ATSTS 200 - instructions for use, dose, side effects, contraindications

auxiliary matter: anhydrous citric acid - 558.50 mg; sodium hydrogen carbonate - 200.00 mg; sodium carbonate anhydrous - 100.00 mg; mannitol - 60.00 mg; lactose anhydrous - 70.00 mg; ascorbic acid 25.00 mg; sodium saccharinate - 6.00 mg; sodium citrate - 0.50 mg; flavoring blackberry "B" - 20,00 mg.

Description:Round flat-bottomed white tablets with a risk on one side, with a smell of blackberries. A slight sulfuric odor is possible. The reconstituted solution: colorless transparent solution with a smell of blackberry. A slight sulfuric odor is possible.

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).

The 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:

1 hypersensitivity to acetylcysteine or other components of the drug;

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

3 pregnancy;

4 the period of breastfeeding;

5 hemoptysis, pulmonary hemorrhage;

6 deficiency of lactase, lactose intolerance, glucose-galactose malabsorption;

7 Children under 2 years of age (for this dosage form).

Carefully:Stomach ulcer and duodenal ulcer in history, bronchial asthma, obstructive bronchitis,hepatic and / or renal insufficiency, intolerance to histamine (avoid prolonged use of the drug, t. 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, hypertension.

Pregnancy and lactation:Data on the use of acetylcysteine during pregnancy and breastfeeding are limited, so the use of the drug in 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 effervescent tablets should be dissolved in a single glass of water. Tablets should be taken immediately after dissolution, in exceptional cases, you can leave ready-to-use solution for 2 hours. Additional fluid intake enhances the mucolytic effect of the drug. With short-term catarrhal diseases, the duration of admission is 5-7 days. For chronic bronchitis and cystic fibrosis, the drug should be taken for a longer time to achieve a preventiveeffect of infections. In the absence of other prescriptions, the following dosages should be adhered to:

Mucolytic therapy:

adults and children over 14 years of age: 1 tablet of effervescent 2-3 times a day (400 - 600 mg);
children from 6 to 14 years: 1 tablet of effervescent 2 times a day (400 mg);
children from 2 to 6 years: 1/2 tablet effervescent 2-3 times a day (200 - 300 mg).

Cystic Fibrosis:

children from 2 to 6 years: 1/2 tablet effervescent 4 times a day (400 mg); children over 6 years of age: 1 tablet of effervescent 3 times a day (600 mg).

Side effects:

According to the World Health Organization (WHO), unwanted 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: skin itching, 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 hyperreactivity of the bronchi in bronchial asthma).

From the gastrointestinal tract

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

Impaired sensory organs

infrequently: noise in ears.

Other

infrequently: headache, fever, individual reports of development bleeding due to the presence of a hypersensitivity reaction, reduced platelet aggregation.

Overdose:

Symptoms: with an erroneous or deliberate overdose, there are such phenomena as diarrhea, vomiting, stomach pain, heartburn and nausea.

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.), it is possible interaction with the thiol group of acetylcysteine, which can lead to a decrease in their antibacterial activity. Therefore, the interval between taking antibiotics and acetylcysteine should be at least 2 hours (except for cefix and loracarbene).

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

Special instructions:

Indication for patients with diabetes mellitus

1 effervescent tablet corresponds to 0.006 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 Lyell's syndrome. If skin and mucous membrane changes occur, the doctor should be consulted immediately, and the drug should be discontinued.

Patients with bronchial asthma and obstructive bronchitis acetylcysteine should be administered with caution under the systemic control of bronchial patency.

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

Special precautions for the destruction of unused medicinal product

There is no need for special precautions for the destruction of the unused drug ACTS®200.

Close the tube tightly after taking the tablet!

Effect on the ability to drive transp. cf. and fur:Data on the negative effect of the drug ATTT® 200 in the recommended doses on the ability to drive vehicles, mechanisms there.

Form release / dosage:Tablets effervescent 200 mg.

Packaging:

When packing Hermes Pharma Gesmb.H., Austria:

Primary packaging

For 20 or 25 tablets in the plastic tuba effervescent.

Secondary packaging

1 tube for 20 tablets of effervescent or 2 or 4 tubes for 25 tablets of effervescent together with instructions for use in a cardboard pack.

When packing Hermes Artsnimittel GmbH, Germany

Primary packaging

4 tablets are effervescent in strips of three-layer material: paper / polyethylene / aluminum.

Secondary packaging

15 strips together with instructions for use in cardboard pack.

Storage conditions:

In a dry place 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 015473/01

Date of registration:11.01.2009

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

Manufacturer: & nbsp

SALUTAS PHARMA, GmbH Germany

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp18.09.2014

Illustrated instructions

Instructions

ATSTS® 200 (ACC® 200)