Ацецекс

General characteristics. Structure:

Active ingredient: 100 mg or 200 mg of Acetylcysteinum.

Excipients: aspartame, lemon oil, tartrazine (Е 102), granulated sugar.

Mucolytic, expectorant, and detoksitsiruyushchy means.

Pharmacological properties:

Pharmacodynamics. Acetylcysteinum – mucolytic and the expectorant derivative of cysteine amino acid. Liquefies a phlegm, increases its volume and 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. Otkhozhdeny phlegms it is facilitated due to increase in mukotsiliarny clearance. Has the antioxidant effect caused by existence of the SH group capable to enter interaction and to neutralize electrophilic oxidizing toxins. Has pneumotyre-tread property, promoting 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. Keeps activity in the presence of a purulent phlegm.

Acetylcysteinum – an antidote at acetaminophen/paracetamol overdose (maintenance or recovery of concentration of glutathione in a liver which inactivates intermediate gepatotoksichny metabolites of acetaminophen).

Pharmacokinetics. At intake quickly and almost it is completely soaked up from digestive tract. Substantially is exposed to effect of "the first passing" through a liver that leads to bioavailability reduction – about 10%. The maximum concentration in a blood plasma is reached in 1-3 hours. There are data on linkng with proteins of plasma for 50% in 4 hours after intake. It is metabolized in a liver to cysteine (pharmacological an active metabolite), diacetylcysteinum and further – to the mixed disulfides; partial metabolism, perhaps, proceeds in an intestinal wall. In plasma is defined in an invariable look, and also in the form of metabolites – N-Acetylcysteinum, N, N-diatsetiltsisteina and ether of cysteine.

It is almost completely excreted in the form of inactive metabolites (inorganic sulfates, diacetylcysteinum), partially in not changed look it is removed with a stake. The renal clearance makes 30% of the general clearance. Plasma elimination half-life of blood - also depends 1 hour on biotransformation speed in a liver: at a liver failure it can last till 8 o'clock. Acetylcysteinum can get through a placental barrier and collect in amniotic liquid.

Indications to use:

Treatment of acute and chronic pathology of bronchopulmonary system at the diseases which are followed by the increased formation of a phlegm with deterioration in expectoration: acute and chronic bronchitis; bronchietasia, chronic obstructive bronchitis; tracheitis; prevention of a syndrome of distal intestinal obstruction at a mucoviscidosis.

Route of administration and doses:

Apply inside after food. Contents of 1 package are dissolved in ½ glasses (about 100 ml) of water, juice or cold tea just before reception. After preparation of solution it should be drunk as soon as possible. The additional use of liquid strengthens mucolytic effect of drug.

Acute and chronic diseases of bronchopulmonary system.
Adults and children are more senior than 14 years apply 400-600 mg of Acetylcysteinum 2-3 times a day.
Children from 6 to 14 years can apply 300-400 mg of Acetylcysteinum 2-3 times a day.
Children from 2 to 6 years apply 200-300 mg of Acetylcysteinum 2-3 times a day.

Prevention of a syndrome of distal intestinal obstruction at a mucoviscidosis.
Children from 1 month to 2 years apply 100-200 mg 3 times a day.
Children of 2-12 years apply 200 mg 3 times a day.
Children of 12-18 years apply 200-400 mg 3 times a day.

At acute uncomplicated diseases drug is used by no more than 4-5 days without observation of the doctor.

The term of treatment of chronic diseases is defined separately. The chronic bronchitis and a mucoviscidosis demanding prolonged treatment or treatment by courses are treated till several months (up to 6 months).

Features of use:

Appropriate security measures at use. At patients with stomach ulcer or a duodenum, Acetylcysteinum can cause bronchial hypersecretion. In such cases when cough or a tussive reflex are insufficient, it is necessary to watch that respiratory tracts remained free.

Drug should be used with care to the patients having bronchial asthma. It is caused by what at preparation of solution can arise reflex брохоспазм because powder at its rash from a package in ware can get to the air inhaled and thus irritate a mucous membrane of a nose.

Patients with diseases of a liver and/or kidneys should apply Acetylcysteinum with care in order to avoid accumulation of nitrogen-containing substances in an organism.

During treatment it is recommended to use enough liquid, it strengthens mucolytic effect.

1 bag of 100 mg contains 0,29 grain units;
1 bag of 200 mg contains 0,28 grain units.

Use during pregnancy and feeding by a breast. Clinical data on use of Acetylcysteinum during pregnancy and a lactation are limited therefore use of drug during this period is possible only when the expected advantage for mother exceeds potential risk for a fruit or the child.

Ability to influence speed of response at control of motor transport or other mechanisms. Data are absent.

Children. Because of the high content of Acetylcysteinum drug is not appointed to children as Mucolyticum at diseases of bronchopulmonary system aged up to 2 years. At babies and small children aged till 1 year Acetylcysteinum can be applied only according to the vital indications and under strict medical observation. At treatment of diseases of bronchopulmonary system children from 2 to 6 years can use drug with the maintenance of Acetylcysteinum of 100 mg in 1 package. Children at the age of 6-14 years can use drug with the maintenance of Acetylcysteinum of 100 mg or 200 mg in 1 package.

Special instructions. Additional reception of liquid strengthens mucolytic effect of Acetylcysteinum. The newborn medicine is appointed only according to vital indications and under strict control of the doctor, without exceeding a dose of 10 mg on 1 kg of body weight.

With care apply Acetylcysteinum at patients with diseases of a liver, kidneys, adrenal glands.

At the patients incapable to clear the throat, during treatment by Acetylcysteinum mechanical suction of a phlegm is necessary.

Patients with bronchial asthma during treatment with Acetylcysteinum when strengthening a bronchospasm need parallel use of broncholitic means.

Side effects:

From a respiratory sistemy:redko – диспноэ, a bronchospasm (it is preferential at patients with hyperreactivity of bronchial system, is associated with bronchial asthma).

GIT: infrequently – heartburn, stomatitis, an abdominal pain, nausea, vomiting, diarrhea.

General disturbances: infrequently – allergic reactions (an itch, urticaria, a dieback, rash, a Quincke's disease), tachycardia, arterial hypotension, fever, a headache, a ring in ears.

 In rare instances – separate heavy reactions from skin (Stephens-Johnson's syndrome and a Lyell's disease), developing of the bleedings most often connected with development of reactions of hypersensitivity; suppression of aggregation of thrombocytes; cases of anemia, hemorrhage, anaphylactic reactions or even shock. In case of changes of skin or a mucous membrane it is necessary to stop use of drug and to see immediately a doctor.

Interaction with other medicines:

Antibiotics of a tetracycline row (except for doxycycline). These drugs are not recommended to be used along with Acetylcysteinum.

Penicillin, cephalosporins, tetracyclines. The interval between oral administration of these drugs and reception of Acetylcysteinum has to make not less than 2 hours.

Antibechics. Combined use of Acetylcysteinum with the means oppressing the tussive center is not recommended because of possible risk of stagnation of a phlegm owing to suppression of a tussive reflex.

Nitroglycerine. Acetylcysteinum can strengthen vazodilatatorny effect of nitroglycerine.

Paracetamol. Acetylcysteinum reduces a hepatotoxic action of paracetamol.

Contraindications:

- Hypersensitivity to drug components.
- A peptic ulcer of a stomach and duodenum in an aggravation stage.
- Pneumorrhagia.
- Pulmonary bleeding.
- Age up to 2 years – as Mucolyticum at diseases of bronchopulmonary system.
- Pregnancy, feeding period breast.
- Diseases of adrenal glands.
- Liver or renal failure.
- Gullet varicosity.
- Fenilketonuriya.

Overdose:

Heavy and life-threatening by-effects at overdose of Acetylcysteinum it is not established. Symptoms: nausea, vomiting, diarrhea.

Treatment – symptomatic.

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.

Issue conditions:

Without recipe

Packaging:

On 3,0 g in the thermowelded packages placed together with a leaf insert in packs from a cardboard No. 10, No. 20.