Fluimucil effervescent tablets 600mg, No. 20

• Diseases of the respiratory system, accompanied by impaired sputum discharge (including bronchitis, tracheitis, bronchiolitis, pneumonia, bronchiectasis, cystic fibrosis, lung abscess, pulmonary emphysema, laryngotracheitis, interstitial lung diseases, atelectasis of the lung / due to bronchial obstruction by a mucous plug /);

• catarrhal and purulent otitis media, sinusitis, incl. sinusitis (to facilitate secretion discharge);

• for the removal of viscous secretions from the respiratory tract in post-traumatic and postoperative conditions.

The drug in the form of effervescent tablets is prescribed for adults at 600 mg (1 tab.) 1 time / day. Before use, the effervescent tablet is dissolved in 1/3 cup of water.

Granules for the preparation of a solution for oral administration are prescribed for adults and children over 6 years old - 200 mg 2-3 times / 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 / 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 cup of water. Children of the first year of life are given to drink the resulting solution from a spoon or feeding bottle.

The duration of the course of treatment is set individually. In acute diseases, the duration of treatment is from 5 to 10 days, in chronic - up to several months.

Effervescent tablets, white, round, with a rough surface; with a lemon, slightly sulfuric smell; the solution prepared as a result of reconstitution of tablets in water should be slightly opalescent, with a characteristic smell and taste of lemon flavor.

1 tab.

acetylcysteine ??600 mg

Excipients: citric acid, sodium bicarbonate, aspartame, lemon flavor.

• Peptic ulcer and duodenal ulcer in the acute phase;

• lactation period;

• children under 2 years of age (for granules for the preparation of oral solution);

• children and adolescents up to 18 years old (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 the age of 2 years is possible only in the presence of vital indications and under strict medical supervision.

• It is prescribed with caution for gastric ulcer and duodenal ulcer, esophageal varicose veins, hemoptysis, pulmonary hemorrhage, phenylketonuria, bronchial asthma, adrenal diseases, hepatic and / or renal failure, arterial hypertension.

pharmachologic effect

Mucolytic drug. It dilutes phlegm, increases its volume and makes it easier to separate. 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 on the epithelial cells of the bronchial mucosa. Stimulates the mucous cells of the bronchi, the secretion of which lyses fibrin. It has a similar effect on the secretion formed in inflammatory diseases of the upper respiratory tract.

It has an antioxidant effect due to the presence of an SH-group capable of neutralizing electrophilic oxidative toxins.

Acetylcysteine ??easily penetrates into the cell, 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 depletion and increases the synthesis of intracellular glutathione, which is involved in the redox processes of cells, contributing to the detoxification of harmful substances. This explains the action of acetylcysteine ??as an antidote for paracetamol poisoning.

Protects alpha1-antitrypsin (elastase inhibitor) from the inactivating effect of HOCI, an oxidant produced by myeloperoxidase of active phagocytes. It also has an anti-inflammatory effect (by suppressing the formation of free radicals and active oxygen-containing substances responsible for the development of inflammation in the lung tissue).

Pharmacokinetics

Suction

When taken orally, it is well absorbed from the gastrointestinal tract. After oral administration, Cmax in plasma is reached after 1-3 hours and is 15 mmol / l. Bioavailability is 10% due to the pronounced 'first pass' effect through the liver.

Distribution

Penetrates into the intercellular space, mainly distributed in the liver, kidneys, lungs, bronchial secretions. Penetrates the placental barrier. Plasma protein binding - 50%.

Metabolism

It is rapidly deacetylated to cysteine ??in the liver. In plasma, there is a mobile equilibrium of free and associated with plasma proteins of acetylcysteine ??and its metabolites (cysteine, cystine, diacetylcystine).

Withdrawal

T1 / 2 when taken orally is 1 hour, with cirrhosis of the liver increases to 8 hours. It is excreted in the urine in the form of inactive metabolites (inorganic sulfates, diacetylcysteine), a small part is excreted unchanged through the intestines.

Side effect

From the digestive system: rarely - heartburn, nausea, a feeling of fullness in the stomach, vomiting, diarrhea; cases of stomatitis development are described.

Allergic reactions: rarely - skin rash, itching, urticaria; cases of bronchospasm development are described.

Others: rarely - nosebleeds, tinnitus; described cases of collapse, decreased platelet aggregation.

Application during pregnancy and lactation

During pregnancy, the use of Fluimucil is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to prescribe the drug during lactation, breastfeeding should be discontinued.

Application for violations of liver function

The drug should be prescribed with caution to patients with liver disease.

Application for impaired renal function

The drug should be prescribed with caution to patients with kidney disease.

Application in children

Contraindicated in children under 2 years of age (for granules for the preparation of oral solution); in children and adolescents up to 18 years of age (for effervescent tablets).

special instructions

Patients with bronchial asthma and obstructive bronchitis can be prescribed FluimucilЃ with caution under the systematic monitoring of bronchial conduction.

The drug contains aspartame, so it should not be prescribed to patients with phenylketonuria.

When dissolving the drug, it is necessary to use glassware, avoid contact with metal and rubber surfaces. When opening the bag with granules, the smell of sulfur is possible, which is the smell of the active substance.

Overdose

FluimucilЃ, when taken at a dose of 500 mg / kg / day, does not cause signs and symptoms of overdose.

Drug interactions

The simultaneous use of Fluimucil with antitussives can increase sputum congestion 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.

The simultaneous administration of Fluimucil and nitroglycerin can lead to an increase in the vasodilating and antiplatelet effect of the latter.

Acetylcysteine ??reduces the hepatotoxic effect of paracetamol.