Fluimucil antibiotic shelf life of the finished solution. Fluimucil-antibiotic it: instructions for use

Many infectious inflammatory diseases respiratory system accompanied by symptoms such as cough and runny nose. There are a large number of methods to eliminate them. One of effective ways treatment is inhalation. This procedure can be used in various medical preparations. Fluimucil for inhalation is excellent for this.

Fluimucil - effective antibiotic which has mucolytic properties

This drug belongs to mucolytics (drugs that actively thin sputum). The basis of this solution for inhalation is active ingredient acetylcysteine. Among the auxiliary components of the drug are sodium hydroxide and disodium edatate, purified water.

Fluimucil has the following properties:

Reduces the viscosity of bronchopulmonary secretion (has a sputum thinning effect).
Has antioxidant properties.
Facilitates the release of mucus from the respiratory system.
Helps soften the mucosa.
Increases the secretion of the bronchi.
Reduces inflammatory process in the respiratory tract by stimulating immune cells.
It has a cleansing effect in the bronchi and paranasal sinuses.

The drug is produced in various pharmaceutical forms:

Liquid for inhalation.
Water for injections.
Tablets for the preparation of fizzy drink.
Granules.

Solution for inhalation has the form of a colorless liquid with a specific smell of sulfur. It is in ampoules, which are placed in plastic holders.

In addition, there is Fluimucil with the antibiotic thiamphenicol. It has the same properties as ordinary solution, but it also provides antibacterial action, since it effectively suppresses the growth and reproduction of pathogenic microorganisms in the pathological focus of the respiratory tract. It is also used in the presence of purulent sputum.

Fluimucil is prescribed for respiratory diseases, to improve sputum discharge

Fluimucil is prescribed as inhalation for the treatment of infectious and inflammatory diseases of the upper and lower divisions respiratory organs, the symptom of which is coughing:

Tonsillitis
Rhinitis
sinusitis
Laryngitis
Pharyngitis
Tracheitis
bronchotracheitis
Pneumonia
Bronchiectasis
Whooping cough
Interstitial lung diseases
Bronchitis in acute and chronic form
lung abscesses

Also indications for the use of Fluimucil is a cough with acute respiratory infections or acute respiratory viral infections. In some cases, the drug is used to treat otitis media.

An antibiotic agent is also effective in pulmonary cystic fibrosis, amyloidosis, fibrosis, tuberculosis, as it destroys staphylococci, Haemophilus influenzae, streptococci and other pathogens.

The drug can be used as prophylactic, to prevent unwanted complications in the postoperative period.

May be given prior to bronchial mucus aspiration and bronchoscopy. Sometimes credited to improve drainage in lung infections such as tuberculosis. It must be remembered that this medicine for inhalation can only be prescribed by a doctor. With the independent use of the drug, the patient's condition may worsen.

The dosage and course of treatment with inhalations with Fluimucil should be prescribed by a doctor!

The procedure with Fluimucil is carried out using special device- nebulizer. It is intended for inhalation with cough and runny nose, which are signs of otolaryngological diseases and respiratory diseases. Nebulizer delivers fast medicinal substance in the focus of pathology and does not adversely affect other organ systems.

There are several types of inhalation devices, however, it is undesirable to use Fluimucil for the use ultrasonic device. Best for the procedure with this tool is suitable compressor nebulizer.

To prepare a liquid for inhalation, it is necessary to open the ampoule and dilute its contents in a chilled boiled water or physiological saline in equal proportions. Such a tool must be diluted in glassware. Rubber or metal containers inactivate the active substance of the drug.

Dosage:

In order to make a liquid for one procedure, take one ampule of Fluimucil 10%, 3 ml each (for adults).
For young patients up to six years of age, the drug is prescribed at a dosage of one milliliter.
Up to 12 years - two milliliters.

Dilute the drug with saline or water in a ratio of 1: 1. For children under two years of age, inhalation is done only in a hospital setting.

With difficulty in nasal breathing, before inhalation, it is recommended to drip the passages of the nose with vasoconstrictor drops. It is better to carry out the manipulation a few hours after eating. The patient's body temperature should be no more than 37.5. After preparation, the liquid is poured into the nebulizer tank. After that, the device is turned on and a special mask is put on to breathe the medicine. The procedure should be carried out at rest, breathing for this should be even.

The finished solution can be placed in the refrigerator and used the next day. To do this, it should only be slightly warmed up.

To prepare a solution with Fluimucil, an IT antibiotic, the powder is diluted with the liquid that is in the package. For one bottle take 8 milliliters of chilled boiled water. For children, use 2 milliliters of solution per inhalation.

More information about inhalations with Fluimucil can be found in the video:

It is not recommended to dilute the agent in a liquid in a larger dose, since the effectiveness of inhalation in this case is noticeably reduced. It is also important to note that this solution should be used immediately and cannot be stored for the next time. The duration of treatment is determined by the specialist, taking into account the nature of the course of the disease and individual characteristics the patient's body. Most often in diseases acute nature the course of therapy is 10 days. If the patient has a chronic respiratory disease, then inhalations can be prescribed for six months.

Incorrect use or overdose of the drug can provoke the development of side effects.

The restriction in the use of the drug concerns individual hypersensitivity to the components of Fluimucil and the tendency to allergic reactions to the drug. Inhalations with medicine are not recommended for diseases circulatory system(thrombocytopenia, anemia, leukopenia). Also contraindications are pregnancy, age up to two years and the period breastfeeding.

Apply with caution this remedy at bronchial asthma, predisposition to bleeding lungs and spastic bronchitis. It is not advisable to use Fluimucil when peptic ulcers in acute form. A contraindication to the use of the drug with an antibiotic is liver failure and kidney pathology. In minimal doses, an inhalation agent is prescribed for elderly patients.

It is important to note that it is not advisable to combine inhalations with the drug with ampicillin or tetracycline.

These antibiotics reduce the therapeutic effect of inhalation. It is also not allowed simultaneously with the use of Fluimucil and means that block cough reflexes. This is due to the fact that antitussive drugs with drugs that thin sputum can provoke stagnation of mucous secretions in the respiratory system. As a complication of this phenomenon, pneumonia can occur.

Side effects of the use of inhalations with Fluimucil include:

stomatitis
irritation of the respiratory mucosa
nasal congestion
cough reflexes

During inhalation in childhood a phenomenon such as nausea may be observed, which is due to the characteristic odor of the drug. In rare cases, bronchospasm is possible. To eliminate it, a bronchodilator is used, which helps to relax the walls of the bronchi.

There are a large number of drugs on the pharmaceutical market that are analogues of Fluimucin. They are available in ampoules with a solution for inhalation. Carry out the procedure with their use using a nebulizer.

The following popular drug analogues have mucolytic properties:

Acestine
Mukomist
Vicks Active ExpectoMed
ACC injection

They are safe and effective for coughs with difficult expectoration. They are prescribed if there are contraindications to the use of Fluimucil or when side effects from its use.

For inflammatory diseases of the upper respiratory tract, drugs are used (antibiotics, antiviral and antitussive drugs), general procedures activating immunity, local procedures. One of the effective ways to treat children and adults is inhalation. In this case, it is necessary to strive for the active substance in the solution to penetrate as deep as possible into the trachea and bronchi.

Modern ultrasonic inhalers make it possible to spray the drug up to smallest particles, which provides a good therapeutic effect.

Fluimucil - synthetic medicinal product manufactured by the Italian company Zambon Group. Active chemical is acetylcysteine.

Acetylcysteine has several types of effects on the upper Airways:

liquefies thick mucous and mucopurulent sputum in paranasal sinuses nose, on the surface of the trachea and bronchi;
enhances mucus production;
has a local anti-inflammatory effect due to the activation of immune cells;
provides cleansing of the bronchi and paranasal cavities;
is not an antibiotic, but in the combined composition, the Fluimucil-antibiotic IT solution additionally has an antimicrobial effect.

Fluimucil and Fluimucil-antibiotic IT are available in a convenient form:

Fluimucil in ampoules of 3 ml of a 10% solution for inhalation, each contains 300 mg of acetylcysteine.

Fluimucil-antibiotic IT in the form of a lyophilizate of 250 and 500 ml in vials. For its dissolution, ampoules with sterile water are placed in the package.

Instructions for use of the solution suggest diluting the opened ampoule in half with boiled water or sterile saline, use within two days. Preparation of the solution must be carried out only in glassware, avoid contact with metal or rubber. These substances inactivate acetylcysteine.

In the lyophilizate for the preparation of a solution for one procedure, add 2 ml of sterile water from an ampoule per 250 ml of the preparation.

The characteristic smell of sulfur compounds is always present when the ampoule is opened.

Fluimucil inhalations are best done using simple home inhalers or the most modern ultrasonic nebulizer. The use of a specially selected mask allows you to treat children with inhalations. It is contraindicated for children under two years of age. The nebulizer is considered the most effective in terms of the method of penetration into the upper and lower respiratory tract. Healing home procedures are indicated for coughing in children and adults accompanying

sharp and Chronical bronchitis,
laryngitis,
rhinitis,
inflammation of the paranasal sinuses,
tracheitis.

Cough associated with acute respiratory viral infection, can be effectively treated with inhaled Fluimucil solution.

Fluimucil for inhalation is prescribed for children from two to six years old, 1 ml twice a day, over six - 2 ml twice a day. Children over 12 years of age and adults can use 3 ml of the solution twice a day. The duration of treatment is determined by the doctor. Usually the course does not exceed ten days.

Antitussives that act on the cough reflex, on the contrary, increase, and sputum stagnation occurs. This option can contribute to the onset of pneumonia in debilitated patients and children.

During inhalation, part of the acetylcysteine is absorbed into the bloodstream. If a person is taking nitrates such as nitroglycerin and other drugs to treat coronary disease heart, then their action is enhanced.

In children, nausea is possible due to the specific smell of the drug. Runny nose, bronchospasm (suffocation attacks), stomatitis are rarely noted.

Absolute contraindications to the use of drugs are:

blood diseases;
increased allergic sensitivity;
pregnancy and lactation period;
up to two years of age.

Also, as with internal use restrictions, according to the instructions, apply to chronic diseases digestive organs, liver, kidneys.

All questions on treatment with Fluimucil should be agreed with the attending physician.

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Nebulizer inhalation is an effective modern method treatment based on the introduction of drugs in the form of an aerosol through the respiratory tract. Especially often inhalations are recommended for diseases accompanied by a cough. This procedure allows you to moisturize and soften the irritated mucous membrane, quickly deliver the medicine to the pathological focus, with virtually no systemic effect on the body.

The pharmaceutical industry produces many drugs for use by inhalation. In this article, we will consider the features of the use of two means for inhalation - Fluimucil and Fluimucil-antibiotic IT.

Fluimucil for inhalation is an effective and safe drug in the form of a solution, which is a clear, colorless liquid with a slight sulfuric odor. Fluimucil is packaged for inhalation in ampoules of 3 ml (10% solution).

Fluimucil belongs to the group of expectorant mucolytic agents. It helps to increase the secretion of sputum, its thinning and facilitating excretion from the body. The drug also has an anti-inflammatory effect. Active ingredient The drug is acetylcysteine. It is assigned for:

bronchitis;
tracheitis;
bronchiolitis;
pneumonia;
interstitial lung diseases, etc.

For the procedure, it is enough to dilute one ampoule of Fluimucil saline in a ratio of 1:1. Inhalations are carried out for 15 - 20 minutes 2 - 4 times a day. Usually during treatment acute diseases the duration of the course does not exceed 10 days. In the case of chronic processes, the doctor may prescribe the drug for a course of up to six months.

Fluimucil may have the following side effects: reflex cough, rhinorrhea, bronchospasm, stomatitis. The drug is contraindicated in peptic ulcer in the stage of exacerbation, pregnancy and lactation (with caution), hypersensitivity to its components.

Fluimucil is an IT antibiotic for inhalation. unique drug, which has both antimicrobial and mucolytic (thinning sputum) action.

It is used to treat inflammatory processes of the respiratory system, accompanied by the accumulation of viscous sputum. Thick sputum or mucous discharge from the nose is difficult to remove, contributes to the formation of obstruction (obstruction) of the nasopharynx and bronchi. Fluimucil - IT antibiotic for inhalation dilutes sputum and promotes its excretion.

The dosage form of the drug allows it to be used in the form of injections or inhalations; this is very convenient, since the choice of method of administration depends on the course of the disease and general condition sick.

Clinical and pharmacological group

Antibiotic in combination with mucolytic and antioxidant.

Terms of sale from pharmacies

Can buy by prescription.

Price

How much does Fluimucil cost in pharmacies? average price is at the level of 770 rubles.

Composition and form of release

Powder obtained by lyophilization, from which a solution is prepared; in vials complete with a solvent, 3 pcs. in a pack.

One bottle contains: glycinate acetylcysteinate thiamphenicol - 0.81 g, including thiamphenicol 500 mg; additional substance - disodium edetate; water as a solvent.

Pharmacological effect

The active active ingredient of Fluimucil, an IT antibiotic for inhalation, is thiamphenicol glycinate acetylcysteinate, which is a single complex of an antibacterial substance and a mucolytic. Absorbed, the complex is divided into:

1) The antibacterial substance thiamphenicol, a derivative of chloramphenicol. It inhibits the formation of a protein necessary for the reproduction of infectious agents. Sensitivity to this agent is shown by most pathogens of infection of a bacterial nature, disease-causing respiratory system:

Gram-positive (capable of Gram staining with gentian violet dye) - staphylococci, streptococci, etc.;
gram-negative (unable to stain according to Gram) - hemophilic and Escherichia coli, salmonella, etc.

2) Mucolytic acetylcysteine - dilutes the secretions and promotes their rapid removal. Together with sputum, infectious agents are also removed, since acetylcysteine prevents them from settling on the epithelium. Cleansing the epithelium from viscous sputum improves the absorption of thiamphenicol.

Indications for use

Fluimucil for inhalation has found its use in the composition combined treatment the following pathologies:

Chronic and acute inflammatory processes in pulmonary tract, including laryngotracheitis, .
Adenoiditis.
Inflammation of the middle ear.
Bronchopneumonia.
Diseases bronchopulmonary system, abscess, .
Complications after surgery.

In addition, the solution for inhalation is prescribed during the period of preparing the patient for various diagnostic and therapeutic procedures on the respiratory system.

Contraindications

diseases and changes in the blood formula (leukopenia, anemia, thrombocytopenia);
individual intolerance to the substances that make up the drug.

Kidney function in children of the first 2 years of life has age-related features, therefore, in them, as well as in patients with severe damage to the liver and kidney functions, the drug should be used with caution.

Appointment during pregnancy and lactation

Assign only if the benefit to the woman outweighs the risk to the fetus. During the period of breastfeeding, if necessary, treatment should be stopped.

Dosage and method of application

As indicated in the instructions for use, Fluimucil-antibiotic IT is administered intramuscularly, used for inhalation, rinsing cavities, and applications.

endotracheally (through a tracheostomy, endotracheal tube, bronchoscope): 1-2 ml of solution once a day; for children, 250 mg of lyophilizate is diluted in 4 ml of the supplied solvent, for adults - 500 mg;
intranasally, instillations into the ears (with lesions of the nasopharynx and ear): injected into each external ear canal or nasal passage 2-4 drops;
inhalation: 1-2 times a day for children 125 mg, adults - 250 mg;
washing sinuses and cavities after surgical interventions in the area of mastoid process and nose: 1-2 ml of solution for 1 procedure; for children, 250 mg of lyophilizate is diluted in 4 ml of the supplied solvent, for adults - 500 mg;
i / m: children under 3 years old - 2 times a day, 125 mg; children from 3 to 7 years - 2 times a day, 250 mg; children from 7 to 12 years old - 250 mg 3 times a day; adolescents from 13 to 15 years old - 2 times a day, 500 mg; adolescents over 15 years of age and adults - 2-3 times a day, 500 mg.

In newborns up to 14 days of life and premature babies, the average daily dose is 25 mg per 1 kg of body weight.

If necessary, in patients with a severe course of the disease in the first 2-3 days of the course, a dose increase of 2 times is allowed, with the exception of patients over 65 years of age, newborns and premature babies. Duration of therapy - no more than 10 days.

When using Fluimucil-antibiotic IT for inhalation, immediately before the procedure, remove the protective aluminum cap from the vial with lyophilizate and open the ampoule with the solvent, inject the latter with a syringe into the closed vial with lyophilisate. After thoroughly mixing the contents of the vial, draw up the recommended dose of the resulting solution with a syringe and pour it into the nebulizer (inhaler) reservoir. Inhalation is carried out for 5-10 minutes using a mask or nasal nozzles.

The resulting solution of Fluimucil-antibiotic IT for inhalation can be stored for 24 hours at a temperature of 5 °C.

Adverse reactions

The use of the drug can cause a number of side effects. Most often, during the procedure, children experience nausea, which is associated with a specific, not very pleasant smell of the drug.

Sometimes there may be irritation of the respiratory mucosa, the appearance of a reflex cough and runny nose, the onset of symptoms of stomatitis. not excluded and allergic reactions on the drug, therefore, before the first use of the solution, doctors are strongly advised to do an allergy test. In isolated cases, a complication such as bronchospasm is possible; a bronchodilator is used to eliminate it, which relaxes the muscles of the bronchi.

Overdose

Cases of overdose with Fluimucil Antibiotic IT are extremely rare. With prolonged uncontrolled use of the drug in high doses, the patient may develop resistance of infectious agents to the components of the drug and the development of superinfection.

With the development of signs of an overdose, the patient is given supportive symptomatic therapy.

special instructions

Fluimucil-antibiotic IT solution should not come into contact with metal and rubber surfaces.

Fluimucil-antibiotic IT does not affect the ability to manage vehicles and other mechanisms.

During treatment, the picture of peripheral blood should be monitored. With a decrease in the number of leukocytes (less than 4 thousand / μl) and granulocytes (more than 40%), the drug is canceled.

Compatibility with other drugs

Co-administration of antitussives may increase sputum stasis due to suppression cough reflex. It is not recommended to mix with other drugs in an aerosol.

FLUIMUCIL-ANTIBIOTIC IT

Release form

lyophilisate for solution for injection

Owner/Registrar

International Classification of Diseases (ICD-10)

A37 Pertussis E84 Cystic fibrosis H66 Purulent and unspecified otitis media J01 Acute sinusitis J04 Acute laryngitis and tracheitis J15 bacterial pneumonia, not elsewhere classified J20 Acute bronchitis J32 Chronic sinusitis J37 Chronic laryngitis and laryngotracheitis J42 Chronic bronchitis, unspecified J43 Emphysema J47 Bronchiectasis J85 Lung and mediastinal abscess Z51.4 Preparatory procedures for follow-up treatment, not elsewhere classified

Pharmacological group

Antibiotic in combination with mucolytic and antioxidant

pharmachologic effect

Thiamphenicol glycinate acetylcysteinate is a complex compound that combines the antibiotic thiamphenicol and the mucolytic acetylcysteine in its composition. After absorption of thiaminefenicol, glycinate acetylcysteinate is cleaved into acetylcysteine and thiamphenicol. Thiamphenicol is a derivative of chloramphenicol, the mechanism of action is associated with inhibition of protein synthesis of a bacterial cell. Thiamphenicol has a wide spectrum of antibacterial activity, is effective in vitro against bacteria, most often causing infections respiratory tract: gram-positive (Streptococcus pneumoniae, Corynebacterium diphtheriae, Staphylococcus spp., Streptococcus pyogenes, Listeria spp., Clostridium spp.) and gram-negative (Haemophilus influenzae, Neisseria spp., Salmonella spp., Escherichia coli, Shigella spp., Bordetella pertussis, Yersinia pestis, Brucella spp., Bacteroides spp.).

Acetylcysteine, breaking the disulfide bonds of mucoproteins, quickly and effectively thins sputum, pus, reduces their viscosity and promotes discharge. Acetylcysteine facilitates the penetration of the antibiotic thiamphenicol into the tissues of the lungs, inhibits the adhesion of bacteria to the epithelium of the respiratory tract.

Pharmacokinetics

T 1/2 is about 3 hours, the volume of distribution is 40-68 liters. Plasma protein binding up to 20%. Excreted by the kidneys by glomerular filtration, 24 hours after administration, the amount of unchanged thiamphenicol in the urine is 50-70% of the administered dose. Penetrates through the placental barrier. Acetylcysteine after application is rapidly distributed in the body, T 1/2 is 2 hours.

In the liver, it is deacetylated to cysteine. In the blood, there is a mobile balance of free and plasma protein-bound acetylcysteine and its metabolites (cysteine, cystine, diacetylcysteine). Acetylcysteine penetrates into the intercellular space, mainly distributed in the liver, kidneys, lungs, bronchial secretions.

It is excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine), a small part is excreted unchanged through the intestines. Penetrates through the placental barrier.

Indications

Diseases of the upper respiratory tract and ENT organs: exudative otitis media, sinusitis, laryngotracheitis;

Diseases of the lower respiratory tract: acute and chronic bronchitis, prolonged pneumonia, lung abscess, emphysema, bronchiectasis, cystic fibrosis, bronchiolitis, whooping cough;

Prevention and treatment of bronchopulmonary complications after thoracic surgical interventions(bronchopneumonia, atelectasis);

Prevention and treatment of obstructive and infectious complications of tracheostomy, preparation for bronchoscopy, bronchoaspiration;

With concomitant nonspecific forms respiratory infections to improve drainage, including cavernous foci, with mycobacterial infections.

Contraindications

Leukopenia;

Thrombocytopenia;

Hypersensitivity to one of the components of the drug.

Carefully: with liver failure and chronic kidney failure. In children of the first two years of life due to age characteristics kidney function.

Side effects

Allergic reactions.

At intramuscular injection a slight burning sensation at the injection site is possible, rarely - reticulocytopenia, anemia, leukopenia, neutropenia, thrombocytopenia.

With inhalation - reflex cough, local irritation of the respiratory tract, stomatitis, rhinitis, nausea. Bronchospasm is possible, in this case bronchodilators are prescribed.

Overdose

Symptoms: change in bacterial flora, superinfection. Reinforcement possible side effects drug (with the exception of allergic reactions).

special instructions

During treatment, the picture of peripheral blood should be monitored. With a decrease in the number of leukocytes (less than 4 thousand / μl) and granulocytes (more than 40%), the drug is canceled.

Fluimucil-antibiotic IT solution should not come into contact with metal and rubber surfaces.

Fluimucil ® -antibiotic IT does not affect the ability to drive vehicles and other mechanisms.

With kidney failure

With caution in chronic renal failure.

In violation of liver function

With caution in liver failure.

Elderly

Do not increase the dose in patients over 65 years of age

Use during pregnancy and lactation

During pregnancy, the drug is prescribed only when the potential benefit to the mother outweighs the potential risk to the fetus.

If necessary, the appointment of the drug during lactation should stop breastfeeding for the duration of treatment.

drug interaction

The simultaneous appointment of antitussive drugs can increase sputum stagnation due to the suppression of the cough reflex. It is not recommended to mix with other drugs in an aerosol.

Mode of application

Fluimucil ® -antibiotic IT is administered intramuscularly, used for inhalations, applications, washing cavities.

Inhalation: adults- 250 mg 1-2 times a day; children- 125 mg 1-2 times a day.

Endotracheally: through a bronchoscope, endotracheal tube, tracheostomy - 1-2 ml of solution (for adults, dissolve in 4 ml of water for injection - 500 mg of dry matter, for children - 250 mg).

Local: for injection into the paranasal sinuses, as well as for washing cavities after surgical interventions in the nose and mastoid process, 1-2 ml of solution ( for adults dissolved in 4 ml of water for injection - 500 mg of dry matter, for kids- 250 mg).

For diseases of the nasopharynx and ear, instill 2-4 drops into each nasal passage or external auditory canal.

Intramuscularly: adults- 500 mg 2-3 times a day; children under 3 years old- 125 mg 2 times a day; 3-7 years- 250 mg 2 times a day; 7-12 years old- 250 mg 3 times a day.

For premature and newborn babies up to 2 weeks the average dose is 25 mg / kg per day.

If necessary, doses can be increased by 2 times (in the first 2-3 days of treatment in especially severe cases). Do not increase the dose in premature and newborn children, as well as in patients over 65 years of age. The course of treatment - no more than 10 days.

Storage conditions and shelf life

At temperatures from 15°C to 25°C. Keep out of the reach of children. Shelf life: lyophilisate for solution for injection and inhalation 500 mg (vials) - 3 years; solvent: water for injection (ampoules) - 5 years; kit - 3 years. Note: The shelf life of the kit is determined by the component with the shortest shelf life.

Mode of application	Intramuscular
Amount in a package	3 pcs
Best before date	36 months
Maximum allowable temperature storage, °C	25°C
Storage conditions	in a dry place
Release form	Solution
Manufacturer country	Italy
Vacation order	On prescription
Active substance	Thiamphenicol glycinate acetylcysteinate (Thiamphenicol, glycinate acetylcysteinate)
Scope of application	Antibiotics
Pharmacological group	J01BA Amphenicols

Instructions for use

Active ingredients

Release form

Compound

Active ingredient: thiamphenicol glycinate acetylcysteinate - 810 mg (in terms of thiamphenicol. - 500 mg) Excipients: disodium edetate. Solvent: water for injection (ampoules) Active ingredient concentration (mg): 500 mg

Pharmacological effect

Thiamphenicol glycinate acetylcysteinate is a complex compound that combines the antibiotic thiamphenicol and the mucolytic acetylcysteine in its composition. after absorption of thiaminefenicol, glycinate acetylcysteinate is cleaved into acetylcysteine and thiamphenicol. thiamphenicol is a derivative of chloramphenicol, the mechanism of action is associated with inhibition of protein synthesis of a bacterial cell. thiamphenicol has a wide spectrum of antibacterial activity, is effective in vitro against bacteria that most often cause respiratory tract infections: gram-positive (streptococcus pneumoniae, corynebacterium diphtheriae, staphylococcus spp., streptococcus pyogenes, listeria spp., clostridium spp.) and gram-negative (haemophilus influenzae, neisseria spp., salmonella spp., escherichia coli, shigella spp., bordetella pertussis, yersinia pestis, brucella spp., bacteroides spp.). discharge. acetylcysteine facilitates the penetration of the antibiotic thiamphenicol into the tissues of the lungs, inhibits the adhesion of bacteria to the epithelium of the respiratory tract.

Pharmacokinetics

Thiamphenicol is rapidly distributed in the body, accumulates in the tissues of the respiratory tract at therapeutic concentrations. (the tissue/plasma concentration ratio is about 1). Cmax in plasma is reached 1 hour after intramuscular injection. T1 / 2 is about 3 hours, the volume of distribution is 40-68 liters. Plasma protein binding up to 20%. Excreted by the kidneys by glomerular filtration, 24 hours after administration, the amount of unchanged thiamphenicol in the urine is 50-70% of the administered dose. Penetrates through the placental barrier. Acetylcysteine after application is rapidly distributed in the body, T1 / 2 is 2 hours. In the liver, it is deacetylated to cysteine. In the blood, there is a mobile balance of free and plasma protein-bound acetylcysteine and its metabolites (cysteine, cystine, diacetylcysteine). Acetylcysteine penetrates into the intercellular space, mainly distributed in the liver, kidneys, lungs, bronchial secretions. It is excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine), a small part is excreted unchanged through the intestines. Penetrates through the placental barrier.

Indications

Fluimucil-antibiotic IT is used to treat infectious and inflammatory diseases caused by microorganisms sensitive to the drug and accompanied by mucostasis. Diseases of the upper respiratory tract and ENT organs: exudative otitis media, sinusitis, laryngotracheitis. Diseases of the lower respiratory tract: acute and chronic bronchitis, prolonged pneumonia , lung abscess, emphysema, bronchiectasis, cystic fibrosis, bronchiolitis, whooping cough. Prevention and treatment of bronchopulmonary complications after thoracic surgical interventions (bronchopneumonia, atelectasis). Prevention and treatment of obstructive and infectious complications of tracheostomy, preparation for bronchoscopy, bronchoaspiration. With concomitant non-specific forms of respiratory infections to improve drainage, including cavernous foci, with mycobacterial infections.

Contraindications

Hypersensitivity to one of the components of the drug; anemia, leukopenia, thrombocytopenia. With caution In liver failure and chronic renal failure. In children of the first two years of life due to age-related features of kidney function.

Precautionary measures

At temperatures from 15°C to 25°C. Keep out of the reach of children.

Use during pregnancy and lactation

During pregnancy, the drug is prescribed only when the potential benefit to the mother outweighs the potential risk to the fetus. If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped for the duration of treatment.

Dosage and administration

Fluimucil-antibiotic IT is administered intramuscularly, used for inhalation, applications, washing cavities. Inhalation: adults - 250 mg 1-2 times a day; children - 125 mg 1-2 times a day. Endotracheally: through a bronchoscope, endotracheal tube, tracheostomy - 1-2 ml of solution (for adults, dissolve in 4 ml of water for injection - 500 mg of dry matter, for children - 250 mg) .Local: for injection into the paranasal sinuses, as well as for washing cavities after surgical interventions in the nose and mastoid process, 1-2 ml of solution (for adults, dissolve in 4 ml of water for injection - 500 mg of dry matter, for children - 250 mg). For diseases of the nasopharynx and ear, instill 2-4 drops into each nasal passage or external auditory passage. Intramuscularly: adults - 500 mg 2-3 times a day; children under 3 years - 125 mg 2 times a day; 3-7 years - 250 mg 2 times a day; 7-12 years old - 250 mg 3 times a day. For premature and newborn babies up to 2 weeks, the average dose is 25 mg / kg per day. If necessary, doses can be increased 2 times (in the first 2-3 days of treatment in particular severe cases). You can not increase the dose in premature and newborn children, as well as in patients over 65 years old. The course of treatment is no more than 10 days.

Side effects

Allergic reactions. With intramuscular injection, a slight burning sensation at the injection site is possible, rarely - reticulocytopenia, anemia, leukopenia, neutropenia, thrombocytopenia. With inhalation - reflex cough, local irritation of the respiratory tract, stomatitis, rhinitis, nausea. Bronchospasm is possible, in this case bronchodilators are prescribed.

Overdose

Symptoms: change in bacterial flora, superinfection. It is possible to increase the side effects of the drug (with the exception of allergic reactions). Supportive therapy is recommended.

Interaction with other drugs

The simultaneous appointment of antitussive drugs can increase sputum stagnation due to the suppression of the cough reflex. It is not recommended to mix with other drugs in an aerosol.

special instructions

During treatment, the picture of peripheral blood should be monitored. With a decrease in the number of leukocytes (less than 4 thousand / μl) and granulocytes (more than 40%), the drug is canceled. Fluimucil-antibiotic IT solution should not come into contact with metal and rubber surfaces. Fluimucil-antibiotic IT does not affect the ability to drive vehicles and other mechanisms.

Fluimucil antibiotic IT for inhalation is an effective remedy against a large number of respiratory diseases caused by pathogenic and opportunistic bacteria.

The drug is produced by the Italian company Zambon SPA and still has no complete analogues.

It is a bottle with a white or light yellow mass, which must be diluted with the supplied water for injection before use. The package contains 3 ampoules of lyophilisate and solvent.

Indications for use: what helps Fluimucil?

The active ingredients of the drug are antibiotic a wide range the actions of thiamphenicol and the mucolytic agent acetylcysteine, which are part of it in the form of a complex compound of thiamphenicol glycinate acetylcysteinate.

It is intended for injections and inhalations, but in most cases, patients are prescribed inhalation therapy, since this significantly increases the safety and effectiveness of treatment.

Indeed, when inhaling a fine suspension of a drug, almost all of its particles fall directly on the inflamed surface of the mucous membrane, where they are most needed.

When choosing the injection method of administration, this advantage is lost, since medicine is carried by the blood throughout the body, and only part of it gets to its destination.

Nevertheless, injections are also used, but they are mainly indicated only for severe conditions patients requiring large doses various medicines, and inhalations for one reason or another cannot be carried out.

Thiamphenicol prevents the formation of bacterial cell wall components, thereby leading to their death. Acetylcysteine also reduces the viscosity of sputum and thereby facilitates the process of its removal.

In addition, it promotes the penetration of thiamphenicol into tissues and reduces the ability of microorganisms to attach to the surface of the mucous membrane.

Thus, Fluimucil-antibiotic IT exhibits antibacterial, mucolytic and anti-inflammatory pharmacological effects.

This is the reason for the prescription of the drug. It is widely used as part of complex therapy:

acute and chronic inflammatory diseases of the NDP, that is, with bronchitis, pneumonia, laryngotracheitis;
adenoiditis, whooping cough, cystic fibrosis, lung abscess, bronchiectasis, tuberculosis;
complications after operations;
otitis;
sharp and chronic sinusitis, rhinopharyngitis.

Taking the remedy is indicated during preparation for serious diagnostic and therapeutic manipulations on the respiratory organs, etc. It is also sometimes used to prevent the development of complications.

Only a doctor can prescribe inhalation therapy if there are strong indications for this! The shelf life of the drug is 3 years. But be sure to keep in mind that it retains its properties only at temperatures up to 25 ° C.

Sinusitis and Fluimucil antibiotic IT

The drug is very often used in ENT practice for sinusitis, and not only in the form of inhalation, but also as a means for professional washing of the paranasal sinuses.

But in order for the drug to have the maximum possible therapeutic effect, before its administration in one way or another, it is recommended to rinse the nose with any saline solution, for example, Aquamaris, Marimer, Humer, Dolphin.

After that, be sure to bury vasoconstrictors, which can be any drugs based on oxymetazoline, xylometazoline, naphazoline, etc. But it is better to choose Rinofluimucil.

This drug not only perfectly eliminates edema, but also dilutes the remaining snot and accelerates their excretion. All this eliminates obstacles for the penetration of the antibiotic directly to the destination - the maxillary (maxillary) sinuses. Features of drug interaction

The medication should not be combined with:

antitussive drugs (Gedelix, Bronchipret, Sinekod, Codelac, Libexin, etc.);
nitroglycerin;
other medicines in the form of an aerosol.

Difference between Fluimucil and Fluimucil Antibiotic IT

Both medicines are produced by the Italian company Zambon SPA. The difference lies in their composition. So, the active substance of Fluimucil is only acetylcysteine, when thiamphenicol is additionally included in Fluimucil-antibiotic. This explains the difference in the action of drugs.

Fluimucil exhibits exclusively anti-inflammatory and mucolytic properties and in no way affects the viability of pathogens. Whereas Fluimucil-antibiotic actively suppresses their ability to grow and reproduce.

Thus, Fluimucil is mainly a means symptomatic therapy and is used exclusively for diseases accompanied by a cough with poor sputum discharge. At the same time, the drug with an antibiotic has a much wider area of use.

How to do inhalations with Fluimucil in a nebulizer: instructions

Since the drug contains an antibiotic, inhalations can only be carried out in compression inhalers or nebulizers with a glass chamber.

Do not pour the solution into metal or rubberized containers. If the patient is diagnosed with airway obstruction, but the use of Fluimucil-antibiotic is still required, bronchodilators are preliminarily taken (Berodual, Ventolin, Berotek, etc.).

Preparation for inhalation consists in diluting the lyophilisate with the supplied solvent. Depending on the model of nebulizer used, it is sometimes recommended to replace 1 ml of water for injection with an equal amount of saline. Do this immediately before the procedure.

Attention

The first time you use it, you need to do an allergy test. To do this, the diluted agent is applied to clean skin inside forearm.

If neither after half an hour, nor after 2 hours, nor after a day, the skin condition has not changed (no rash, redness, itching, etc.), inhalations can be started.

To dilute the drug is necessary:

remove the metal cap and rubber stopper from the lyophilizate vial;
by pressing hard on the head or using a special nail file, open the ampoule with water for injection along the fault line (colored ring);
pour the solvent into the vial and mix thoroughly.

Adults are shown taking 250 mg of the drug, which corresponds to 2 ml (half) of the prepared remedy, in one procedure. The remaining solution can be stored for a day in a bottle tightly sealed with a factory rubber stopper in the refrigerator.

Although many experts claim that it breaks down in water, therefore, it is advised to prepare a fresh solution before each inhalation.

From 2 to 4 inhalations should be carried out per day. Each one is approximately 15 minutes long. In the treatment of diseases of the nose and ear, such as sinusitis, frontal sinusitis, otitis media and others, it is worth using a special nasal inhaler nozzle.

To combat bacterial lesions of the lower respiratory tract, accompanied by a cough, a mouthpiece is more suitable.

As a rule, the course of treatment is 7-10 days. However, sometimes longer therapy is required. In such cases, how many days Fluimucil-antibiotic IT can be used should be checked with the attending physician, but a control blood test should be done every 3 days.

The drug is canceled if the total blood pressure shows a decrease:

the level of leukocytes up to 4000 units / μl and below;
the number of granulocytes by 40% or more.

Fluimucil antibiotic IT for inhalation: how to breed for children?

Quite often, pediatricians prescribe Fluimucil for inhalation to a child. Indeed, it is not contraindicated in children, but up to 3 years it is used with great care, since only by this time does the formation of the kidneys end. Therefore, when treating babies under 3 years old, the dosage should be treated with particular scrupulousness.

The pediatric dosage for the nebulizer is 125 mg. To prepare a solution for inhalation, you must perform the above steps, maintaining the same proportions.

But children for one procedure need to use only 1 milliliter of the finished solution. To achieve dosing accuracy, we recommend using an insulin syringe.

As in the treatment of adults, children with serious respiratory problems are often prescribed loading doses during the first 2-3 days of treatment. The exception is premature and newborn babies. For them, any excess of the therapeutic dose is dangerous.

Children are usually inhaled through a mask that covers the mouth and nose at the same time. But if the child is old enough to inhale healing mixture through a nasal nozzle or mouthpiece, it is worth using them.

Depending on the severity of the pathology and the age of the patient, the procedures are carried out 2 or 3 times a day for several minutes for babies and up to 15 minutes for teenagers.

During pregnancy

Fluimucil for inhalation instructions do not prohibit use during pregnancy, but only on condition that the planned benefit for future mother higher than the potential harm to the fetus.

This is due to the fact that with this method of administration, the drug practically does not penetrate into the systemic circulation and cannot harm the developing fetus.

But do not forget that acetylcysteine is able to pass through the placental barrier and affect the child. Therefore, visiting a doctor and obtaining his permission to conduct inhalation therapy mandatory for pregnant women.

Contraindications and side effects

The drug is prescribed with caution when:

disorders of the bone marrow;
severe pathologies of the liver and kidneys;
exacerbations of stomach and duodenal ulcers;
pulmonary bleeding, hemoptysis;
bronchial asthma.

Although sometimes signs hypersensitivity appear only after 2 or 3 doses. Also, if it becomes necessary to carry out inhalations during lactation, it is recommended to refuse breastfeeding for the entire duration of treatment.

As for side effects, Fluimucil antibiotic IT is usually well tolerated, but in isolated cases, especially with an overdose, the appearance of:

runny nose and reflex cough;
bronchospasm (mainly in patients with bronchial asthma);
stomatitis;
nausea;
rashes on the skin or swelling of the larynx, which is a symptom of intolerance to the components of the drug.

The drug still has no complete analogues. You can only find a replacement for the usual Fluimucil, which contains only acetylcysteine. This substance acts as an agent in:

Mukobene;
Mucomix, etc.

However, if it is not possible to obtain this medicine, it can be replaced with other antibiotics suitable for inhalation.

But only a doctor should prescribe them, based on the characteristics of the course of the disease, the age of the patient, the presence of concomitant pathologies, etc.

Thus, Fluimucil antibiotic IT is good remedy to fight bacterial infections upper and lower respiratory tract, especially accompanied by cough.

It has practically no contraindications and rarely provokes the development of side effects. But do not forget that the drug contains an antibiotic, so it should be used only for serious pathologies that the body cannot cope with on its own and only as directed by a doctor. Reviews

ENT - my organs weak spots. I often get sick, chronic diseases. Therefore, during exacerbations, inhalations often have to be done. From my doctor I learned about such a drug as Fluimucil-antibiotic and I already have a positive experience from inhalation manipulations with this remedy. You need to do 2 inhalations 3 times a day, this is enough.

From negative points this is that it has a very bitter taste and after inhalations you can not eat or drink for about 30 minutes, this will allow the medicine to stay longer on the mucous membrane, thereby increasing the effectiveness of the treatment. Tatiana, 35 years old

I fell ill in again, again had to resort to inhalation. The child’s runny nose did not go away for a long time, the “green thick snot". It's good that there is a nebulizer, a necessary thing, especially if you have small children. During treatment, one package of Fluimucil IT antibiotic was dispensed, in which 3 vials of powder and 3 ampoules containing sterile water for diluting these powders.

According to the instructions, 2 inhalations per day were carried out, mixing in a ratio of 1/3 of the diluted drug and 1 ml of saline. In three days, the condition improved much, the snot almost disappeared, according to at least from green to transparent. Elena, 27 years old

The advantage of this drug is that, when inhaled with it, the antibiotic that is part of it acts locally and selectively, so many side effects are excluded. Our daughter had a wet cough for a long time. The child is exhausted.

The temperature reached 38, there were no wheezing in the lungs, but it was still hard for her to breathe. We tried to do inhalations with Lazolvan 3 times a day, but they did not help us at all. The doctor made a diagnosis acute pharyngitis and prescribed Fluimucil inhalations. It was necessary to dilute 1 bottle of powder with water and 10 ml of saline.

The pediatric dosage is 120 mg per inhalation twice a day, one vial is for 4 applications and can be stored in the refrigerator. Conducted inhalation 4 days. As a result, a significant improvement in the condition of the child. Of the minuses, this is the price of the drug, not cheap. Alexander, 31 years old

The cost of the drug in pharmacies depends on the type of packaging and location. locality. For example: