Instructions ACC 100 powder for oral solution 100 mg sachet No. 20
Composition
active ingredient: acetylcysteine;
1 sachet contains acetylcysteine 100 mg;
excipients: sucrose, ascorbic acid, saccharin, orange flavoring.
Dosage form
Powder for oral solution.
Main physicochemical properties: white to yellowish powder, possible presence of agglomerates, with an orange odor.
Pharmacotherapeutic group
Mucolytics. ATC code R05C B01.
Pharmacological properties
Pharmacodynamics
Acetylcysteine (ACC) is a mucolytic, expectorant agent 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. The mucolytic effect of the drug is of a chemical nature. Due to the free sulfhydryl group, acetylcysteine breaks the disulfide bonds of acidic mucopolysaccharides, which leads to depolymerization of sputum mucoproteins and a decrease in mucus viscosity, and promotes expectoration and discharge of bronchial secretions. The drug remains active in the presence of purulent sputum.
Acetylcysteine also has antioxidant pneumoprotective properties, which is due to the binding of chemical radicals with its sulfhydryl groups and, thus, their neutralization. In addition, the drug promotes the increase in the synthesis of glutathione - an important factor of intracellular protection not only against oxidative toxins of exogenous and endogenous origin, but also against a number of cytotoxic substances. This feature of acetylcysteine makes it possible to effectively use the latter in case of paracetamol overdose.
Pharmacokinetics
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 further mixed disulfides. Bioavailability is very low - about 10%. Maximum plasma concentration is reached 1-3 hours after administration. Plasma protein binding is approximately 50%. Acetylcysteine is excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine).
The elimination half-life is determined mainly by rapid biotransformation in the liver and is approximately 1 hour. In case of reduced liver function, the half-life is prolonged to 8 hours.
Indication
Treatment of acute and chronic diseases of the bronchopulmonary system that require reducing the viscosity of sputum, improving its discharge and expectoration.
Contraindication
Hypersensitivity to acetylcysteine or to other components of the drug. Gastric and duodenal ulcer in the acute stage, hemoptysis, pulmonary hemorrhage.
Interaction with other medicinal products and other types of interactions
The use of antitussives with acetylcysteine may increase sputum congestion due to a decrease in the cough reflex.
When used simultaneously with antibiotics such as tetracyclines (except doxycycline), ampicillin, amphotericin B, cephalosporins, aminoglycosides, their interaction with the thiol group of acetylcysteine is possible, which leads to a decrease in the activity of both drugs. Therefore, the interval between the use of these drugs should be at least 2 hours. This does not apply to cefixime and loracarbef.
Activated charcoal reduces the effectiveness of acetylcysteine.
It is not recommended to dissolve acetylcysteine with other drugs in the same glass.
Acetylcysteine reduces the hepatotoxic effect of paracetamol.
Synergism of acetylcysteine with bronchodilators is noted.
Acetylcysteine can be a cysteine donor and increase glutathione levels, which helps detoxify oxygen free radicals and certain toxic substances in the body.
Concomitant administration of nitroglycerin and acetylcysteine may lead to an increase in the vasodilating effect of nitroglycerin.
Upon contact with metals or rubber, sulfides with a characteristic odor are formed, so glassware should be used to dissolve the drug.
Application features
It is recommended to use the drug with caution in patients with a history of gastric and duodenal ulcers, especially in case of concomitant use of other medications that irritate the gastric mucosa.
There are isolated reports of severe skin reactions (Stevens-Johnson and Lyell syndromes) when taking acetylcysteine, therefore, in the event of changes in the skin or mucous membranes, you should immediately stop using the drug and consult a doctor regarding its further use.
Acetylcysteine should be prescribed with caution to patients with bronchial asthma due to the possible development of bronchospasm. If the contents of the sachet are poured into dishes during the preparation of the solution, the powder may enter the air and irritate the nasal mucosa, which may result in reflex bronchospasm.
The use of acetylcysteine causes liquefaction of bronchial secretions. If the patient is unable to cough up sputum effectively, postural drainage and bronchoaspiration are necessary.
Acetylcysteine affects histamine metabolism, so long-term therapy should not be prescribed to patients with histamine intolerance, as this may lead to symptoms of intolerance (headache, vasomotor rhinitis, itching).
The drug contains sucrose, so it should not be prescribed to patients with rare hereditary forms of fructose intolerance, sucrase-isomaltase deficiency or glucose-galactose malabsorption syndrome.
One sachet of ACC® 100 contains 2.8 g of sucrose (approximately 0.24 bread units); one sachet of ACC® 200 contains 2.7 g of sucrose (approximately 0.23 bread units). This should be taken into account when using the drug in patients with diabetes.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Use during pregnancy or breastfeeding
During pregnancy or breastfeeding, the use of acetylcysteine is possible only if the expected benefit to the mother outweighs the potential risk to the fetus or child.
Method of administration and doses
Adults and children over 14 years of age are prescribed 400-600 mg of acetylcysteine per day, divided into 1-3 doses.
Children from 6 to 14 years old are prescribed 400-600 mg per day, divided into 2-3 doses.
Children from 2 to 6 years old are prescribed 200-400 mg per day, divided into 2 doses.
The drug is recommended to be taken after meals. Dissolve the contents of the sachet in ½ glass of water, juice or cold tea. After preparing the solution, it should be drunk as soon as possible. In some cases, due to the presence of a stabilizer - ascorbic acid - in the composition of the drug, the prepared solution can be left for about 2 hours before use. Additional fluid intake enhances the mucolytic effect of the drug.
The duration of treatment for chronic diseases is determined by the doctor depending on the nature and course of the disease. In acute uncomplicated diseases, acetylcysteine is used for 5-7 days.
Children
Used for children from 2 years old.
Overdose
There are no data on cases of overdose with oral administration of acetylcysteine.
Symptoms: nausea, vomiting, diarrhea. Children are at risk of hypersecretion.
Therapy: treatment is symptomatic.
Adverse reactions
The following classification is used to describe the frequency of side effects: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000), very rare (< 1/10000).
From the cardiovascular system: infrequently - tachycardia, arterial hypotension.
From the nervous system: infrequently - headache.
Skin: infrequently - allergic reactions (itching, urticaria, exanthema, eczema, rashes, angioedema).
On the part of the organ of hearing: infrequently - ringing in the ears.
On the part of the respiratory system: rarely - dyspnea, bronchospasm (mainly in patients with bronchial hyperreactivity associated with bronchial asthma), rhinorrhea.
On the part of the digestive tract: infrequently - heartburn, dyspepsia, stomatitis, abdominal pain, nausea, vomiting, diarrhea, bad breath.
General disorders: uncommon - fever.
Isolated severe skin reactions (Stevens-Johnson and Lyell syndromes) have been reported. Bleeding has been reported very rarely with the use of acetylcysteine, most often associated with the development of hypersensitivity reactions. There have been cases of decreased platelet aggregation, but there is no clinical confirmation of this. Angioedema, facial edema, cases of anemia, hemorrhage, anaphylactic reactions or even shock have been reported very rarely.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
3 g of powder per sachet. 20 sachets per carton.
Vacation category
Without a prescription.
Producer
Salutas Pharma GmbH, Germany
Location of the manufacturer and its business address
Otto-von-Guericke-Allee, 1, 39179 Barleben, Germany.
