sprays of the drug per day and the duration of the course of treatment are determined by the doctor, depending on the indications, age, body weight and characteristics of the patient’s body.

According to the instructions for the drug, the daily dose for adults and children over 12 years of age is 4 times a day, 1 spray of aerosol. Children are sprayed with the drug 1 pump 2 times a day. The duration of the course of therapy is no more than a week; if during this period the patient’s condition has not improved, then you should consult a doctor again to clarify the diagnosis or prescribe another drug.

Side effects and overdose

In general, the drug is well tolerated by patients and only in rare cases the following side effects may develop:

  • Burning and sore throat after spraying the aerosol;
  • Cough and sneezing;
  • Watery eyes and difficulty breathing;
  • Bronchospasm in rare cases;
  • Dryness of the mucous membranes of the mouth or nasal cavity.

If the aerosol is used excessively and the recommended dose is exceeded, an overdose of the drug may develop, which is manifested by the following symptoms:

  • Nausea, abdominal pain;
  • Watery eyes and redness of the eyes;
  • The appearance of a constant unpleasant taste in the mouth;
  • Allergic skin reactions - itching, rashes, urticaria.

In very rare cases, due to an overdose of the drug, the patient may develop angioedema or anaphylaxis. This drug should not be used for more than 7 days due to the high risk of developing superinfection.

Use of the drug during pregnancy and breastfeeding

In medicine, there is no reliable information about the safety of the active substance in relation to the fetus. While expecting a child, a woman is not recommended to use this drug for therapeutic or prophylactic purposes. Although in small doses, the drug still enters the general bloodstream, and then through the placenta to the fetus. The 96% ethanol contained in the aerosol can lead to delayed mental development of the fetus in the womb and various anomalies. Gynecologists always try to find an alternative topical drug for the expectant mother that will not be dangerous for the development of the child and the further course of pregnancy.

During lactation, this drug can be used only under the supervision of a doctor and for serious indications. In some cases, the issue of temporarily stopping breastfeeding should be addressed.

Conditions for storing and dispensing the drug

Aerosol Bioparox is available in pharmacies without a prescription. The can of the drug should be stored out of the reach of children at a temperature of no more than 25 degrees. It is very important to avoid direct sunlight on the can. The used cylinder must not be heated or punctured due to the high risk of explosion! The shelf life of the drug is 2 years; it is recommended to shake the can vigorously before each spraying.

Bioparox analogues

There are currently no analogues of Bioparox.

The following drugs have a similar, but less pronounced antiseptic effect: Hexoral, Isofra, Faringosept, Tantum Verde, Chlorophyllipt, Grammidin.

These drugs are cheaper and do not contain antibiotics. In addition, not all of them come in spray form. Therefore, they cannot be called close analogues.

Bioparox price

Price range of Bioparox aerosol in pharmacies RUB.

Source: http://bezboleznej.ru/bioparoks

Bioparox - official instructions for use

The Federal Service for Surveillance in Healthcare, as part of the performance of the state function of monitoring the safety of medicines in circulation on the territory of the Russian Federation, brings to the attention of subjects of medicines circulation a letter from Servier Laboratories about the termination of registration certificates and the revocation of approvals for use medicinal product "Bioparox (MHH: Fusafungin), dosed aerosol for inhalation" registration certificate Ns P N015629/O1 dated July 16, 2009, registration certificate holder - Servier Laboratories (France).

Registration number:

Trade name: BIOPAROX ®

International nonproprietary name:

Dosage form:

Compound:

One cylinder containing 10 ml of solution (0.59 ml of concentrate and 9.41 ml of propellant) contains:

Active substance: fusafungine 50 mg.

Excipients: aromatic additive, 00 mg, anhydrous ethanol 200.00 mg, saccharin 1.25 mg, isopropyl myristate 85.32 mg, propellant norflurane (1,1,1,2-tetrafluoroethane, HFA-134a) 11386.00 mg .

Composition of flavor additive 14868: geranyl acetate, isoamyl acetate, anise alcohol, ethanol 96%, phenylethanol, methyl anthranilate, Badian extract (anise oil), Carvi extract (caraway fruit extract), Cloves extract (clove tree bud extract), Coriander extract (coriander seeds extract), wormwood tarragon herb oil, China mint extract (field mint extract), Florida Valencia orange extract (sweet orange fruit peel), Paraguay small grain extract (orange extract), Peppercorn extract (pimento fruit extract), extract Rosemary (rosemary flower extract), ethyl vanillin, geraniol, heliotropin, indole, linalol, isopropyl myristate.

One dose is 4 inhalations. One inhalation corresponds to 0.125 mg of fusafungine. One cylinder contains 400 inhalations.

Aerosol aluminum can equipped with a metering valve.

Contents: the bottle contains a yellow solution with a specific odor.

Pharmacotherapeutic group:

Fusafungin is a topical antibiotic with anti-inflammatory properties.

Under in vitro conditions, the drug has an antimicrobial effect on the following microorganisms, which suggests a similar effect in vivo: group A streptococci (group A Streptococci), pneumococcus (Pneumococci), cnfabkjrjrr (Staphylococci), some strains of Neisseria, some anaerobes, fungi of the genus candida (Candida albicans) and mycoplasma pneumoniae (Mycoplasma pneumoniae).

Fusafungin has a pronounced anti-inflammatory effect by reducing the concentration of tumor necrosis factor (TNF-a) and suppressing the synthesis of free radicals by macrophages while maintaining phagocytosis.

Fusafungin is mainly distributed in the oropharynx and nasal cavity. In blood plasma, fusafungin can be detected in very low concentrations (no more than 1 ng/ml), which does not affect the safety of the drug.

Treatment of infectious and inflammatory diseases of the respiratory tract (rhinitis, pharyngitis, nasopharyngitis, tracheitis, laryngitis, tonsillitis, condition after tonsillectomy, sinusitis).

- Hypersensitivity to the active substance or to the excipients included in the drug.

- Children under 30 months (2.5 years) (risk of developing laryngospasm).

With caution: BIOPAROX ® should be used with caution in patients prone to allergic reactions and bronchospasm (see section “Side Effects”).

PREGNANCY AND BREASTFEEDING

There are no clinical data on use during pregnancy. In this regard, the drug should be prescribed to pregnant women with caution.

Long-term studies on laboratory animals did not reveal embryo-, genotoxic effects or teratogenic effects on the fetus. Due to the lack of data on excretion in breast milk, the use of BIOPAROX ® is not recommended for nursing women.

Used for inhalation (through the mouth and/or nose).

Adults: 4 inhalations through the mouth and/or 2 inhalations into each nostril 4 times a day.

Children: inhalation through the mouth and/or inhalation into each nasal passage 4 times a day.

To make maximum use of the activity of the BIOPAROX ® drug, it is important to follow the prescribed dosage and follow the rules for using the supplied attachments. To maintain a lasting therapeutic effect, it is necessary to observe the duration of the prescribed treatment: it is not recommended to stop treatment when the first signs of improvement appear, since premature cessation of therapy can lead to relapse.

You should always have the drug with you, placing it in the attached portable carrying case.

The duration of the usual course of treatment should not exceed 7 days.

At the end of the course of therapy, you should consult a doctor to assess the effectiveness of treatment.

If symptoms of the disease and/or elevated temperature persist during therapy with BIOPAROX ®, you must inform your doctor about this.

In the case of pronounced clinical manifestations of a bacterial infection, treatment with BIOPAROX ® in combination with systemic antibiotics is possible.

Method of use of the drug BIOPAROX ®

Before using the canister for the first time, press the base 4 times to activate it.

Place the appropriate nozzle on the balloon (white, for inhalation of the drug through the mouth, or yellow (for adults) and transparent (for children), for administration through the nose) (Fig. 1).

Using the drug through the nose:

The container with the drug must be held vertically with the nozzle upward, holding it between the thumb and forefinger.

  • Clean your nose before using the drug.
  • Attach the nozzle (yellow for adults or transparent for children) to the balloon and insert it into the nasal passage (while holding the opposite nasal passage and closing the mouth).
  • While inhaling deeply through your nose, press the base of the balloon vigorously and all the way (Fig. 2).

Using the drug by mouth:

Place the white nozzle on the balloon (Fig. 3) and insert it into your mouth, pressing it tightly with your lips. Hold the balloon as shown in Fig. 4.

Pharyngitis, tonsillitis, condition after removal of tonsils, laryngitis

  • Press the balloon firmly and for a long time, taking a deep breath, to completely irrigate the tonsils and pharynx. Tracheitis
  • Cough, then deeply inhale the aerosol mixture and hold your breath for a few seconds to irrigate the trachea more completely.

Nozzles for the mouth and nose must be disinfected every other day using a cotton swab soaked in 90% ethyl alcohol.

The following side effects were observed while taking fusafungin with the following frequency: very often (≥ 1/10), often (≥ 1/100, Allergic reactions are observed very rarely. Local, rapid reactions may develop, mainly in patients predisposed to allergies.

Common disorders and symptoms

Very common: sneezing, unpleasant taste in the mouth, redness of the mucous membrane of the eyes.

Common: dry mucous membranes of the respiratory tract, irritation in the throat, cough, nausea.

Unknown frequency: vomiting. There is usually no need to stop treatment.

From the immune system

Very rare: anaphylactic shock.

From the respiratory system

Very rare: asthmatic attacks, attacks of bronchial asthma, shortness of breath, laryngospasm, Quincke's edema, including laryngeal edema.

From the skin

Very rare: rash, itching, urticaria.

If allergic reactions develop, the drug should be discontinued and the drug should not be resumed.

Due to the risk of anaphylactic shock, in the event of respiratory, laryngeal or skin (itching, generalized erythema) symptoms, intramuscular injection of epinephrine (adrenaline) 0.01 mg/kg is recommended immediately. If necessary, repeat the intramuscular injection after a minute.

There is limited information on fusafungine overdose.

Symptoms: poor circulation, numbness in the mouth, dizziness, increased sore throat, burning sensation in the throat

In case of overdose, treatment should be symptomatic with subsequent observation.

INTERACTIONS WITH OTHER MEDICINES

No specific studies on interactions with other drugs have been conducted.

Bioparox ® does not affect the ability to drive a car or the speed of mental and physical reactions.

It is not recommended to exceed the duration of the standard 7-day course of therapy in accordance with the general rules for the use of antibiotics. At the end of the 7-day course of therapy, you must consult a doctor to assess the effectiveness of treatment.

May cause skin irritation.

The drug contains a small amount of ethanol, less than 100 mg/dose.

Do not spray the drug into the eyes.

Do not store the drug near strong heat sources.

Do not expose to temperatures above 50°C.

Avoid breaking the seal of the cylinder body and preventing it from burning even after the drug has been completely used.

Aerosol for inhalation dosed 0.125 mg/inhalation.

10 ml of solution (400 inhalations) in an aluminum aerosol can. The cylinder has a metering valve equipped with three spray nozzles: for the nose (yellow for adults and transparent for children) and mouth (white), and an activator cap.

One bottle with spray nozzles and an activator cap in a blister pack with a case for portable carrying and instructions for medical use in a cardboard box.

No special storage conditions are required.

Keep out of the reach of children.

DO NOT USE AFTER THE EXPIRATION DATE STATED ON THE PACKAGING.

The registration certificate was issued to Servier Laboratories

France, produced by: Open Joint Stock Company Pharmaceutical

EGIS plant, Hungary

Open Joint Stock Company Pharmaceutical Plant EGIS, Hungary:

30-38, st. Keresturi, H-1106 Budapest, Hungary

30-38, Kereszturi ut, H-1106 Budapest, Hungary

For any questions, please contact the Representative Office of Servier Laboratories JSC.

Representative office of JSC Servier Laboratories:

115054, Moscow, Paveletskaya square, 2, building 3

Source: http://medi.ru/instrukciya/bioparoks_3686/