Acetylcysteine ​​tablet form. International non-proprietary name

Release form

effervescent tablets

Owner/Registrar

VERTEKS, JSC

International Classification of Diseases (ICD-10)

E84 Cystic fibrosis J01 Acute sinusitis J05 Acute obstructive laryngitis [croup] and epiglottitis 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 rheological properties 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 bacterial adhesion to epithelial cells bronchial mucosa. Stimulates the mucous cells of the bronchi, the secret of which lyses fibrin. Similar action has on the secret formed during inflammatory diseases ENT organs.

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, powerful antioxidant and a 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 detoxification 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 (by suppressing 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.

Indications

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 secretion), cystic fibrosis (as part of combination therapy).

Preparation for bronchoscopy, bronchography, aspiration drainage.

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

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

Paracetamol overdose.

Contraindications

peptic ulcer and duodenum in the acute phase, hemoptysis, pulmonary hemorrhage, 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 used medicinal product.

Side effects

From the side 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 if available hypersensitivity a slight and quickly passing burning sensation may appear, and therefore it is recommended to inject the drug deep into the muscle.

At 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 when the following diseases and states: peptic ulcer history of stomach and duodenum; bronchial asthma, obstructive bronchitis; hepatic and / or renal failure; histamine intolerance (should be avoided long-term use, because acetylcysteine ​​interferes with histamine metabolism 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.

When using acetylcysteine ​​in patients with bronchial asthma it is necessary to provide drainage of sputum. 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, the 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.

Minimum age from. 2 years
Mode of application oral
Amount in a package 20 pcs
Best before date 36 months
Maximum allowable temperature storage, °C 25°C
Storage conditions in a dry place
Release form Effervescent tablet
Manufacturer country Slovenia
Vacation order Without recipe
Active substance Acetylcysteine ​​(Acetylcysteine)
Scope of application Pulmonology
Pharmacological group R05CB Mucolytics

Instructions for use

Active ingredients
Release form

Tablets

Compound

1 tablet contains: Active substances: ethinyl estradiol (micronized, in the form of betadex clathrate) - 20 mcg, drospirenone (micronized) - 3 mg, calcium levomefolate (micronized) - 451 mcg. Excipients: lactose monohydrate - 45.329 mg, microcrystalline cellulose - 24.8 mg, croscarmellose sodium - 3.2 mg, hyprolose (5 cP) - 1.6 mg, magnesium stearate - 1.6 mg , talc - 202.4 mcg, titanium dioxide - 558 mcg, iron dye red oxide - 26 mcg.

Pharmacological effect

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, important component 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

Absorption and distribution Absorption is high. Bioavailability when taken orally is 10%, due to the pronounced effect of the first pass through the liver. The time to reach Cmax in plasma is 1-3 hours. Plasma protein binding is 50%. Penetrates through the placental barrier. Data on the ability of acetylcysteine ​​to penetrate the BBB and be released from breast milk absent. Metabolism and excretion Rapidly metabolized in the liver to form a pharmacologically active metabolite - cysteine, as well as diacetylcysteine, cystine and mixed disulfides. Excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine). T1 / 2 is about 1 hour. Pharmacokinetics in special clinical situations Impaired liver function leads to an extension of T1 / 2 to 8 hours.

Indications

Respiratory diseases accompanied by the formation of viscous sputum 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); - childhood up to 14 years (ACC; Long); - children under 2 years of age (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 kidney failure; histamine intolerance (long-term use of the drug should be avoided, since 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.

Use during pregnancy and lactation

Due to insufficient data, the use of the drug during pregnancy is contraindicated. If it is necessary to use the drug during lactation, the issue of stopping breastfeeding should be resolved.

Dosage and administration

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. Adults and adolescents over 14 years of age are recommended to prescribe the drug 200 mg 2-3 times / day (ACC; 100 or ACC; 200), which corresponds to 400-600 mg acetylcysteine ​​​​per day, or 600 mg (ACC; Long) 1 time / day. Children aged 6 to 14 years are recommended to take 1 tab. (ACC; 100) 3 times / day, or 2 tab. (ACC; 100) or 1 tab. (ACC; 200) 2 times / day, which corresponds to 300-400 mg of acetylcysteine ​​per day. Children aged 2 to 5 years are recommended to take the drug 1 tab. (ACC; 100) or 1/2 tab. (ACC; 200) 2-3 times / day, which corresponds to 200-300 mg of acetylcysteine ​​per day. For cystic fibrosis, children over the age of 6 years are recommended to take the drug 2 tablets. (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. For 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.

Side effects

According to WHO unwanted effects classified according to their frequency of occurrence as follows: very common (≥1/10), common (≥1/100,

Overdose

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

Interaction with other drugs

At simultaneous application acetylcysteine ​​and antitussives due to suppression 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.

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. If changes in the skin and mucous membranes occur, the patient should immediately stop taking the drug and consult a doctor. When the drug dissolves, use glassware, avoid contact with metals, rubber, oxygen, easily oxidizing substances. - until 18.00).1 tablet effervescent 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 destroying unused drug ACC; effervescent tablets. Influence on the ability to drive vehicles and control mechanisms Data on negative influence drug on the ability to control vehicles and mechanisms, when used at recommended doses, no.

Farm group:

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



General characteristics. Compound:

Active ingredient: 200 mg of acetylcysteine.

Excipients: vitamin C, sodium carbonate anhydrous, sodium bicarbonate, lemon acid anhydrous, sorbitol, macrogol 6000, sodium citrate, sodium saccharinate, lemon flavor.

Mucolytic agent that thins mucus.


Pharmacological properties:

Pharmacokinetics. mucolytic agent. Liquefies sputum, increases its volume, facilitates excretion, promotes expectoration. The action of acetylcysteine ​​is associated with the ability of its sulfhydryl groups to break the disulfide bonds of sputum acid mucopolysaccharides, which leads to depolarization of mucoproteins and a decrease in mucus viscosity. Remains active in the presence of purulent sputum.

It has an antioxidant effect due to the presence of the SH-group, which is able to interact and neutralize electrophilic oxidative toxins. Acetylcysteine ​​promotes an increase in the synthesis of glutathione, which is an important antioxidant factor in intracellular protection and ensures the maintenance functional activity and morphological integrity of the cell.

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.

Indications for use:

Respiratory diseases and conditions accompanied by the formation of viscous and mucopurulent sputum: acute and chronic, due to a bacterial and / or viral infection, atelectasis due to blockage of the bronchi by a mucous plug, (to facilitate secretion discharge), (as part of combination therapy).

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

Paracetamol overdose.


Important! Get to know the treatment

Dosage and administration:

Individual. 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.

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

Application Features:

Use during pregnancy and lactation.Adequate and strictly controlled clinical research The safety of acetylcysteine ​​during pregnancy and lactation has not been established.

During pregnancy and lactation, the use of acetylcysteine ​​is possible only if the intended benefit to the mother outweighs the potential risk to the fetus or infant.

Application in children.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.

Inside 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.

Acetylcysteine ​​is used with caution in patients with bronchial asthma, diseases of the liver, kidneys, adrenal glands. 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.

Side effects:

On the part of the digestive system: rarely - a feeling of fullness in the stomach.

Allergic reactions: rarely - itching,.

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.

When inhaled: possible reflex, local irritation of the respiratory tract; rarely - rhinitis.

Others: rarely - nasal,.

On the part 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), a change in 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).

Interaction with other drugs:

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.

Contraindications:

Peptic ulcer of the stomach and duodenum in the acute phase, hemoptysis, hypersensitivity to acetylcysteine.

Storage conditions:

In places inaccessible to children. Temperature not more than 25 °С. Ready 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.


1 tablet contains: acetylcysteine ​​200.00 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

It has a mucolytic effect on sputum (mucus) in the lumen of the bronchial tract. 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.

Indications for use

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 media, sinusitis, including sinusitis (facilitation of discharge of the secret).

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

Mode of application

Inside, after eating, after dissolving the effervescent tablets in a glass of water. Effervescent tablets should be taken immediately after dissolution.
The following dosages are usually recommended:
- 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).

Interaction

With the simultaneous use of acetylcysteine ​​and antitussives, sputum stagnation may increase due to the suppression of the cough reflex, so this combined treatment should only be done 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.

Side effect

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, decreased 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 sense organs:
- infrequently - tinnitus.
Others:
- rarely - nosebleeds, rhinorrhea, fever, decreased platelet aggregation.
If you experience unwanted side effects, you should consult a doctor.

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, impaired adrenal function, varicose veins veins of the esophagus, in persons prone to pulmonary hemorrhage, hemoptysis, arterial hypotension, 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).

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.
During the period of use of the drug, patients are recommended to drink plenty of fluids, which supports the secretolytic effect of the drug.
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.

In this article, you can read the instructions for using the drug Acetylcysteine. Reviews of site visitors - consumers are presented this medicine, as well as the opinions of medical specialists on the use of Acetylcysteine ​​in their practice. A big request to actively add your reviews about the drug: did the medicine help or not help get rid of the disease, what complications were observed and side effects, possibly not declared by the manufacturer in the annotation. Acetylcysteine ​​analogues in the presence of existing structural analogues. Use for the treatment of bronchitis, pneumonia and other diseases accompanied by cough with sputum in adults, children, as well as during pregnancy and lactation. The composition of the drug.

Acetylcysteine- mucolytic agent, 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.

Compound

Acetylcysteine ​​+ excipients.

Pharmacokinetics

When taken orally, it is well absorbed from the gastrointestinal tract. Significantly undergoes the effect of the 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.

Indications

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 the secret);
  • cystic fibrosis (as part of combination therapy).

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

Paracetamol overdose.

Release form

Effervescent tablets 200 mg and 600 mg.

Powder for solution for oral administration 100 mg and 200 mg.

Solution for inhalation.

Instructions for use and dosing regimen

inside. Adults - 200 mg 2-3 times a day in the form of granules, tablets or capsules.

Children 2-6 years old - 200 mg 2 times a day or 100 mg 3 times a day in the form of a water-soluble granulate; under 2 years - 100 mg 2 times a day; 6-14 years - 200 mg 2 times a day.

At chronic diseases within a few weeks: adults - 400-600 mg per day in 1-2 doses; children 2-14 years old - 100 mg 3 times a day; with cystic fibrosis - for children from 10 days to 2 years - 50 mg 3 times a day, 2-6 years - 100 mg 4 times a day, over 6 years - 200 mg 3 times a day in the form of a water-soluble granulate, effervescent tablet or in capsules.

Inhalation. For aerosol therapy in ultrasonic devices, 20 ml of a 10% solution or 2-5 ml of a 20% solution are sprayed, in devices with a distribution valve - 6 ml of a 10% solution. Duration of inhalation - 15-20 minutes; multiplicity - 2-4 times a day. During treatment acute conditions average duration therapy - 5-10 days; with long-term therapy of chronic conditions, the course of treatment is up to 6 months. In the case of a strong secretolytic action, the secret is sucked off, and the frequency of inhalations and daily dose reduce.

Intratracheal. For washing the bronchial tree during therapeutic bronchoscopy, a 5-10% solution is used.

locally. Buried in the nasal passages 150-300 mg (for 1 procedure).

Parenterally. It is administered intravenously (preferably by drip or slow jet - within 5 minutes) or intramuscularly. Adults - 300 mg 1-2 times a day.

Children from 6 to 14 years old - 150 mg 1-2 times a day. For children under the age of 6 years, oral administration is preferable; for children under the age of 1 year, intravenous administration of acetylcysteine ​​is possible only for health reasons in a hospital setting. In the event that there are still indications for parenteral therapy, the daily dose for children under the age of 6 years should be 10 mg / kg of body weight.

For intravenous administration the solution is further diluted with 0.9% NaCl solution or 5% dextrose solution in a 1:1 ratio.

The duration of therapy is determined individually (no more than 10 days). In patients older than 65 years - use the minimum effective dose.

Side effect

  • heartburn;
  • nausea, vomiting;
  • diarrhea;
  • feeling of fullness in the stomach;
  • skin rash;
  • hives;
  • 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;
  • reflex cough;
  • local irritation of the respiratory tract;
  • stomatitis;
  • rhinitis;
  • nosebleeds;
  • noise in ears;
  • a decrease in 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 in 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).

Contraindications

  • peptic ulcer of the stomach and duodenum in the acute phase;
  • hemoptysis;
  • pulmonary bleeding;
  • pregnancy;
  • lactation period (breastfeeding);
  • hypersensitivity to acetylcysteine.

Use during pregnancy and lactation

The use of Acetylcysteine ​​during pregnancy and lactation (breastfeeding) is contraindicated.

Use in children

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.

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

special instructions

Acetylcysteine ​​is used with caution in patients with bronchial asthma, diseases of the liver, kidneys, adrenal glands.

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, the silver may tarnish, but this does not affect the effectiveness of acetylcysteine ​​and does not harm the patient.

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.

At simultaneous reception acetylcysteine ​​and nitroglycerin may enhance the vasodilating and antiplatelet action of the latter.

Acetylcysteine ​​reduces the hepatotoxic effect of paracetamol.

Pharmaceutically incompatible with solutions of other medicines. On contact with metals, rubber forms sulfides with a characteristic odor.

Analogues of the drug Acetylcysteine

Structural analogues according to active ingredient:

  • N-AC-ratiopharm;
  • N-acetylcysteine;
  • Acestine;
  • Acetylcysteine ​​Canon;
  • Acetylcysteine ​​Teva;
  • Acetylcysteine ​​solution for inhalation 20%;
  • Acetylcysteine ​​solution for injection 10%;
  • Acetylcysteine ​​PS;
  • ACC injection;
  • ACC Long;
  • AC-FS;
  • Vicks Active ExpectoMed;
  • Mukobene;
  • Mukomist;
  • Mukonex;
  • Fluimucil;
  • Exomyuk 200;
  • Espa National

Analogues for pharmacological group(secretolytics):

  • Marshmallow syrup;
  • Ambrobene;
  • Ambroxol;
  • Ambrosan;
  • Ambrosol;
  • Ascoril;
  • Bromhexine;
  • Bronchicum;
  • Bronchicum inhalate;
  • Bronchicum cough lozenges;
  • Bronchicum cough syrup;
  • Bronchipret;
  • Bronchostop;
  • Bronchothil;
  • Gedelix;
  • Hexapneumine;
  • GeloMyrtol;
  • Herbion primrose syrup;
  • Herbion plantain syrup;
  • Glycyram;
  • Breast collection;
  • Breast elixir;
  • Joset;
  • Dr. MOM;
  • Dr. Theiss plantain syrup;
  • Zedex;
  • Insty;
  • Carbocysteine;
  • Cashnol;
  • Codelac Broncho;
  • Coldact Broncho;
  • Coldrex broncho;
  • Lazolvan;
  • Libeksin Muko;
  • Linkas;
  • Mukaltin;
  • Mukosol;
  • expectorant collection;
  • Pectosol;
  • Pectusin;
  • Pertussin;
  • Prospan;
  • Rinicold Broncho;
  • Sinupret;
  • Mixture for inhalation;
  • Licorice syrup;
  • Solutan;
  • Stoptussin;
  • Cough tablets;
  • Terpinhydrate;
  • Travisil;
  • Tussamag;
  • Tussin;
  • Tussin plus;
  • Fervex for cough;
  • Flavamed;
  • Flavamed forte;
  • Fluifort;
  • Fluditec;
  • Halixol;
  • Erdostein.

In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases that the corresponding drug helps with and see the available analogues for the therapeutic effect.