Pharmacological properties

Pharmacodynamics. Acetylcysteinum (azz) — mucolytic, expectorant which is applied to fluidifying of a phlegm at the diseases of a respiratory system which are followed by formation of dense slime. Acetylcysteinum is derivative cysteine amino acids. the mucolytic effect of medicine has the chemical nature. at the expense of free sulfhydryl group Acetylcysteinum breaks disulfide bridges of acid mucopolysaccharides that leads to a depolymerization of mukoproteid of a phlegm and reduction of viscosity of slime and promotes expectoration and an otkhozhdeniye of a bronchial secret. medicine keeps activity in the presence of a purulent phlegm.

Acetylcysteinum has also antioxidant pneumotyre-tread properties that is caused by binding by its sulfhydryl groups of chemical radicals and, thus, their neutralization. Besides, medicine promotes increase in synthesis of glutathione — an important factor of intracellular protection not only against oxidizing toxins of exogenous and endogenous origin, but also from some cytotoxic substances. This feature of Acetylcysteinum gives the chance to effectively apply the last at paracetamol overdose.

Pharmacokinetics. After oral administration Acetylcysteinum quickly and completely is soaked up and exposed to metabolism in a liver with formation of cysteine, pharmacological an active metabolite and also diacetylcysteinum, cystine and further — the mixed disulfides. Bioavailability very low — about 10%. With _max in blood plasma it is reached in 1–3 h after reception. Linking with proteins of blood plasma — 50%. Acetylcysteinum is emitted with kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteinum).

T _½ is defined p by generally fast biotransformation in a liver and makes about 1 h. In case of depression of function of a liver of T _½

Indication

Treatment of sharp and chronic diseases of a bronchopulmonary system at which reduction of viscosity of a phlegm, improvement of its otkhozhdeniye and expectoration is necessary increases to 8 h

.

Use

Recommended mode of administration of medicament ацц® solution oral:

adults and children are aged more senior than 12 years: on 10 ml 2–3 times a day (an equivalent of 400-600 mg of Acetylcysteinum a day);

children at the age of 2–6 years: on 5 ml 2–3 times a day (an equivalent of 200-300 mg of Acetylcysteinum a day);

children at the age of 6–12 years: on 10 ml 2–3 times a day (an equivalent of 400-600 mg of Acetylcysteinum a day).

10 ml of solution oral correspond to a half of a measured cap or 2 syringes.

Route of administration. ACC ^® oral accept solution after a meal. The dose should be measured the syringe for medicines for oral administration or by means of a measured cap which is applied complete with medicine.

Dosage measurement by means of the syringe

1. To remove a cap, safe for children, having pressed it down and turning to the left.

2. To insert the perforated stopper which is included in the package, in a bottle neck. If it is not possible to insert completely a stopper, it is possible to put on a cap and to twirl it. The stopper is means for connection of the syringe in a bottle, it has to remain inserted into a bottle neck.

3. To insert the syringe into a stopper opening. The piston has to be so far pushed in the syringe as it is possible.

4. It is careful to turn upside down a bottle together with the syringe, to pull the piston to the mark corresponding to the necessary quantity of milliliters (ml). If in solution which got to the syringe there are bubbles, it is necessary to press the piston to release the syringe, and to slowly gather solution again. If for reception more than 5 ml are appointed, the syringe should be filled several times.

5. To turn a bottle up a neck and to pull out the syringe from a perforated stopper.

6. Solution it is possible to give to drink the child directly from the syringe or previously to pour out solution of the syringe in a spoon. If the child receives solution directly from the syringe, he should be put exactly. Solution from the syringe should be produced slowly, directing it to the internal surface of a cheek so that the child did not choke.

After use the syringe needs to be washed with clear water.

should not accept means of ACC ^® solution oral longer than 4-5 days without consultation with the doctor. ACC solution oral should be accepted after a meal.

Contraindication

Hypersensitivity to active agent or any of excipients. a peptic ulcer of a stomach and duodenum in an aggravation stage, a pneumorrhagia, pulmonary bleeding.

Side effects

For the description of frequency of side effects use the following classification: very often (≥1/10), it is frequent (≥1/100, 1/10), infrequently (≥1/1000, 1/100), is rare (≥1/10,000, 1/1000), is very rare (1/10,000).

from a cardiovascular system: infrequently — tachycardia, arterial hypotension.

from nervous system: infrequently — a headache.

from skin: infrequently — allergic reactions (itch, urticaria, a dieback, eczema, rash, a Quincke's disease).

from an organ of hearing: infrequently — a ring in ears.

from a respiratory system: seldom — short wind, a bronchospasm (mainly at patients with hyperreactivity of a bronchial system which is associated with OH), a rhinorrhea.

from a digestive tract: infrequently — heartburn, dyspepsia, stomatitis, an abdominal pain, nausea, vomiting, diarrhea, an unpleasant smell from a mouth.

General frustration: infrequently — fever.

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It was reported about separate heavy reactions from skin (Stephens's syndromes — Johnson and Layell). At use of Acetylcysteinum it was very seldom reported about developing of bleedings which were most often connected with development of reactions of hypersensitivity. Noted cases of decrease in aggregation of platelets, however it does not have clinical confirmation. It was very seldom reported about a Quincke's edema, a face edema, cases of anemia, a hemorrhage, anaphylactic reactions or even shock.

Special instructions

Recommend to take with care the medicament to patients with ulcer of stomach and duodenum in the anamnesis, especially in case of the accompanying intake of other medicines which irritate a mucous membrane of a stomach.

and to consult with the doctor concerning his further reception.

Acetylcysteinum influences metabolism of a histamine therefore patients should not appoint long therapy with intolerance of a histamine as it can lead to emergence of symptoms of intolerance (a headache, vasomotorial rhinitis, an itch).

should appoint by

With care Acetylcysteinum to patients with OH and with an ulcer in the anamnesis.

oral 1.78 mmol (41.02 mg) of sodium contain

1 ml of solution. It should be considered when prescribing medicine to the patients observing limited on sodium content (low content of sodium / the low content of salt) a diet.

Use during pregnancy and feeding by a breast. During pregnancy and feeding by a breast use of Acetylcysteinum is possible only if the expected advantage for mother exceeds potential risk for a fruit or the child.

Children. Apply at children aged from 2 years. As the relevant data concerning the dosing mode for newborns are absent, ACC ^® solution oral at such patients can be applied only after consultation with the doctor.

Ability to influence speed of response at control of vehicles or work with other mechanisms. Does not influence.

Interaction

Use together with Acetylcysteinum of antibechics can increase stagnation of a phlegm because of reduction of a tussive reflex.

At simultaneous application with such antibiotics as tetracyclines (except doxycycline), ampicillin, Amphotericinum B, cephalosporins, aminoglycosides, their interaction with thiol group of Acetylcysteinum is possible

that leads to decrease of the activity of both medicines. Therefore the interval between use of these medicines has to make not less than 2 h. It does not concern a tsefiksim and a lorakarbef.

Activated carbon reduces efficiency of Acetylcysteinum.

does not recommend to dissolve

Acetylcysteinum in one glass with other medicines.

Acetylcysteinum reduces expressiveness of hepatotoxic action of paracetamol.

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notes synergism of Acetylcysteinum with bronchial spasmolytics.

Atsetiltsistein can be the donor of cysteine and increase the level of the glutathione promoting a detoxication of free radicals of oxygen and certain toxics in an organism.

Concomitant use of nitroglycerine and Acetylcysteinum can lead

to strengthening of vasodilating effect of nitroglycerine.

Overdose

Is not present data on cases of overdose of the dosage forms of Acetylcysteinum intended for intake.

Acetylcysteinum at reception in a dose of 500 mg/kg/days does not cause signs and symptoms of overdose.

Symptoms. The overdose can be shown by gastrointestinal symptoms, such as nausea, vomiting and diarrhea.

Treatment. There is no specific antidote at poisoning with Acetylcysteinum, therapy symptomatic.

Storage conditions

does not demand special storage conditions. after packing opening to store solution at a temperature not above 25 °C no more than 18 days. to store out of children's reach.