Fluimucil solution for oral administration 2%, 100ml

Violation of sputum discharge: bronchitis, tracheitis, bronchiolitis, pneumonia, bronchiectasis, cystic fibrosis, interstitial lung disease, lung atelectasis (due to bronchial obstruction by a mucous plug).

Catarrhal and purulent otitis media, sinusitis, sinusitis (relief of secretion discharge). Removal of viscous secretions from the respiratory tract in post-traumatic and postoperative conditions.

Inside.

The maximum daily dose of acetylcysteine ??is 600 mg / day.

Adults: 15 ml of oral solution 40 mg / ml 1 time per day (corresponds to 600 mg of acetylcysteine ??per day).

Children: - children from 2 to 5 years: 5 ml of oral solution 20 mg / ml 2-3 times a day (corresponds to 200 - 300 mg of acetylcysteine ??per day) - children from 6 to 14 years: 5 ml of oral solution 20 mg / ml 3-4 times a day or 4 ml of a solution for oral administration 40 mg / ml 2 times a day (corresponds to 300 - 400 mg of acetylcysteine ??per day) - children over 14 years of age: 15 ml of oral solution 40 mg / ml 1 time per day (corresponds to 600 mg of acetylcysteine ??per day).

The oral solution is transparent or slightly opalescent, colorless with a characteristic raspberry odor and a faint sulfur odor.

1 pack.

acetylcysteine ??20 mg

Excipients: methyl parahydroxybenzoate 1.0 mg, sodium benzoate 1.5 mg, disodium edetate 1.0 mg, sodium carmellose 4.0 mg, sodium saccharinate 0.4 mg, raspberry flavor 2.5 mg, sodium hydroxide to pH 6.5, purified water to 1.0 ml.

• Hypersensitivity to acetylcysteine ??and other components of the drug,

• children under 2 years of age;

• peptic ulcer of the stomach and duodenum in the acute stage,

• lactation period.

With care: gastric ulcer and duodenal ulcer, esophageal varicose veins, hemoptysis, pulmonary hemorrhage, adrenal diseases, hepatic and / or renal failure, arterial hypertension.

pharmachologic effect

Mucolytic agent is a derivative of the amino acid cysteine. It has a mucolytic effect, increases the volume of sputum, facilitates its discharge due to a direct effect on the rheological properties of sputum.

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. Reduces induced hyperplasia of mucoid cells, enhances the production of surface active compounds by stimulating type II pneumocytes, stimulates mucociliary activity, which leads to an improvement in mucociliary clearance. Remains active in the presence of purulent, mucopurulent and mucous 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. Has a similar effect on the secret,formed in inflammatory diseases of the ENT organs. It has an antioxidant effect due to the ability of its reactive sulfhydryl groups (SH-groups) to bind to oxidative radicals and thus neutralize them.

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

When taken orally, it is well absorbed from the gastrointestinal tract. To a large extent undergoes the effect of the 'first pass' through the liver, which leads to a decrease in bioavailability. Binding to blood plasma proteins up to 50% (4 hours after oral administration). It is metabolized in the liver and possibly in the intestinal wall. In plasma, it is determined unchanged, as well as in the form of metabolites - N-acetylcysteine, N, N-diacetylcysteine ??and cysteine ??ester. Renal clearance is 30% of the total clearance.

Side effect

Allergic reactions: urticaria, rash, itching, angioedema, anaphylactic reactions, facial edema. From the nervous system: headache. On the part of the organ of hearing and balance: tinnitus. From the side of the cardiovascular system: tachycardia, lowering blood pressure, bleeding From the respiratory system: bronchospasm, dyspnea. From the digestive system: vomiting, diarrhea, stomatitis, abdominal pain, nausea, dyspepsia. General reactions: pyrexia.

Use of the drug during pregnancy and lactation.

The drug is prescribed during pregnancy 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.

Side effect

In rare cases, possible: nausea, heartburn, a feeling of fullness in the stomach, vomiting, diarrhea, skin rash, itching, urticaria, nosebleeds, tinnitus. When taking acetylcysteine, cases of the development of bronchospasm, collapse, stomatitis, and a decrease in platelet aggregation have been described.

Overdose

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

Interaction with other medicinal products

The combined use of acetylcysteine ??with antitussives can increase sputum congestion due to suppression of the cough reflex. With simultaneous use 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 these drugs should be at least 2 hours. The simultaneous intake of acetylcysteine ??and nitroglycerin can lead to an increase in the vasodilator and antiplatelet effect of the latter. Acetylcysteine ??eliminates the toxic effects of paracetamol.

special instructions

Patients with bronchial asthma and obstructive bronchitis should be prescribed acetylcysteine ??with caution under systematic monitoring of bronchial patency. FluimucilЃ oral solution 40 mg / ml contains sorbitol; patients with hereditary fructose intolerance should not take this drug. Influence on the ability to drive vehicles, mechanisms There are no data confirming the effect of acetylcysteine ??on the ability to drive vehicles.