Instructions ACC 200 effervescent tablets 200 mg No. 20
Composition
active ingredient: acetylcysteine;
1 tablet contains acetylcysteine 200 mg;
excipients: anhydrous citric acid, sodium bicarbonate, anhydrous sodium carbonate, mannitol (E 421), anhydrous lactose, ascorbic acid, sodium citrate, sodium saccharin, blackberry flavoring "B" (contains sorbitol (E 420).
Dosage form
Effervescent tablets.
Main physicochemical properties: white, round, flat tablets with a blackberry odor and a score on one side.
Pharmacotherapeutic group
Medicines used for coughs and colds. Mucolytics.
ATX code R05C B01.
Pharmacological properties
Pharmacodynamics
Acetylcysteine (ACC) is a mucolytic expectorant used to thin sputum in respiratory diseases accompanied by the formation of thick mucus. Acetylcysteine is a derivative of the amino acid cysteine. The mucolytic effect of the drug is chemical in 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, severe exacerbation of bronchial asthma.
Interaction with other medicinal products and other types of interactions
Interaction studies were conducted only with adults.
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.
Concomitant administration of nitroglycerin and acetylcysteine has been associated with significant hypotension and significant temporal artery dilation. If concomitant administration of nitroglycerin and acetylcysteine is necessary, patients should be monitored for hypotension, which may be severe, and should be warned of the possibility of headache.
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.
Upon contact with metals or rubber, sulfides with a characteristic odor are formed, so glassware should be used to dissolve the drug.
Impact on laboratory tests.
Acetylcysteine may interfere with the colorimetric assay of salicylates and the determination of ketone bodies in urine.
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.
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).
Acetylcysteine should be administered with caution to patients with a history of bronchial asthma.
Patients with bronchial asthma should be closely monitored during treatment due to the possible development of bronchospasm. In the event of bronchospasm, treatment with acetylcysteine should be discontinued immediately.
Acetylcysteine should be administered with caution to patients with liver or kidney disease to avoid the accumulation of nitrogenous substances in the body.
The use of acetylcysteine, especially at the beginning of treatment, may cause liquefaction of bronchial secretions and increase their volume, especially in children under 2 years of age. If the patient is unable to cough up sputum effectively, postural drainage and bronchoaspiration are necessary.
Effervescent tablets contain sodium compounds. 1 tablet of 200 mg contains 4.3 mmol (or 99 mg) of sodium. This should be taken into account by patients on a controlled sodium diet and caution should be exercised.
Since the medicinal product contains sorbitol (E 420), patients with rare hereditary problems of fructose intolerance should not take this medicine.
The drug contains lactose, therefore patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not use it.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect.
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 should be prescribed 400–600 mg of acetylcysteine per day, divided into 1–3 doses.
Children aged 6 to 14 years should be prescribed 400–600 mg per day, divided into 2–3 doses.
Children aged 2 to 6 years should be prescribed 200–400 mg per day, divided into 2 doses.
The drug is recommended to be taken after meals. The tablet should be dissolved in a glass of water and the solution should be drunk as soon as possible. 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 should be used for 4–5 days.
Children
Use for children over 2 years of age.
Overdose
There are no reports of overdose with oral acetylcysteine. Volunteers have taken 11.6 g of acetylcysteine per day for 3 months without any serious adverse effects. Oral doses of up to 500 mg acetylcysteine/kg body weight/day have been tolerated without any symptoms of intoxication.
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 organs 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 acetylcysteine, most often in association with hypersensitivity reactions. There have been cases of decreased platelet aggregation, but there is no clinical evidence for this. Angioedema, facial edema, anemia, hemorrhage, anaphylactic reactions, or even anaphylactic shock have been reported very rarely.
Expiration date
2 years.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep the tube tightly closed.
Packaging
20 tablets in a tube; 1 tube in a cardboard box.
Vacation category
Without a prescription.
Producer
Salutas Pharma GmbH
Location of the manufacturer and its business address
Otto-von-Güricke-Allee 1, 39179, Barleben, Germany.
