Ass is liquid. Powder, syrup and tablets for children ACC - instructions for use and analogues. How to breed and take, special instructions

tab. thorn. 100 mg, No. 20

Acetylcysteine ​​100 mg

No. UA/8272/01/01 from 10/13/2009 to 10/13/2014

since. d / p r-ra d / peror. approx. 100 mg sachet 3 g, No. 20

Acetylcysteine ​​100 mg

No. UA/2030/02/01 from 06/26/2007 to 06/26/2012

tab. thorn. 200 mg, No. 20

Acetylcysteine ​​200 mg

Other Ingredients: Citric acid, sodium bicarbonate, mannitol, lactose, ascorbic acid, sodium citrate, saccharin, sorbitol, flavor.

No. UA/8272/01/02 from 10/13/2009 to 10/13/2014

since. d / p r-ra d / peror. approx. 200 mg sachet 3 g, No. 20

Acetylcysteine ​​200 mg

Other Ingredients: Sucrose, Ascorbic Acid, Saccharin, Flavouring.

No. UA/2031/02/01 dated 06/26/2007 to 06/26/2012

ACC® LONG

tab. thorn. 600 mg tuba, #10

Acetylcysteine ​​600 mg

Other Ingredients: Ascorbic acid, saccharin, lactose, citric acid, mannitol, sodium carbonate, sodium citrate, sodium cyclamate, sodium bicarbonate, flavor.

No. UA/6568/01/01 dated 06/26/2007 to 06/26/2012

ACC® HOT DRINK

por d/p hot nap d/per prim 200 mg/3 g sachet 3 g, no. 20

Acetylcysteine ​​200 mg/3 g

No. UA/6568/02/02 from 10/13/2009 to 10/13/2014

por d/p hot nap d/per prim 600 mg/3 g sachet 3 g, no. 6

Acetylcysteine ​​600 mg/3 g

Other Ingredients: sucrose, ascorbic acid, sodium saccharin, flavors.

No. UA/6568/02/01 from 10/13/2009 to 10/13/2014

ACC® CHILDREN

since. d/oral solution 20 mg/ml vial. 30 g, d/p 75 ml solution, No. 1

since. d/oral solution 20 mg/ml vial. 60 g, d/p 150 ml solution, No. 1

Acetylcysteine ​​20 mg/ml

Other Ingredients: Methyl parahydroxybenzoate, propyl parahydroxybenzoate, sorbitol, sodium citrate, fragrance.

No. UA/7453/01/01 dated 12/18/2007 to 12/18/2012

Pharmacological properties:

acetylcysteine ​​(ACC) is a mucolytic expectorant used to thin sputum in diseases of the respiratory system, accompanied by the formation of thick mucus. Acetylcysteine ​​is a derivative of the amino acid cysteine. It acts secretolytically and increases the motility of the respiratory tract. The mucolytic effect of the drug has a chemical nature. Due to the presence of a free sulfhydryl group, acetylcysteine ​​breaks the disulfide bonds of acid mucopolysaccharides, which leads to depolymerization of mucoproteins of purulent sputum. As a result, the viscosity of sputum decreases. The drug also has antioxidant pneumoprotective properties, which are due to the binding of its sulfhydryl groups of chemical radicals and, thus, their neutralization. In addition, the drug helps to increase the synthesis of glutathione, an important factor in chemical detoxification. This feature of acetylcysteine ​​makes it possible to effectively use it in acute poisoning with paracetamol and other toxic substances (aldehydes, phenols). After oral administration, acetylcysteine ​​is rapidly and completely absorbed and metabolized in the liver to form cysteine, a pharmacologically active metabolite, as well as diacetylcysteine, cystine, and later mixed disulfides. Bioavailability is very low - about 10%. Plasma protein binding is approximately 50%. Acetylcysteine ​​is excreted by the kidneys as inactive metabolites (inorganic sulfates, diacetylcysteine). T1 / 2 is determined mainly by rapid biotransformation in the liver and is about 1 hour. In the case of a decrease in liver function, T1 / 2 increases to 8 hours.

Indications:

diseases of the respiratory tract, accompanied by the formation of a viscous secret, including acute and chronic bronchitis, bronchiectasis, chronic obstructive bronchitis, cystic fibrosis, tracheitis.

Application:

adults and children over the age of 14 are prescribed at a dose of 400-600 mg / day, children aged 6-14 years - at a dose of 300-400 mg / day in 2 doses, from 2 to 5 years - 200-300 mg / day . Infants from the 10th day of life and children under the age of 2 years are prescribed 50 mg 2-3 times a day. In cystic fibrosis, patients weighing > 30 kg can be prescribed at a dose of up to 800 mg / day. Children over the age of 6 years are usually prescribed 200 mg 3 times a day, 2-5 years - 100 mg 4 times a day, infants (starting from the 10th day of life) and children under the age of 2 years are prescribed 50 mg 2-3 times a day. Taken after meals. The contents of the sachet or tablet are dissolved in 1/2 cup of water, juice or iced tea. In acute uncomplicated diseases, the duration of the drug is usually 5-7 days. Treatment for chronic diseases is carried out for a long time or in courses of several months (up to 6 months).

Contraindications:

hypersensitivity to acetylcysteine ​​or other components of the drug, peptic ulcer of the upper gastrointestinal tract, hemoptysis, pulmonary bleeding. ACC for Children is contraindicated in hepatitis, renal failure (to avoid an increase in nitrogen-containing substances in the body).

Side effects:

extremely rarely, heartburn, nausea, vomiting, diarrhea, headache, stomatitis, tinnitus, allergic reactions, arterial hypotension, bronchospasm (in persons with bronchial hyperreactivity), skin rash and itching, tachycardia can occur. Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause sporadic hypersensitivity reactions. At the first signs of hypersensitivity reactions, the drug is stopped.

Special instructions:

in patients with gastric or duodenal ulcers, acetylcysteine ​​should be used with caution. The drug should be used with caution in patients with asthma. This is due to the fact that during the preparation of the solution, reflex bronchospasm may occur, since the powder may enter the inhaled air, as a result of which the nasal mucosa is irritated. During treatment with acetylcysteine, it is recommended to drink a sufficient amount of fluid. Patients with rare hereditary fructose intolerance should not take the drug. Sorbitol may have a mild laxative effect. Additional fluid intake enhances the mucolytic effect of the drug. Children. Children under the age of 1 year, acetylcysteine ​​is prescribed only for health reasons; treatment is carried out under the strict supervision of a physician. In children under 2 years of age, acetylcysteine ​​should only be used under medical supervision. Do not use ACC 200 for the treatment of children under the age of 2 years, ACC LONG - in children under the age of 14 years. Despite the fact that there is no information about the embryotoxic effect of acetylcysteine, during pregnancy the drug is prescribed only under strict indications and under the supervision of a physician. There is no evidence of a negative effect on the ability to drive vehicles or work with complex mechanisms.

Interactions:

tetracycline antibiotics (with the exception of doxycycline) are not recommended to be used simultaneously with ACC for Children. Cases of inactivation of antibiotics of other groups by acetylcysteine ​​were noted exclusively during in vitro experiments, with direct mixing of the latter. But for the safety of the patient, the interval between taking antibiotics and acetylcysteine ​​should be at least 2 hours. With the simultaneous use of the drug with antitussives, due to a decrease in the cough reflex, dangerous stagnation of mucus is possible. Acetylcysteine ​​may potentiate the vasodilating effect of nitroglycerin. In vitro incompatibility of acetylcysteine ​​with semisynthetic penicillins, cephalosporins, aminoglycosides is noted. There is no data on the incompatibility of the drug with antibiotics such as amoxicillin, erythromycin and cefuroxime.

ACC (ACC)

Compound

Effervescent tablets: acetylcysteine ​​and auxiliary components (ascorbic acid, sucrose, saccharin, flavoring).

Powder: acetylcysteine ​​and auxiliary components (sucrose).

ACC Long effervescent tablets: acetylcysteine ​​and auxiliary components (ascorbic acid, sodium citrate, saccharin, sodium cyclamate, lactose, citric acid, sodium carbonate, mannitol, sodium bicarbonate, flavoring).

ACC for children: acetylcysteine.

pharmachologic effect

The active substance is acetylcysteine, a cysteine ​​derivative (amino acid). It has a mucolytic, expectorant effect due to the rupture of bisulfide bonds of sputum mucopolysaccharides. This depolymerizes mucoproteins and reduces the viscosity of bronchial secretions. As a result, mucociliary clearance increases and sputum discharge improves. Acetylcysteine ​​has an antioxidant and pneumoprotective effect, which is associated with the binding properties of sulfhydryl groups. It is an antidote for acute poisoning with aldehydes, paracetamol and phenols (the detoxifying effect is possible due to increased production of glutathione).

Acetylcysteine ​​is almost immediately completely absorbed from the gastrointestinal tract when administered internally. The active metabolite is cysteine, which is formed in the liver. Further, the metabolism of acetylcysteine ​​passes through the formation of diacetylcysteine, cystine. The end product of metabolism is mixed disulfides.

Bioavailability is 10%. Cmax is determined by internal use after 1-3 hours. Plasma proteins bind 50% of acetylcysteine. The maximum concentration of the pharmacologically active metabolite in the blood is 2 µmol/l.

Inactive metabolites are excreted in the urine (inorganic sulfates, diacetylcysteine), but a small amount of acetylcysteine ​​is excreted unchanged in the feces.

The half-life of acetylcysteine ​​depends on biotransformation in the liver. With liver failure, it is 8 hours, while normally it is 1 hour. It passes through the hematoplacental barrier and can accumulate in the amniotic fluid.

Indications for use

Acetylcysteine ​​is prescribed in all cases of diseases with accumulation of thick viscous sputum in the bronchial tree and upper respiratory tract, namely:
Acute and chronic bronchitis, including obstructive;
bronchiolitis;
tracheitis;
Bronchial asthma ;
bronchiectasis;
cystic fibrosis;
Laryngitis;
sinusitis;
Median exudative otitis.

Mode of application

The daily dose for the treatment of cystic fibrosis in patients weighing more than 30 kg is used up to 800 mg. Children from the 10th day of life and up to 2 years old use 50 mg 2-3 r / s. At the age of 2-5 years - 400 mg per day, divided into 4 doses. From 6 years old - 600 mg / s (divided into 3 doses). Treatment is continued for a long time, courses for several months (3-6).
In all other cases, the daily dose for children from 14 years of age and adults is 400-600 mg. From 6 to 14 years - 300-400 mg (divided into 2 doses), 2-5 years - 200-300 mg (divided into 2 doses). Children from the 10th day of life and up to 2 years old use 50 mg 2-3 r / s. In acute diseases without complications, the drug is prescribed for 5-7 days. In case of complications or chronic course, course treatment is possible (up to 6 months).

ACC is taken after a meal. The tablet or the contents of the sachet must be dissolved in half a glass of liquid (cold tea, water, juice).

Side effects

From the gastrointestinal tract - stomatitis, nausea, vomiting, diarrhea, heartburn.
From the side of the central nervous system - headache, tinnitus.
From the side of the CCC - arterial hypotension, increased heart rate.

Allergic reactions - bronchospasm (especially with bronchial hyperreactivity), rash and itching of the skin. Often the cause of hypersensitivity to the drug is the presence of propyl and methyl parahydroxybenzoate in the composition.

Contraindications

Hypersensitivity to acetylcysteine ​​and excipients
peptic ulcer
hereditary fructose intolerance
Pulmonary bleeding or hemoptysis
In pediatric practice - with hepatitis and renal failure (the threat of accumulation of nitrogen-containing products).

Pregnancy

There is no embryotoxic effect in acetylcysteine, however, during pregnancy, as well as during breastfeeding, it is prescribed only if there are indications under the supervision of a physician.

drug interaction

Tetracycline and its derivatives (except doxycycline) should not be used together with ACC in pediatrics.
During experimental in vitro studies, there were no cases of inactivation of other types of antibacterial drugs. However, it is recommended to observe the interval between taking ACC and antibiotic at least 2 hours. In vitro, the incompatibility of acetylcysteine ​​with semi-synthetic penicillins, aminoglycoside and cephalosporin antibiotics has been proven. Such studies have not been conducted with erythromycin, amoxicillin and cefuroxime.

Simultaneous use of antitussive drugs can lead to stagnation of the secretion of the respiratory tract.

The use of nitroglycerin may enhance the vasodilating effect of the latter.

Overdose

In pediatric practice, cases of hypersecretion in infants are described. Side effects that threaten life and health are not described. In case of overdose (dyspeptic disorders), symptomatic therapy is prescribed.

Release form

ACC 100, 200 - effervescent tablets, 20 pcs.
ACC hot drink - powder for preparing a hot drink for internal use - 200 mg (20 sachets) and 600 mg (6 sachets).
ACC-long - effervescent tablets (600 mg), 10 pcs. in a tube.
ACC powder for solution for oral administration - 100, 200 mg, 2 pcs. packaged.

ACC for children - powder for the preparation of a solution for oral administration 30 g in a 75 ml vial (20 mg / ml) and 60 g in a 150 ml vial (20 mg / ml).

Storage conditions

In places inaccessible to children. Temperature not more than 30°С. The finished solution should be stored for no more than 12 days in the refrigerator (at a temperature of 2-8°C).

Nosological classification (ICD-10)

Acute sinusitis (J01)

Acute obstructive laryngitis [croup] and epiglottitis (J05)

Bacterial pneumonia, not elsewhere classified (J15)

Acute bronchitis (J20)

Chronic sinusitis (J32)

Chronic laryngitis and laryngotracheitis (J37)

Chronic bronchitis, unspecified (J42)


For the best mucolytic effect in the treatment with acetylcysteine, you should drink plenty of fluids.

10 ml of the prepared oral solution contains 0.31 carbohydrate units, which should be taken into account for patients with diabetes.

Sorbitol has a slight laxative effect on the stool.

For newborns and children under 1 year of age, acetylcysteine ​​​​is used exclusively for health reasons under strict medical supervision. The recommended dosage (10 mg/kg body weight) must not be changed.
ACC 200 is not used at the age of up to 2 years.
ACC Long is not recommended for children under 14 years of age.

The speed of reaction when driving and working with machinery does not change when taking acetylcysteine.

The authors

Attention!
Description of the drug ACC" on this page is a simplified and supplemented version of the official instructions for use. Before purchasing or using the drug, you should consult a doctor and read the annotation approved by the manufacturer.
Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide on the appointment of the drug, as well as determine the dose and methods of its use.

Description of the dosage form

Effervescent tablets, 100 mg: round flat-cylindrical white, with a smell of blackberry. There may be a slight sulfur odor. Reconstituted Solution: colorless transparent with blackberry smell. There may be a slight sulfur odor.

Granules for oral solution preparation (orange): homogeneous, white, without agglomerates, with an orange smell.

Syrup: clear, colorless, slightly viscous solution with a cherry smell.

pharmachologic effect

pharmachologic effect- mucolytic.

Pharmacodynamics

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 its viscosity. The drug remains active in the presence of purulent sputum.

It has an antioxidant effect based on 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 of bacterial etiology in patients with chronic bronchitis and cystic fibrosis.

Pharmacokinetics

Absorption is high. It is rapidly metabolized in the liver with the formation of a pharmacologically active metabolite - cysteine, as well as diacetylcysteine, cystine and mixed disulfides. Bioavailability when taken orally is 10% (due to the presence of a pronounced effect of the first passage through the liver). Tmax in plasma is 1-3 hours. Communication with plasma proteins is 50%. It is excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine). T 1 / 2 is about 1 hour, liver dysfunction leads to an extension of T 1 / 2 to 8 hours. Penetrates through the placental barrier. There are no data on the ability of acetylcysteine ​​to penetrate the BBB and be excreted in breast milk.

Indications for ACC ® 100

For all dosage forms

diseases of the respiratory system, accompanied by the formation of viscous sputum difficult to separate:

Acute and chronic bronchitis;

Obstructive bronchitis;

Tracheitis;

laryngotracheitis;

Pneumonia;

lung abscess;

bronchiectasis;

Bronchial asthma;

Chronic obstructive pulmonary disease;

bronchiolitis;

cystic fibrosis;

acute and chronic sinusitis;

inflammation of the middle ear (otitis media).

Contraindications

For all dosage forms

hypersensitivity to acetylcysteine ​​or other components of the drug;

peptic ulcer of the stomach and duodenum in the acute stage;

hemoptysis, pulmonary bleeding;

pregnancy;

breastfeeding period;

children's age up to 2 years.

For effervescent tablets, 100 mg, optional

lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Carefully: peptic ulcer of the stomach and duodenum in history; 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.

For mortar pellets optional

sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose deficiency.

Carefully: peptic ulcer of the stomach and duodenum in history; arterial hypertension; varicose veins of the esophagus; bronchial asthma; obstructive bronchitis; diseases of the adrenal glands; 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).

extra for syrup

Carefully: peptic ulcer of the stomach and duodenum in history; bronchial asthma; 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.

Use during pregnancy and lactation

Data on the use of acetylcysteine ​​during pregnancy and breastfeeding are limited. The use of the drug during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

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

Side effects

According to WHO, adverse reactions 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 (≥1/10000, <1/1000); очень редко (<1/10000); частота неизвестна — по имеющимся данным установить частоту возникновения не представлялось возможным.

Allergic reactions: infrequently - pruritus, rash, exanthema, urticaria, angioedema, decreased blood pressure, tachycardia; 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 gastrointestinal tract: infrequently - stomatitis, abdominal pain, nausea, vomiting, diarrhea; heartburn, dyspepsia (except syrup).

From the sense organs: infrequently - tinnitus.

Others: very rarely - headache, fever, isolated reports of the development of bleeding due to the presence of a hypersensitivity reaction, a decrease in platelet aggregation.

Interaction

For all dosage forms

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

Simultaneous administration of acetylcysteine ​​with vasodilators and nitroglycerin may lead to increased vasodilating action.

With simultaneous use with antibiotics for oral administration (including penicillins, tetracyclines, cephalosporins), their interaction with the thiol group of acetylcysteine ​​is possible, which can lead to a decrease in their antibacterial activity. Therefore, the interval between taking antibiotics and acetylcysteine ​​should be at least 2 hours (except for cefixime and loracarbene).

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

Dosage and administration

inside, after meal.

Mucolytic therapy

Adults and children over 14 years of age: 2 tab. effervescent 100 mg 2-3 times a day or 2 packs. ACC ® granules for the preparation of a solution of 100 mg 2-3 times a day, or 10 ml of syrup 2-3 times a day (400-600 mg of acetylcysteine ​​per day).

Children from 6 to 14 years old: 1 tab. effervescent 100 mg 3 times a day or 2 tablets. effervescent 2 times a day, or 1 pack. ACC ® granules for solution 3 times a day or 2 packs. 2 times a day, or 5 ml of syrup 3-4 times a day or 10 ml of syrup 2 times a day (300-400 mg of acetylcysteine ​​per day).

Children from 2 to 6 years old: 1 tab. effervescent 100 mg or 1 pack. ACC ® granules for the preparation of a solution of 100 mg 2-3 times a day, or 5 ml of syrup 2-3 times a day (200-300 mg of acetylcysteine ​​per day).

cystic fibrosis

For patients with cystic fibrosis (a congenital metabolic disorder with frequent infections of the bronchial tract) and weighing more than 30 kg, if necessary, it is possible to increase the dose to 800 mg of acetylcysteine ​​per day.

Children over 6 years old: 2 tab. effervescent 100 mg or 2 pak. ACC ® granules 100 mg for solution 3 times a day, or 10 ml syrup 3 times a day (600 mg acetylcysteine ​​per day).

Children from 2 to 6 years old: 1 tab. effervescent 100 mg or 1 pack. ACC ® granules 100 mg for solution, or 5 ml syrup 4 times a day (400 mg acetylcysteine ​​per day).

Effervescent tablets should be dissolved in 1 glass of water and taken immediately after dissolution, in exceptional cases, you can leave the solution ready for use for 2 hours.

Granules for oral solution (orange) should be dissolved in water, juice or iced tea and taken after meals.

Additional fluid intake enhances the mucolytic effect of the drug. With short-term colds, the duration of administration 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.

ACC ® syrup is taken with a measuring syringe or a measuring cup, which is in the package. 10 ml of syrup corresponds to 1/2 measuring cup or 2 filled syringes.

Using a measuring syringe

1. Open the vial cap by pushing it in and turning it counterclockwise.

2. Remove the plug with a hole from the syringe, insert it into the neck of the vial and press it in until it stops. The stopper is designed to connect the syringe to the vial and remains in the neck of the vial.

3. Insert the syringe firmly into the stopper. Carefully turn the bottle upside down, pull the syringe plunger down and draw up the required amount of syrup. If air bubbles are visible in the syrup, press the plunger all the way down, then refill the syringe. Return the vial to its original position and remove the syringe.

4. The syrup from the syringe should be poured onto a spoon or directly into the child's mouth (in the buccal area, slowly, so that the child can swallow the syrup properly), while taking the syrup, the child should be in an upright position.

5. After use, rinse the syringe with clean water.

Note for diabetic patients: 1 effervescent tablet corresponds to 0.006 XE; 1 pack ACC ® granules for the preparation of a solution of 100 mg corresponds to 0.24 XE; 10 ml (2 measuring spoons) of ready-to-use syrup contain 3.7 g of D-glucitol (sorbitol), which corresponds to 0.31 XE.

Overdose

Symptoms: acetylcysteine ​​at doses up to 500 mg/kg did not cause any symptoms of intoxication. With an erroneous or deliberate overdose, such phenomena as diarrhea, vomiting, stomach pain, heartburn and nausea can be observed. Children may experience hypersecretion of sputum.

Treatment: symptomatic.

special instructions

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

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

Do not take the drug immediately before bedtime (it is recommended to take the drug before 18:00).

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

Special precautions for the disposal of unused medicinal product. There is no need for special precautions when destroying unused product.

extra for syrup

The use of the drug in patients with renal and / or hepatic insufficiency should be avoided in order to avoid additional formation of nitrogenous compounds.

1 ml of syrup contains 41.02 mg of sodium. This should be taken into account when using the drug in patients on a diet aimed at limiting sodium intake (with a reduced sodium / salt content).

Release form

Effervescent tablets, 100 mg.

When packing Hermes Pharma Ges.m.b.Kh., Austria: 20 tab. effervescent in a plastic or aluminum tube. 1 tube of 20 tab. effervescent in a cardboard box.

Granules for oral solution (orange), 100 mg. 3 g granules in bags of combined material (aluminum foil/paper/PE). 20 pack in a cardboard box.

Syrup, 20 mg/ml. In dark glass bottles, sealed with white caps with a sealing membrane, child-resistant, with a protective ring, 100 ml.

Dosing devices:

Transparent measuring cup (cap), graduated at 2.5; 5 and 10 ml;

Transparent dosing syringe, graduated at 2.5 and 5 ml, with white plunger and adapter ring for attaching to the vial.

1 vial together with dosing devices in a cardboard box.

Manufacturer

Effervescent tablets

1. Hermes Pharma Ges.m.b.H., Austria.

2. Hermes Artsnaimittel GmbH, Germany.

Granules for solution preparation

Marketing authorization holder: Sandoz d.d., Verovshkova 57, 1000 Ljubljana, Slovenia.

Produced by: Lindopharm GmbH, Neustraße 82, 40721 Hilden, Germany.

Syrup

Pharma Wernigerode GmbH, Germany.

Marketing authorization holder: Sandoz d.d. Verovshkova 57, Ljubljana, Slovenia.

Instructions for use

ACC instructions for use

Dosage form

The syrup is clear, colorless, slightly viscous, with a cherry smell.

Compound

Acetylcysteine ​​20 mg

Excipients: methyl parahydroxybenzoate - 1.3 mg, sodium benzoate - 1.95 mg, disodium edetate - 1 mg, sodium saccharinate - 1 mg, sodium carmellose - 2 mg, sodium hydroxide (10% aqueous solution) - 30-70 mg, Cherry flavor - 1.5 mg, purified water - 910.25-950.25 mg.

Pharmacodynamics

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 of 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.

Side effects

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.

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

Other: rarely - nosebleeds, rarely - tinnitus.

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).

Selling Features

Released without a prescription

Special conditions

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.

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

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

Paracetamol overdose.

Contraindications

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

Use during pregnancy and lactation

Adequate and strictly controlled clinical studies of the safety of acetylcysteine ​​during pregnancy and lactation have not been conducted.

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 for violations of liver function

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

Application for violations of kidney function

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

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 / 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.

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.

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