ACC 200 sachets instructions for use. Effervescent tablets ACC: instructions for use for cough. Contraindications and side effects of "ACC"

HEXAL HEXAL/ Salutas Pharma GmbH Hexal AG Hermes Pharma Ges. M.b.H./ Salutas Pharma GmbH Lindopharm GmbH/Salutas Pharma GmbH OTHERS Salutas Pharma GmbH Salutas Pharma GmbH/Hexal AG

Country of origin

Austria/Germany Germany Russia Slovenia

Product group

Respiratory system

Mucolytic drug

Release forms

  • Granules for preparing a solution for oral administration, 3 g each - sachets - 20 pcs per pack. Effervescent tablets - 20 pcs per pack.

Description of the dosage form

  • Granules for the preparation of a solution for oral administration (orange) are white, homogeneous, without agglomerates, with the smell of orange. Granules for the preparation of a solution for oral administration are white, homogeneous, no more than 1.5 mm in size, without agglomerates and mechanical impurities, with the smell of lemon and honey. Effervescent tablets are white, round, flat, scored, with a blackberry scent.

Pharmacological action

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. 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.

Pharmacokinetics

ACC® is well absorbed when taken orally. Due to the high “first pass” effect through the liver, the bioavailability of ACC® is about 10%. The maximum concentration in blood plasma is reached after approximately 1 hour. The half-life from plasma is 2 hours. Acetylcysteine ​​and its metabolites are excreted mainly by the kidneys.

Special conditions

For bronchial asthma and obstructive bronchitis, acetylcysteine ​​should be prescribed with caution under systematic monitoring of bronchial patency. If side effects develop, you should stop taking the drug. When dissolving the drug, it is necessary to use glass containers and avoid contact with metals, rubber, oxygen, and easily oxidized substances. 1 effervescent tablet ACC 100 and ACC 200 corresponds to 0.006 XE. 1 effervescent tablet ACC LONG corresponds to 0.01 XE. ACC (in the form of granules for the preparation of an oral solution of 200 mg) corresponds to 0.21 XE, ACC (in the form of granules for the preparation of an oral solution of 600 mg) - 0.17 XE. ACC (in granules for the preparation of a solution for oral administration 100 mg and 200 mg with the scent of orange) 100 mg corresponds to 0.24 XE, 200 mg - 0.23 XE. Use in pediatrics Children under 6 years of age are recommended to prescribe the drug in dosage forms with a lower content of acetylcysteine.

Compound

  • Acetylcysteine ​​200 mg Excipients: ascorbic acid, citric acid anhydride, lactose anhydride, mannitol, sodium citrate, sodium bicarbonate, saccharin, blackberry flavoring "B". Acetylcysteine ​​200 mg Excipients: ascorbic acid, saccharin, sucrose (sucrose), orange flavor. Acetylcysteine ​​200 mg Excipients: ascorbic acid, saccharin, sucrose (sucrose), lemon and honey flavors.

ACC 200 indications for use

  • - diseases of the respiratory system, accompanied by increased formation of viscous mucus that is difficult to separate (acute and chronic bronchitis, obstructive bronchitis, pneumonia, bronchiectasis, bronchial asthma, bronchiolitis, cystic fibrosis, laryngitis); - acute and chronic sinusitis; - otitis media.

ACC 200 contraindications

  • - peptic ulcer of the stomach and duodenum in the acute phase; - hemoptysis; - pulmonary hemorrhage; - pregnancy; - lactation period (breastfeeding); - 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); - hypersensitivity to acetylcysteine ​​and other components of the drug. The drug should be used with caution 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. ACC LONG should not be prescribed to children under 14 years of age. In this category of patients, it is recommended to use oral dosage forms with a lower acetylcysteine ​​content.

ACC 200 dosage

  • 200 mg

ACC 200 side effects

  • From the side of the central nervous system: rarely - headache, tinnitus. From the digestive system: rarely - stomatitis; in some cases - diarrhea, vomiting, heartburn and nausea. From the cardiovascular system: in some cases - drop in blood pressure, tachycardia. From the respiratory system: in isolated cases - the development of pulmonary hemorrhage as a manifestation of a hypersensitivity reaction. Allergic reactions: in isolated cases - bronchospasm (mainly in patients with a hyperreactive bronchial system with bronchial asthma), skin rash, itching and urticaria.

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. There is a synergism between acetylcysteine ​​and bronchodilators. Pharmaceutical interactions Acetylcysteine ​​is pharmaceutically incompatible with antibiotics (penicillins, cephalosporins, erythromycin, tetracycline and amphotericin B) and proteolytic enzymes. Acetylcysteine ​​reduces the absorption of cephalosporins, penicillins and tetracycline, so they should be taken orally no earlier than 2 hours after taking acetylcysteine. When acetylcysteine ​​comes into contact with metals and rubber, sulfides with a characteristic odor are formed.

Storage conditions

  • store in a dry place
  • keep away from children
Information provided by the State Register of Medicines.

Synonyms

  • Acetylcysteine, ACC 100, ACC-Long, Mukonex, Fluimucil, Exomyuk 200, N-AC-Ratiopharm

Instructions for the drug ACC 200: description of the drug, annotation, in what doses to take it, composition, contraindications and side effects.

Instructions for medical use of the drugACC® 200 / ACC® 200

Trade name

International nonproprietary name

Acetylcysteine

Dosage form

Powder for solution for oral administration 200 mg

Composition of the drug ACC 200

1 sachet (bag) with 3 g of powder contains

active substance - acetylcysteine ​​200 mg

excipients: ascorbic acid (vitamin C), saccharin, sucrose, orange flavor.

Description of the drug ACC 200

Fine, homogeneous, white or yellowish powder with an orange odor.

The resulting solution: colorless, slightly opalescent, with the smell of orange.

Pharmacotherapeutic group

Expectorants. Mucolytics.

ATC code R05 CB01

Pharmacological properties

Pharmacokinetics

After oral administration, acetylcysteine ​​(ACC 200) is rapidly absorbed from the gastrointestinal tract (GIT) and metabolized in the liver into cysteine, a pharmacologically active metabolite, as well as into 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 prolonged plasma elimination half-lives 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 (in 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 ACC 200

Mucolytic therapy of acute and chronic bronchopulmonary diseases accompanied by impaired secretion and transport 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).

For cystic fibrosis

Children over 6 years of age

1 sachet of powder 3 times a day (corresponds to 600 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.

In the case of chronic bronchitis and cystic fibrosis, long-term treatment should be carried out to prevent infection.

Preparation of the solution:

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

Side effects on ACC 200

Rarely (³ 0.1% -< 1%): стоматит, диарея, рвота, изжога и тошнота, головная боль, шум в ушах; кровотечения, частично связанные с реакциями повышенной чувствительности; снижение агрегации тромбоцитов

Very rarely (<0,01%): аллергические реакции - зуд, крапивница, кожная сыпь, бронхиолоспазм, тахикардия и артериальная гипотензия.

Reports regarding bronchiolospasm primarily concerned patients with increased bronchial system reactivity associated with bronchial asthma.

Contraindications to the drug ACC 200

Hypersensitivity to acetylcysteine ​​or any other component of the drug

Kidney failure

Liver failure.

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.

Tetracycline chloride should be administered separately and at least two hours apart.

Reports regarding inactivation of antibiotics (semisynthetic penicillins, tetracyclines, cephalosporins and aminoglycosides) resulting from concomitant use of acetylcysteine ​​or other mucolytic drugs are based solely on laboratory experiments in which the relevant substances were directly mixed. However, for safety reasons, oral antibiotics should be administered separately at least two hours apart.

In cases of simultaneous administration of nitroglycerin (glycerol trinitrate) with acetylcysteine, an increase in its vasodilatory effect and inhibitory effect on platelet aggregation was observed. The clinical significance of these data has not yet been established.

Special instructions

The secretolytic effect of ACC® is supported by sufficient fluid intake.

Caution should be exercised when prescribing ACC to patients with a history of bronchial asthma or peptic ulcer disease.

Pregnancy and lactation

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

The drug does not affect the ability to concentrate.

Overdose

Not identified

Release form and packaging

ACC® 200 is available in sachets/bags of 3 g; No. 20, 50 or 100 sachets in a cardboard box along with enclosed instructions for use.

Storage conditions

Store at a temperature not exceeding +30°C.

Keep out of the reach of children!

Shelf life

Do not use after the expiration date stated on the packaging.

Vacation conditions

Over the counter

Manufacturer

Salutas Pharma GmbH

Otto von Guericke Allee 1

D-39179, Barleben, Germany

Hexal AG, Germany Industrialstrasse 25

D-83607 Holzkirchen, Germany

Salutas Pharma GmbH

Otto-von-Guericke-Allee-1

D-39179, Barleben, Germany

Hexal AG, Germany Industriestraβe 25 D-83607 Holzkirchen, Germany

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The drug is in powder form for the preparation of a solution for oral use. ACC 200- mucolytic agent.
The presence of sulfhydryl groups in the structure of acetylcysteine ​​promotes the rupture of disulfide bonds of acidic mucopolysaccharides of sputum, which leads to a decrease in the viscosity of mucus. 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 for use

ACC 200 recommended for respiratory diseases accompanied by the formation of viscous, difficult to separate sputum: acute and chronic bronchitis, obstructive bronchitis, laryngotracheitis, pneumonia, bronchiectasis, bronchial asthma, bronchiolitis, cystic fibrosis.
Acute and chronic sinusitis, inflammation of the middle ear (otitis media).

Directions for use

In the absence of other prescriptions, it is recommended to adhere to the following dosages ACC 200:
Mucolytic therapy:
Adults and adolescents over 14 years of age are recommended to take 1 sachet of ACC 200 mg 2 - 3 times a day (400 - 600 mg per day).
Children aged 6 to 14 years are recommended to take ACC 200 mg 3 times a day, ½ sachet or 2 times a day, 1 sachet (300 - 400 mg per day).
Children aged 2 to 5 years are recommended to take 2-3 times a day, ½ sachet of ACC 200 mg (200-300 mg per day).
Cystic fibrosis:
Children over 6 years of age are recommended to take 1 sachet of ACC 200 mg (600 mg per day) 3 times a day. Children aged 2 to 5 years are recommended to take ½ sachet of ACC 200 mg 4 times a day (400 mg per day). For patients with cystic fibrosis and a body weight of more than 30 kg, if necessary, the dose can be increased to 800 mg of acetylcysteine ​​per day. The granules should be dissolved in water, juice or iced tea and taken after meals.

Side effects

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

Contraindications

Contraindications to the use of the drug ACC 200 are: hypersensitivity to acetylcysteine ​​or other components of the drug, pregnancy, breastfeeding, children under 2 years of age.
With caution - peptic ulcer of the stomach and duodenum in the acute stage; hemoptysis, pulmonary hemorrhage, esophageal varices, bronchial asthma, adrenal diseases, liver and/or kidney failure.

Pregnancy

:
For safety reasons, due to insufficient data, the prescription of the drug ACC 200 during pregnancy and lactation is possible only if the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Interaction with other drugs

With the simultaneous use of acetylcysteine ​​and antitussives, mucus stagnation may occur due to suppression of the cough reflex. Therefore, such combinations should be selected with caution.
The simultaneous use of acetylcysteine ​​and nitroglycerin can lead to an increase in the vasodilatory effect of the latter.
Pharmaceutically incompatible with antibiotics (penicillins, cephalosporins, erythromycin, tetracycline and amphotericin B) and proteolytic enzymes.
Upon contact with metals and rubber, sulfides with a characteristic odor are formed.
Reduces the absorption of penicillins, cephalosporins, tetracycline (they should be taken no earlier than 2 hours after ingestion of acetylcysteine).

Overdose

In case of mistaken or intentional overdose ACC 200 phenomena such as diarrhea, vomiting, stomach pain, heartburn and nausea are observed.
To date, no severe or life-threatening side effects have been observed.

Storage conditions

At a temperature not higher than 25°C. Keep out of the reach of children.

Release form

3 g of granulate in bags made of three-layer material (aluminium-paper-polythene).
20 or 50 sachets in a cardboard box.

Compound

1 bag of granules weighing 3 g ACC 200 for the preparation of a solution for oral administration contains: 200 mg of acetylcysteine.
Excipients: sucrose, ascorbic acid, saccharin, orange flavor.

Additionally

Instructions for patients with diabetes.
1 sachet ACC 200 mg corresponds to 0.23 BE.
For patients with bronchial asthma and obstructive bronchitis, acetylcysteine ​​should be prescribed with caution under systematic monitoring of bronchial patency.
When treating patients with diabetes, it is necessary to take into account that the drug contains sucrose.
When working with the drug, you must use glass containers and avoid contact with metals, rubber, oxygen, and easily oxidized substances.

Basic parameters

Name: ACC 200
ATX code: R05CB01 -

Children's immunity develops gradually. This is the reason for special susceptibility to colds. One of the most unpleasant symptoms of a cold is a cough.

It can be dry and wet. A dry cough causes pain and discomfort in the throat area. To treat it, ACC powder is prescribed for children.

This article discusses the instructions for using ACC powder (100 and 200 mg) for children, collects reviews from parents about the children's medicine, and indicates the price of the drug.

Composition and pharmacological properties

ACC is a medical drug to combat. Produced in Germany and Slovenia, has an expectorant and anti-inflammatory effect.

The main active ingredient of the drug is acetylcysteine. Auxiliary components are sodium saccharinate, ascorbic acid, sucrose and flavoring.

The drug is available in tablet and powder format. The second option is prescribed in childhood.

The package of the drug contains 20 packets of granules. They are white in color and have a pleasant aroma. Depending on the additive, it can be lemon, orange or honey.

ACC gives an expectorant effect. It is also prescribed when purulent type of sputum occurs.

It is possible to use the drug for preventive purposes, for chronic diseases of the respiratory system.

Indications

ACC powder is prescribed for any type of disease accompanied by sputum production in the pulmonary tract.

Preparation makes cough more productive. The active component reduces the inflammatory process, making the child feel better.

Indications specified in the instructions for the medicine:

Before prescribing the drug, The doctor should listen to the child's breathing with a stethoscope.

In the presence of viscous and thick sputum, exhalation will be prolonged, and breathing will be heavy, with moist wheezing.

Contraindications

Prescription of the dosage of the drug in the presence of diseases of the gastrointestinal tract is carried out with caution.

If you have individual histamine intolerance, long-term use of ACC is not recommended.

Doctors advise using ACC with caution if you are prone to varicose veins in the esophagus.

In case of renal or liver failure during treatment, it is necessary to monitor the condition of the organs through testing.

Direct contraindications to taking medicinal granules:

  • bleeding in the lung area;
  • presence of sensitivity to the components of the drug;
  • acute form of gastrointestinal diseases;
  • age up to 2 years;
  • fructose intolerance.

How quickly it helps

Active component of the drug has mucus thinning properties through the process of depolymerization of mucoproteins.

The antioxidant effect is based on the ability to bind to oxidative radicals, eliminating their viability. The intensity of the inflammatory process decreases.

The process of metabolism of the active substances of the drug is carried out in the liver. The maximum concentration of components in blood cells is reached approximately 2 hours after administration. The elimination process is carried out by the kidneys.

Sputum discharge is noted on the first day of using the drug.

Complete disappearance of the cough reflex occurs after a full course of treatment. Its duration depends on the severity of the disease.

Dosage - 100 or 200 mg

How to drink ACC powder for children? Mucolytic therapy involves following the dosage prescribed by the doctor.

At the age of 2 to 6 years, it is allowed to take 100 mg of the drug no more than 3 times a day. At the age of 6 to 14 years, a single dose is 200 mg. But the number of receptions remains the same.

The daily dose for adolescents over the age of 14 years is 400-600 mg of the drug per day. This amount is spread over 2 doses.

In severe cases of the disease, the dosage is increased. If the child’s body weight exceeds 30 kg, then the daily dose of the drug can reach 800 mg.

How to dilute and take, special instructions

Before use, ACC powder must be dissolved in hot water. For 100 mg of the drug you will need 100 ml of liquid.

The resulting ACC solution (suspension) for children is taken orally, hot, regardless of food.

Without supervision from medical representatives, the drug can be used for no longer than 5 days. In case of complications of the disease, the course of treatment is extended. But this nuance is discussed with the attending physician.

If you have diabetes mellitus, ACC should be used with caution. The composition of the drug includes sucrose. This is taken into account when prescribing dosage.

Possibility of combination with other substances

Combining ACC powder with agents of a similar effect can lead to stagnation of mucus in the respiratory organs.

Simultaneous use with antibiotics such as tetracycline, penicillin and cephalosporin is undesirable. Acetylcysteine ​​reduces the antibacterial effect of these components.

ACC increases the vasodilatory effect of nitroglycerin, so it is advisable to reduce its dosage.

Any combination of ACC with medications is discussed with a pediatrician to prevent possible side effects.

Overdose and side effects

Overdose is possible during treatment Therefore, you should follow the dosage regimen prescribed by your doctor.

Exceeding the dosage is fraught with the appearance of characteristic symptoms. These include stomach pain, stool disturbances, nausea, and heartburn.

In this case, gastric lavage is indicated. You should remain in bed and stop using the drug.

Side effects may occur during treatment:

There are two packaging volume options - 100 and 200 mg. The package contains 20 serving packets.

The cost of a medicine with a dosage of 100 mg is 130 rubles. In some areas it reaches 150 rubles. The average price of a package with a dosage of 200 mg is 180 rubles.

The optimal storage temperature should not exceed 25 degrees. The powder package should be stored in a place protected from light.

The shelf life is 4 years from the date of issue. After its expiration, it is prohibited to use the drug.