Fluimucil solution for injection and inhalation 10%, 3ml No. 5

• 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; preparation for bronchoscopy, bronchography, aspiration drainage;

• for washing abscesses, nasal passages, maxillary sinuses, middle ear, fistula treatment, operating field during operations on the nasal cavity and mastoid process.

Inhalation

For aerosol therapy, 3-9 ml of a 10% solution is sprayed in ultrasound devices, in devices with a distribution valve - 6 ml of a 10% solution. Duration of inhalation - 15-20 minutes; frequency rate - 2-4 times / day. In the treatment of acute conditions, the average duration of therapy is 5-10 days; with long-term therapy of chronic conditions, the course of treatment is up to 6 months. Due to the high safety of the drug, the frequency of taking and the relative amount of the dose can be changed by the doctor within acceptable limits, depending on the patient's condition and the therapeutic effect. There is no need to change the adult dose if the drug is used to treat children. In the case of a strong secretolytic action, the secret is aspirated, and the frequency of inhalations and the daily dose are reduced.

Intratracheally

For washing the bronchial tree during medical bronchoscopy, 1-2 ampoules or more are used per day, depending on clinical indications.

Locally

Instilled into the external auditory canal and nasal passages 150-300 mg (1.5-3 ml) for 1 procedure. Parenterally

Introduce intravenously (preferably drip or slow jet over 5 minutes) or intramuscularly. Adults - 300 mg (3 ml) 1-2 times / day; children from 6 to 14 years old - 150 mg (1.5 ml) 1-2 times / day. The daily dose for children under 6 years of age is 10 mg / kg of body weight, for children under 1 year of age, intravenous administration of acetylcysteine ??is possible only for health reasons in a hospital setting. The duration of treatment should be determined by the results of the change in the patient's condition. It should be borne in mind that oral administration of the drug is preferable for children under 6 years of age. High local and general tolerance of the drug allows for long courses of treatment. For intravenous administration, the solution is additionally diluted with 0.9% sodium chloride solution or 5% dextrose solution in a 1: 1 ratio. The duration of therapy is determined individually (no more than 10 days).In patients over 65, the minimum effective dose is used.

Solution for injection and inhalation is transparent, colorless, with a faint sulfurous odor; after opening the ampoule, with prolonged contact with air, a faint pink-purple tint may appear.

1 ml 1 amp.

acetylcysteine ??100 mg 300 mg

Excipients: disodium edetate, sodium hydroxide, water d / i.

• Peptic ulcer and duodenal ulcer in the acute phase;

• lactation period;

• hypersensitivity to acetylcysteine.

• It is prescribed with caution for gastric ulcer and duodenal ulcer in remission, esophageal varicose veins, hemoptysis, pulmonary hemorrhage, bronchial asthma (with intravenous administration, the risk of bronchospasm increases), adrenal diseases, hepatic and / or renal insufficiency, arterial hypertension as well as children under 6 years of age. For children under 1 year old, intravenous administration of acetylcysteine ??is possible only for health reasons in a hospital setting.

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. With the on / in the introduction of 600 mg of acetylcysteine ??Cmax in plasma is 300 mmol / l.

Distribution

Penetrates into the intercellular space, mainly distributed in the liver, kidneys, lungs, bronchial secretions. Penetrates the placental barrier. Vd in equilibrium is 0.34 l / kg.

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). Excretion T1 / 2 is 2 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

With aerosol therapy: reflex cough, irritation of the respiratory tract, rhinorrhea; rarely - stomatitis, bronchospasm. With i / m administration: burning at the injection site, skin rash, urticaria; with long-term treatment - impaired liver and / or kidney function.

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

Application is possible according to the dosage regimen. Use with caution in children under 6 years of age. It should be borne in mind that oral administration of the drug is preferable for children under 6 years of age.

Use in elderly patients

In patients over 65 years of age, the minimum effective dose is used.

special instructions

Patients with bronchial asthma and obstructive bronchitis should be prescribed acetylcysteine ??with caution under systematic monitoring of bronchial patency. With a shallow intramuscular injection of the drug and in the presence of increased sensitivity, a slight and rapidly passing burning sensation may appear, and therefore it is recommended to inject the drug deep into the muscle. The ampoule of Fluimucil is opened before use. The opened ampoule can be stored in the refrigerator for 24 hours, during which time the drug can only be used for inhalation. Fluimucil solution should not come into contact with rubber and metal surfaces.

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. 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 acetylcysteine ??and antibiotics should be at least 2 hours. taking Fluimucil and nitroglycerin can lead to an increase in the vasodilating effect of the latter. Acetylcysteine ??reduces the hepatotoxic effect of paracetamol. Pharmaceutical incompatible with other drug solutions.