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FLUIMUCIL (solution)

and an antibiotic, because without it we couldn’t even cope with the temperature.
In general, at the beginning of June 2021, we “met” a completely new antibiotic for us - Fluimucil Antibiotic IT. In general, I knew about Fluimucil before, but I never thought that there was also “”... an IT antibiotic.” A new ENT-audiologist (we had never been to this doctor before, we came to her as the one on duty) prescribed us inhalations with this “IT”. And she warns that it smells foul (for example, her husband shrinks from the smell), but it is extremely effective! Dosing method according to its scheme: mix the contents of the bottle and ampoule with each other,

leave the resulting solution for 3 days,

Mix 1 part with some other drug (I don’t remember which one) in a nebulizer and breathe only once a day. And that our temperature will drop in 2 days. In general, they started giving the child inhalations. How he screamed! The husband and grandmother or husband and grandfather held the child (sometimes the grandmother was also the third “fighter”), and I held the mask to my mouth. The child was struggling! I don’t know how this antibiotic smelled to my child, but on the 2nd day my husband said that even he was starting to choke. We did NOT complete the course of treatment (it seems like 6 inhalations were prescribed); we barely managed to get through the first 3 days. But they canceled it because on the 2nd day the child started bleeding from the nose. On the third day, during the third inhalation, my nose started bleeding even more! But just a couple of hours after the first inhalation, the child’s temperature dropped sharply to 37.5, and the next day there was no temperature at all.

As a mother, I was confused by the fact that the ENT-audiologist told us that the ready-made solution in the bottle should be divided into 3 days, but the instructions say that this cannot be done:

After some time, I again went to see an ENT specialist, who prescribed this antibiotic for us, and she said that this was the first time she had heard that inhalations with this antibiotic had a side effect in the form of nosebleeds. I am NOT claiming that the child bled twice precisely because of the inhaled vapors. But I admit it. I also admit that the child could have been disgusted by the smell of this drug, or he, like the husband, had difficulty breathing and that’s why he screamed and struggled so wildly, and blood began to flow from the screams, roars and tension. Let me remind you once again that it was always held by at least 2 adults. And the child struggled and screamed like never before! (Before that time he had not liked inhalations before, but we had never seen or heard such hysterics). I will also note that after that antibiotic (3-day course) we never had otitis media, but we did put tubotitis (checked several times in the summer). Well, recently we removed the cause of otitis and tubotitis - adenoids. The ENT specialists insisted. I hope that we will forget about otitis media and that my hearing will gradually return to normal. If anything, I dosed the drug using a syringe - it’s very convenient to measure the required dosage. I also note that the drug is difficult to find. Even some pharmacists in completely different pharmacies either have not heard of it at all, or have heard of it, but have never brought it to the pharmacy. But it seems that I found this drug in the 5th or 6th pharmacy. By the way, it is not cheap, especially if used according to the instructions - for inhalation, use only a freshly opened bottle.

Buy Fluimucil granules for the preparation of solution Orange 200 mg No. 20 in pharmacies

Brief description Mucolytic drug with antioxidant properties

Composition One sachet contains: active substance: acetylcysteine - 200 mg; excipients: aspartame 25 mg, betacarotene 12.3 mg, orange flavor 100 mg, sorbitol 662.7 mg.

Pharmacological action Mucolytic drug. Liquefies mucus, increases its volume and facilitates its separation. The action of acetylcysteine is associated with the ability of its sulfhydryl groups to break intra- and intermolecular disulfide bonds of acidic mucopolysaccharides of sputum, which leads to depolarization of mucoproteins and a decrease in sputum viscosity. Remains active in the presence of purulent sputum. Increases the secretion of less viscous sialomucins by goblet cells, reduces the adhesion of bacteria to the epithelial cells of the bronchial mucosa. Stimulates mucous cells of the bronchi, the secretion of which is lysed by fibrin. It has a similar effect on the secretions formed during inflammatory diseases of the ENT organs. It has an antioxidant effect due to the presence of an SH group that can neutralize electrophilic oxidative toxins. Acetylcysteine easily penetrates into the cell and is deacetylated to L-cysteine, from which intracellular glutathione is synthesized. Glutathione is a highly reactive tripeptide, a powerful antioxidant and cytoprotector that neutralizes endogenous and exogenous free radicals and toxins. Acetylcysteine prevents exhaustion and helps increase the synthesis of intracellular glutathione, which is involved in the redox processes of cells, promoting the detoxification of harmful substances. This explains the effect of acetylcysteine as an antidote for paracetamol poisoning. Protects alpha1-antitrypsin (elastase inhibitor) from the inactivating effects of HOCl, an oxidizing agent produced by myeloperoxidase of active phagocytes. It also has an anti-inflammatory effect (by suppressing the formation of free radicals and reactive oxygen-containing substances responsible for the development of inflammation in the lung tissue).

Indications : respiratory diseases accompanied by impaired sputum discharge (including bronchitis, tracheitis, bronchiolitis, pneumonia, bronchiectasis, cystic fibrosis, lung abscess, pulmonary emphysema, laryngotracheitis, interstitial lung diseases, pulmonary atelectasis /due to blockage of the bronchi by mucus plug/ ); - catarrhal and purulent otitis media, sinusitis, incl. sinusitis (to facilitate the passage of secretions); - to remove viscous secretions from the respiratory tract in post-traumatic and postoperative conditions.

Method of administration and dosage The drug in the form of effervescent tablets is prescribed to adults at 600 mg (1 tablet) 1 time/day. Before use, the effervescent tablet is dissolved in 1/3 glass of water. Granules for the preparation of a solution for oral administration are prescribed to adults and children over 6 years old - 200 mg 2-3 times a day; children aged 2 to 6 years - 200 mg 2 times / day or 100 mg 3 times / day; children aged 1 to 2 years - 100 mg 2 times a day. In newborns, the drug is used only for health reasons at a dose of 10 mg/kg body weight under the strict supervision of a physician. Before use, the required amount of granules is dissolved in 1/3 glass of water. Children of the first year of life are given the resulting solution to drink from a spoon or feeding bottle. The duration of treatment is determined individually. For acute diseases, the duration of treatment is from 5 to 10 days, for chronic diseases - up to several months.

Side effects From the digestive system: rarely - heartburn, nausea, feeling of fullness in the stomach, vomiting, diarrhea; Cases of the development of stomatitis have been described. Allergic reactions: rarely - skin rash, itching, urticaria; Cases of bronchospasm have been described. Other: rarely - nosebleeds, tinnitus; Cases of collapse and decreased platelet aggregation have been described.

Contraindications - peptic ulcer of the stomach and duodenum in the acute phase; - lactation period; - children under 2 years of age (for granules for the preparation of a solution for oral administration); - children and adolescents up to 18 years of age (for effervescent tablets); - hypersensitivity to acetylcysteine. The use of the drug in the form of granules for the preparation of a solution for oral administration in children under 2 years of age is possible only if there are vital indications and under strict medical supervision. Prescribed with caution for peptic ulcers of the stomach and duodenum, varicose veins of the esophagus, hemoptysis, pulmonary hemorrhage, phenylketonuria, bronchial asthma, diseases of the adrenal glands, liver and/or kidney failure, arterial hypertension.

Overdose of Fluimucil® when taken at a dose of 500 mg/kg/day does not cause signs and symptoms of overdose.

Special instructions For patients with bronchial asthma and obstructive bronchitis, Fluimucil® can be prescribed with caution under systematic monitoring of bronchial conduction. The drug contains aspartame, so it should not be prescribed to patients with phenylketonuria. When dissolving the drug, you must use glass containers and avoid contact with metal and rubber surfaces. When opening a bag of granules, there may be a smell of sulfur, which is the smell of the active substance.

Interaction with other drugs The simultaneous use of Fluimucil with antitussives may increase sputum stagnation due to suppression of the cough reflex. When used simultaneously with antibiotics, such as tetracyclines (excluding doxycycline), ampicillin, amphotericin B, their interaction with the thiol group of acetylcysteine is possible, which leads to a decrease in the activity of both drugs, therefore the interval between taking acetylcysteine and antibiotics should be at least 2 hours. Simultaneous taking Fluimucil and nitroglycerin can lead to an increase in the vasodilatory and antiplatelet effects of the latter. Acetylcysteine reduces the hepatotoxic effect of paracetamol.

Storage conditions The drug should be stored in a dry place, out of reach of children, at a temperature not exceeding 25°C. Shelf life: 3 years.

Fluimucil antibiotic IT lyof.d/r-ra d/in and inhal.500mg bottle with solution N3

Registration Certificate Holder

ZAMBON (Italy)

Dosage form

Medicine - Fluimucil®-Antibiotic IT (Fluimucil-Antibiotic IT)

Description

Lyophilisate for the preparation of solution for injection and inhalation
1 fl.
thiamphenicol glycinate acetylcysteinate 810 mg, including thiamphenicol 500 mg

Excipients

: disodium edetate.

Solvent:

water d/i (4 ml).

810 mg - bottles (3) complete with solvent (amp. 3 pcs.) - plastic trays (1) - cardboard packs.

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 surgery (bronchopneumonia, atelectasis);
prevention and treatment of obstructive and infectious complications of tracheostomy, preparation for bronchoscopy, bronchoaspiration;
with concomitant nonspecific forms of respiratory infections to improve drainage, including cavernous lesions, with mycobacterial infections.

Contraindications for use

anemia;
leukopenia;
thrombocytopenia;
hypersensitivity to one of the components of the drug.

Carefully:

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

pharmachologic effect

Thiamphenicol glycinate acetylcysteinate is a complex compound that combines the antibiotic thiamphenicol and the mucolytic acetylcysteine. After absorption of thiaminephenicol, glycinate acetylcysteinate is split into acetylcysteine and thiamphenicol. Thiamphenicol is a derivative of chloramphenicol, the mechanism of action is associated with inhibition of bacterial cell protein synthesis. Thiamphenicol has a wide spectrum of antibacterial action and 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.).

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

Drug interactions

The simultaneous administration of antitussives may increase sputum stagnation due to suppression of the cough reflex. It is not recommended to mix with other aerosol medications.

Dosage regimen

Fluimucil® antibiotic IT is administered intramuscularly and used for inhalation, application, and cavity rinsing.

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

Endotracheal:

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 administration into the paranasal sinuses, as well as for washing cavities after surgical interventions in the area of 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 children
- 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
- 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, the dose can be increased by 2 times (in the first 2-3 days of treatment in particularly 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 is no more than 10 days.

Overdose

Symptoms:

change in bacterial flora, superinfection. It is possible that the side effects of the drug may increase (with the exception of allergic reactions).

Maintenance therapy is recommended.

Side effect

Allergic reactions.

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

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

special instructions

During treatment, peripheral blood patterns should be monitored. If the number of leukocytes (less than 4 thousand/μl) and granulocytes (by more than 40%) decreases, the drug is discontinued.

Fluimucil IT antibiotic 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.

Storage conditions

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

Best before date

Shelf life: lyophilisate for the preparation of solution for injection and inhalation 500 mg (bottles) - 3 years; solvent: water for injection (ampoules) - 5 years; set - 3 years.

Note: The expiration date of the kit is determined by the component with the shortest expiration date.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - With caution. Restrictions when breastfeeding - Contraindicated.

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 during treatment.

Use for renal impairment

Restrictions for impaired renal function - With caution.

With caution in chronic renal failure.

Use for liver dysfunction

Restrictions for liver dysfunction - With caution. With caution for liver failure.

Use in elderly patients

Restrictions for elderly patients - Use with caution.

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

Use in children

Restrictions for children - With caution.

With caution in children of the first two years of life due to age-related characteristics of kidney function.

Terms of sale

On prescription.

Contacts for inquiries

ZAMBON S.p.A. (Italy)

ZAMBON SpA

Representative office in Russia Zambon Pharma LLC 119002 Moscow, Glazovsky per. 7, off. 17 Tel.; Fax