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

Description:Homogeneous granules of white color without agglomerates and mechanical impurities with the smell of lemon and honey. When sifting through a 1.5 mm sieve, no particles should remain on the screen.

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 in the oral route of administration 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 T_1/2up 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;

- abscess of the lung;

- 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;

- hemoptysis, pulmonary hemorrhage;

- sugarase / isomaltase deficiency, fructose intolerance, glucose-galactose insufficiency;

- pregnancy;

- the period of breastfeeding;

- children under 14 years (for this dosage form).

Carefully:Stomach ulcer and duodenal ulcer in history, arterial hypertension, bronchial asthma, obstructive bronchitis, hepatic and / or renal failure,intolerance to histamine (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 diseases.

Pregnancy and lactation:

Data on the use of acetylcysteine during pregnancy and breastfeeding are limited, so the use of the drug when pregnancy is contraindicated.

If it is necessary to use the drug in the period of breastfeeding, the question of its cessation should be resolved.

Dosing and Administration:

Inside, after eating.

The granules are dissolved, stirring, in 1 glass of hot water. The resulting solution is drunk hot. If necessary, the prepared solution can be left for 3 hours. Additional fluid intake enhances the mucolytic effect of the drug.

With short-term catarrhal diseases, the course duration is 5-7 days. For long-term illnesses, the course of therapy is determined by the attending physician. For chronic bronchitis and cystic fibrosis, the drug should be taken for a longer time to achieve a preventive effectwith infections.

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

Mucolytic therapy: adults and adolescents over 14 years of age: 1 sachet (600 mg) once a day.

Side effects:

According to the World Health Organization (WHO), undesirable effects are classified according to their frequency of development as follows: very often (≥1/10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100), rarely (≥1 / 10000, <1/1000) and very rarely (<1/10000); frequency is unknown (the frequency of occurrence of phenomena can not be determined on the basis of available data).

Allergic reactions:

infrequently: pruritus, rash, exanthema, urticaria, angioedema, lowering of arterial pressure, tachycardia;

rarely: anaphylactic reactions up to anaphylactic shock, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).

From the respiratory system:

rarely: shortness of breath, bronchospasm (mainly in patients with bronchial hyperreactivity in bronchial asthma).

From the gastrointestinal tract:

infrequently: stomatitis, abdominal pain, nausea, vomiting, diarrhea, heartburn, indigestion.

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:

Acetylcysteine at a dose of 500 mg / kg / day does not cause signs and symptoms of an overdose.

In case of erroneous or deliberate overdose, such phenomena as diarrhea, vomiting, stomach pain, heartburn and nausea are 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 reception with vasodilating agents and nitroglycerin may lead to an increase in vasodilator action.

Special instructions:

When treating patients with diabetes it is necessary to take into account that the preparation contains sucrose.

Indication for patients with diabetes mellitus: 1 sachet ATSTS® 600 mg corresponds to 0.17 XE.

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 toxic epidermal necrolysis (Lyell's syndrome). If skin and mucous membrane changes occur, the doctor should be consulted immediately, and the drug should be discontinued.

Do not take the drug immediately before bedtime (it is recommended to take the drug before 6pm).

There is no need for special precautions for the destruction of the unused drug ACTS®.

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

Data on the adverse effects of ATSTS® in recommended doses on the ability to drive vehicles and perform other activities that require concentration of attention and speed of psychomotor reactions are not.

Form release / dosage:Granules for solution for oral administration 100, 200, 600 mg.

Packaging:

3 grams of granules in a bag of three-layer material (aluminum foil / paper / polyethylene). For 6, 10 or 20 bags in a cardboard box together with instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:P N 015474/01

Date of registration:16.11.2009 / 30.05.2017

Expiration Date:Unlimited

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

Manufacturer: & nbsp

SALUTAS PHARMA, GmbH Germany

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp22.09.2017

Illustrated instructions

Instructions

ACTS® (ACC®)