Tablets ACC 200. Effervescent tablets ACC: instructions for use for cough. Use during pregnancy and lactation

Mucolytic drug

Active substance

Release form, composition and packaging

ACC 100

◊ Effervescent tablets white, round, flat-cylindrical, with the smell of blackberries; there may be a slight sulfuric odor; the reconstituted solution is colorless transparent with the smell of blackberries; There may be a slight sulfuric odor.

Excipients: anhydrous citric acid - 679.85 mg, - 194 mg, anhydrous sodium carbonate - 97 mg, mannitol - 65 mg, anhydrous lactose - 75 mg, ascorbic acid - 12.5 mg, sodium saccharinate - 6 mg, sodium citrate - 0.65 mg, blackberry flavor "B" - 20 mg.

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

◊ Effervescent tablets white, round, flat-cylindrical, with a notch on one side, with the smell of blackberries; there may be a slight sulfuric odor; the reconstituted solution is colorless transparent with the smell of blackberries; There may be a slight sulfuric odor.

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

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

◊ Effervescent tablets white, round, flat-cylindrical, with a chamfer and a notch on one side, with the smell of blackberries; there may be a slight sulfuric odor; the reconstituted solution is colorless transparent with the smell of blackberries; There may be a slight sulfuric odor.

Excipients: anhydrous citric acid - 625 mg, sodium bicarbonate - 327 mg, sodium carbonate - 104 mg, - 72.8 mg, lactose - 70 mg, ascorbic acid - 75 mg, sodium cyclamate - 30.75 mg, sodium saccharinate dihydrate - 5 mg, sodium citrate dihydrate - 0.45 mg, blackberry flavor "B" - 40 mg.

10 pieces. - polypropylene tubes (1) - cardboard packs.
20 pcs. - polypropylene tubes (1) - cardboard packs.

pharmachologic effect

Acetylcysteine is a derivative of the amino acid cysteine. It has a mucolytic effect, facilitates the discharge of sputum 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 oxidative 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%, which is due to the pronounced “first pass” effect through the liver. The time to reach Cmax in the blood is 1-3 hours.

Binding to blood plasma proteins - 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

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). T 1/2 is about 1 hour.

Pharmacokinetics in special clinical situations

Impaired liver function leads to an extension of T1/2 to 8 hours.

Indications

- diseases of the respiratory system, accompanied by the formation of viscous, difficult to separate sputum (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 hemorrhage;

- pregnancy;

- lactation period (breastfeeding);

— children under 14 years of age (ACC Long);

- children under 2 years of age (ACC 100, ACC 200);

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

- hypersensitivity to the components of the drug.

Carefully the drug should be used in patients with a history of gastric and duodenal ulcers; for bronchial asthma, obstructive bronchitis; liver 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.

Dosage

The drug is taken orally after meals. Effervescent tablets should be dissolved in 1 glass of water. The tablets should be taken immediately after dissolution; in exceptional cases, you can leave the prepared solution for 2 hours. Additional fluid intake enhances the mucolytic effect of the drug.

Adults and teenagers over 14 years old It is recommended to prescribe the drug 200 mg (2 tablets ACC 100, 1 tablet ACC 200) 2-3 times/day, which corresponds to 400-600 mg of acetylcysteine per day, or 600 mg (ACC Long) 1 time/day.

It is recommended to take the drug 1 tablet. (ACC 100) or 1/2 tab. (ACC 200) 2-3 times/day, which corresponds to 200-300 mg of acetylcysteine per day.

At cystic fibrosischildren over 6 years old It is recommended to take the drug 2 tablets. (ACC 100) or 1 tablet. (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.

At short-term colds Duration of treatment is 5-7 days. At chronic bronchitis and cystic fibrosis the drug should be used for a longer period of time to prevent infections.

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), очень редко (<10 000), частота неизвестна (частоту возникновения нельзя определить на основании имеющихся данных).

Allergic reactions: uncommon - skin 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 cardiovascular system: infrequently - decreased blood pressure, tachycardia.

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

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

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

Overdose

Symptoms: In case of an erroneous or intentional overdose, phenomena such as diarrhea, vomiting, stomach pain, heartburn, and nausea are observed.

Treatment: carrying out symptomatic therapy.

Drug interactions

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

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).

Concomitant use with vasodilators and nitroglycerin may lead to an enhanced vasodilator effect.

special instructions

For bronchial asthma and obstructive bronchitis, acetylcysteine should be prescribed with caution under systematic monitoring of bronchial patency.

Severe allergic reactions such as Stevens-Johnson syndrome and Lyell's syndrome have been very rarely reported with the use of acetylcysteine. 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 glass containers and avoid contact with metals, rubber, oxygen, and easily oxidized substances.

You should not take the drug immediately before bedtime (the preferred time of administration is before 18.00).

1 effervescent tablet ACC 100 or ACC 200 corresponds to 0.006 XE, 1 effervescent tablet ACC Long corresponds to 0.001 XE.

There is no need for special precautions when disposing of unused ACC effervescent tablets.

Impact on the ability to drive vehicles and operate machinery

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

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 decided.

Use in childhood

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 200).

Shelf life - 3 years.

After taking the tablet, the tube should be tightly closed.

Effervescent tablets - 1 tablet:

Active ingredients: acetylcysteine 200 mg;
Excipients: ascorbic acid - 25 mg, anhydrous sodium carbonate - 93 mg, sodium bicarbonate - 894 mg, anhydrous citric acid - 998 mg, sorbitol - 695 mg, macrogol 6000 - 70 mg, sodium citrate - 500 mg, sodium saccharinate - 5 mg, lemon flavor - 20 mg.

24 tablets per pack.

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 acidic mucopolysaccharides of sputum, 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 mucous cells of the bronchi, the secretion of which is lysed by fibrin. It has a similar effect on the secretions formed during inflammatory diseases of the ENT organs.

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

Acetylcysteine easily penetrates into the cell and is 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 exhaustion and helps increase the synthesis of intracellular glutathione, which is involved in the redox processes of cells, promoting the detoxification of harmful substances. This explains the effect of acetylcysteine as an antidote for paracetamol poisoning.

Protects alpha1-antitrypsin (elastase inhibitor) from the inactivating effects 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 reactive 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. It is largely subject to the “first pass” effect through the liver, which leads to a decrease in bioavailability. Binding to plasma proteins up to 50% (4 hours after oral administration). 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 accounts for 30% of the total clearance.

Acetylcysteine: 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 with a mucus plug, sinusitis (to facilitate the passage of secretions ), cystic fibrosis (as part of combination therapy).

Preparation for bronchoscopy, bronchography, aspiration drainage.

Removal of viscous secretions 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.

Acetylcysteine: Contraindications

Peptic ulcer of the stomach and duodenum in the acute phase, hemoptysis, pulmonary hemorrhage, increased sensitivity to acetylcysteine.

Use with caution in the following diseases and conditions: history of gastric and duodenal ulcers, bronchial asthma, obstructive bronchitis, liver and/or renal failure, histamine intolerance (long-term use should be avoided, since acetylcysteine affects the metabolism of histamine and may lead to signs of intolerance such as headache, vasomotor rhinitis, itching), esophageal varices, adrenal diseases, arterial hypertension.

Use during pregnancy and breastfeeding

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 drug used.

Contraindicated for use during pregnancy and lactation (breastfeeding).

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.

Directions for use and doses

Orally for adults and children over 6 years old - 200 mg 2-3 times a 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: Side effects

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

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

Other: rarely - nosebleeds, tinnitus.

From the laboratory parameters: a decrease in prothrombin time is possible due to the administration of large doses of acetylcysteine (monitoring the state of the blood coagulation system is necessary), changes in the results of the test for the quantitative determination of salicylates (colorimetric test) and the test for the quantitative determination of ketones (sodium nitroprusside test).

Acetylcysteine

Registration number: LP-000623

Tradename: Acetylcysteine

International nonproprietary name: Acetylcysteine

Dosage form: powder for solution for oral administration

Composition per package:

acetylcysteine - 0.100 g or 0.200 g.

Excipients: ascorbic acid - 0.025 g, sorbitol (sorbitol) - 0.7527 g or 0.6507 g, orange flavor (food flavor "Orange") - 0.1 g, aspartame - 0.02 g.

Description: white granules with a yellowish tint. When the contents of one packet are dissolved in 80 ml of warm water for 5 minutes with stirring, an opalescent solution with a slightly yellowish tint and the smell of orange is formed.

Pharmacotherapeutic group: expectorant (mucolytic) agent

ATX code:

Pharmacological properties

Pharmachologic effect. A mucolytic agent that thins sputum, increases its volume, and facilitates the separation of sputum.

The action is associated with the ability of free sulfhydryl groups of acetylcysteine to break intra- and intermolecular disulfide bonds of acidic mucopolysaccharides of sputum, which leads to depolymerization of mucoproteins and a decrease in sputum viscosity (in some cases this leads to a significant increase in sputum volume, which requires aspiration of bronchial contents). Remains active against purulent sputum. Does not affect immunity.

It has a similar effect on the secretions formed during inflammatory diseases of the ENT organs.

It has an antioxidant effect due to the presence of an SH group that can neutralize electrophilic oxidative toxins.

Protects alpha1-antitrypsin (elastase inhibitor) from the inactivating effects of HOCl-oxidizer produced by myeloperoxidase of active phagocytes.

It also has some anti-inflammatory effect (by suppressing the formation of free radicals and reactive oxygen-containing substances responsible for the development of inflammation in the lung tissue).

Pharmacokinetics. Absorption - high, bioavailability - 10% (due to the presence of a pronounced “first pass” effect through the liver - deacetylation with the formation of cysteine), time to reach maximum concentration (TCmax) in plasma - 1-3 hours after oral administration, binding to plasma proteins - 50 %.

The half-life (T1/2) is about 1 hour, with liver cirrhosis it increases to 8 hours. It is excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine), a small part is excreted unchanged in the feces.

Penetrates the placental barrier and accumulates in the amniotic fluid.

Indications for use

Impaired sputum discharge: bronchitis, tracheitis, bronchiolitis, pneumonia, bronchiectasis, cystic fibrosis, lung abscess, emphysema, laryngotracheitis, bronchial asthma, pulmonary atelectasis (due to blockage of the bronchi by mucus plug).

Catarrhal and purulent otitis media, sinusitis, sinusitis (facilitation of secretion discharge).

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

Preparation for bronchoscopy, bronchography, aspiration drainage.

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

Contraindications

Hypersensitivity to acetylcysteine or other components of the drug, phenylketonuria, sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption, pregnancy, breastfeeding, children under 2 years of age.

Directions for use and doses

Inside. The granules are dissolved in 1/3 cup of water.

Adults and adolescents over 14 years old - 200 mg 2-3 times a day (400 - 600 mg per day).

Children from 2 to 5 years old - 100 mg 2-3 times a day (200-300 mg per day). Children from 6 to 14 years old - 200 mg 2 times a day or 3 times a day 100 mg (300-400 mg per day).

For chronic diseases over several weeks:

adults and adolescents over 14 years old - 400-600 mg/day in 1-2 doses; children 2-14 years old - 100 mg 3 times a day (300 mg per day).

For cystic fibrosis:

children from 2 to 6 years old - 100 mg 4 times a day (400 mg per day);

children over 6 years old - 200 mg 3 times a day (600 mg per day).

The duration of therapy is determined individually (no more than 10 days). In patients over 65 years of age, the minimum effective dose is used.

Carefully

Peptic ulcer of the stomach and duodenum (in the acute phase), varicose veins of the esophagus, hemoptysis, pulmonary hemorrhage, diseases of the adrenal glands, liver and/or kidney failure, arterial hypotension.

Overdose

Symptoms: diarrhea, heartburn, nausea, vomiting, stomach pain. Treatment: symptomatic.

special instructions

When working with the drug, you must use glass containers and avoid contact with metals, rubber, oxygen, and easily oxidizing substances.

In patients with broncho-obstructive syndrome, it must be combined with bronchodilators.

Side effect

Nausea, vomiting, feeling of fullness in the stomach, rhinorrhea, drowsiness, fever, stomatitis; allergic reactions (skin rash, itching, urticaria, bronchospasm (mainly in patients with bronchial hyperreactivity).

Interaction with other drugs

Pharmaceutically incompatible with other drug solutions.

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

When taken simultaneously with nitroglycerin, the vasodilator effect of the latter is enhanced; reduces the absorption of drugs from the penicillin, cephalosporin, tetracycline group (they should be taken no earlier than 2 hours after taking acetylcysteine).

Use during pregnancy and breastfeeding

For safety reasons, due to insufficient data, prescribing the drug in

pregnancy and lactation are possible only if the expected benefit to the mother outweighs the risk to the fetus or infant.

Impact on the ability to drive vehicles and machinery

When driving vehicles or potentially dangerous mechanisms

Use the drug with caution.

Release form

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

1 g in heat-sealable bags made of combined packaging material.

20 or 30 packages along with instructions for use are placed in cardboard packs for consumer packaging.

Storage conditions:

In a dry place at a temperature not exceeding 25°C.

Best before date:

2 years. Do not use after the expiration date.

◊ tab. effervescent 200 mg: 20, 50, 60 or 100 pcs. Reg. No.: P N015473/01

Clinical and pharmacological group:

Mucolytic drug

Release form, composition and packaging

◊ Effervescent tablets white, round, flat, scored, with the smell of blackberries.

Excipients: citric acid anhydride - 558.5 mg, sodium bicarbonate - 300 mg, mannitol - 60 mg, ascorbic acid - 25 mg, lactose anhydride - 70 mg, sodium citrate - 0.5 mg, saccharin - 6 mg, blackberry flavoring "B" - 20 mg.

4 things. - strips (15) - cardboard boxes.
20 pcs. - aluminum tubes (1) - cardboard boxes.
20 pcs. - plastic tubes (1) - cardboard boxes.
25 pcs. - aluminum tubes (2) - cardboard boxes.
25 pcs. - plastic tubes (2) - cardboard boxes.
25 pcs. - aluminum tubes (4) - cardboard boxes.
25 pcs. - plastic tubes (4) - cardboard boxes.

Description of the active components of the drug " ACC ®»

pharmachologic effect

Mucolytic drug. The presence of sulfhydryl groups in the structure of the acetylcysteine molecule promotes the rupture of disulfide bonds of acidic mucopolysaccharides of sputum, which leads to a decrease in the viscosity of mucus. It has a mucolytic effect, facilitates the discharge of sputum 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.

Indications

— diseases of the respiratory system, accompanied by increased formation of viscous, difficult to separate sputum (acute and chronic bronchitis, obstructive bronchitis, pneumonia, bronchiectasis, bronchial asthma, bronchiolitis, cystic fibrosis);

— acute and chronic sinusitis;

- otitis media.

Dosage regimen

Adults and teenagers over 14 years old It is recommended to prescribe the drug 200 mg 2-3 times a day (ACC ® 100 or ACC ® 200), which corresponds to 400-600 mg of acetylcysteine per day.

Children aged 2 to 5 years It is recommended to take the drug 1 tablet. (ACC ® 100) or 1/2 tab. (ACC ® 200) 2-3 times a day, which corresponds to 200-300 mg of acetylcysteine per day.

At cystic fibrosischildren over 6 years old It is recommended to take the drug 2 tablets. (ACC ® 100) or 1 tablet. (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. Patients with body weight more than 30 kg for cystic fibrosis, if necessary, you can increase the dose to 800 mg/day.

At short-term colds Duration of treatment is 5-7 days. At chronic bronchitis and cystic fibrosis the drug should be used for a longer period of time to prevent infections.

The drug should be taken after meals. Additional fluid intake enhances the mucolytic effect of the drug.

Effervescent tablets (ACC ® 100 and ACC ® 200) should be dissolved in 1/2 glass of water. Take immediately after dissolution; in exceptional cases, you can leave the prepared solution for 2 hours.

Side effect

From the nervous system: rarely - headache, tinnitus.

From the digestive system: rarely - stomatitis; very rarely - diarrhea, vomiting, heartburn and nausea.

From the cardiovascular system: very rarely - decreased blood pressure, tachycardia.

Allergic reactions: in isolated cases - bronchospasm (mainly in patients with bronchial hyperreactivity), skin rash, itching and urticaria.

Others: in isolated cases - the development of bleeding as a manifestation of a hypersensitivity reaction.

Contraindications

- peptic ulcer of the stomach and duodenum in the acute phase;

- hemoptysis;

- pulmonary hemorrhage;

- pregnancy;

- lactation period (breastfeeding);

- hypersensitivity to the components of the drug.

WITH caution the drug should be used in patients with varicose veins of the esophagus, with an increased risk of developing pulmonary hemorrhage and hemoptysis, with bronchial asthma, diseases of the adrenal glands, liver and/or kidney failure.

Pregnancy and lactation

Due to insufficient data, the use of the drug during pregnancy and lactation is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus or child.

Use for liver dysfunction

The drug should be taken with caution used for liver failure.

Use for renal impairment

The drug should be taken with caution used for renal failure.

Application for children

Contraindications: children under 6 years of age (the drug is in the form of granules for the preparation of a solution for oral administration 200 mg); children under 14 years of age (dosage forms containing acetylcysteine 600 mg).

special instructions

For bronchial asthma and obstructive bronchitis, acetylcysteine should be prescribed with caution under systematic monitoring of bronchial patency.

If adverse reactions develop, the patient should stop taking the drug and consult a doctor.

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

When treating patients with diabetes, it is necessary to take into account that 1 effervescent tablet ACC ® 100 and ACC ® 200 corresponds to 0.006 XE.

Impact on the ability to drive vehicles and operate machinery

There is no data on the negative effect of the drug in recommended doses on the ability to drive vehicles and perform other activities that require concentration and speed of psychomotor reactions.

Overdose

In case of an erroneous or intentional overdose, the following are observed: symptoms such as diarrhea, vomiting, stomach pain, heartburn, nausea. To date, no severe or life-threatening side effects have been observed.

Drug interactions

Conditions for dispensing from pharmacies

The drug is approved for use as a means of OTC.

Storage conditions and periods

The drug should be stored out of reach of children, in a dry place at a temperature not exceeding 25°C. Shelf life - 3 years.

After taking the tablet, the tube should be tightly closed.

Drug interactions

With the simultaneous use of acetylcysteine and antitussives, dangerous mucus stagnation may occur due to suppression of the cough reflex (use the combination with caution).

When taking acetylcysteine and nitroglycerin simultaneously, the vasodilatory effect of nitroglycerin may be enhanced.

Synergism between acetylcysteine and bronchodilators has been noted.

Acetylcysteine reduces the absorption of cephalosporins, penicillins and tetracycline, so they should be taken orally no earlier than 2 hours after taking acetylcysteine.

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

When acetylcysteine comes into contact with metals and rubber, sulfides with a characteristic odor are formed.

1 sachet contains 3 g of powder

active substance: acetylcysteine 200 mg

excipients: sucrose, ascorbic acid, saccharin, dry orange flavor 1:1000 Sotteri 289**

(**- Orange flavor essence 11.1%, dextrose anhydride 82.7%, lactose 6.2%)

Description

Powder from white to yellowish color, with partial agglomeration of particles, with the smell of orange.

The reconstituted solution is colorless, transparent or slightly opalescent.

Pharmacotherapeutic group

Drugs for the treatment of diseases of the respiratory system. Medicines to relieve symptoms of colds and coughs. Expectorants. Mucolytics. Acetylcysteine

ATX code R05 CB01

Pharmacological properties

Pharmacokinetics

After oral administration, acetylcysteine is rapidly absorbed from the gastrointestinal tract (GIT) and metabolized in the liver to cysteine, a pharmacologically active metabolite, as well as diacetylcysteine, cystine and various mixed disulfides.

Due to the high first pass effect through the liver, the bioavailability of acetylcysteine is very low (approximately 10%).

In humans, maximum plasma concentrations are reached after 1-3 hours. The maximum plasma concentration of the cysteine metabolite is about 2 µmol/l. The binding of acetylcysteine to plasma protein is approximately 50%.

Acetylcysteine is excreted through the kidneys almost exclusively in the form of inactive metabolites (inorganic sulfates, diacetylcysteine).

The half-life in plasma is approximately 1 hour and is mainly determined by hepatic biotransformation. Therefore, impaired liver function leads to a prolongation of the plasma half-life of up to 8 hours.

Pharmacodynamics

Acetylcysteine is a derivative of the amino acid cysteine. Acetylcysteine has secretolytic and secretomotor effects in the respiratory tract. It breaks disulfide bonds between mucopolysaccharide chains and has a depolymerizing effect on DNA chains (with purulent sputum). Thanks to these mechanisms, the viscosity of sputum decreases.

An alternative mechanism of acetylcysteine is based on the ability of its reactive sulfhydryl group to bind chemical radicals and thereby neutralize them.

Acetylcysteine helps increase glutathione synthesis, which is important for the detoxification of toxic substances. This explains its antidote effect in paracetamol poisoning.

When used prophylactically, it has a protective effect on the frequency and severity of exacerbations of bacterial infections, which was found in patients with chronic bronchitis and cystic fibrosis.

Indications for use

Secretolytic therapy for acute and chronic diseases of the bronchi and lungs, accompanied by impaired formation and elimination of sputum.

Directions for use and dosage

ACC® 200 is taken only in the form of a prepared solution, after meals.

Adults and teenagers aged 14 years and older

1 sachet of powder 2-3 times a day (corresponds to 400-600 mg of acetylcysteine per day).

Children and teenagers from 6 to 14 years old

1 sachet of powder 2 times a day (corresponds to 400 mg of acetylcysteine per day).

The duration of treatment depends on the type and severity of the disease and should be determined by the attending physician.

Preparation of the solution:

The powder is dissolved in a glass of boiled water and taken after meals.

Side effects

Not often (≥1/1000,<1/100)

Allergic reactions (itching, urticaria, skin rash, bronchospasm, Quincke's edema, exanthema)

Tachycardia

Arterial hypotension

Headache

Fever

Stomatitis, abdominal pain, diarrhea, vomiting, heartburn, nausea

Noise in ears

Rarely (≥1/10000,<1/1000)

Dyspnea, bronchospasm mainly in patients with increased reactivity of the bronchial system associated with bronchial asthma

Dyspepsia

Very rarely (< 1/10 000)

Bleeding and hemorrhage, partly associated with hypersensitivity reactions

Anaphylactic reactions, up to anaphylactic shock

Stevens-Johnson syndrome, Lyell's syndrome

Unknown

Facial swelling

Various studies have shown a decrease in platelet aggregation under the influence of acetylcysteine. At present, the clinical significance of this phenomenon has not been established.

Contraindications

Hypersensitivity to any component of the drug

Peptic ulcer of the stomach and duodenum in the acute stage

Hemoptysis, pulmonary hemorrhage

Bronchial asthma in the acute stage

Phenylketonuria

Children under 6 years old

Intolerance to fructose, galactose, deficiency of saccharin-isomaltose, lactose, glucose-galactose malabsorption syndrome

With caution: varicose veins of the esophagus, bronchial asthma, diseases of the adrenal glands, liver and/or kidney failure, arterial hypertension.

Drug interactions

The simultaneous use of acetylcysteine and antitussives can cause dangerous secretory stagnation due to a decrease in the cough reflex. For this reason, this combination therapy option must be based on a particularly accurate diagnosis.

To achieve the best therapeutic effect, oral antibiotics (penicillins, tetracyclines and aminoglycosides) should be administered separately, with a two-hour time interval. This does not apply to cefixime and loracarbef.

The use of activated carbon in large doses can weaken the effect of acetylcysteine.

The simultaneous use of nitroglycerin and acetylcysteine should be carried out under the supervision of a physician, as the vasodilatory effect and inhibitory effect on platelet aggregation may be enhanced.

Acetylcysteine may interfere with the colorimetric assay for the determination of salicylates.

Acetylcysteine may interfere with the results of ketone bodies in urine tests.

special instructions

If changes occur in the skin and mucous membranes, the patient should immediately stop taking acetylcysteine and consult a doctor.

In patients with bronchial asthma and obstructive bronchitis, ACC® 200 should be prescribed with caution under systematic monitoring of bronchial conduction due to the risk of developing bronchospasm.

The use of the drug ACC® 200 can lead to dilution of sputum in the bronchi and a slight increase in its volume. If the cough reflex is insufficient, postural drainage or aspiration is used.

Patients with histamine intolerance should take ACC® 200 in short courses, due to the effect on the metabolism of histamine itself and the possible appearance of intolerance symptoms (for example, headache, runny nose, itching).