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Acetylcysteinum

Препарат Ацетилцистеин. ЗАО "Вертекс" Россия


Producer: CJSC Verteks Russia

Code of automatic telephone exchange: R05CB01

Release form: Firm dosage forms. Tablets are sparkling.

Indications to use: Chronic bronchitis. Acute bronchitis. Tracheitis. Pneumonia. Bronchoectatic disease. Bronchial asthma. Sinusitis. Mucoviscidosis.


General characteristics. Structure:

Active ingredient: 200 mg of Acetylcysteinum.

Excipients: ascorbic acid, sodium carbonate anhydrous, Natrii hydrocarbonas, citric acid anhydrous, sorbitol, macrogoal 6000, sodium citrate, sodium saccharinate, fragrance lemon.

The mucolytic means liquefying a phlegm.




Pharmacological properties:

Pharmacokinetics. Mucolytic means. Liquefies a phlegm, increases its volume, facilitates allocation, promotes expectoration. Action of Acetylcysteinum is connected with ability of its sulphhydryl groups to terminate disulfide bridges of acid mucopolysaccharides of a phlegm that leads to depolarization of mukoproteid and reduction of viscosity of slime. Keeps activity in the presence of a purulent phlegm.

Has the antioxidant effect caused by existence of the SH group capable to enter interaction and to neutralize electrophilic oxidizing toxins. Acetylcysteinum promotes increase in synthesis of glutathione which is an important antioxidant factor of intracellular protection and provides maintenance of functional activity and morphological integrity of a cell.

Pharmacokinetics. At intake it is well absorbed from a GIT. Substantially is exposed to effect of "the first passing" through a liver that leads to bioavailability reduction. Linkng with proteins of a blood plasma to 50% (in 4 h after intake). It is metabolized in a liver and, perhaps, in an intestinal wall. In plasma is defined in not changed look, and also in the form of metabolites - N-Acetylcysteinum, N, N-diatsetiltsisteina and ether of cysteine.

The renal clearance makes 30% of the general clearance.


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, an atelectasis owing to obstruction of bronchial tubes a mucous stopper, sinusitis (for 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.

Paracetamol overdose.


Route of administration and doses:

Individual. Inside to adults and children 6 years - on 200 mg of 2-3 times/days are more senior; to children aged from 2 up to 6 years - on 200 mg of 2 times/days or on 100 mg of 3 times/days, up to 2 years - on 100 mg of 2 times/days.

In oil the adult - on 300 mg of 1 times/days, children - on 150 mg of 1 times/days.


Features of use:

Use at pregnancy and feeding by a breast. Adequate and strictly controlled clinical trials of safety of Acetylcysteinum at pregnancy and in the period of a lactation it is not carried out.

At pregnancy and in the period of a lactation use of Acetylcysteinum is possible only if the estimated advantage for mother exceeds potential risk for a fruit or the baby.

Use for children. When using Acetylcysteinum at patients with bronchial asthma it is necessary to provide a phlegm drainage. At newborns apply only according to vital indications in a dose 10 mg/kg under strict control of the doctor.

Inside to children 6 years - on 200 mg of 2-3 times/days are more senior; to children aged from 2 up to 6 years - on 200 mg of 2 times/days or on 100 mg of 3 times/days, up to 2 years - on 100 mg of 2 times/days.

With care apply Acetylcysteinum at patients with bronchial asthma, diseases of a liver, kidneys, adrenal glands. When using Acetylcysteinum at patients with bronchial asthma it is necessary to provide a phlegm drainage. At newborns apply only according to vital indications in a dose 10 mg/kg under strict control of the doctor.

Between reception of Acetylcysteinum and antibiotics it is necessary to observe 1-2 hour interval.

Acetylcysteinum reacts with some materials, such as iron, copper and rubber used in the device for spraying. In places of possible contact with solution of Acetylcysteinum it is necessary to apply the details made of the following materials: glass, plastic, aluminum, chrome-plated metal, tantalum, silver of the established test or stainless steel. After contact silver can grow dull, but it does not influence efficiency of Acetylcysteinum and does not do harm to the patient.


Side effects:

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

Allergic reactions: seldom - skin rash, an itch, a small tortoiseshell, a bronchospasm.

At superficial introduction in oil and with hypersensitivity there can be an easy and quickly taking place burning in this connection it is recommended to administer the drug deeply in a muscle.

At inhalation use: reflex cough, local irritation of respiratory tracts are possible; seldom - stomatitis, rhinitis.

Others: seldom - nasal bleedings, a sonitus.

From laboratory indicators: decrease in a prothrombin time against the background of purpose of high doses of Acetylcysteinum is possible (observation of a condition of system of a blood coagulation), change of test results of quantitative definition of salicylates (the colorimetric test) and the test of quantitative definition of ketones (the test with Natrium nitroprussicum is necessary).


Interaction with other medicines:

Simultaneous use of Acetylcysteinum with antibechics can increase stagnation of a phlegm because of suppression of a tussive reflex.

At simultaneous use with antibiotics (including tetracycline, ampicillin, B Amphotericinum) their interaction with thiol group of Acetylcysteinum is possible.

Acetylcysteinum reduces a hepatotoxic action of paracetamol.


Contraindications:

Peptic ulcer of a stomach and duodenum in an aggravation phase, a blood spitting, pulmonary bleeding, hypersensitivity to Acetylcysteinum.



Storage conditions:

In the places unavailable to children. Temperature is no more than 25 °C. Ready solution is subject to storage of no more than 7 days in the refrigerator (at a temperature of 2-8 °C).


Issue conditions:

According to the recipe


Packaging:

On 2, 4 or 24 sparkling tablets in strip packagings or cases polypropylene. On 1 case or 6-12 packagings in a cardboard pack.



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