Each ml contains: N-acetylcysteine 100 mg.
Pharmacology: N-acetylcysteine exerts an intensive mucolytic-fluidifying action on mucous and mucopurulent secretions, by depolymerizing the mucoproteic complexes and the nucleic acids which confer viscosity to the vitreous and purulent component of the sputum and of the secretions.
Furthermore, N-acetylcysteine exert a direct antioxidant action, being provided with a free thiol (-SH) nucleophilic group which is able to interact directly with the electophilic group of the oxidant radicals. Of particular interest is the recent demonstration that N-acetylcysteine protects α-1-antitrypsin, enzyme inhibiting elastase, from the inactivation due to the action of hypochlorous acid (HOCl), a powerful oxidant agent produced by the myeloperoxidase enzyme of activated phagocytes.
Due to its molecular structure, N-acetylcysteine can easily cross the cellular membranes. Inside the cell, N-acetylcysteine is deacetylized to L-cysteine, an amino acid is indispensable for the glutathione synthesis (GSH).
GSH is a highly reactive tripeptide, found ubiquitously in the various tissue of animals and is essential for the maintenance of functional capacity as well as cellular morphological integrity, as it represents the most important protective, endocellular mechanism against oxidant radical, either of external or internal nature, as well as toward numerous cytotoxic substances. These features make N-acetylcysteine particularly suitable for the treatment of acute and chronic infections of the respiratory system, characterized by thick viscous and mucopurulent secretions.
N-acetylcysteine plays a role of primary importance in the maintenance of adequate GSH levels that contributing to the cellular protection from harmful agents which through progressive GSH depletion, would be able to express their cytotoxic action, as in case of acetaminophen poisoning.
Due to this mechanism of action, N-acetycysteine also indicated as a specific antidote in acetaminophen poisoning, in the course of cyclophosphamide treatment and hemorrhagic cystitis in the letter case it provides SH- groups necessary to inactivate acrolein, a toxic metabolite that is reported to be responsible of uropathy during chemotherapic.
Due to its antioxidant properties as precursor of the endocellular glutathione, acetylcysteine can also protect the respiratory tract opposing the harmful effect of the oxidant agents.
N-acetylcysteine is used for the treatment of respiratory infection, characterized by thick and viscous hypersecretions.
Aerosol administration: Nebulize 1 ampoule each time, 1-2 times per day for 5-10 days.
The aerosol apparatus used should be made of glass or plastic material. When the apparatus has parts of metal or rubber, these have to be washed with water after use. Clean nebulizing equipment immediately after use to prevent clogging of small orifices or corrosion of metal parts.
No particular toxic signs and symptoms have been observed, even in patients treated with high doses of N-acetylcysteine by systemic route. Very high doses of N-acetylcysteine by topical administration could produce an excessive and massive liquefaction of the mucopurulent secretions, particularly in subjects with inadequate coughing reflex or expectoration, in whom it may be necessary to use mechanical methods of bronchial suction.
Hypersensitivity to the N-acetylcysteine.
Administration of N-acetylcysteine, particularly by aerosol, can at the beginning of treatment, liquefy the bronchial secretions and simultaneously increase the volume. If patient is unable to properly expectorate, it is necessary to clear the airways by postural drainage or eventually by bronchosuction to avoid retention of secretions.
Patients suffering from bronchial asthma must be closely monitored as bronchospasm may occur during the treatment. In such event the treatment must be immediately suspended.
N-acetylcysteine aerosol may worsen cough in patients suffering from acute bronchial asthma.
A sulphur odour is felt on opening the ampoules or transferred to the aerosol equipment, may assume a pink colour, but it does not affect the efficacy and safety of the product.
Use of product by systemic route, may occasionally be followed by hypersensitivity reactions such as urticaria and rarely bronchospasm. During administration by aerosol, nose-pharyngeal, and gastrointestinal irritation such as rhinorrhea, stomatitis, nausea, vomiting, and dyspepsia may also be experienced.
N-acetylcysteine may be administered concurrently with common bronchodilators, vasoconstrictors, etc. When local treatment with N-acetylcysteine and antibiotic is necessary, it is advisable to administer the two drugs separately since incompatibility between N-acetylcysteine and certain antibiotic may exist.
Store at temperature below 25°C.
R05CB01 - acetylcysteine ; Belongs to the class of mucolytics. Used in the treatment of wet cough.
Soln for inhalation (amp) 100 mg/mL x 3 mL x 5's.