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

Zambon S.p.A., Italy

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Product Overview

Structure

Active substance:

acetylcysteine ������300 mg;

Excipients:

disodium edetate - 3 mg;

sodium hydroxide - 74 mg;

water for injection - up to 3 ml

pharmachologic effect

Farmgroup: 

expectorant (mucolytic) agent.

Farm action:

 Fluimucil is a mucolytic drug. It dilutes sputum, increases its volume and facilitates its separation. The action of acetylcysteine ������is associated with the ability of its sulfhydryl groups to break intramolecular and intermolecular disulfide bonds of acid mucopolysaccharides of sputum, which leads to the depolarization of mucoproteins and a decrease in the viscosity of sputum. It 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 mucous 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, 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 helps to increase the synthesis of intracellular glutathione, which is involved in the oxidation-reduction processes of cells, contributing to the detoxification of harmful substances. This explains the effect of acetylcysteine ������as an antidote for paracetamol poisoning.


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

Indications

Respiratory diseases accompanied by the formation of increased viscosity sputum (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,

With caution, the drug should be prescribed to patients with diseases of the liver and kidneys.

Side effects

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


Allergic reactions: rarely - skin rash, itching, urticaria, bronchospasm.


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


Local reactions: with parenteral administration, a slight burning sensation at the injection site is possible; with inhalation use - a 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 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 these drugs should be at least 2 hours.

The simultaneous use of acetylcysteine ������and nitroglycerin can lead to increased vasodilator and disaggregant action of the latter.

Acetylcysteine ������eliminates the toxic effects of paracetamol.

How to take, course of administration and dosage

Solution for injection can be administered parenterally, inhalation, endobronchial.

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

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

Endobronchial administration: is introduced accordingly using permanent tubes, a bronchoscope, etc. 300-600 mg (1-2 ampoules) or more per day, depending on clinical indications.

Overdose

Acetylcysteine ������when taken in doses of 500 mg / kg per day did not cause signs and symptoms of an overdose.

Special instructions

It is prescribed with caution to patients prone to pulmonary hemorrhages, hemoptysis, with liver, kidney diseases, adrenal gland dysfunction, patients with bronchial asthma and obstructive bronchitis (and under systematic control of bronchial obstruction).

When dissolving acetylcysteine, it is necessary to use glassware, avoid contact with metal and rubber surfaces. At the opening of the package, the smell of sulfur is possible, this is the smell of the active substance, 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. Using the drug from a previously opened ampoule for injection is prohibited.

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

Release form

Fluimucil Injection and Inhalation Solution is clear, colorless, with a faint sulfuric odor; after opening the ampoule with prolonged contact with air, a slight pink-purple hue may appear.

Storage conditions

At room temperature (not higher than 25 ° C).

Shelf life

3 years.

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