In this article you can read the instructions for use of the drug Acetylcysteine. Reviews of site visitors - consumers of this medicine, as well as the opinions of specialist doctors on the use of Acetylcysteine in their practice are presented. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not stated by the manufacturer in the annotation. Acetylcysteine analogues in the presence of existing structural analogues. Use for the treatment of bronchitis, pneumonia and other diseases accompanied by cough with sputum in adults, children, as well as during pregnancy and lactation. Composition of the drug.
Acetylcysteine- mucolytic agent, 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.
Compound
Acetylcysteine + excipients.
Pharmacokinetics
When taken orally, it is well absorbed from the gastrointestinal tract. Substantially undergoes first pass effect through the liver, resulting in decreased 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.
Indications
Respiratory diseases and conditions accompanied by the formation of viscous and mucopurulent sputum:
Removal of viscous secretions from the respiratory tract in post-traumatic and postoperative conditions.
Paracetamol overdose.
Release forms
Effervescent tablets 200 mg and 600 mg.
Powder for solution for oral administration 100 mg and 200 mg.
Solution for inhalation.
Instructions for use and dosage regimen
Inside. Adults - 200 mg 2-3 times a day in the form of granules, tablets or capsules.
Children 2-6 years old - 200 mg 2 times a day or 100 mg 3 times a day in the form of a water-soluble granulate; under 2 years - 100 mg 2 times a day; 6-14 years - 200 mg 2 times a day.
For chronic diseases for several weeks: adults - 400-600 mg per day in 1-2 doses; children 2-14 years old - 100 mg 3 times a day; for cystic fibrosis - children from 10 days to 2 years - 50 mg 3 times a day, 2-6 years - 100 mg 4 times a day, over 6 years - 200 mg 3 times a day in the form of a water-soluble granulate, effervescent tablet or capsules .
Inhalation. For aerosol therapy, 20 ml of a 10% solution or 2-5 ml of a 20% solution are sprayed in ultrasound devices; in devices with a distribution valve - 6 ml of a 10% solution. Duration of inhalation - 15-20 minutes; frequency - 2-4 times a day. When treating acute conditions, the average duration of therapy is 5-10 days; for long-term therapy of chronic conditions, the course of treatment is up to 6 months. In the case of a strong secretolytic effect, the secretion is sucked out, and the frequency of inhalations and the daily dose are reduced.
Intratracheal. To wash the bronchial tree during therapeutic bronchoscopy, use a 5-10% solution.
Locally. 150-300 mg is instilled into the nasal passages (for 1 procedure).
Parenterally. Administer intravenously (preferably dropwise or slowly in a stream over 5 minutes) or intramuscularly. Adults - 300 mg 1-2 times a day.
Children from 6 to 14 years old - 150 mg 1-2 times a day. For children under 6 years of age, oral administration is preferable; for children under 1 year of age, intravenous administration of acetylcysteine is possible only for health reasons in a hospital setting. If there are still indications for parenteral therapy, the daily dose for children under 6 years of age should be 10 mg/kg body weight.
For intravenous administration, the solution is further diluted with 0.9% NaCl solution or 5% dextrose solution in a 1:1 ratio.
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.
Side effect
Contraindications
Use during pregnancy and breastfeeding
The use of Acetylcysteine is contraindicated during pregnancy and lactation (breastfeeding).
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.
Orally for children over 6 years old - 200 mg 2-3 times a day; children aged 2 to 6 years - 200 mg 2 times a day or 100 mg 3 times a day, up to 2 years - 100 mg 2 times a day.
special instructions
Acetylcysteine is used with caution in patients with bronchial asthma, diseases of the liver, kidneys, and adrenal glands.
A 1-2 hour interval should be observed between taking acetylcysteine and antibiotics.
Acetylcysteine reacts with some materials such as iron, copper and rubber used in the spray device. In places of possible contact with acetylcysteine solution, parts made of the following materials should be used: glass, plastic, aluminum, chromed metal, tantalum, sterling silver or stainless steel. After contact, silver may tarnish, but this does not affect the effectiveness of acetylcysteine and does not cause harm to the patient.
Drug interactions
The simultaneous use of acetylcysteine with antitussives may increase sputum stagnation due to suppression of the cough reflex.
When used simultaneously with antibiotics (including tetracycline, ampicillin, amphotericin B), their interaction with the thiol group of acetylcysteine is possible.
When taking acetylcysteine and nitroglycerin simultaneously, the vasodilator and antiplatelet effects of the latter may be enhanced.
Acetylcysteine reduces the hepatotoxic effect of paracetamol.
Pharmaceutically incompatible with solutions of other drugs. On contact with metals and rubber, it forms sulfides with a characteristic odor.
Analogues of the drug Acetylcysteine
Structural analogues of the active substance:
Analogs by pharmacological group (secretolytics):
If there are no analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps, and look at the available analogues for the therapeutic effect.
Acetylcysteine
soluble tablets
Merkle GmbH, Germany
1 tablet contains:
active substance: acetylcysteine 200.00 mg / 600.00 mg;
excipients: anhydrous citric acid 843.03 mg/648.99 mg, sodium bicarbonate 695.64 mg/548.72 mg, lemon flavor 100.00 mg/100.00 mg, adipic acid 100.00 mg/12.83 mg, fine adipic acid 20.00 mg/48.99 mg, povidone 21.33 mg/20.47 mg, aspartame 20.00 mg/20.00 mg.
Pharmacotherapeutic group:
Expectorant mucolytic agent
S.01.X.A.08 Acetylcysteine
R.05.C.B.01 Acetylcysteine
Pharmacodynamics:
Acetylcysteine has a mucolytic effect on sputum (mucus) in the lumen of the bronchial tract, determined by its secretolytic and secretomotor properties. The drug dilutes sputum, increasing its volume, making it easier to separate. Its effect continues even in the presence of purulent sputum.
The mechanism of action of acetylcyteine is based on the ability of the sulfhydryl groups of the drug to break the disulfide bonds of acidic mucopolysaccharides of sputum, which leads to depolarization of mucoproteins and a decrease in mucus viscosity.
Helps increase the synthesis of glutathione, which is an antioxidant factor of intracellular protection and ensures the maintenance of the functional activity and morphological integrity of the cells of the mucous membrane of the respiratory tract, which, in particular, explains its effectiveness as an antidote for paracetamol poisoning.
Due to the ability of sulfhydryl groups to neutralize electrophilic oxidative toxins, acetylcysteine has an antioxidant effect.
It also has moderate anti-inflammatory properties (by suppressing the formation of free radicals and reactive oxygen species responsible for the development of inflammation in the lung tissue).
Pharmacokinetics:
When taken orally, acetylcysteine is well absorbed from the gastrointestinal tract. Subject to the “first pass” effect through the liver, it is metabolized to form cysteine, diacetylcysteine, cystine and disulfides, which reduces the bioavailability of the drug to 10%. The maximum concentration of acetylcysteine in the blood plasma is achieved after 1-3 hours, and in patients with impaired liver function - after 8 hours.
The therapeutic effect is observed after 30-90 minutes and lasts for 2-4 hours.
It is excreted mainly by the kidneys in the form of inactive metabolites, a small part is excreted unchanged through the intestines.
Penetrates the placental barrier and accumulates in the amniotic fluid.
Respiratory diseases and conditions accompanied by the formation of viscous, difficult to separate mucopurulent sputum:
Acute and chronic bronchitis;
Chronic obstructive pulmonary disease (COPD);
Tracheitis due to bacterial and/or viral infection;
Bronchiolitis;
Pneumonia;
Bronchial asthma;
Bronchiectasis;
Atelectasis due to blockage of the bronchi by mucus plug;
Cystic fibrosis (as part of combination therapy);
Removal of viscous secretions from the respiratory tract in post-traumatic and postoperative conditions;
Catarrhal and purulent otitis, sinusitis, including sinusitis (facilitation of secretion).
The drug is used in the treatment of paracetamol overdose.
Known hypersensitivity to acetylcysteine or other ingredients of the finished dosage form;
Pregnancy, breastfeeding period;
Peptic ulcer of the stomach and duodenum in the acute phase;
Phenylketonuria;
Children up to 14 years of age (for 600 mg tablets): children up to 2 years of age (for 200 mg tablets).
Carefully:
Acetylcysteine is used with extreme caution in patients with bronchial asthma, liver disease, kidney disease, adrenal dysfunction, varicose veins of the esophagus, in persons prone to pulmonary hemorrhage, hemoptysis, arterial hypotension, histamine intolerance (long-term use of the drug should be avoided, since acetylcysteine affects histamine metabolism and can lead to signs of intolerance such as headache, vasomotor rhinitis, itching).
Adverse effects are classified according to their frequency of development as follows: very often (≥ 1/10), often (≥1/100,
From the central nervous system: rarely - headache, drowsiness.
From the gastrointestinal tract: rarely - heartburn, nausea, vomiting, diarrhea, stomatitis, feeling of fullness in the stomach.
Allergic reactions: uncommon - skin rash, itching, urticaria, tachycardia, decreased blood pressure, angioedema; rarely - bleeding, partially associated with a hypersensitivity reaction; very rarely - anaphylactic reactions up to anaphylactic 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 senses: infrequently - tinnitus.
Other: rarely - nosebleeds, rhinorrhea, fever, decreased platelet aggregation.
If unwanted side effects occur, you should consult a doctor.
With the simultaneous use of acetylcysteine and antitussives, sputum stagnation may increase due to suppression of the cough reflex, therefore such combined treatment should only be carried out under direct medical supervision.
There is evidence that the thiol group of acetylcysteine can neutralize the activity of some antibiotics (amphotericin B, ampicillin, tetracyclines, excluding doxycycline, semisynthetic penicillins, cephalosporins, aminoglycosides). Therefore, it is advisable to take these antibiotics orally 2 hours after taking acetylcysteine.
It has also been established that antibiotics such as amoxicillin, doxycycline, erythromycin, thiamphenicol, and cefuroxime do not interact with acetylcysteine.
There are reports that the simultaneous use of acetylcysteine and nitroglycerin can lead to an increase in the vasodilatory effect of the latter and a decrease in platelet aggregation.
Acetylcysteine reduces the hepatotoxic effect of paracetamol.
Orally, after meals, after dissolving the effervescent tablets in a glass of water. Effervescent tablets should be taken immediately after dissolution.
Adults and adolescents over 14 years of age: 1 effervescent tablet 2-3 times a day (400-600 mg acetylcysteine per day);
Children aged 6 to 14 years: 1 effervescent tablet 2 times a day (400 mg acetylcysteine per day);
Children aged 2 to 6 years: 1/2 effervescent tablet 2-3 times a day (200-300 mg acetylcysteine per day).
Treatment of cystic fibrosis:
Children over 6 years old: 1 effervescent tablet 3 times a day (600 mg acetylcysteine per day):
Children aged 2 to 6 years: 1/2 effervescent tablet 4 times a day (400 mg acetylcysteine per day).
The duration (continuity) of use depends on the characteristics of the disease. When treating chronic bronchitis and cystic fibrosis, treatment can be long-term (up to several months).
To date, cases of overdose of acetylcysteine preparations when administered orally have not been described. At a dose of 500 mg/kg, acetylcysteine did not cause symptoms of poisoning. Theoretically, diarrhea, heartburn, nausea, vomiting, and stomach pain are possible.
Treatment: symptomatic.
When using the drug in patients with bronchial asthma, it is necessary to ensure sputum drainage and combine it with bronchodilators.
When using the drug, it is necessary to use glass containers and avoid contact of the drug with metal, rubber, oxygen, and easily oxidizing substances.
Severe allergic reactions such as Stevens-Johnson syndrome and Lyell's syndrome have been very rarely reported with the use of acetylcysteine. If changes occur in the skin and mucous membranes, you should immediately consult a doctor and stop taking the drug.
Each effervescent tablet contains 20 mg of aspartame (equivalent to the content of 11.2 mg of phenylalanine), as a result of which the drug cannot be used by patients with phenylketonuria.
Impact on the ability to drive vehicles. Wed and fur.:
There is no data on the negative effects of acetylcysteine in recommended doses on the ability to drive vehicles and operate machinery.
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Effervescent tablets - 1 tablet:
24 tablets per pack.
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).
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.
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.
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.
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.
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.
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).
One of the very popular mucolytic drugs is ACC 200, so it is often prescribed for coughs with viscous sputum. But is this medicine suitable for children?
ACC 200 is produced in two forms:
The active substance in ACC 200 is acetylcysteine, of which each tablet or each serving packet contains, as the name implies, 200 mg. ACC 200 powder also includes sucrose, sodium saccharinate, ascorbic acid and flavorings (lemon and honey). In addition to vitamin C and orange flavor, orange granules contain saccharin and sucrose for a sweet taste.
Additional substances in the tablets are citric acid, milk sugar, bicarbonate, saccharinate, sodium citrate and carbonate, mannitol, ascorbic acid and blackberry flavor.
The main effect of acetylcysteine, which is contained in ACC 200, is mucolytic. Such a substance directly affects sputum in the respiratory tract, changing its rheological properties. This is due to the ability to destroy the bonds of mucopolysaccharides in sputum, as a result of which the viscosity of the secretion decreases. In this case, the drug does not lose activity, even if there is pus in the sputum.
Acetylcysteine also has antioxidant properties, because it is able to neutralize oxidative radicals and stimulate the formation of glutathione. The result of this action will be an increase in cell protection and a decrease in the intensity of inflammation.
For a video review of the drug ACC 200 in powder form, see below.
The instructions for use clarify that the use of acetylcysteine is permitted from the age of two. In this case, a single dose for children under 6 years of age is usually 100 mg of the active substance, so you have to divide the sachet or tablet in half. The drug ACC 200 is designed for ages over 6 years.
Doctors prescribe ACC 200 if necessary to improve sputum separation and thin it. The medicine is prescribed in childhood for:
The drug should not be taken in the following situations:
Prescribing medication requires increased attention from the doctor if the child has bronchial asthma, high blood pressure, kidney, adrenal or liver diseases have been identified. The granules should not be given to children with fructose intolerance or sucrase deficiency.
Effervescent tablets are contraindicated in cases of lactose intolerance or lactase deficiency.
ACC 200 powder should be diluted and given to the child to drink after meals. For one sachet, take half a glass of liquid, which can be represented not only by water, but also by cool tea or juice. Effervescent tablets are diluted only with water.
The prepared solution should be drunk as soon as possible after preparation. Due to the presence of ascorbic acid in the composition, the diluted medicine can be stored for up to two hours after it is diluted with liquid.
The dose of the medicine will depend on age:
The duration of treatment with ACC 200 should be determined by the doctor, but in acute pathologies without complications, the drug is often prescribed for 5-7 days.
If the dosage of ACC for a child is too high, the baby’s body will react to the drug with nausea, loose stools or vomiting. Symptomatic therapy can help in such a situation.
To purchase ACC 200 at a pharmacy, you do not need a doctor's prescription. The average cost of a package with 20 sachets is 130 rubles.
The temperature at the storage location of ACC 200 should not exceed +25°C. ACC 200 sachets have a shelf life of 4 years from the date of release, while effervescent tablets have a shelf life of only 3 years. After removing the effervescent tablet from the tube, check the tightness of the package.
Effervescent tablets, 100 mg: round, flat-cylindrical, white, with a blackberry scent. There may be a faint sulfuric odor. Reconstituted solution: colorless transparent with blackberry scent. There may be a faint sulfuric odor.
Granules for preparing a solution for oral administration (orange): homogeneous, white, without agglomerates, with the smell of orange.
Syrup: transparent, colorless, slightly viscous solution with a cherry odor.
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 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 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 of bacterial etiology in patients with chronic bronchitis and cystic fibrosis.
Absorption is high. Rapidly metabolized in the liver to form 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 first-pass effect through the liver). Tmax in blood plasma is 1-3 hours. Communication with blood plasma proteins is 50%. Excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine). T1/2 is about 1 hour, impaired liver function leads to an extension of T1/2 to 8 hours. Penetrates the placental barrier. There are no data on the ability of acetylcysteine to penetrate the BBB and be excreted in breast milk.
For all dosage forms
respiratory diseases accompanied by the formation of viscous, difficult to separate sputum:
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).
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 hemorrhage;
pregnancy;
breastfeeding period;
children under 2 years of age.
For effervescent tablets, 100 mg, additionally
lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
Carefully: history of gastric and duodenal ulcers; 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; adrenal gland diseases; arterial hypertension.
For granules for preparing a solution additionally
sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose deficiency.
Carefully: history of gastric and duodenal ulcers; arterial hypertension; varicose veins of the esophagus; bronchial asthma; obstructive bronchitis; adrenal gland diseases; 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).
Extra for syrup
Carefully: history of gastric and duodenal ulcers; bronchial asthma; 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; adrenal gland diseases; arterial hypertension.
Data on the use of acetylcysteine during pregnancy and breastfeeding are limited. The use of the drug during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus.
If it is necessary to use the drug during lactation, the issue of stopping breastfeeding should be decided.
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: uncommon - skin itching, 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: uncommon - stomatitis, abdominal pain, nausea, vomiting, diarrhea; heartburn, dyspepsia (except syrup).
From the senses: infrequently - tinnitus.
Others: very rarely - headache, fever, isolated reports of bleeding due to a hypersensitivity reaction, decreased platelet aggregation.
For all dosage forms
With the simultaneous use of acetylcysteine and antitussives, sputum stagnation may occur due to suppression of the cough reflex. Therefore, such combinations should be selected with caution.
Simultaneous administration of acetylcysteine with vasodilating agents and nitroglycerin can lead to increased vasodilatory effects.
When used simultaneously with antibiotics for oral administration (including penicillins, tetracyclines, cephalosporins), they may interact with the thiol group of acetylcysteine, 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).
Upon contact with metals and rubber, sulfides with a characteristic odor are formed.
Inside, after meal.
Mucolytic therapy
Adults and children over 14 years of age: 2 tables each 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 acetylcysteine per day).
Children from 6 to 14 years old: 1 table each effervescent 100 mg 3 times a day or 2 tablets. effervescent 2 times a day, or 1 pack. ACC ® granules for preparing a 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 table each. 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 acetylcysteine per day).
Cystic fibrosis
For patients with cystic fibrosis (an inborn error of metabolism with frequent bronchial tract infections) and a body weight of more than 30 kg, if necessary, the dose can be increased to 800 mg of acetylcysteine per day.
Children over 6 years old: 2 tables each effervescent 100 mg or 2 packs. 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 table each. 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, the ready-to-use solution can be left 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. For short-term colds, the duration of use is 5-7 days.
For chronic bronchitis and cystic fibrosis, the drug should be taken for a longer period of time to achieve a preventive effect against infections.
ACC ® syrup is taken using a measuring syringe or measuring cup contained in the package. 10 ml of syrup corresponds to 1/2 measuring cup or 2 filled syringes.
Using a measuring syringe
1. Open the bottle cap by pressing on it and turning it counterclockwise.
2. Remove the cap with the hole from the syringe, insert it into the neck of the bottle and press in until it stops. The stopper is designed to connect the syringe to the bottle and remains in the neck of the bottle.
3. Insert the syringe tightly into the stopper. Carefully turn the bottle upside down, pull the syringe plunger down and draw the required amount of syrup. If air bubbles are visible in the syrup, press the plunger all the way, then refill the syringe. Return the bottle 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 (into the cheek area, slowly, so that the child can swallow the syrup properly); the child should be in an upright position while taking the syrup.
5. After use, rinse the syringe with clean water.
Instructions for patients with diabetes: 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 scoops) of ready-to-use syrup contains 3.7 g of D-glucitol (sorbitol), which corresponds to 0.31 XE.
Symptoms: acetylcysteine, when taken at a dose of up to 500 mg/kg, did not cause any symptoms of intoxication. In case of an erroneous or intentional overdose, phenomena such as diarrhea, vomiting, stomach pain, heartburn and nausea may occur. Children may experience hypersecretion of sputum.
Treatment: symptomatic.
When working with the drug, you must use glass containers and avoid contact with metals, rubber, oxygen, and easily oxidized substances.
Severe allergic reactions such as Stevens-Johnson syndrome and Lyell's syndrome have been very rarely reported with the use of acetylcysteine. If changes occur in the skin and mucous membranes, you should immediately consult a doctor and stop taking the drug.
In patients with bronchial asthma and obstructive bronchitis, acetylcysteine should be prescribed with caution under systemic monitoring of bronchial patency.
You should not take the drug immediately before bedtime (it is recommended to take the drug before 18:00).
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 or use machinery.
Special precautions when disposing of unused medicinal products. There is no need for special precautions when disposing of unused drug.
Extra for syrup
The use of the drug should be avoided in patients with renal and/or liver failure to avoid additional formation of nitrogenous compounds.
1 ml of syrup contains 41.02 mg of sodium. This must be taken into account when using the drug in patients on a diet aimed at limiting sodium intake (reduced sodium/salt).
Effervescent tablets, 100 mg.
When packaging Hermes Pharma Ges.m.b.H., Austria: 20 tablets. effervescent in a plastic or aluminum tube. 1 tube of 20 tablets. effervescent in a cardboard box.
Granules for solution for oral administration (orange), 100 mg. 3 g granules in bags made of a combined material (aluminum foil/paper/PE). 20 packs 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 a white piston and an adapter ring for attaching to the bottle.
1 fl. together with dosing devices in a cardboard box.
Effervescent tablets
1. Hermes Pharma Ges.m.b.H., Austria.
2. Hermes Arzneimittel GmbH, Germany.
Granules for preparing a solution
Registration certificate holder: Sandoz d.d., Verovškova 57, 1000 Ljubljana, Slovenia.
Manufactured by: Lindopharm GmbH, Neustrasse 82, 40721 Hilden, Germany.
Syrup
Pharma Wernigerode GmbH, Germany.
Marketing authorization holder: Sandoz d.d. Verovškova 57, Ljubljana, Slovenia.
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