Fluimucil solution for injection and inhalation 100mg/ml 3ml ampoules, 5pcs

Composition

Active ingredient:

acetylcysteine 300 mg;

Auxiliary substances:

disodium edetate-3 mg;

sodium hydroxide-74 mg;

water for injection-up to 3 ml

Pharmacological action

Pharmaceutical group:

expectorant (mucolytic) agent. Pharmaceutical action:

Fluimucil is a mucolytic drug. Dilutes sputum, 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. It 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. It stimulates mucosal cells of the bronchi, the secret of which lyses fibrin. It has a similar effect on the secret formed in inflammatory diseases of ENT organs.

It has an antioxidant effect due to the presence of the SH group, which can neutralize electrophilic oxidative toxins. Acetylcysteine easily penetrates into the cell, deacetylates 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 effect of acetylcysteine as an antidote for paracetamol poisoning.

Protects alpha 1-antitrypsin (elastase inhibitor) from the inactivating effect of the carrier oxidant produced by the 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).

Indications

Diseases of the respiratory system, accompanied by the formation of sputum of increased viscosity (acute and chronic bronchitis, pneumonia, bronchiectasis, cystic fibrosis, bronchial asthma).

Contraindications

Hypersensitivity to acetylcysteine, peptic ulcer of the stomach and duodenum in the acute stage,

Caution should be exercised when prescribing the drug to patients with liver and kidney diseases.

Side effects

From the digestive system: rarely-heartburn, nausea, vomiting, diarrhea, stomatitis.

Allergic reactions: rarely – skin rash, pruritus, urticaria, bronchospasm.

Other: rarely-nosebleeds, tinnitus, collapse, decreased platelet aggregation.

Local reactions: with parenteral use, a slight burning sensation at the injection site is possible; with inhalation use, reflex cough, local irritation of the respiratory tract, stomatitis, rhinitis; rarely-bronchospasm (in this case, the appointment of bronchodilators is necessary).

Interaction

The combined use of acetylcysteine with antitussive agents may increase sputum congestion due to suppression of the cough reflex.

When used simultaneously with such antibiotics 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.

Simultaneous use of acetylcysteine and nitroglycerin may lead to increased vasodilating and antiplatelet effects of the latter.

Acetylcysteine eliminates the toxic effects of paracetamol.

How to take, course of use and dosage

The solution for injection can be administered parenterally, by inhalation, or endobronchially.

Adults, intramuscularly deep or intravenously-usually 300 mg (1 ampoule 3 ml) 1-2 times a day. Children 6-14 years – 1/2 dose for adults. The daily dose for children under 6 years of age is 10 mg / kg. The duration of treatment should be determined based on the results of changes in the patient’s condition. High local and general tolerance to the drug allows for long-term treatment courses.

Inhalation: usually 300 mg (1 ampoule) 1-2 times a day for 5-10 days or longer courses; the frequency of use and the dose size can be changed by the doctor depending on the patient’s condition and therapeutic effect. Children are prescribed in the same dosage.

Endobronchial use: administered appropriately with permanent tubes, a bronchoscope, etc. at 300-600 mg (1-2 ampoules) or more per day, depending on clinical indications.

Overdose

Acetylcysteine at doses of 500 mg / kg per day did not cause signs and symptoms of overdose.

Special instructions

With caution, it is prescribed to patients prone to pulmonary bleeding, hemoptysis, with liver and kidney diseases, with impaired adrenal function, patients with bronchial asthma and obstructive bronchitis (and under systematic monitoring of bronchial patency).

When acetylcysteine is dissolved, it is necessary to use glassware, avoid contact with metal and rubber surfaces. When opening the package, the smell of sulfur is possible, this is the smell of the Active ingredient, and not evidence of poor quality of the drug.

The ampoule of Fluimucil is opened before use. The opened ampoule can be stored in the refrigerator for 24 hours. Use of the drug from a previously opened ampoule for injection is prohibited.

Fluimucil solution should not come into contact with rubber or metal surfaces.

Form of production

Fluimucil solution for injection and inhalation is clear, colorless, with a faint sulfur smell; after opening the ampoule, a faint pink-purple hue may appear during prolonged contact with air.

Storage conditions

At room temperature (no higher than 25 °C).

Shelf

life is 3 years.

Active ingredient

Acetylcysteine

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Description

Children as prescribed by a doctor, Adults as prescribed by a doctor

Indications

Chronic obstructive pulmonary disease, Sinusitis, Tracheitis, Cough, Bronchitis, Sinusitis, pneumonia