ATSTS - instructions for use, dose, side effects, contraindications

auxiliary substances: methyl parahydroxybenzoate - 1.30 mg, sodium benzoate - 1.95 mg,disodium edetate - 1.00 mg, sodium saccharinate - 1.00 mg, sodium carmellose - 2.00 mg, sodium hydroxide, 10% aqueous solution - 30.00 - 70.00 mg, flavoring "Cherry" - 1.50 mg , purified water - 910.25 - 950.25 mg.

Description:Transparent, colorless, slightly viscous solution with a cherry smell.

Pharmacotherapeutic group:Expectorant mucolytic agent

ATX: & nbsp

S.01.X.A.08 Acetylcysteine

R.05.C.B.01 Acetylcysteine

Pharmacodynamics:

Acetylcysteine is a derivative of the amino acid cysteine. It has a mucolytic effect, facilitates the escape of sputum due to a direct effect on the rheological properties of sputum. The effect is due to the ability to rupture the disulfide bonds of the mucopolysaccharide chains and cause the depolymerization of sputum mucoproteins, which leads to a decrease in the viscosity of the sputum. The drug remains active in the presence of purulent sputum.

Has an antioxidant effect, based on the ability of its reactive sulfhydryl groups (SH-groups) bind to oxidative radicals and, thus, neutralize them.

Besides, acetylcysteine promotes the synthesis of glutathione, an important component of the antioxidant system and chemical detoxification of the body.The antioxidant effect of acetylcysteine increases the protection of cells from the damaging effect of free radical oxidation, which is characteristic of an intensive inflammatory reaction.

With the preventive use of acetylcysteine, there is a decrease in the frequency and severity of exacerbations of bacterial etiology in patients with chronic bronchitis and cystic fibrosis.

Pharmacokinetics:

Absorption is high. Rapidly metabolized in the liver to form a pharmacologically active metabolite - cysteine, as well as diacetylcysteine, cystine and mixed disulfides. Bioavailability at ingestion is 10% (because of the pronounced effect of "first passage" through the liver). Time to reach the maximum concentration (C_m_Oh) in blood plasma is 1 - 3 hours. Communication with blood plasma proteins - 50%. It is excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine). Half-life (T_1/2) is about 1 hour, abnormal liver function leads to an elongation of T₁/2 up to 8 hours Penetrates through the placental barrier. Data on the ability of acetylcysteine to penetrate the blood-brain barrier and excrete with breast milk are absent.

Indications:

Diseases of the respiratory system, accompanied by the formation of viscous hard-to-recover sputum:

- acute and chronic bronchitis;

- obstructive bronchitis;

- tracheitis, laryngotracheitis;

- pneumonia, lung abscess;

- bronchiectasis, bronchial asthma, chronic obstructive pulmonary disease (COPD), bronchiolitis, cystic fibrosis;

- acute and chronic sinusitis, inflammation of the middle ear (otitis media).

Contraindications:

- hypersensitivity to acetylcysteine or other components of the drug;

- peptic ulcer of the stomach and duodenum in the stage of exacerbation;

- pregnancy;

- lactation period;

- hemoptysis, pulmonary hemorrhage;

- children under 2 years.

Carefully:

Stomach ulcer and duodenal ulcer in history, bronchial asthma, hepatic and / or renal

insufficiency, histamine intolerance (avoid prolonged use of the drug; acetylcysteine affects the metabolism of histamine and can lead to signs of intolerance such as headache, vasomotor rhinitis, pruritus), varicose veins of the esophagus, adrenal gland diseases, hypertension.

Pregnancy and lactation:Data on the use of acetylcysteine during pregnancy and breastfeeding are limited. The use of the drug during pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus. If it is necessary to use the drug during lactation, the question of stopping breastfeeding should be resolved.

Dosing and Administration:

Inside, after eating.

Syrup ATSTS® is taken with a measuring syringe or a measuring cup in the package. 10 ml syrup ACC® corresponds to 1/2 cup or 2 filled syringes.

Additional fluid intake enhances the mucolytic effect of the drug.

In the absence of other prescriptions, the following dosages should be adhered to:

adults and children over 14 years of age: 10 ml of syrup 2-3 times a day (400 - 600 mg of acetylcysteine);

children from 6 to 14 years old: 5 ml of syrup 3 times a day or 10 ml of syrup 2 times a day (300-400 mg of acetylcysteine);

children from 2 to 5 years: 5 ml of syrup 2-3 times a day (200-300 mg of acetylcysteine).

In cystic fibrosis:

children over 6years old: 10 ml of syrup 3 times a day (600 mg of acetylcysteine);

children from 2 to 6 years old: 5 ml of syrup 4 times a day (400 mg of acetylcysteine). With short-term catarrhal diseases, the course duration is 4-5 days.

For long-term illnesses, the course of therapy is determined by the attending physician. In chronic bronchitis and cystic fibrosis, the drug should be taken for a longer time to achieve a preventive effect in infections.

Using a measuring syringe:

- open the lid of the vial by pressing it and turning it counterclockwise;

- remove the syringe from the syringe with the hole, insert it into the neck of the vial and press it all the way in. The stopper is designed to connect the syringe to the vial and remains in the neck of the vial;

- firmly insert the syringe into the cork. Carefully turn the bottle upside down, pull the syringe plunger down and dial the required number of milliliters (ml) of syrup. If air bubbles are visible in the syrup, press the plunger all the way, then refill the syringe. Return the vial to its original position and remove the syringe;

- syrup from a syringe should be poured on a spoon or directly into the baby's mouth (in the cheek area, slowly, so that the child can swallow the syrup properly), while the syrup is being taken, the child should be in an upright position;

- after use, flush the syringe with clean water.

Side effects:

According to the World Health Organization (WHO), adverse reactions are classified according to their frequency of development as follows: very frequent (> 1/10), frequent (> 1/100, <1/10), not frequent (> 1/1000, <1/100), rare (> 1/10000, <1/1000) and very rare (<1/10000); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

Allergic reactions: infrequently: pruritus, rash, exanthema, urticaria, angioedema, lowering of arterial pressure, tachycardia; rarely: anaphylactic reactions up to shock, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).

From the respiratory system: rarely: shortness of breath, bronchospasm (mainly in patients with hyperreactivity of the bronchi in bronchial asthma).

From the gastrointestinal tract: infrequently: stomatitis, abdominal pain, nausea, vomiting, diarrhea.

From the sense organs infrequently: noise in ears.

Other: rarely: headache, fever, isolated reports of the development of bleeding due to the presence of a hypersensitivity reaction, a decrease in platelet aggregation.

Overdose:

In case of erroneous or deliberate overdose, such phenomena as diarrhea, vomiting, pain in the stomach, heartburn and nausea are observed. To date, no serious and life-threatening side effects have been observed. Treatment: symptomatic.

Interaction:

With the simultaneous use of acetylcysteine and antitussives Because of the suppression of the cough reflex, sputum stasis may occur.

When used simultaneously with antibiotics for oral administration (penicillins, tetracyclines, cephalosporins, etc.), they may interact with the thiol group of acetylcysteine, which may lead to a decrease in their antibacterial activity. Therefore, the interval between taking antibiotics and acetylcysteine should be at least 2 hours (except cefixime and loracarbef).

Simultaneous application with vasodilating agents and nitroglycerin may lead to an increase in vasodilator action.

Special instructions:

When working with the drug should use glassware, avoid contact with metals, rubber, oxygen, easily oxidizable substances.

With the use of acetylcysteine, very rarely reported cases of severe allergic reactions, such as Stevens-Johnson syndrome and Lyell's syndrome. If skin and mucous membrane changes occur, the doctor should be consulted immediately, and the drug should be discontinued.

Use of the drug in patients with renal and / or liver failure should be avoided to avoid additional formation of nitrogenous compounds.

1 ml of syrup contains 41.02 mg of sodium. This should be taken into account when applying the drug to patients who follow a diet aimed at limiting sodium intake (with a reduced sodium / salt content).

Effect on the ability to drive transp. cf. and fur:

Information on the effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions are absent.

Form release / dosage:Syrup 20 mg / ml.

Packaging:

To 100 ml of syrup in bottles of dark glass, sealed with white caps with sealing membrane, with the function of protection from opening by children, with a protective ring.

Dosing devices:

- transparent measuring cup (cap), graduated to 2.5, 5 and 10 ml;

- a transparent syringe for dosing, graduated 2.5 and 5 ml with a white piston and with an adapter ring for fixing on the vial.

1 bottle together with dosing devices and together with instructions for use in cardboard pack.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years. Do not use after the expiration date indicated.

After opening, the vial should not be stored for more than 18 days at a temperature not exceeding 25 ° C.

There is no need for special precautions when destroying an unused preparation.

Terms of leave from pharmacies:Without recipe

Registration number:LP-002668

Date of registration:21.10.2014

The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia

Manufacturer: & nbsp

SALUTAS PHARMA, GmbH Germany

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp21.05.2015

Illustrated instructions

Instructions

ACTS® (ACC®)