Description of the dosage form
Effervescent tablets, 100 mg: round flat-cylindrical white, with the smell of blackberries. 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.
pharmachologic effect
pharmachologic effect- mucolytic.Pharmacodynamics
Acetylcysteine is a derivative of the amino acid cysteine. Has a mucolytic effect, facilitates sputum discharge due to direct impact 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.
At prophylactic use 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. 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 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. Data on the ability of acetylcysteine to penetrate the BBB and be released from breast milk are missing.
Indications of the drug ACC ®
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 disease lungs;
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 stomach and duodenum in the acute stage;
hemoptysis, pulmonary hemorrhage;
pregnancy;
period breastfeeding;
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; hepatic and/or renal 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 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.
Use during pregnancy and breastfeeding
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.
Side effects
According to WHO unwanted reactions classified according to their frequency of occurrence as follows: very common (≥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.
Interaction
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.
Directions for use and doses
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.
Overdose
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.
special instructions
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).
Release form
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.
Manufacturer
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.
◊ tab. effervescent 200 mg: 20, 50, 60 or 100 pcs. Reg. No.: P N015473/01
Clinical and pharmacological group:
Mucolytic drug
Release form, composition and packaging
◊ Effervescent tablets white, round, flat, scored, with the smell of blackberries.
Excipients: citric acid anhydride - 558.5 mg, sodium bicarbonate - 300 mg, mannitol - 60 mg, ascorbic acid - 25 mg, lactose anhydride - 70 mg, sodium citrate - 0.5 mg, saccharin - 6 mg, blackberry flavoring "B" - 20 mg.
4 things. - strips (15) - cardboard boxes.
20 pcs. - aluminum tubes (1) - cardboard boxes.
20 pcs. - plastic tubes (1) - cardboard boxes.
25 pcs. - aluminum tubes (2) - cardboard boxes.
25 pcs. - plastic tubes (2) - cardboard boxes.
25 pcs. - aluminum tubes (4) - cardboard boxes.
25 pcs. - plastic tubes (4) - cardboard boxes.
Description of the active components of the drug " ACC ®»
pharmachologic effect
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. It has a mucolytic effect, facilitates the discharge of sputum due to a direct effect on the rheological properties of sputum. 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
— diseases of the respiratory system, accompanied by increased formation of viscous, difficult to separate sputum (acute and chronic bronchitis, obstructive bronchitis, pneumonia, bronchiectasis, bronchial asthma, bronchiolitis, cystic fibrosis);
— acute and chronic sinusitis;
- otitis media.
Dosage regimen
Adults and teenagers over 14 years old It is recommended to prescribe the drug 200 mg 2-3 times a day (ACC ® 100 or ACC ® 200), which corresponds to 400-600 mg of acetylcysteine per day.
Children aged 2 to 5 years It is recommended to take the drug 1 tablet. (ACC ® 100) or 1/2 tab. (ACC ® 200) 2-3 times a day, which corresponds to 200-300 mg of acetylcysteine per day.
At cystic fibrosischildren over 6 years old It is recommended to take the drug 2 tablets. (ACC ® 100) or 1 tablet. (ACC ® 200) 3 times/day, which corresponds to 600 mg of acetylcysteine per day. Children aged 2 to 6 years- 1 tab. (ACC ® 100) or 1/2 tab. (ACC ® 200) 4 times/day, which corresponds to 400 mg of acetylcysteine per day. Patients with body weight more than 30 kg for cystic fibrosis, if necessary, you can increase the dose to 800 mg/day.
At short-term colds Duration of treatment is 5-7 days. At chronic bronchitis and cystic fibrosis the drug should be used for a longer period of time to prevent infections.
The drug should be taken after meals. Additional fluid intake enhances the mucolytic effect of the drug.
Effervescent tablets (ACC ® 100 and ACC ® 200) should be dissolved in 1/2 glass of water. Take immediately after dissolution; in exceptional cases, you can leave the prepared solution for 2 hours.
Side effect
From the nervous system: rarely - headache, tinnitus.
From the digestive system: rarely - stomatitis; very rarely - diarrhea, vomiting, heartburn and nausea.
From the cardiovascular system: very rarely - decreased blood pressure, tachycardia.
Allergic reactions: in isolated cases - bronchospasm (mainly in patients with bronchial hyperreactivity), skin rash, itching and urticaria.
Others: in isolated cases - the development of bleeding as a manifestation of a hypersensitivity reaction.
Contraindications
- peptic ulcer of the stomach and duodenum in the acute phase;
- hemoptysis;
- pulmonary hemorrhage;
- pregnancy;
- lactation period (breastfeeding);
- hypersensitivity to the components of the drug.
WITH caution the drug should be used 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.
Pregnancy and lactation
Due to insufficient data, the use of the drug during pregnancy and lactation is possible only in cases where the expected benefit to the mother outweighs the potential risk to the fetus or child.
Use for liver dysfunction
The drug should be taken with caution used for liver failure.
Use for renal impairment
The drug should be taken with caution used for renal failure.
Application for children
Contraindications: 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).
special instructions
For bronchial asthma and obstructive bronchitis, acetylcysteine should be prescribed with caution under systematic monitoring of bronchial patency.
If adverse reactions develop, the patient should stop taking the drug and consult a doctor.
When dissolving the drug, it is necessary to use glass containers and avoid contact with metals, rubber, oxygen, and easily oxidized substances.
When treating patients with diabetes, it is necessary to take into account that 1 effervescent tablet ACC ® 100 and ACC ® 200 corresponds to 0.006 XE.
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 and perform other activities that require concentration and speed of psychomotor reactions.
Overdose
In case of an erroneous or intentional overdose, the following are observed: symptoms such as diarrhea, vomiting, stomach pain, heartburn, nausea. To date, no severe or life-threatening side effects have been observed.
Drug interactions
Conditions for dispensing from pharmacies
The drug is approved for use as a means of OTC.
Storage conditions and periods
The drug should be stored out of reach of children, in a dry place at a temperature not exceeding 25°C. Shelf life - 3 years.
After taking the tablet, the tube should be tightly closed.
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.
Synergism between acetylcysteine and bronchodilators has been noted.
Acetylcysteine reduces the absorption of cephalosporins, penicillins and tetracycline, so they should be taken orally no earlier than 2 hours after taking acetylcysteine.
Acetylcysteine is pharmaceutically incompatible with antibiotics (penicillins, cephalosporins, erythromycin, tetracycline and amphotericin B) and proteolytic enzymes.
When acetylcysteine comes into contact with metals and rubber, sulfides with a characteristic odor are formed.
Pharmacies offer many types of medicines for the treatment of infections accompanied by sputum production. It's very difficult to choose.
Of the variety of drugs presented on pharmacy shelves, the most popular are. Instructions for use “Effervescent tablets 200 mg” indicate the optimal concentration of the active substance in the composition of the drug.
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Classmates
ACC 200 mg is used as an additional drug to facilitate coughing during a productive cough. For this purpose, it is one of the best options among all mucolytics. Used from 2 years of age. The medicine is easy to prepare and has a blackberry flavor that children like. The review presents instructions for use of the mucolytic drug, the composition of ACC 200, and the mechanism of action on the body. It is indicated for what diseases it is used. Consumer reviews are described.
Composition of effervescent tablet ACC 200 mg
The drug contains acetylcysteine containing 200 mg. Other ingredients that provide flavor, color and shape are present:
- citric and ascorbic acids;
- sodium carbonate;
- mannitol;
- lactose;
- sucrose;
- sodium citrate;
- flavoring
Mechanism of action
ACC 200 is used in the treatment of infectious and inflammatory respiratory diseases accompanied by sputum production. The action of the active substance acetylcysteine is aimed at liquefying the viscous secretion and removing it from the bronchi.
A decrease in mucus viscosity occurs due to the rupture of disulfide bonds of mucolytic polysaccharides. The medicine can also be used for cases of sputum with pus. The expectorant property promotes the rapid removal of liquefied secretions from the bronchi, thereby clearing the respiratory tract of accumulated microbes, pus and mucus.
ACC 200 mg effervescent tablets are taken as prescribed by the therapist in the recommended dosages.
Absorption of the drug occurs in the gastrointestinal tract, and the maximum concentration is achieved 60–180 minutes after taking the drug. The half-life from the body is within an hour, if there are disturbances in the liver - up to 8 hours. Use during pregnancy is not recommended because it is unknown how it may act, since data on this issue are limited.
What is treated with this medicine?
According to the instructions for use, ACC 200 is used in the treatment of infections characterized by cough and mucus that cannot be coughed up:
- abscess pneumonia;
- cystic fibrosis;
The indication for use is, in any form, inflammation of the bronchioles with the appearance of mucus.
The use of acetylcysteine-containing drugs for preventive purposes reduces the number and severity of annual exacerbations of bronchitis and cystic fibrosis.
It should be noted that the form of use in the form of effervescent tablets contributes to the exacerbation of gastritis, ulcers and other gastrointestinal diseases. Therefore, it is recommended to drink only after meals and not on an empty stomach.
Instructions for use of ACC at a dosage of 200 mg indicate the following contraindications:
- sensitivity to substances contained in the composition;
- bleeding in the lungs;
- coughing up blood;
- the period of bearing a child and breastfeeding;
- inability to tolerate lactose, low levels of lactase;
- age up to 2 years.
ACC 200 is rarely prescribed if the patient has a history of disorders of the adrenal glands, liver and kidney diseases, or arterial hypertension.
The pharmacy sells tubes with four, twenty or twenty-five tablets, which must contain instructions for using ACC 200.
Instructions for use
Your doctor will tell you how to take ACC 200 in the form of effervescent tablets, or you can learn about this from the instructions for use. You should study the “adverse reactions” item in more detail before starting to take a mucolytic agent:
- the appearance of noise and pain in the head;
- the pressure decreases, tachycardia is observed;
- possible upset stool, feeling of nausea;
- sometimes stomatitis appears;
- allergic manifestations in the form of itchy urticaria, rashes, exanthema, edema;
- bronchospasm;
- dyspnea;
- rarely - anaphylactic shock and bleeding.
How to drink?
Instructions for use of ACC effervescent tablets at a dose of 200 mg provide detailed information on the method of administration:
- Prepare a glass of water 200 ml.
- Place a tablet in it.
- Wait for dissolution and drink.
A dose of ACC within the range of 400 mg per day is prescribed to children from the age of six; from the age of 14, a solution of 1 tablet is prescribed at a time three times a day.
If the child is between two and five years old, then dissolve half a tablet of ACC in 200 ml or 100 ml of water and take it twice a day.
You should drink only freshly prepared solution.
To increase the effect and enhance the effect of the drug, you should wash down the solution with a large amount of tea or juice, or fruit juice.
Mucolytic drugs are prescribed only in the complex treatment of diseases, and are not monotherapy. If there is no sputum and only phlegm is present, taking the drug is not recommended.
It should not be taken together with cough suppressants to avoid sputum stagnation.
Antibiotics reduce the effectiveness of ACC 200 when a reaction occurs with acetylcysteine. They must be taken separately, at least 120 minutes apart.
Taken together with vasodilating drugs and nitroglycerin increases the vasodilatory effect.
What water to dissolve in?
A 200 mg tablet should be dissolved in a 200 ml glass of boiled warm water. The pediatric dose can be dissolved in 100 ml of water.
How long can I take it?
Best before date
The shelf life of ACC 200 is limited to three years, subject to storage conditions. Keep in dry places where the air temperature does not rise above 25 C. Keep in tightly closed packaging.
What kind of reviews does the drug receive?
Numerous positive reviews about ACC 200 effervescent tablets indicate the effectiveness of the medical product. The emphasis is on rapid relief of the body's condition, increasing the removal of sputum after several doses.
The release form in the form of effervescent tablets is considered by consumers to be convenient to store and use. Children like the pleasant blackberry taste and do not cause negative reactions (refusal to use) when taken.
Parents report that the drug is well tolerated by children with rare adverse reactions. Some consumers regret the presence of contraindications to the use of ACC 200.
Effervescent tablets ACC in a dose of 100 mg are perfect for young children to thin thick mucus, enhance the local immune system through phagocyte cells, and combat inflammatory processes.
One tablet consists of 100 mg of acetylcysteine and auxiliary components. Sold in a tube of twenty pieces.
People with stomach disease and diabetes, children under 2 years of age, pregnant and lactating women, people with liver and kidney diseases should not drink.
An hour after consuming the solution, the effect of the active component - acetylcysteine - appears. ACC 100 is excreted by the kidneys.
The method of use and dose are prescribed by the attending physician depending on the degree and duration of the infection.
ACC Long 600 mg is one of the forms of a medicine from the ACC group, the advantage of which is the ability to treat patients with doses with a high concentration of the active substance - acetylcysteine. The effect of the medicine is observed within 12 hours after administration. A large dosage is convenient for use by adults and patients with cystic fibrosis.
The active ingredient is contained in a dose of 600 mg in an effervescent tablet. Long in the name of the drug means a longer effect on the body and taking one dose per day. The prepared solution is stored for no more than two hours. It is advisable to drink immediately after preparation.
In pharmacy chains you can buy a package of six, ten or twenty tablets.
Taking a tablet with a high dosage of acetylcysteine should only be started with the permission of a doctor in order to avoid negative consequences.
The instructions for use describe possible consequences and more detailed information about ACC Long 600 mg.
Useful video
What diseases cause a choking cough, dry or wet, and what to do in each of these conditions, see the following video:
Conclusion
- ACC 200 mg is a long-acting mucolytic and expectorant drug.
- Prescribed for inflammation of the respiratory system in complex therapy with other medications for the treatment of wet cough with mucus discharge.
- The dose and frequency of administration are prescribed by the attending physician individually for each patient.
- How to drink ACC 200 is indicated in the instructions for use.
- To avoid side effects and negative reactions from the body, before starting use, you should consult a specialist and read the instructions for use.
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Acetylcysteine
Registration number: LP-000623
Tradename: Acetylcysteine
International nonproprietary name: Acetylcysteine
Dosage form: powder for solution for oral administration
Composition per package:
acetylcysteine - 0.100 g or 0.200 g.
Excipients: ascorbic acid - 0.025 g, sorbitol (sorbitol) - 0.7527 g or 0.6507 g, orange flavor (food flavor "Orange") - 0.1 g, aspartame - 0.02 g.
Description: white granules with a yellowish tint. When the contents of one packet are dissolved in 80 ml of warm water for 5 minutes with stirring, an opalescent solution with a slightly yellowish tint and the smell of orange is formed.
Pharmacotherapeutic group: expectorant (mucolytic) agent
ATX code:
Pharmacological properties
Pharmachologic effect. A mucolytic agent that thins sputum, increases its volume, and facilitates the separation of sputum.
The action is associated with the ability of free sulfhydryl groups of acetylcysteine to break intra- and intermolecular disulfide bonds of acidic mucopolysaccharides of sputum, which leads to depolymerization of mucoproteins and a decrease in sputum viscosity (in some cases this leads to a significant increase in sputum volume, which requires aspiration of bronchial contents). Remains active against purulent sputum. Does not affect immunity.
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 presence of an SH group that can neutralize electrophilic oxidative toxins.
Protects alpha1-antitrypsin (elastase inhibitor) from the inactivating effects of HOCl-oxidizer produced by myeloperoxidase of active phagocytes.
It also has some 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).
Pharmacokinetics. Absorption - high, bioavailability - 10% (due to the presence of a pronounced “first pass” effect through the liver - deacetylation with the formation of cysteine), time to reach maximum concentration (TCmax) in plasma - 1-3 hours after oral administration, binding to plasma proteins - 50 %.
The half-life (T1/2) is about 1 hour, with liver cirrhosis it increases to 8 hours. It is excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine), a small part is excreted unchanged in the feces.
Penetrates the placental barrier and accumulates in the amniotic fluid.
Indications for use
Impaired sputum discharge: bronchitis, tracheitis, bronchiolitis, pneumonia, bronchiectasis, cystic fibrosis, lung abscess, emphysema, laryngotracheitis, bronchial asthma, pulmonary atelectasis (due to blockage of the bronchi by mucus plug).
Catarrhal and purulent otitis media, sinusitis, sinusitis (facilitation of secretion discharge).
Removal of viscous secretions from the respiratory tract in post-traumatic and postoperative conditions.
Preparation for bronchoscopy, bronchography, aspiration drainage.
For washing abscesses, nasal passages, maxillary sinuses, middle ear; treatment of fistulas, surgical field during operations on the nasal cavity and mastoid process.
Contraindications
Hypersensitivity to acetylcysteine or other components of the drug, phenylketonuria, sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption, pregnancy, breastfeeding, children under 2 years of age.
Directions for use and doses
Inside. The granules are dissolved in 1/3 cup of water.
Adults and adolescents over 14 years old - 200 mg 2-3 times a day (400 - 600 mg per day).
Children from 2 to 5 years old - 100 mg 2-3 times a day (200-300 mg per day). Children from 6 to 14 years old - 200 mg 2 times a day or 3 times a day 100 mg (300-400 mg per day).
For chronic diseases over several weeks:
adults and adolescents over 14 years old - 400-600 mg/day in 1-2 doses; children 2-14 years old - 100 mg 3 times a day (300 mg per day).
For cystic fibrosis:
children from 2 to 6 years old - 100 mg 4 times a day (400 mg per day);
children over 6 years old - 200 mg 3 times a day (600 mg per day).
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.
Carefully
Peptic ulcer of the stomach and duodenum (in the acute phase), varicose veins of the esophagus, hemoptysis, pulmonary hemorrhage, diseases of the adrenal glands, liver and/or kidney failure, arterial hypotension.
Overdose
Symptoms: diarrhea, heartburn, nausea, vomiting, stomach pain. Treatment: symptomatic.
special instructions
When working with the drug, you must use glass containers and avoid contact with metals, rubber, oxygen, and easily oxidizing substances.
In patients with broncho-obstructive syndrome, it must be combined with bronchodilators.
Side effect
Nausea, vomiting, feeling of fullness in the stomach, rhinorrhea, drowsiness, fever, stomatitis; allergic reactions (skin rash, itching, urticaria, bronchospasm (mainly in patients with bronchial hyperreactivity).
Interaction with other drugs
Pharmaceutically incompatible with other drug solutions.
Upon contact with metals and rubber, sulfides with a characteristic odor are formed.
When taken simultaneously with nitroglycerin, the vasodilator effect of the latter is enhanced; reduces the absorption of drugs from the penicillin, cephalosporin, tetracycline group (they should be taken no earlier than 2 hours after taking acetylcysteine).
Use during pregnancy and breastfeeding
For safety reasons, due to insufficient data, prescribing the drug in
pregnancy and lactation are possible only if the expected benefit to the mother outweighs the risk to the fetus or infant.
Impact on the ability to drive vehicles and machinery
When driving vehicles or potentially dangerous mechanisms
Use the drug with caution.
Release form
Powder for solution for oral administration 100 mg and 200 mg.
1 g in heat-sealable bags made of combined packaging material.
20 or 30 packages along with instructions for use are placed in cardboard packs for consumer packaging.
Storage conditions:
In a dry place at a temperature not exceeding 25°C.
Best before date:
2 years. Do not use after the expiration date.
The drug has as its main substance acetylcysteine . Additional components in tablets –, saccharin , sucrose , flavoring .
In addition to the main substance, each package of powder contains flavoring additive "Aromatic" Lemon , lactose monohydrate , .
Release form
The medicine is available in the form of a solution for internal use or capsules. In addition, such a release form is known as effervescent tablets.
pharmachologic effect
Mucolytic action.
Pharmacodynamics and pharmacokinetics
About acetylcysteine It is important to know what it is and what its mechanism of action is before using the drug. It is a derivative amino acid cysteine . The effect of the drug Acetylcysteine is due to the fact that it sulfhydryl group splits disulfide acidic connections sputum mucopolysaccharides . This is what causes mucolytic action. Mucoregulatory activity depends on increased secretion of less viscous substances sialomucins by goblet cells . On epithelial cells bronchial mucosa, bacterial adhesion is reduced. This is due to a decrease in viscosity sputum and promotions mucociliary clearance .
The disinfecting effect of the drug is due to the action of free sulfhydryl group that influences electrophilic oxidative toxins , neutralizing them.
This drug protects cells from free radicals both through direct interaction with them and through transport cysteine for synthesis .
The drug is quickly broken down when used internally. But him bioavailability – approximately 10%. The degree of binding to plasma proteins is 50%. The maximum concentration is observed after 60-180 minutes. The active substance can be supplied through placental barrier and accumulate in the amniotic fluid. The half-life is 60 minutes. At – up to 8 hours.
Excreted mainly by the kidneys as inactive. Some part is excreted unchanged by the intestines. In plasma it is determined unchanged, and also as metabolite N-acetylcysteine , cysteine ester And N,N-diacetylcysteine .
Indications for use
The medicine is used for difficult separation sputum , lung , catarrhal And purulent otitis , removal of viscous secretions from the respiratory tract after operations, as well as in the case of post-traumatic conditions. In addition, among his testimony are interstitial lung diseases , cystic fibrosis , lungs , poisoning
Contraindications
This remedy should not be used during an exacerbation, pulmonary , hypersensitivity to the drug hemoptysis , .
Side effects
The drug may cause adverse reactions such as:
- rash, bronchospasm ;
- nausea, stomatitis , vomiting, feeling of a full stomach;
In rare cases, tinnitus, burning at the injection site (if a solution is used), as well as a reflex cough are possible. rhinorrhea and local irritation of the respiratory tract with inhalation application.
Instructions for use of Acetylcysteine (Method and dosage)
Dosages are selected depending on the age and nature of the patient’s disease.
Instructions for use of Acetylcysteine indicate that for children 2–6 years old, a daily dosage of 100 mg 3 times or 200 mg 2 times is usually indicated. The medicine is used in the form of a water-soluble granule. And for children under 2 years of age, a daily dose of 2 times 100 mg is prescribed. In turn, children 6-14 years old are given 200 mg daily 2 times, in case of cystic fibrosis – 200 mg 3 times. The medicine can be taken in the form of effervescent tablets, capsules or granules.
Adults take 200 mg of the drug 2-3 times every day in any possible form of release.
For aerosol therapy 20 ml of a 10% solution is sprayed in ultrasonic devices, and 6 ml of a 10% solution is sprayed in devices with a distribution valve. Inhalation do every day for 15-20 minutes 2-4 times. For acute conditions, therapy lasts 5-10 days, for chronic conditions – up to six months.
With strong secretolytic action needs to be sucked secret , as well as reduce the frequency of use and dosage of the drug.
Overdose
In case of overdose, the medicine can cause nausea, abdominal pain, and vomiting.
Therapy is symptomatic. In case of severe symptoms of overdose, you should urgently consult a specialist.
Interaction
Combination of the drug with oral taking semi-synthetic penicillins , cephalosporins , tetracyclines (with the exception of ), aminoglycosides requires compliance with a two-hour interval. Acetylcysteine with others antitussives medications can cause dangerous mucus stagnation. When combined with this medicine, it may also increase vasodilating action .
Terms of sale
The drug is approved for over-the-counter release.
Storage conditions
Optimal storage conditions for Acetylcysteine: dry, dark place, out of reach of children, temperature not higher than 25 °C, sealed packaging.
Best before date
Five years.
Acetylcysteine analogues
Level 4 ATX code matches:The following common analogues of Acetylcysteine are sold:
- Vicks Active ExpectoMed ;
- N-AC-ratiopharm ;
- N-acetylcysteine ;
- Acestine ;
- Acetylcysteine SEDICO ;
- Mukobene ;
- Mukonex ;
- N-AC-ratiopharm ;
- Exomyuk 200 ;
- Mucomist .
They are all similar in their action, but may have some application features.
