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

Excipients: citric acid anhydrous - 625.00 mg; sodium hydrogen carbonate - 327.00 mg; sodium carbonate - 104.00 mg; Mannitol - 72.80 mg; lactose 70.00 mg; ascorbic acid - 75,00 mg; sodium cyclamate - 30.75 mg; sodium saccharinate dihydrate - 5.00 mg; sodium citrate dihydrate 0.45 mg; flavored blackberry "B" - 40,00 mg.

Description:

Round flat cylindrical tablets of white color, with a facet and a risk on one side, with the smell of blackberry. A slight sulfuric odor is possible.

Reconstituted solution: colorless transparent solution with a smell of blackberry, maybe the presence of a weak.

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 action is due to the ability to rupture the disulfide bonds of mucopolysaccharide chains and cause the depolymerization of sputum muco-proteins, which leads to a decrease in the viscosity of 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 for oral administration is 10% (because of the pronounced effect of "first passage" through the liver). The time to reach the maximum concentration in blood plasma is 1-3 hours. The connection with blood plasma proteins is 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 T_1/2 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;

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;

pregnancy;

lactation period;

children under 14 years of age (for this dosage form);

deficiency of lactase, lactose intolerance, glucose-galactose malabsorption.

Carefully:Stomach ulcer and duodenal ulcer in history, bronchial asthma, obstructive bronchitis, hepatic and / or renal insufficiency, intolerance to histamine. 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, so the use of the drug in pregnancy is contraindicated.

If it is necessary to use the drug during lactation, the question of stopping breastfeeding 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. In chronic bronchitis and cystic fibrosis, the drug should be taken for a longer time to achieve a preventive effect.

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 once 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: pruritus, rash, exanthema, urticaria; angioedema, decreased blood 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 sense organs

infrequently: noise in ears.

From the gastrointestinal tract

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

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:

Symptoms: in case of erroneous or intentional 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.), 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:

Guideline for patients with diabetes mellitus:

1 effervescent tablet corresponds to 0.001 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® Long.

Close the tube tightly after taking the tablet!

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

Data on the adverse effects of the drug ACTS® Long at the recommended doses on the ability to drive vehicles, no mechanisms.

Form release / dosage:The effervescent tablets are 600 mg.

Packaging:

Primary packaging

For 6, 10 or 20 tablets of effervescent in a tube of polypropylene.

Secondary packaging

For 1 tube in a cardboard pack together with instructions for use.

Storage conditions:

In dry, the dark place at a temperature of no higher than 30 ° C. Keep out of the reach of children.

Shelf life:

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

Terms of leave from pharmacies:Without recipe

Registration number:P N008857

Date of registration:31.08.2010

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

Manufacturer: & nbsp

SALUTAS PHARMA, GmbH Germany

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp11.032015

Illustrated instructions

Instructions

ACTS® Long (ACC® long)