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 (a congenital metabolic disorder 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.
Cases of 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.
Instructions for medical use
medicine
ACC ® 200
Tradename
International nonproprietary name
Acetylcysteine
Dosage form
Powder for solution for oral administration 200 mg
Compound
1 sachet contains 3 g of powder
active substance: acetylcysteine 200 mg
Excipients: sucrose, ascorbic acid, saccharin, dry orange flavor 1:1000 Sotteri 289**
(**- Orange flavor essence 11.1%, dextrose anhydride 82.7%, lactose 6.2%)
Description
Homogeneous white powder, free of particle agglomerates, with an orange scent.
The reconstituted solution is colorless, transparent or slightly opalescent.
Pharmacotherapeutic group
Medicines to relieve symptoms of colds and coughs.
Expectorants. Mucolytics. Acetylcysteine
ATX code R05 CB01
Pharmacological properties
Pharmacokinetics
After oral administration, acetylcysteine is rapidly absorbed from the gastrointestinal tract (GIT) and metabolized in the liver into cysteine, a pharmacologically active metabolite, as well as into diacetylcysteine, cystine and various mixed disulfides.
Due to the high first pass effect through the liver, the bioavailability of acetylcysteine is very low (approximately 10%).
In humans, maximum plasma concentrations are reached after 1-3 hours. The maximum plasma concentration of the cysteine metabolite is about 2 µmol/l. The binding of acetylcysteine to plasma protein is approximately 50%.
Acetylcysteine is excreted through the kidneys almost exclusively in the form of inactive metabolites (inorganic sulfates, diacetylcysteine).
The plasma elimination half-life is approximately 1 hour and is mainly determined by hepatic biotransformation. Therefore, impaired liver function leads to a prolongation of the plasma half-life of up to 8 hours.
Pharmacodynamics
Acetylcysteine is a derivative of the amino acid cysteine. Acetylcysteine has secretolytic and secretomotor effects in the respiratory tract. It breaks disulfide bonds between mucopolysaccharide chains and has a depolymerizing effect on DNA chains (with purulent sputum). Thanks to these mechanisms, the viscosity of sputum decreases.
An alternative mechanism of acetylcysteine is based on the ability of its reactive sulfhydryl group to bind chemical radicals and thereby neutralize them.
Acetylcysteine helps increase glutathione synthesis, which is important for the detoxification of toxic substances. This explains its antidote effect in paracetamol poisoning.
When used prophylactically, it has a protective effect regarding the frequency and severity of exacerbations of bacterial infections, which was found in patients with chronic bronchitis and cystic fibrosis.
Indications for use
Secretolytic therapy for acute and chronic diseases of the bronchi and lungs, accompanied by impaired formation and removal of sputum.
Directions for use and dosage
ACC ® 200 is taken only in the form of a prepared solution, after meals.
Adults and teenagers aged 14 years and older
1 sachet of powder 2-3 times a day (corresponds to 400-600 mg of acetylcysteine per day).
Children and teenagers from 6 to 14 years old
1 sachet of powder 2 times a day (corresponds to 400 mg of acetylcysteine per day).
The duration of treatment depends on the type and severity of the disease and should be determined by the attending physician.
Preparation of the solution:
The powder is dissolved in a glass of boiled water and taken after meals.
Side effects
Infrequently(≥1/1000, <1/100)
- allergic reactions (itching, urticaria, skin rash, bronchospasm, Quincke's edema)
Tachycardia
Arterial hypotension
Headache
Fever
Stomatitis, abdominal pain, diarrhea, vomiting, heartburn, nausea
Noise in ears
Rarely (≥1/10000, <1/1000)
Dyspnea, bronchospasm mainly in patients with increased reactivity of the bronchial system associated with bronchial asthma
Dyspepsia
Very rarely (< 1/10 000)
Bleeding and hemorrhage, partly associated with hypersensitivity reactions
Anaphylactic reactions, up to anaphylactic shock
Stevens-Johnson syndrome, Lyell's syndrome
Unknown
Facial swelling
Contraindications
Hypersensitivity to any component of the drug
Peptic ulcer of the stomach and duodenum in the acute stage
Hemoptysis, pulmonary hemorrhage
Bronchial asthma in the acute stage
Phenylketonuria
Children under 6 years old
Fructose intolerance, glucose-galactose or sucrose-isomaltose malabsorption syndrome
Carefully: varicose veins of the esophagus, bronchial asthma, diseases of the adrenal glands, liver and/or kidney failure, arterial hypertension.
Drug interactions
The simultaneous use of acetylcysteine and antitussives can cause dangerous secretory stagnation due to a decrease in the cough reflex. For this reason, this combination therapy option must be based on a particularly accurate diagnosis.
To achieve the best therapeutic effect, oral antibiotics (penicillins, tetracyclines and aminoglycosides) should be administered separately, with a two-hour time interval. This does not apply to cefixime and loracarbef.
The use of activated carbon in large doses can weaken the effect of acetylcysteine.
The simultaneous use of nitroglycerin and acetylcysteine should be carried out under the supervision of a physician, as the vasodilatory effect and inhibitory effect on platelet aggregation may be enhanced.
Acetylcysteine may interfere with the colorimetric assay for the determination of salicylates.
Acetylcysteine may interfere with the results of ketone bodies in urinalysis.
special instructions
If changes occur in the skin and mucous membranes, the patient should immediately stop taking acetylcysteine and consult a doctor.
In patients with bronchial asthma and obstructive bronchitis, ACC ® 200 should be prescribed with caution under systematic monitoring of bronchial conduction due to the risk of developing bronchospasm.
The use of the drug ACC ® 200 can lead to dilution of sputum in the bronchi and a slight increase in its volume. If the cough reflex is insufficient, postural drainage or aspiration is used.
Patients with histamine intolerance should take ACC ® 200 in short courses, due to the effect on the metabolism of histamine itself and the possible appearance of intolerance symptoms (for example, headache, runny nose, itching).
1 sachet contains 2.7 g of sucrose. This should be taken into account when prescribing the drug ACC ® 200 to patients suffering from diabetes mellitus.
Pregnancy and lactation
The use of the drug ACC ® 200 during pregnancy and lactation is possible in cases where the intended benefit to the mother outweighs the potential risk to the fetus and child, although animal studies have not revealed any direct or indirect toxicity affecting pregnancy, embryonic and/or postnatal life. development.
Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms
Does not affect.
Overdose
Symptoms: nausea, vomiting, diarrhea; children have a risk of hypersecretion.
Treatment: symptomatic.
Release form and packaging
3 g per sachet. 20 or 50 sachets along with instructions for medical use in the state and Russian languages are placed in a cardboard pack
Storage conditions
Store at a temperature not exceeding 30°C.
Keep out of the reach of children!
Shelf life
Do not use after the expiration date stated on the package.
Conditions for dispensing from pharmacies
Over the counter
Manufacturer/Packager
Lindopharm GmbH, Germany
Registration Certificate Holder
Hexal AG, Germany
Address of the organization that accepts claims from consumers regarding the quality of products (products) on the territory of the Republic of Kazakhstan
Representative office of JSC Sandoz Pharmaceuticals d.d. in the Republic of Kazakhstan, Almaty, st. Luganskogo 96,
Phone number: +7 727 258 10 48, fax: +7 727 258 10 47
e-mail: [email protected]
8 800 080 0066 - toll-free number within Kazakhstan
Registration number: P N015474/01
Trade name of the drug: ACC®
International nonproprietary name: acetylcysteine.
Dosage form: granules for the preparation of solution for oral administration (orange).
Compound:
1 sachet contains:
- active substance: acetylcysteine - 100.0/200.0 mg;
- Excipients: sucrose at 2829.5/2717.0 mg; ascorbic acid -12.5/25.0 mg; saccharin - 8.0/8.0 mg; orange flavoring - 50.0/50.0 mg.
Description: homogeneous white granules without agglomerates with an orange smell.
Pharmacotherapeutic group: mucolytic agent.
ATX code: R05CB01.
Pharmacological properties
Pharmacodynamics
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 sputum 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.
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 after oral administration is 10% (due to the presence of a pronounced “first pass” effect through the liver). The time to reach the maximum concentration (Cmax) in the blood plasma is 1-3 hours. The connection with blood plasma proteins is 50%. It is excreted primarily by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine). The half-life (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 blood-brain barrier and be excreted in breast milk.
Indications for use
Respiratory diseases accompanied by the formation of viscous, difficult to separate sputum:
- acute and obstructive bronchitis;
- , laryngotracheitis;
- , lung abscess;
- bronchiectasis;
- bronchial asthma;
- (COPD);
- bronchiolitis, cystic fibrosis.
Acute and chronic sinusitis, inflammation of the middle ear (otitis media).
Contraindications
- hypersensitivity to acetylcysteine or other components of the drug;
- peptic ulcer of the stomach and duodenum in the acute stage;
- hemoptysis, pulmonary hemorrhage;
- sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose deficiency;
- pregnancy;
- breastfeeding period;
- children under 2 years of age (for this dosage form).
Carefully:
a history of gastric and duodenal ulcers, arterial hypertension, bronchial asthma, obstructive bronchitis, and/or 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, diseases of the adrenal glands.
Use during pregnancy and breastfeeding
Data on the use of acetylcysteine during pregnancy and breastfeeding are limited, therefore the use of the drug during pregnancy is contraindicated. If it is necessary to use the drug during breastfeeding, the issue of stopping it should be decided.
Mode of application
The granules 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 course duration is 5-7 days. For long-term illnesses, the course of therapy is determined by the attending physician. For chronic bronchitis, the drug should be taken for a longer period of time to achieve a preventive effect against infections. In the absence of other prescriptions, it is recommended to adhere to the following dosages:
Mucolytic therapy:
- adults and adolescents over 14 years of age: 2 sachets of ACC® 100 mg or 1 sachet of ACC® 200 mg 2-3 times a day (400-600 mg per day);
- children from 6 to 14 years old: 1 sachet 3 times a day or 2 sachets 2 times a day ACC® 100 mg (300-400 mg per day). ACC® 200 mg should be taken 3 times a day, 1/2 sachet or 2 times a day, 1 sachet (300-400 mg per day);
- children from 2 to 6 years: 1 sachet of ACC® 100 mg or 1/2 sachet of ACC® 200 mg 2-3 times a day (200-300 mg per day).
Cystic fibrosis:
- children over 6 years old: 2 sachets of ACC® 100 mg or 1 sachet of ACC® 200 mg 3 times a day (600 mg per day);
- children from 2 to 6 years: 1 sachet of ACC® 100 mg or 1/2 sachet of ACC® 200 mg 4 times a day (400 mg per day);
- patients weighing > 30 kg: if necessary, the dose can be increased to 800 mg.
Side effect
According to the World Health Organization (WHO), adverse effects are classified according to their frequency as follows: very often (> 1/10), often (> 1/100,<1/10), нечасто (>1/1000, <1/100), редко (>1/10000, <1/1000) и очень редко (<1/10000); частота неизвестна (частоту возникновения явлений нельзя определить на основании имеющихся данных).
Allergic reactions:
uncommon: skin itching, rash, exanthema, angioedema, decreased blood pressure, tachycardia;
very rare: anaphylactic reactions up to anaphylactic shock, Stevens-Johnson syndrome,
toxic epidermal necrolysis (Lyell's syndrome).
From the respiratory system:
rarely: bronchospasm (mainly in patients with bronchial hyperreactivity in bronchial asthma).
From the gastrointestinal tract:
uncommon: stomatitis, abdominal pain, nausea, vomiting, diarrhea, heartburn, dyspepsia.
From the senses:
uncommon: tinnitus.
Others:
very rarely: headache, fever, isolated reports of bleeding due to a hypersensitivity reaction, decreased platelet aggregation.
Overdose
Acetylcysteine when taken in doses of 500 mg/kg/day does not cause signs and symptoms of overdose. In case of an erroneous or intentional overdose, phenomena such as diarrhea, vomiting, stomach pain, heartburn and nausea are observed.
Treatment: symptomatic.
Interaction with other drugs
With the simultaneous use of acetylcysteine and due to suppression of the cough reflex, sputum stagnation may occur.
When used simultaneously with oral antibiotics (penicillins, tetracyclines, cephalosporins, etc.), 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 loracarbef):
Simultaneous use with vasodilating agents and nitroglycerin can lead to increased vasodilatory effects.
special instructions
When treating patients with diabetes, it is necessary to take into account that the drug contains sucrose.
Instructions for patients with diabetes mellitus:
- 1 sachet of ACC® 100 mg corresponds to 0.24 XE.
- 1 sachet of ACC® 200 mg corresponds to 0.23 XE.
When working with the drug, you must use glass containers and avoid contact with metals, rubber, oxygen, and easily oxidized substances.
Cases of severe allergic reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (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.
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 machinery
There is no data on the negative impact of the drug ACC® in recommended doses on the ability to drive vehicles and perform other activities that require concentration and speed of psychomotor reactions.
Special precautions when disposing of unused medicinal product There is no need for special precautions when destroying unused ACC® drug.
Release form
3 g of granules per bag made of a combined material (aluminum foil/paper/polyethylene). 20 and 50 sachets per cardboard box along with instructions for use.
Storage conditions
At a temperature not higher than 25 °C.
Keep out of the reach of children.
Best before date
Do not use after expiration date.
Vacation conditions
Over the counter.
Manufacturer
Sandoz d.d., Verovshkova 57, 1000 Ljubljana, Slovenia; Manufactured by: Lindopharm GmbH, Neustrasse 82, 40721 Hilden, Germany. Consumer complaints should be directed to Sandoz CJSC.
In the presence of a severe cough, accompanied by poorly separated sputum, treatment should begin with taking medications aimed at improving the rheological properties of the secretions released from the bronchi. After taking such drugs, the mucus becomes less viscous and is quickly cleared from the breathing tubes, which gives more space for air to pass through and renew the mucous layer. One of these medications is ACC powder. For comfortable and effective treatment, you must first decide how to properly dilute ACC-200 powder.
What does the powder contain?
"ACC-200" is a powder of small granular particles. One sachet contains 200 mg of active drug. The drug contains the following components:
- acetylsteine;
- additional substances - honey, citrus flavors, sucrose, saccharin, as well as ascorbic acid.
Small granules in powder are painted white, less often yellow. If you sniff, you can smell citrus and honey.
How does it affect the human body?
Powder "ACC-200" soluble belongs to the group of expectorant drugs of the mucolytic type, which help speed up the process of removing sputum accumulated in the bronchi of the patient.
Acetylcysteine, which affects the rheological properties of bronchial mucus (increases its fluidity), helps to achieve such good results. This component turns out to be effective even when clots of pus are detected in the sputum coming out.
When should you start taking it?
The instructions for the drug indicate the main diseases leading to the appearance of an acute cough. It is recommended to start taking ACC powder during the following processes:
- cystic fibrosis;
- bronchiolitis, COPD, bronchial asthma, bronchiectasis
- lung abscess;
- actively developing pneumonia;
- acute, chronic or obstructive bronchitis;
- tracheitis and laryngotracheitis.
To determine how to dilute the “ACC” powder, you should consider in detail the instructions for taking the drug.
Instructions on how to dilute ACC-200 powder
How to take the product correctly? How to dilute ACC powder (200 mg)? Before diluting the drug, you should read the instructions for the medicine in detail again. Only strict adherence to the dosage and rules of administration will help achieve a good effect and the absence of adverse reactions. There are no special features in the procedure, just follow these steps:
- the bag with granules inside should be unpacked by cutting with scissors or tearing the top edge;
- pour the contents into a deep bowl;
- Pour the preparation with hot water (200 ml is enough).
If you start gently stirring the mixture with a spoon, you can achieve a faster dilution of the drug. The instructions on how to dilute ACC powder indicate that hot water should be used.
How to take a mucus thinner correctly
To achieve the maximum effect from the medication, you should also consider the issue of its correct administration. The following features are taken into account:
- according to the instructions, the finished mixture should be drunk immediately after preparation (the temperature should remain hot) after eating;
- when using the solution during a cold and cough, the active components of the medication are more quickly absorbed into the bloodstream and spread throughout the body, which leads to a mucolotic effect;
- if the patient has a febrile condition, then before taking the finished mixture should be cooled to room temperature;
- The prepared mixture should not be left for more than 3 hours after preparation, since such a composition will no longer be suitable and will not bring any results.
The soluble drug "ACC" can be used by children over 6 years of age and adults. The maximum dosage for a child under 14 years of age is 600 mg per day, evenly distributed over several doses. It is forbidden to prescribe the dosage yourself; to do this, you need to consult a doctor.
How to dilute ACC powder? The instructions for use allow you to take other heated liquids together with it, because they will only enhance the mucoltic effect and speed up the healing process.
Duration of taking the medicine
Before taking any medication, the patient must study all possible contraindications and adverse reactions. Knowing such information will help you decide whether it is even possible to take such a drug in a particular situation. The main contraindications of "ACC-200" include:
- the beginning of ulcer progression;
- the presence of bleeding in the lungs or the release of blood along with sputum;
- in the presence of any type of glucose-galactose deficiency;
- women carrying a child and breastfeeding;
- children who have not yet turned 6 years old.
In addition, patients who have an increased allergic reaction to the additional components in the composition or to the main active substance are prohibited from using the drug.
Patients should take “ACC” in powder form with particular care:
- hypertension;
- bronchial asthma (in acute conditions it is completely prohibited);
- peptic ulcers;
- diseases of the adrenal glands;
- allergy to histamine;
- renal or liver failure.
It is also important to remember that the use of medications, especially long-term use, can at any time provoke the appearance of a negative reaction - allergies, breathing problems, dyspeptic disorders, and more. Most often, conditions of this type occur as a result of an overdose.
Reviews about taking the drug "ACC"
For several decades, the leading position in the market of pharmacological drugs has been occupied by the drug "ACC", and reviews of this drug for the most part continue to be positive.
According to doctors, the powder leads to adverse reactions in very rare cases. Many people call this drug the main one in the home pharmacy.
But there are also some distinctive features that consumers considered disadvantages:
- a large list of contraindications, which is why many are simply afraid to start taking the drug;
- cannot be used while pregnant and breastfeeding;
- not available to children under six years of age.
How to take in childhood
It is quite difficult to choose any medicine for a child. Children not only show high sensitivity to medications, but can also be capricious if the drug has an unpleasant taste or repulsive odor.
The manufacturer of the ACC powder produces many forms of the drug suitable for certain ages. They are distinguished by a large number of additional components in the composition and a different dose of the active substance. ACC-100 can be taken by children over 2 years of age.
Rules for diluting the product
How to dilute ACC powder? The prescribed drug must be taken following all the instructions of the attending physician. At the same time, it is important to remember that there are some contraindications and even strict restrictions.
Unlike other medications, ACC powder can be diluted quickly and easily. It won't require much time or effort. The instructions on how to dilute it say that the contents of the sachet should be poured into a separate container, filled with water and mixed thoroughly. It is best to prepare the consistency in a glass glass. Plastic and metal cups cannot be used for these purposes. Experts recommend giving the child the solution immediately after preparing it.
What water to use for dissolution
How to dilute ACC powder so as not to exceed the dosage and prevent adverse reactions? The components included in the product allow the use of plain water to create a solution. The resulting mixture does not emit an unpleasant odor and tastes sweet, which the baby will definitely like.
But before preparing the product, it is important to note that only boiled and hot water should be used. The instructions for taking the medication indicate that diluting the powder with boiling water is prohibited.
Maintaining correct intake
Only if the parent follows the basic rules for taking ACC powder will he be able to achieve a quick and trouble-free recovery for the child. Acetylsteine powder, according to the instructions, should be consumed according to the following scheme:
- At the age of 2 to 6 years - a whole packet or half of it 4 times a day (maximum daily dosage - from 200 to 400 mg, which will depend on body weight).
- Children aged 6 to 14 years can take one sachet three times a day or two sachets - 2 times. The daily dose does not exceed 400 mg.
- Adolescents over 14 years of age are allowed to use two sachets three times a day (dosage no more than 600 mg).
The described treatment regimens for children of different ages have a good effect in the fight against any disease indicated in the instructions, excluding cystic fibrosis. To treat the disease, children aged 2 to 6 years are prescribed 1 packet four times a day; after 6 years, the number of packets increases to two, and the number of doses - to 3. If the child weighs more than 30 kg, the daily dosage may increase slightly.
The treatment time with this remedy should not exceed a week. If the disease is chronic or during the prevention of exacerbation, the treatment period may increase, but the final decision will be made by the doctor.
What a parent needs to know
Often, for complex treatment, therapists prescribe additional antibiotics. The combined use of powder and some antibiotics can cause reduced activity of the latter.
According to the instructions, "ACC" in powder form should be consumed immediately after antibiotics. However, the drug cannot be combined with vasodilating medications. The combination of such drugs can lead to a strong vasodilating effect.
Before diluting ACC granules for a child, it is recommended to learn about the main contraindications. This may include:
- diabetes;
- peptic ulcer disease at the time of exacerbation;
- if you have an allergic reaction to substances in the product;
- formation of blood clots in sputum.
It is prohibited to use the medication during pregnancy, as there is a risk of penetration of the active components of the drug into the amniotic fluid. "ACC" should be used with caution in the presence of cystic fibrosis, purulent discharge, liver and kidney failure, and problems with the functioning of the urinary system.
Analogues of "ACC"
If for certain reasons the patient cannot take acetylsteine, then you can pay attention to other drugs that your doctor will help you choose. The main analogues include "ViksActiv", "Expectomed", "Mukonex" and "Acetylcysteine".
"ViksActiv" is produced in Germany and has an expectorant and mucolytic effect. Prescribed for children over two years of age.
"Acetylcysteine" is available in the form of effervescent powder and tablets. Before diluting the medicine for a child, it is important to note that it is not taken for a dry cough. Analogs have the same contraindications.
The attending physician will help you select an analogue of "ACC" and determine the dosage and duration of the course of treatment for the disease after consultation and identification of the characteristics of the patient's body.
Instructions for use:
ACC is a drug belonging to the group of mucolytic drugs. The active ingredient of the drug is acetylcysteine.
pharmachologic effect
ACC helps liquefy mucus in the respiratory tract and eliminate it, and has an expectorant effect. ACC is an antidote (a substance that can neutralize the toxic effects of poisons and toxins) for poisoning with paracetamol, aldehydes, and phenols.
ACC is well absorbed from the gastrointestinal tract, the maximum level of the drug in the blood is observed 1-3 hours after administration. The binding of acetylcysteine to plasma proteins is 50%. The drug is excreted in urine and feces (insignificant amounts). The half-life during normal liver function is 1 hour, and in case of liver failure it is extended to 8 hours.
ACC passes through the placenta and can accumulate in amniotic fluid.
Release form
ACC 100 and ACC 200 are available in the form of effervescent tablets, 20 pieces per package.
ACC hot drink is available in the form of powder for preparing the drink, 200 and 600 mg per package.
ACC Long is produced in the form of effervescent tablets, 600 mg per package (10 pieces).
ACC powder for the preparation of a solution for internal use, 100 and 200 mg per package.
Children's ACC is produced in the form of powder for internal use, 30 grams in a 75 ml bottle and 60 grams in a 150 ml bottle.
Indications for use of ACC
Indications for the use of ACC are all diseases and conditions in which there is an accumulation of sputum in the respiratory tract. These include:
Bronchitis in acute and chronic form;
Obstructive bronchitis;
Tracheitis;
Bronchiolitis;
Bronchiectasis;
Bronchial asthma;
Sinusitis;
Laryngitis;
Cystic fibrosis;
Exudative otitis media of the middle ear.
Method of administration of ACC and dose
According to the instructions, ACC is used for the treatment of cystic fibrosis in the following doses:
For patients weighing more than 30 kg, the daily dose of ACC is 800 mg;
ACC for children from the 10th day of life to 2 years is used 50 mg 2-3 times a day;
ACC for children aged 2 to 5 years is prescribed at a dose of 400 mg/day. The daily dose is divided into four doses.
ACC for children after six years of age is used at a dose of 600 mg, which is divided into 3 doses per day.
The course of treatment for ACC is from 3 to 6 months.
According to the instructions, ACC is used for other diseases according to a different scheme.
The use of ACC for adults and children after 14 years of age ranges from 400 to 600 mg per day.
The use of ACC for children from 6 to 12 years old is 300-400 mg, divided into 2 doses per day.
ACC for children aged 2 to 5 years is prescribed in a daily dose of 200-300 mg, which must be divided into 2 doses.
For children from the 10th day of life to 2 years of age, the use of ACC is indicated at a dose of 50 mg 2-3 times a day.
The course of treatment for an uncomplicated course of the disease is 5-7 days; in the presence of complications or a chronic course of the disease, the course of treatment can vary widely and reach 6 months.
According to the instructions, ACC should be taken after meals. Dissolve effervescent tablets (ACC 100, ACC 200, ACC long) or a sachet (ACC hot drink or ACC powder for oral solution, ACC for children) in 100 ml of liquid (tea, juice, water).
Side effects
The use of ACC can provoke the development of the following side effects:
Gastrointestinal tract: diarrhea, nausea, vomiting, heartburn, stomatitis;
CNS: tinnitus, headaches;
Heart and blood vessels: arrhythmia, increased blood pressure.
Contraindications
Contraindications to the use of ACC are:
Hypersensitivity to ACC components;
Peptic ulcer;
Bleeding from the lungs;
Fructose intolerance;
Hepatitis and kidney failure (for children).
Pregnancy and lactation
Prescription of ACC during pregnancy and breastfeeding is possible only according to a doctor's indications.
additional information
ACC should be used with caution for gastric and duodenal ulcers.
Patients with bronchial asthma should prepare the ACC solution with care, since particles of the drug inhaled with air can cause bronchial spasm.
For a more effective mucolytic effect (thinning and removal of sputum), you should drink plenty of fluids along with taking the drug.
ACC is prescribed to newborns in exceptional cases as prescribed by the doctor.
Storage conditions
The drug must be kept out of the reach of children at a temperature of no more than 30 degrees. The prepared solution must be stored in the refrigerator for no more than 12 days.
