ACC effervescent tablets: instructions for use for cough. Acetylcysteine-teva tablets effervescent merkle What reviews does the drug receive

J15 Bacterial pneumonia, not elsewhere classified J20 Acute bronchitis J32 Chronic sinusitis J37 Chronic laryngitis and laryngotracheitis J42 Chronic bronchitis, unspecified J45 Asthma J47 Bronchiectasia

Pharmacological group

Mucolytic drug

pharmachologic effect

Mucolytic agent, is a derivative of the amino acid cysteine. It has a mucolytic effect, increases the volume of sputum, facilitates its discharge due to a direct effect on the rheological properties of sputum. The action of acetylcysteine ​​is associated with the ability of its sulfhydryl groups to break intra- and intermolecular disulfide bonds of sputum acid mucopolysaccharides, which leads to depolarization of mucoproteins and a decrease in sputum viscosity. Remains active in the presence of purulent sputum.

Increases the secretion of less viscous sialomucins by goblet cells, reduces the adhesion of bacteria to the epithelial cells of the bronchial mucosa. Stimulates the mucous cells of the bronchi, the secret of which lyses fibrin. It has a similar effect on the secret formed in inflammatory diseases of the upper respiratory tract.

It has an antioxidant effect due to the ability of its reactive sulfhydryl groups (SH-groups) to bind to oxidizing radicals and thus neutralize them.

Acetylcysteine ​​easily penetrates into the cell, deacetylated to L-cysteine, from which intracellular glutathione is synthesized. Glutathione is a highly reactive tripeptide, a powerful antioxidant and cytoprotector that neutralizes endogenous and exogenous free radicals and toxins. Acetylcysteine ​​prevents depletion and promotes an increase in the synthesis of intracellular glutathione, which is involved in the redox processes of cells, contributing to the detoxification of harmful substances. This explains the action of acetylcysteine ​​as an antidote for paracetamol poisoning.

Protects alpha1-antitrypsin (an elastase inhibitor) from the inactivating effect of HOCl, an oxidizing agent produced by myeloperoxidase of active phagocytes. It also has an anti-inflammatory effect (due to the suppression of the formation of free radicals and active oxygen-containing substances responsible for the development of inflammation in the lung tissue).

Pharmacokinetics

When taken orally, it is well absorbed from the gastrointestinal tract. Significantly undergoes the effect of "first pass" through the liver, which leads to a decrease in bioavailability. Binding to plasma proteins up to 50% (4 hours after ingestion). Metabolized in the liver and possibly in the intestinal wall. In plasma, it is determined unchanged, as well as in the form of metabolites - N-acetylcysteine, N,N-diacetylcysteine ​​and cysteine ​​ester.

Renal clearance is 30% of the total clearance.

Respiratory diseases and conditions accompanied by the formation of viscous and mucopurulent sputum: acute and chronic bronchitis, tracheitis due to bacterial and / or viral infection, pneumonia, bronchiectasis, bronchial asthma, atelectasis due to blockage of the bronchi by a mucous plug, sinusitis (to facilitate the discharge of secretions ), cystic fibrosis (as part of combination therapy).

Preparation for bronchoscopy, bronchography, aspiration drainage.

Removal of viscous secret from the respiratory tract in post-traumatic and postoperative conditions.

For washing abscesses, nasal passages, maxillary sinuses, middle ear, treatment of fistulas, surgical field during operations on the nasal cavity and mastoid process.

Paracetamol overdose.

Peptic ulcer of the stomach and duodenum in the acute phase, hemoptysis, pulmonary bleeding, pregnancy, lactation (breastfeeding), hypersensitivity to acetylcysteine.

Contraindications for use in children under 14 years of age depend on the dosage form and are indicated in the instructions for use of the medicinal product used.

From the digestive system: rarely - heartburn, nausea, vomiting, diarrhea, a feeling of fullness in the stomach.

Allergic reactions: rarely - skin rash, itching, urticaria, bronchospasm.

With a shallow intramuscular injection and in the presence of hypersensitivity, a slight and quickly passing burning sensation may appear, and therefore it is recommended to inject the drug deep into the muscle.

For inhalation use: possible reflex cough, local irritation of the respiratory tract; rarely - stomatitis, rhinitis.

Others: rarely - nosebleeds, tinnitus.

From the side of laboratory indicators: it is possible to reduce the prothrombin time against the background of the appointment of large doses of acetylcysteine ​​(it is necessary to monitor the state of the blood coagulation system), change the results of the test for the quantitative determination of salicylates (colorimetric test) and the test for the quantitative determination of ketones (test with sodium nitroprusside).

special instructions

Use with caution in the following diseases and conditions: peptic ulcer of the stomach and duodenum in history; bronchial asthma, obstructive bronchitis; hepatic and / or renal failure; histamine intolerance (long-term use should be avoided, as acetylcysteine ​​affects histamine metabolism and may lead to signs of intolerance such as headache, vasomotor rhinitis, itching); varicose veins of the esophagus; diseases of the adrenal glands; arterial hypertension.

When using acetylcysteine ​​in patients with bronchial asthma, it is necessary to ensure sputum drainage. In newborns, it is used only for health reasons at a dose of 10 mg / kg under the strict supervision of a physician.

Between taking acetylcysteine ​​and antibiotics, a 1-2 hour interval should be observed.

Acetylcysteine ​​reacts with some materials such as iron, copper and rubber used in the nebulizer. In places of possible contact with an acetylcysteine ​​solution, parts made of the following materials should be used: glass, plastic, aluminum, chrome-plated metal, tantalum, silver of an established standard or stainless steel. After contact, silver may tarnish, but this does not affect the effectiveness of acetylcysteine ​​and does not harm the patient.

Compliance with the route of administration and the dosage form used should be strictly observed.

With kidney failure

Use acetylcysteine ​​with caution in patients with kidney disease.

In violation of the functions of the liver

Use acetylcysteine ​​with caution in patients with liver disease.

Use during pregnancy and lactation

Use during pregnancy and lactation (breastfeeding) is contraindicated.

drug interaction

Simultaneous use of acetylcysteine ​​with antitussives may increase sputum stagnation due to suppression of the cough reflex.

With simultaneous use with antibiotics (including tetracycline, ampicillin, amphotericin B), their interaction with the thiol group of acetylcysteine ​​is possible.

Acetylcysteine ​​reduces the hepatotoxic effect of paracetamol.

Inside adults and children over 6 years old - 200 mg 2-3 times / day; children aged 2 to 6 years - 200 mg 2 times / day or 100 mg 3 times / day, up to 2 years - 100 mg 2 times / day.

Parenterally: In / m adults - 300 mg 1 time / day, children - 150 mg 1 time / day.

Enter in / in (preferably drip or slow jet over 5 minutes) or / m. Adults - 300 mg 1-2 times / day; children from 6 to 14 years old - 150 mg 1-2 times / day. The daily dose for children under 6 years of age is 10 mg / kg of body weight; in children under 1 year of age, intravenous administration of acetylcysteine ​​is possible only for health reasons in a hospital setting. The duration of treatment should be determined by the results of changes in the patient's condition.

For inhalation and intratracheal use, the dose, frequency of use and duration of the course are set individually.

Active substance

Acetylcysteine

Dosage form

soluble tablets

Manufacturer

Merkle GmbH, Germany

Compound

1 tablet contains:

active substance: acetylcysteine ​​200.00 mg / 600.00 mg;

excipients: anhydrous citric acid 843.03 mg / 648.99 mg, sodium bicarbonate 695.64 mg / 548.72 mg, lemon flavor 100.00 mg / 100.00 mg, adipic acid 100.00 mg / 12.83 mg, finely dispersed adipic acid 20.00 mg / 48.99 mg, povidone 21.33 mg / 20.47 mg, aspartame 20.00 mg / 20.00 mg.

pharmachologic effect

Pharmacotherapeutic group:

Expectorant mucolytic agent

S.01.X.A.08 Acetylcysteine

R.05.C.B.01 Acetylcysteine

Pharmacodynamics:

Acetylcysteine ​​has a mucolytic effect on sputum (mucus) in the lumen of the bronchial tract, which is determined by its secretolytic and secretomotor properties. The drug dilutes sputum, increasing its volume, facilitates its separation. Its action persists even in the presence of purulent sputum.

The mechanism of action of acetylcytein is based on the ability of the sulfhydryl groups of the drug to break the disulfide bonds of sputum acid mucopolysaccharides, which leads to depolarization of mucoproteins and a decrease in mucus viscosity.

It helps to increase the synthesis of glutathione, which is an antioxidant factor of intracellular protection and ensures the maintenance of the functional activity and morphological integrity of the cells of the mucous membrane of the respiratory tract, which, in particular, explains its effectiveness as an antidote for paracetamol poisoning.

Due to the ability of sulfhydryl groups to neutralize electrophilic oxidative toxins, acetylcysteine ​​has an antioxidant effect.

It also has moderate anti-inflammatory properties (by suppressing the formation of free radicals and reactive oxygen species responsible for the development of inflammation in the lung tissue).

Pharmacokinetics:

When taken orally, acetylcysteine ​​is well absorbed from the gastrointestinal tract. Exposed to the effect of "first pass" through the liver, metabolized to form cysteine, diacetylcysteine, cystine and disulfides, which reduces the bioavailability of the drug to 10%. The maximum concentration of acetylcysteine ​​in plasma is reached after 1-3 hours, and in patients with impaired liver function - after 8 hours.

The therapeutic effect is observed after 30-90 minutes and lasts for 2-4 hours.

It is excreted mainly by the kidneys in the form of inactive metabolites, a small part is excreted unchanged through the intestines.

Penetrates through the placental barrier, accumulates in the amniotic fluid.

Indications

Respiratory diseases and conditions accompanied by the formation of viscous, difficult to separate mucopurulent sputum:

Acute and chronic bronchitis;

Chronic obstructive pulmonary disease (COPD);

Tracheitis due to bacterial and / or viral infection;

bronchiolitis;

Pneumonia;

Bronchial asthma;

bronchiectasis;

Atelectasis due to blockage of the bronchi by a mucous plug;

Cystic fibrosis (as part of combination therapy);

Removal of a viscous secret from the respiratory tract in post-traumatic and postoperative conditions;

Catarrhal and purulent otitis, sinusitis, including sinusitis (facilitation of discharge of the secret).

The drug is used in the treatment of an overdose of paracetamol.

Contraindications

Known hypersensitivity to acetylcysteine ​​or other ingredients of the finished dosage form;

Pregnancy, breastfeeding period;

Peptic ulcer of the stomach and duodenum in the acute phase;

Phenylketonuria;

Children under 14 years of age (for 600 mg tablets): children under 2 years of age (for 200 mg tablets).

Carefully:

Acetylcysteine ​​is used with extreme caution in patients with bronchial asthma, diseases of the liver, kidneys, adrenal dysfunction, esophageal varicose veins, in persons prone to pulmonary bleeding, hemoptysis, arterial hypotension, histamine intolerance (long-term use of the drug should be avoided, because acetylcysteine affects histamine metabolism and may lead to signs of intolerance such as: headache, vasomotor rhinitis, pruritus).

Side effects

Undesirable effects are classified according to their frequency of development as follows: very often (≥ 1/10), often (≥1/100,

From the side of the central nervous system: rarely - headache, drowsiness.

From the gastrointestinal tract: rarely - heartburn, nausea, vomiting, diarrhea, stomatitis, a feeling of fullness in the stomach.

Allergic reactions: infrequently - skin rash, itching, urticaria, tachycardia, lowering blood pressure, angioedema; rarely - bleeding, partially associated with a hypersensitivity reaction; very 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 senses: infrequently - tinnitus.

Other: rarely - nosebleeds, rhinorrhea, fever, decreased platelet aggregation.

If you experience unwanted side effects, you should consult a doctor.

Interaction

With the simultaneous use of acetylcysteine ​​and antitussives, sputum stagnation may increase due to the suppression of the cough reflex, so such combined treatment should only be carried out under direct medical supervision.

There is evidence that the thiol group of acetylcysteine ​​can neutralize the activity of some antibiotics (amphotericin B, ampicillin, tetracyclines, excluding doxycycline, semi-synthetic penicillins, cephalosporins, aminoglycosides). Therefore, it is advisable to take these antibiotics orally 2 hours after taking acetylcysteine.

It has also been established that such antibiotics as amoxicillin, doxycycline, erythromycin, thiamphenicol, cefuroxime do not interact with acetylcysteine.

There are reports that the simultaneous administration of acetylcysteine ​​and nitroglycerin can lead to an increase in the vasodilating effect of the latter and a decrease in platelet aggregation.

Acetylcysteine ​​reduces the hepatotoxic effect of paracetamol.

How to take, course of administration and dosage

Inside, after eating, after dissolving the effervescent tablets in a glass of water. Effervescent tablets should be taken immediately after dissolution.

Adults and adolescents over 14 years of age: 1 effervescent tablet 2-3 times a day (400-600 mg of acetylcysteine ​​per day);

Children aged 6 to 14 years: 1 effervescent tablet 2 times a day (400 mg of acetylcysteine ​​per day);

Children aged 2 to 6 years: 1/2 effervescent tablet 2-3 times a day (200-300 mg of acetylcysteine ​​per day).

Cystic fibrosis treatment:

Children over 6 years: 1 effervescent tablet 3 times a day (600 mg of acetylcysteine ​​per day):

Children aged 2 to 6 years: 1/2 effervescent tablet 4 times a day (400 mg of acetylcysteine ​​per day).

Duration (continuity) of application depends on the characteristics of the disease. In the treatment of chronic bronchitis and cystic fibrosis, treatment can be long (up to several months).

Overdose

To date, cases of overdose with oral acetylcysteine ​​preparations have not been described. At a dose of 500 mg/kg, acetylcysteine ​​did not cause symptoms of poisoning. Theoretically possible diarrhea, heartburn, nausea, vomiting, stomach pain.

Treatment: symptomatic.

Special Instructions

When using the drug in patients with bronchial asthma, it is necessary to ensure sputum drainage, combined with taking bronchodilators.

When using the drug, it is necessary to use glassware, avoid contact of the drug with metal, rubber, oxygen, easily oxidizing substances.

When using acetylcysteine, cases of severe allergic reactions such as Stevens-Johnson syndrome and Lyell's syndrome have been reported very rarely. If there are changes in the skin and mucous membranes, you should immediately consult a doctor, the drug should be stopped.

Each effervescent tablet contains 20 mg of aspartame (equivalent to 11.2 mg of phenylalanine), as a result of which the drug should not be used in patients with phenylketonuria.

Influence on the ability to drive transport. cf. and fur.:

There are no data on the negative effects of acetylcysteine ​​in recommended doses on the ability to drive vehicles and mechanisms.

? Constant use Acetylcysteine ​​effervescent tablets 200 mg, 20 pcs.. Storage conditions Acetylcysteine ​​effervescent tablets 200 mg, 20 pcs.. Acetylcysteine ​​effervescent tablets 200 mg, 20 pcs. buy on site. Take with you Acetylcysteine ​​effervescent tablets 200 mg, 20 pcs.. Best of Acetylcysteine ​​effervescent tablets 200 mg, 20 pcs.. Choice Acetylcysteine ​​effervescent tablets 200 mg, 20 pcs..

acetylcysteine, drug, through, rarely, acetylcysteine, sputum, day, can, application, acetylcysteine, tablets, action, tablet, syndrome, necessary, admission, side, intake, acid, pathways, aged, after, illness, follows, substance, accept, shelf life, conditions, neutralize, storage, paracetamol, effervescent, also, contraindications, cystic fibrosis

P N015473/01

Trade name of the drug:

ACC® 200

International non-proprietary name:

acetylcysteine (acetylcysteine)

Chemical name ACC® 200 :

N-acetyl L-cysteine

Dosage form ACC® 200:

effervescent tablets

Composition of ACC® 200

1 effervescent tablet contains:

active substance: acetylcysteine ​​- 200.0 mg;

Excipients: citric acid anhydride - 558.5 mg; sodium hydrogen carbonate - 300.0 mg; mannitol - 60.0 mg; ascorbic acid - 25.0 mg; lactose anhydride - 70.0 mg; sodium citrate - 0.5 mg; saccharin - 6.0 mg; blackberry flavor "B" - 20.0 mg.

ACC® 200 Description:

white, round, flat tablets with a blackberry odor.

Pharmacotherapeutic group:

mucolytic agent.

ATX code:

R05CB01

Pharmacological properties

Pharmacodynamics

The presence of sulfhydryl groups in the structure of acetylcysteine ​​contributes to the breaking of disulfide bonds of sputum acid mucopolysaccharides, which leads to a decrease in the viscosity of mucus. It has a mucolytic effect, facilitates sputum discharge due to a direct effect on the rheological properties of sputum. The drug remains active in the presence of purulent sputum.

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

ACC® 200 Indications for use:

Respiratory diseases accompanied by the formation of viscous sputum difficult to separate: acute and chronic bronchitis, obstructive bronchitis, pneumonia, bronchiectasis, bronchial asthma, 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 acute stage, hemoptysis, pulmonary hemorrhage, pregnancy, breastfeeding.

Carefully

varicose veins of the esophagus, bronchial asthma, diseases of the adrenal glands, liver and / or kidney failure.

Acetylcysteine ​​should be used with caution in patients prone to pulmonary bleeding, hemoptysis.

Pregnancy and lactation period:

As a safety precaution, due to insufficient data, prescribing the drug during pregnancy and lactation is possible only if the intended benefit to the mother outweighs the potential risk to the fetus or infant.

ACC® 200 dosage:

Adults and adolescents over the age of 14:

2-3 times a day, 1 effervescent tablet (400-600 mg of acetylcysteine ​​per day).

Children aged 6 to 14:3 times a day for 1/2 effervescent tablet, or 2 times a day for 1 effervescent tablet (300 - 400 mg of acetylcysteine).

Children aged 2 to 5 years:2-3 times a day, 1/2 effervescent tablet (200-300 mg of acetylcysteine).

Cystic fibrosis:

For patients with cystic fibrosis and weighing more than 30 kg, if necessary, it is possible to increase the dose to 800 mg of acetylcysteine ​​per day.

Children aged 2 to 6 years - 1/2 effervescent tablet (400 mg of acetylcysteine ​​per day) 4 times a day.

Effervescent tablets should be dissolved in half a glass of water and taken after meals. Tablets should be taken immediately after dissolution, in exceptional cases, you can leave the solution ready for use for 2 hours.

Additional fluid intake enhances the mucolytic effect of the drug.

With short-term colds, 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 against infections.

Note for diabetic patients:

1 effervescent tablet corresponds to 0.006 bread. units

Side effects:

In rare cases, headaches, inflammation of the oral mucosa (stomatitis) and tinnitus are observed. Extremely rare - diarrhea, vomiting, heartburn and nausea, a drop in blood pressure,increased heart rate (tachycardia). In isolated cases, allergic reactions are observed, such as bronchospasm (mainly in patients with bronchial hyperreactivity), skin rash, itching and urticaria. In addition, there are isolated reports of the development of bleeding due to the presence of hypersensitivity reactions. With the development of side effects, you should stop taking the drug and consult a doctor. Overdose:

With an erroneous or deliberate overdose, such phenomena as diarrhea, vomiting, stomach pain, heartburn and nausea are observed. So far, no severe and life-threatening side effects have been observed.

Interaction with other means:

With the simultaneous use of acetylcysteine ​​​​andantitussivesdue to the suppression of the cough reflex, mucus stagnation may occur. Therefore, such combinations should be chosen with caution.

Concomitant use of acetylcysteine ​​andnitroglycerinmay lead to an increase in the vasodilating effect of the latter.

Pharmaceutically incompatible with antibiotics (penicillins, cephalosporins, erythromycin, tetracycline and amphotericin B) and proteolytic enzymes.

Upon contact with metals, rubber, sulfides are formed with a characteristic odor.

Reduces the absorption of penicillins, cephalosporins, tetracyclines (they should be taken no earlier than 2 hours after ingestion of acetylcysteine).

Special instructions:

Patients with bronchial asthma and obstructive bronchitis should be prescribed acetylcysteine ​​with caution under the systematic control of bronchial patency.

When treating patients with diabetes, it must be taken into account that the tablets contain sucrose: 1 effervescent tablet corresponds to 0.006 bread. units

When working with the drug, it is necessary to use glassware, avoid contact with metals, rubber, oxygen, easily oxidized substances.

Influence on the ability to drive vehicles and perform other activities that require concentration and speed of psychomotor reactions

There are no data on the negative effect of the drug ACC® 200 at recommended doses on the ability to drive vehicles and perform other activities that require concentration of attention and speed of psychomotor reactions.

АЦЦ® 200 release form:

20 or 25 tablets in an aluminum or plastic tube.

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

4 tablets in strips of 3-layer material: paper / polyethylene / aluminum.

15 strips with instructions for use in a cardboard box.

Storage conditions:

In a dry place, out of reach of children, at a temperature not exceeding 25 °C.

Close the tube tightly after taking the pill!

Shelf life of the medicinal product:

3 years.

Do not use after the stated expiration date.

Vacation from pharmacies:

Over the counter.

Manufacturer

Sandoz d.d., Verovshkova 57, 1000 Ljubljana, Slovenia.

Manufactured by Salutas Pharma GmbH, Germany.

Send consumer claims to ZAO Sandoz:

ACC 200 (acetylcysteine) is an expectorant drug from the multinational pharmaceutical company Sandoz. Its active ingredient, acetylcysteine, is one of the most well-studied and effective mucolytics (drugs that thin mucus and make it easier to clear from the lungs). One of the advantages of acetylcysteine ​​over other mucolytic agents is the presence of antioxidant activity in this substance. It is the closest relative of glutathione, one of the key components of antioxidant defense, which has a protective effect on the respiratory tract and inactivates aggressive free radicals. The antitoxic potential of the drug should also be noted. Pathogenic bacteria tend to produce toxins that disrupt tissue pH and promote inflammation. The release of toxins entails oxidative stress, as a result of which the concentration of sulfhydryl groups in cells decreases. Acetylcysteine ​​provides its thiol groups, thereby protecting tissues from oxidative damage and neutralizing toxins. In this regard, acetylcysteine ​​is rightfully considered one of the most versatile detoxification agents. Moreover: it is often used as an antidote for poisoning with various pharmacological substances and poisons. Acetylcysteine ​​also prevents pathogenic bacteria from settling on the mucous membrane of the respiratory tract.

ACC 200 is well absorbed in the gastrointestinal tract. Rapidly undergoes metabolic transformations in the liver. Metabolites of the drug are pharmacologically active. The peak concentration of the active component in the blood plasma is observed 1-3 hours after oral administration. The half-life is about 1 hour. ACC 200 is indicated for diseases of the respiratory tract, accompanied by the production of a thick pathological secretion of the tracheobronchial tree, including inflammation of the mucous membrane of the lungs and bronchi, spasmodic bronchitis, inflammation of the mucous membrane of the trachea, larynx, nonspecific inflammation of the lung tissue with the formation of purulent-necrotic cavities, bronchial asthma, cystic fibrosis , inflammation of the sinuses, acute inflammation of the middle ear. The optimal time for taking the drug is after a meal. Additional fluid intake increases the mucolytic potential of the drug. With short colds, the duration of the drug course is 5-7 days. If the pathological process is chronic, pharmacotherapy continues for a longer period of time until the desired effect of the treatment is achieved. Persons suffering from bronchial asthma should be prescribed the drug with the condition of obligatory control of bronchial patency. It is not recommended to take ACC 200 in the evening (after 18:00) and before going to bed.

Pharmacology

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

It has an antioxidant effect due to the ability of its reactive sulfhydryl groups (SH-groups) to bind to oxidizing radicals and thus neutralize them.

In addition, 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 effects of free radical oxidation, which is characteristic of an intense inflammatory reaction.

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

Pharmacokinetics

Suction and distribution

Absorption is high. Bioavailability when taken orally is 10%, due to the pronounced effect of "first pass" through the liver. The time to reach Cmax in blood plasma is 1-3 hours.

Plasma protein binding - 50%. Penetrates through the placental barrier. There are no data on the ability of acetylcysteine ​​to penetrate the BBB and be excreted in breast milk.

Metabolism and excretion

It is rapidly metabolized in the liver with the formation of a pharmacologically active metabolite - cysteine, as well as diacetylcysteine, cystine and mixed disulfides.

It is excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine). T 1/2 is about 1 hour.

Pharmacokinetics in special clinical situations

Impaired liver function leads to a prolongation of T 1/2 to 8 hours.

Release form

Effervescent tablets, white, round, flat-cylindrical, scored on one side, with a blackberry odor; there may be a slight sulfuric odor; reconstituted solution - colorless transparent with blackberry odor; There may be a slight sulfur odor.

Excipients: anhydrous citric acid - 558.5 mg, sodium bicarbonate - 200 mg, anhydrous sodium carbonate - 100 mg, mannitol - 60 mg, anhydrous lactose - 70 mg, ascorbic acid - 25 mg, sodium saccharinate - 6 mg, sodium citrate - 0.5 mg, blackberry flavor "B" - 20 mg.

20 pcs. - plastic tubes (1) - cardboard packs.
20 pcs. - aluminum tubes (1) - packs of cardboard.

Dosage

The drug is taken orally after a meal. Tablets should be taken immediately after dissolution, in exceptional cases, you can leave the finished solution for 2 hours. Additional fluid intake enhances the mucolytic effect of the drug.

In cystic fibrosis, children over the age of 6 years are recommended to take the drug 2 tab. (ACC ® 100) or 1 tab. (ACC ® 200) 3 times / day, which corresponds to 600 mg of acetylcysteine ​​per day. Children aged 2 to 6 years - 1 tab. (ACC ® 100) or 1/2 tab. (ACC ® 200) 4 times / day, which corresponds to 400 mg of acetylcysteine ​​per day.

With short-term colds, the duration of admission is 5-7 days. In chronic bronchitis and cystic fibrosis, the drug should be used for a longer time to prevent infections.

Overdose

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

Treatment: symptomatic therapy.

Interaction

With the simultaneous use of acetylcysteine ​​and antitussives, due to the suppression of the cough reflex, sputum stagnation may occur.

With the simultaneous use of acetylcysteine ​​and oral antibiotics (penicillins, tetracyclines, cephalosporins, etc.), the latter may interact with the thiol group of acetylcysteine, which can lead to a decrease in antibacterial activity. Therefore, the interval between taking antibiotics and acetylcysteine ​​should be at least 2 hours (except for cefixime and loracarbef).

Simultaneous use with vasodilators and nitroglycerin may lead to an increase in the vasodilating effect.

Side effects

According to WHO, undesirable effects are classified according to their frequency of development as follows: very often (≥1/10), often (≥1/100,<1/10), нечасто (≥1/1000, <1/100), редко (≥1/10 000, <1/1000) и очень редко (<10 000), частота неизвестна (частоту возникновения нельзя определить на основании имеющихся данных).

Allergic reactions: infrequently - itching, rash, exanthema, urticaria, angioedema; very 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 bronchial hyperreactivity in bronchial asthma).

From the side of the cardiovascular system: infrequently - a decrease in blood pressure, tachycardia.

From the digestive system: infrequently - stomatitis, abdominal pain, nausea, vomiting, diarrhea, heartburn, dyspepsia.

On the part of the organ of hearing: infrequently - tinnitus.

Other: infrequently - headache, fever; in isolated cases - the development of bleeding as a manifestation of a hypersensitivity reaction, a decrease in platelet aggregation.

Indications

• respiratory diseases accompanied by the formation of viscous sputum that is difficult to separate (acute and chronic bronchitis, obstructive bronchitis, tracheitis, laryngotracheitis, pneumonia, lung abscess, bronchiectasis, bronchial asthma, COPD, bronchiolitis, cystic fibrosis);
• acute and chronic sinusitis;
• otitis media.

Contraindications

• peptic ulcer of the stomach and duodenum in the acute phase;
• hemoptysis;
• pulmonary bleeding;
• pregnancy;
• lactation period (breastfeeding);
• children's age up to 14 years (ACC ® Long);
• children's age up to 2 years (ACC ® 100 and ACC ® 200);
• lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
• hypersensitivity to the components of the drug.

The drug should be used with caution in patients with a history of gastric and duodenal ulcer; with bronchial asthma, obstructive bronchitis; hepatic and / or renal failure; histamine intolerance (long-term use of the drug should be avoided, because acetylcysteine ​​affects the metabolism of histamine and can lead to signs of intolerance, such as headache, vasomotor rhinitis, itching); varicose veins of the esophagus; diseases of the adrenal glands; arterial hypertension.

Application features

Use during pregnancy and lactation

Due to insufficient data, the use of the drug during pregnancy is contraindicated.

If necessary, the use of the drug during lactation should decide on the termination of breastfeeding.

Application for violations of liver function

Application for violations of kidney function

Use in children

The use of the drug is contraindicated in children under 14 years of age (for ACC ® Long), in children under 2 years of age (for ACC ® 100 and ACC ® 200).

special instructions

In bronchial asthma and obstructive bronchitis, acetylcysteine ​​should be administered with caution under the systematic control of bronchial patency.

When using acetylcysteine, cases of severe allergic reactions such as Stevens-Johnson syndrome and Lyell's syndrome have been reported very rarely. If changes in the skin and mucous membranes occur, the patient should immediately stop taking the drug and consult a doctor.

When dissolving the drug, it is necessary to use glassware, avoid contact with metals, rubber, oxygen, easily oxidized substances.

Do not take the drug immediately before bedtime (the preferred time of admission is before 18.00).

1 effervescent tablet ACC ® 100 and ACC ® 200 corresponds to 0.006 XE, 1 effervescent tablet ACC ® Long - 0.001 XE.

There is no need for special precautions when discarding unused ACC ® effervescent tablets.

Influence on the ability to drive vehicles and control mechanisms

There are no data on the negative effect of the drug on the ability to drive vehicles and mechanisms, when used in recommended doses.

Farm group:

Release form: Solid dosage forms. The tablets are effervescent.

General characteristics. Compound:

Pharmacological properties:

Indications for use:

Important! Get to know the treatment

Dosage and administration:

Application Features:

Side effects:

Interaction with other drugs:

Contraindications:

Storage conditions:

In places inaccessible to children. Temperature not more than 25 °С. The finished solution must be stored for no more than 7 days in the refrigerator (at a temperature of 2-8 ° C).

Leave conditions:

On prescription

Package:

2, 4 or 24 effervescent tablets in blister packs or polypropylene cases. 1 pencil case or 6-12 packs in a cardboard box.