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Acetylcysteinum

Препарат Ацетилцистеин. РУП "Белмедпрепараты" Республика Беларусь


Producer: RUP of Belmedpreparata Republic of Belarus

Code of automatic telephone exchange: R05CB01

Release form: Firm dosage forms. Powder for oral administration.

Indications to use: Bronchial asthma. Bronchoectatic disease. Chronic bronchitis. Acute bronchitis. Tracheitis. Pneumonia. Atelectasis of lungs. Emphysema of lungs. Otitis. Purulent otitis. Antritis. Sinusitis. Mucoviscidosis.


General characteristics. Structure:

Active ingredient: 200 mg  of Acetylcysteinum (N - acetyl - L - cysteine).

Vvspomogatelny substances: vkusoaromatichesky Aromatik additive lemon, aspartame, lactoses monohydrate.




Pharmacological properties:

Pharmacodynamics. Mucolytic means, liquefies a phlegm, increases its volume, facilitates department of a phlegm. Action is connected with ability of free sulphhydryl groups of Acetylcysteinum to break off inside - and intermolecular disulfide bridges of acid mucopolysaccharides of a phlegm that leads to a depolymerization of mucoproteins and reduction of viscosity of a phlegm (in some cases it leads to significant increase in volume of a phlegm that demands aspiration of contents of bronchial tubes). Keeps activity at a purulent phlegm. Does not influence immunity.

Increases secretion of less viscous sialomutsin scyphoid cells, reduces adhesion of bacteria on epithelial cells of a mucous membrane of bronchial tubes. Stimulates mucous cells of bronchial tubes which secret lyses fibrin. Has similar effect on the secret which is formed at inflammatory diseases of ENT organs. Has the antioxidant effect caused by existence of the SH group capable to neutralize electrophilic oxidizing toxins. Protects alfa1-antitrypsin (elastase inhibitor) from the inactivating influence of NOCL - the oxidizer developed by myeloperoxidase of active phagocytes.

Possesses also some antiinflammatory action (due to suppression of formation of the free radicals and active oxygen-containing agents responsible for development of an inflammation in pulmonary fabric).

Pharmacokinetics. Absorption - high. Bioavailability - 10%. Time of achievement of the maximum concentration in plasma - 1-3 h. Communication with proteins of plasma - 50%. Gets through a placental barrier, collects in amniotic liquid. It is metabolized in a liver (has effect of "the first passing" through a liver - a dezatsetilirovaniye with formation of cysteine). The poluvyveleniye period about 1 h, at a liver failure increases to 8 h.

It is removed by kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteinum), an insignificant part is allocated in not changed view with fecal masses.


Indications to use:

- diseases of a respiratory organs and states which are followed by formation of a viscous and mucopurulent phlegm: acute and chronic bronchitis, tracheitis owing to a bacterial and/or viral infection, pneumonia, a bronchoectatic disease, bronchial asthma, emphysema of lungs, a lung atelectasis (owing to obstruction of bronchial tubes a mucous stopper);

- catarral and purulent otitis, antritis, sinusitis (simplification of an otkhozhdeniye of a secret);

- a mucoviscidosis (as a part of a combination therapy);

- removal of a viscous secret from respiratory tracts at posttraumatic and postoperative states.


Route of administration and doses:

Inside, after food. Contents of a package are dissolved in 100 ml (1/2 glasses) of warm drinking water, well stirred and drunk right after preparation.

The adult - 1 package (200 mg of Acetylcysteinum) 2-3 times a day, to children are 2-14 years - 1 package (200 mg of Acetylcysteinum) 2 times a day.

At chronic diseases: the adult - 2-3 packages (400-600 mg/days of Acetylcysteinum) in 1-2 receptions; children are 2-14 years old - 1/2 packages (100 mg of Acetylcysteinum) 3 times a day.

At a mucoviscidosis - to children at the age of 2-6 years - 1/2 packages (100 mg of Acetylcysteinum) 4 times a day, are more senior than 6 years - 1 package (200 mg of Acetylcysteinum) 3 times a day.

The course of treatment at acute uncomplicated diseases makes 5-7 days. Treatment of chronic diseases spend a long time or courses till several months.


Features of use:

Not to mix drug with other medicines. During the work with drug it is necessary to use glasswares, to avoid contact with metals and rubber (formation of sulfides with a characteristic smell is possible), oxygen, the easily oxidized substances.

Precautionary measures. It is necessary to apply with care at the persons inclined to a bronchospasm (at approach of the phenomena of a bronchospasm appoint bronchodilatory means). At patients with a bronkhoobstruktivny syndrome it is necessary to combine with bronchial spasmolytics. When using Acetylcysteinum at patients with bronchial asthma it is necessary to provide a phlegm drainage.


Side effects:

From the alimentary system: seldom - nausea, vomiting, feeling of overflow of a stomach, stomatitis.

Allergic reactions: seldom - skin rash, an itch, a small tortoiseshell, a bronchospasm (it is preferential at patients with hyperreactivity of bronchial tubes).

Others: seldom - drowsiness, fever.


Interaction with other medicines:

Acetylcysteinum increases (mutually) effect of bronchial spasmolytics. Acetylcysteinum pharmaceutical is incompatible with antibiotics (cephalosporins, penicillin, erythromycin, tetracyclines), proteolytic enzymes. It reduces their absorption therefore they should be accepted not earlier than in 2 hours after reception of Acetylcysteinum.

Mixing of solutions of Acetylcysteinum with solutions of antibiotics and proteolytic enzymes can cause a drug inactivation. Simultaneous use of Acetylcysteinum with antibechics can increase stagnation of a phlegm because of suppression of a tussive reflex.

Strengthens vasodilating effect of nitroglycerine.

Acetylcysteinum reduces a hepatotoxic action of paracetamol.


Contraindications:

Hypersensitivity to Acetylcysteinum, children's age up to 2 years, pregnancy, the lactation period.

With care: a peptic ulcer of a stomach and a 12-perstny gut (in an aggravation phase), a gullet varicosity, a pneumorrhagia, pulmonary bleeding, a fenilketonuriya (contains aspartame), bronchial asthma (risk of development of a bronchospasm), diseases of adrenal glands, a liver and/or renal failure, arterial hypotension.


Overdose:

Symptoms: diarrhea, heartburn, nausea, vomiting, stomach ache.

Treatment: at emergence of the expressed symptoms of overdose to see a doctor.


Storage conditions:

To store in the place protected from moisture and light at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 2 years. Not to use after the period of validity specified on packaging.


Issue conditions:

Without recipe


Packaging:

On 3 g (0,2 g of Acetylcysteinum) in packages. On 10 or 20 packages in packaging No. 10 and No. 20.



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