Symptoms: acetylcysteine when taken at a dose of up to 500 mg / kg did not cause any symptoms of intoxication. With an erroneous or deliberate overdose, such phenomena as diarrhea, vomiting, stomach pain, heartburn and nausea can be observed. Children may experience sputum hypersecretion.
Treatment: symptomatic.
3 years
After reconstitution, the product must be administered immediately.
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, optional
lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
With caution: a history of gastric and duodenal ulcer, bronchial asthma, obstructive bronchitis, hepatic and/or renal insufficiency, 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), esophageal varicose veins, adrenal diseases, arterial hypertension.
For granules for the preparation of the solution in addition
sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose deficiency.
With caution: a history of gastric and duodenal ulcer, arterial hypertension, esophageal varicose veins, bronchial asthma, obstructive bronchitis, adrenal diseases, hepatic and/or renal insufficiency, 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).
For the syrup in addition
With caution: a history of gastric and duodenal ulcer, bronchial asthma, hepatic and / or renal insufficiency, 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), esophageal varicose veins, adrenal diseases, arterial hypertension.
For all dosage forms
With the simultaneous use of acetylcysteine and antitussive agents, due to the suppression of the cough reflex, sputum stagnation may occur. Therefore, such combinations should be selected with caution.
Concomitant administration of acetylcysteine with vasodilators and nitroglycerin may lead to an increase in the vasodilator effect.
When used simultaneously with oral antibiotics (including penicillins, tetracyclines, cephalosporins) , they may interact with the thiol group of acetylcysteine, which may 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, rubber forms sulfides with a characteristic smell..
Aspartame (E951)
Sorbitol (E420)
Lemon flavour (contains maltodextrin, a form of glucose)
Sunset yellow (E110)
Powder for the preparation of a solution for oral administration, Substance, Substance-powder, effervescent tablets
According to WHO, adverse reactions are classified according to their frequency of development as follows: very common (≥1/10), common (≥1/100, <1/10), infrequent (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), frequency unknown — according to available data, it was not possible to determine the frequency of occurrence.
Allergic reactions: infrequently-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 hyperreactivity of the bronchi in bronchial asthma).
From the gastrointestinal tract: infrequently-stomatitis, abdominal pain, nausea, vomiting, diarrhea, heartburn, dyspepsia (except syrup).
On the part of the senses: infrequently-tinnitus.
Other: very rarely-headache, fever, isolated reports of bleeding due to the presence of hypersensitivity reactions, decreased platelet aggregation.
Acute toxicity studies in rats and mice, by oral, intraperitoneal and intravenous administration showed acetylcysteine to be of low toxicity. LD50 values greater than 7 g / kg in mice and 6 g / kg in rats have been reported. Chronic toxicity studies with acetylcysteine in rats at doses up to 2000 mg/ kg/ day and dogs at doses up to 300 mg/ kg / day for periods up to 52 weeks demonstrate that acetylcysteine is well tolerated, even at higher doses. In reproductive toxicity studies in rats and rabbits, the oral administration of doses up to 2000 mg / kg / day did not show changes in reproductive capacity, teratogenic effects or peri/postnatal toxicity.
For all dosage forms
diseases of the respiratory system, accompanied by the formation of viscous sputum difficult to separate:
- acute and chronic bronchitis,
- obstructive bronchitis,
- tracheitis,
- laryngotracheitis,
- pneumonia,
- lung abscess,
- bronchiectatic disease,
- bronchial asthma,
- chronic obstructive pulmonary disease,
- bronchiolitis,
- cystic fibrosis,
acute and chronic sinusitis,
inflammation of the middle ear (otitis media).
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 effect 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.
The absorption is high. It is rapidly metabolized in the liver to form a pharmacologically active metabolite-cysteine, as well as diacetylcysteine, cystine and mixed disulfides. Oral bioavailability is 10% (due to the presence of a pronounced effect of the first passage through the liver). Tmax in the blood plasma is 1-3 hours. The bond with plasma proteins is 50%. It is excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine). T1/2 it is about 1 h, impaired liver function leads to an elongation of the T1/2 up to 8 hours. Penetrates through the placental barrier. There are no data on the ability of acetylcysteine to penetrate the BBB and be excreted in breast milk.
05/07/2016
Acetylcysteine
NTC S.r.l.
Via Luigi Razza, 3-20124, Milan
Italy
At a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf life of the drug ADC®effervescent tablets 100 mg — 3 years.
syrup 20 mg / ml — 2 years. After opening, store the bottle for no more than 10 days at a temperature not exceeding 25 °C
powder for the preparation of a solution for oral administration of 100 mg orange (s) — 4 years.
granules for the preparation of a solution for oral administration of 100 mg orange (s) — 4 years.
Do not use after the expiration date indicated on the package.
ADC® 100
| Effervescent tablets | 1 table. |
| active substance: | |
| acetylcysteine | 100 mg |
| excipients: citric acid anhydrous-679.85 mg, sodium bicarbonate-194 mg, sodium carbonate anhydrous-97 mg, mannitol-65 mg, ascorbic acid-12.5 mg, lactose anhydrous-75 mg, sodium saccharinate-6 mg, sodium citrate-0.65 mg, blackberry flavor " B» — 20 mg |
ADC®
| Granules for the preparation of a solution for oral administration (orange) | 1 pack. |
| active substance: | |
| acetylcysteine | 100 mg |
| excipients: sucrose-2829.5 mg, ascorbic acid-12.5 mg, saccharin-8 mg, orange flavor-50 mg |
| Syrup | 1 ml |
| active substance: | |
| acetylcysteine | 20 mg |
| excipients: methyl parahydroxybenzoate-1.3 mg, sodium benzoate-1.95 mg, disodium edetate-1 mg, sodium saccharinate-1 mg, sodium carmellose-2 mg, sodium hydroxide, 10% aqueous solution-30-70 mg, Cherry flavor-1.5 mg, purified water-910.25-950.25 mg |
ADC® 100
Effervescent tablets, 100 mg.
When packing Hermes Pharma Ges. m. b. H., Austria: 20 tablespoons of effervescent in a plastic or aluminum tube. 1 tube of 20 tablespoons. effervescent in a cardboard pack.
ADC®
Granules for the preparation of a solution for oral administration (orange), 100 mg. 3 g of pellets in bags made of a combined material (aluminum foil/paper/PE). 20 pack. in a cardboard box.
Syrup, 20 mg / ml. In bottles made of dark glass, capped with white caps with a sealing membrane, with the function of protection against opening by children, with a protective ring, 100 ml.
Metering devices:
- transparent measuring cup (cap), graduated to 2.5, 5 and 10 ml,
- transparent syringe for dosing, graduated by 2.5 and 5 ml with a white piston and with an adapter ring for fixing to the bottle.
1 fl. together with the dosing devices in a cardboard pack.
PL 35730/0009
Data on the use of acetylcysteine during pregnancy and breastfeeding are limited. The use of the drug during pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus.
If you need to use the drug during lactation, you should decide whether to stop breastfeeding.
Acetylcysteine
Patients with bronchial asthma should be closely monitored during therapy; if' bronchospasm occurs, treatment with Acetylcysteine 200 mg Powder for Oral Solution should be discontinued immediately.
Administration of acetylcysteine, especially at the beginning of treatment, may liquefy bronchial secretions and, at the same time, increase their volume. If the patient is unable to expectorate efficiently, to avoid retention of secretions postural drainage and tracheal suction should be used.
There are no studies on the efficacy and safety of acetylcysteine 200 mg three times daily in adolescent population. However, mild to severe adverse reactions have been reported with the use of IV acetylcysteine in adults and adolescents.
This medicine contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
This medicine contains aspartame, which is a source phenylalanine. This may be harmful to people with phenylketonuria.
This medicine contains a colouring agent called sunset yellow (Ell0), which may cause allergic reactions.
Acetylcysteine can cause interference with the colorimetric assay method for the determination of salicylates.
Acetylcysteine can interfere with tests for ketones in urine.
Upon opening the sachet the powder may smell of sulphur (rotten egg smell). This is a normal characteristic of the active substance. Upon addition of water the solution will have a citrus odour.
No studies on the effects on the ability to drive or use machines have been performed. Acetylcysteine 200 mg Powder for Oral Solution has no known effect on the ability to drive and use machines.
Inside. The powder is dissolved in 1 cup of hot water, taken orally after meals.
In the absence of other appointments, the following recommendations should be followed.
Acetylcysteine® at a dosage of 200 mg: adults and children over 14 years of age-2-3 times a day for 1 pack. (400-600 mg), children from 6 to 14 years — 2 times a day for 1 pack. (400 mg), from 2 to 6 years — 2-3 times a day for 1/2 pack. (200-300 mg). With cystic fibrosis: children from 2 to 6 years — 2 times a day for 1 pack. (400 mg), older than 6 years — 3 times a day for 1 pack. (600 mg).
Acetylcysteine® at a dosage of 600 mg: adults and children over 14 years old — 1 time a day for 1 pack. (600 mg). With cystic fibrosis: children over 6 years of age-1 time a day for 1 pack. (600 mg).
Additional fluid intake increases the mucolytic effect of the drug.
For short-term colds, the duration of administration is 5-7 days. In chronic bronchitis and cystic fibrosis, the drug should be taken for a longer time to prevent infections. For long-term diseases, the duration of therapy is determined by the attending physician.
ADC® 100
ADC®
Inside, after the meal.
In the absence of other prescriptions, it is recommended to adhere to the following dosages.
Mucolytic therapy
Adults and children over 14 years of age: 2 tablets of effervescent 100 mg 2-3 times a day or 2 packs of ADC® 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 of acetylcysteine per day).
Children from 6 to 14 years old: 1 tab. effervescent 100 mg 3 times a day or 2 tab. effervescent 2 times a day, or 1 pack. ADC® granules for the preparation of the 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 of effervescent 100 mg or 1 pack of ADC® 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 of acetylcysteine per day).
Cystic fibrosis
For patients with cystic fibrosis (congenital metabolic disorder with frequent bronchial tract infections) and a body weight of more than 30 kg, if necessary, it is possible to increase the dose to 800 mg of acetylcysteine per day.
Children over 6 years old: 2 tablets of effervescent 100 mg or 2 packs of ADC® granules of 100 mg for the preparation of the solution 3 times a day, or 10 ml of syrup 3 times a day (600 mg of acetylcysteine per day).
Children from 2 to 6 years old: 1 table of effervescent 100 mg or 1 pack of ADC® granules of 100 mg for the preparation of the solution, or 5 ml of syrup 4 times a day (400 mg of acetylcysteine per day).
Effervescent tablets should be dissolved in 1 cup of water and taken immediately after dissolution, in exceptional cases, you can leave the solution ready for use for 2 hours.
Granules for the preparation of a solution for oral administration (orange) should be dissolved in water, juice or cold tea and taken after meals.
Additional fluid intake increases the mucolytic effect of the drug. For short-term colds, the duration of administration is 5-7 days.
In chronic bronchitis and cystic fibrosis, the drug should be taken for a longer time to achieve a preventive effect against infections.
ADC Syrup® take with a measuring syringe or measuring cup, located 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 it and turning it counterclockwise.
2. Remove the plug with a hole from the syringe, insert it into the neck of the bottle and push it all the way down. The plug is designed to connect the syringe to the bottle and remains in the neck of the bottle.
3. Insert the syringe firmly into the plug. Carefully turn the bottle upside down, pull the plunger of the syringe down and collect the required amount of syrup. If air bubbles are visible in the syrup, press the plunger until it stops, then fill the syringe again. Return the bottle to its original position and remove the syringe.
4. The syrup from the syringe should be poured on a spoon or directly into the child's mouth (in the cheek area, slowly, so that the child can swallow the syrup properly), while taking the syrup, the child should be in an upright position.
5. After use, rinse the syringe with clean water.
Indication for patients with diabetes mellitus: 1 effervescent tablet corresponds to 0.006 XE, 1 pack. ADC® granules for the preparation of a solution of 100 mg corresponds to 0.24 XE, 10 ml (2 scoops) of ready-to-use syrup contain 3.7 g of D-glucitol (sorbitol), which corresponds to 0.31 XE.
No special requirements for disposal. Any unused product should be disposed of in accordance with local requirements.
R05CB01 Acetylcysteine
05/07/2016
Drug Interactions
Antitussive drugs and acetylcysteine should not be administered concomitantly because reducing the cough reflex may lead to a build-up of bronchial secretions.
Activated charcoal may reduce the effect of acetylcysteine.
It is advisable not to mix Acetylcysteine 200 mg Powder for Oral Solution with other medicinal products.
In vitro tests have shown that when cephalosporin antibiotics and acetylcysteine are mixed, there is a degree of antibiotic inactivation. It is precautionary to advise the administration of oral antibiotics at least two hours before or after acetylcysteine.
Concurrent administration of nitroglycerin and acetylcysteine causes significant hypotension and leads to temporal artery dilation with possible onset of headache.
If concurrent administration of nitroglycerin and acetylcysteine is required, patients should be monitored and warned for hypotension that can be severe and accompanied by a headache.
