ACC 200 effervescent tablets 200mg №20 №1

Name:
ACC 200 spike. tab. 200 mg in tubes No. 20 Storage conditions Keep out of the reach of children, dry place at a temperature not exceeding 25°C. Expiration date from the date of manufacture3 years
Description:
of goods White effervescent tablets, round, flat-cylindrical, with a notch on one side, with a blackberry smell; there may be a slight sulfuric odor; reconstituted solution – colorless transparent with blackberry odor; There may be a slight sulfur odor. Pharmacological actionAcetylcysteine is a derivative of the amino acid cysteine. It has a mucolytic effect, facilitates sputum discharge due to a direct effect on the rheological properties of sputum. The action is due to the ability to break the disulfide bonds of mucopolysaccharide chains and cause depolymerization of sputum mucoproteins, which leads to a decrease in sputum viscosity. The drug remains active in the presence of purulent sputum. It has an antioxidant effect due to the ability of its reactive sulfhydryl groups (SH-groups) to bind to oxidizing radicals and thus neutralize them. In addition, acetylcysteine promotes the synthesis of glutathione, an important component of the antioxidant system and chemical detoxification of the body. The antioxidant effect of acetylcysteine increases the protection of cells from the damaging effects of free radical oxidation, which is characteristic of an intense inflammatory reaction. With the prophylactic use of acetylcysteine, there is a decrease in the frequency and severity of exacerbations in patients with chronic bronchitis and cystic fibrosis. Pharmacokinetics Absorption and distribution Absorption is high. Bioavailability when taken orally is 10%, due to the pronounced effect of “first pass” through the liver. The time to reach Cmax in plasma is 1-3 hours. Plasma protein binding is 50%. Penetrates through the placental barrier. There are no data on the ability of acetylcysteine to penetrate the BBB and be excreted in breast milk. Metabolism and excretion Rapidly metabolized in the liver with the formation of a pharmacologically active metabolite – cysteine, as well as diacetylcysteine, cystine and mixed disulfides. It is excreted by the kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteine). T1 / 2 is about 1 hour. Pharmacokinetics in special clinical cases Impaired liver function leads to a prolongation of T1 / 2 up to 8 hours. Indications for use pneumonia, lung abscess, bronchiectasis, bronchial asthma, COPD, bronchiolitis, cystic fibrosis); – acute and chronic sinusitis; Use during pregnancy and lactation Due to insufficient data, the use of the drug during pregnancy is contraindicated. If necessary, the use of the drug during lactation should decide on the termination of breastfeeding. Cautions In bronchial asthma and obstructive bronchitis, acetylcysteine should be administered with caution under the systematic control of bronchial patency. When using acetylcysteine, cases of severe allergic reactions such as Stevens-Johnson syndrome and Lyell’s syndrome have been reported very rarely. If changes in the skin and mucous membranes occur, the patient should immediately stop taking the drug and consult a doctor. When dissolving the drug, it is necessary to use glassware, avoid contact with metals, rubber, oxygen, easily oxidized substances. Do not take the drug immediately before bedtime (the preferred time of admission is before 18.00). 1 effervescent tablet ACC® 100 or ACC® 200 corresponds to 0.006 XE, 1 effervescent tablet ACC® Long – 0.001 XE. There is no need for special precautions when discarding unused ACC® effervescent tablets. Influence on the ability to drive vehicles and control mechanisms There are no data on the negative effect of the drug on the ability to drive vehicles and mechanisms, when used in recommended doses. With caution (Precautions) With caution, the drug should be used in patients with a history of gastric ulcer and duodenal ulcer; with bronchial asthma, obstructive bronchitis; hepatic and / or renal failure; histamine intolerance (long-term use of the drug should be avoided, because 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; arterial hypertension. Contraindications Peptic ulcer of the stomach and duodenum in the acute phase; – hemoptysis; – pulmonary bleeding; – pregnancy; – lactation period (breastfeeding); – children’s age up to 14 years (ACC® Long); – children’s age up to 2 years (ACC® 100, ACC® 200); – lactase deficiency, lactose intolerance, glucose-galactose malabsorption; – Hypersensitivity to the components of the drug. Dosage and administration The drug is taken orally after meals. Effervescent tablets should be dissolved in 1 glass of water. Tablets should be taken immediately after dissolution, in exceptional cases, you can leave the finished solution for 2 hours. Additional fluid intake enhances the mucolytic effect of the drug. Adults and adolescents over 14 years of age are recommended to prescribe the drug 200 mg (2 tab. ACC® 100, 1 tab. ACC® 200) 2-3 times / day, which corresponds to 400-600 mg of acetylcysteine per day, or 600 mg (ACC ® Long) 1 time / day. Children aged 6 to 14 years are recommended to take 1 tab. (ACC® 100) 3 times / day, or 2 tab. (ACC® 100) or 1 tab. (ACC® 200) 2 times / day, which corresponds to 300-400 mg of acetylcysteine per day. Children aged 2 to 6 years are recommended to take the drug 1 tab. (ACC® 100) or 1/2 tab. (ACC® 200) 2-3 times / day, which corresponds to 200-300 mg of acetylcysteine per day. In cystic fibrosis, children over the age of 6 years are recommended to take the drug 2 tab. (ACC® 100) or 1 tab. (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. With short-term colds, the duration of admission is 5-7 days. In chronic bronchitis and cystic fibrosis, the drug should be used for a longer time to prevent infections. OverdoseSymptoms: in case of erroneous or deliberate overdose, such phenomena as diarrhea, vomiting, stomach pain, heartburn, nausea are observed. Treatment: symptomatic therapy. Side effectAccording to WHO, undesirable effects are classified according to their frequency of development as follows: very often (?1/10), often (?1/100, <1/10), infrequently (?1/1000, <1/100) , rare (≥1/10,000, <1/1000), very rare (<10,000), frequency unknown (frequency of occurrence cannot be determined based on the available data). Allergic reactions: infrequently - itching, rash, exanthema, urticaria, angioedema; 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 side of the cardiovascular system: infrequently - a decrease in blood pressure, tachycardia. From the digestive system: infrequently - stomatitis, abdominal pain, nausea, vomiting, diarrhea, heartburn, dyspepsia. On the part of the organ of hearing: infrequently - tinnitus. Other: infrequently - headache, fever; in isolated cases - the development of bleeding as a manifestation of a hypersensitivity reaction, a decrease in platelet aggregation. Active ingredient: acetylcysteine 200 mg Excipients: anhydrous citric acid - 558.5 mg, sodium bicarbonate - 200 mg, anhydrous sodium carbonate - 100 mg, mannitol - 60 mg, anhydrous lactose - 70 mg, ascorbic acid - 25 mg, sodium saccharinate - 6 mg, sodium citrate - 0.5 mg, blackberry flavor "B" - 20 mg. Interaction with other drugs With the simultaneous use of acetylcysteine and antitussives, due to the suppression of the cough reflex, sputum stagnation may occur. With the simultaneous use of acetylcysteine and oral antibiotics (penicillins, tetracyclines, cephalosporins, etc.), the latter may interact with the thiol group of acetylcysteine, which can lead to a decrease in antibacterial activity. Therefore, the interval between taking antibiotics and acetylcysteine should be at least 2 hours (except for cefixime and loracarbef). Simultaneous use with vasodilators and nitroglycerin may lead to an increase in the vasodilating effect. Release form Effervescent tablets, white, round, flat-cylindrical, with a notch on one side, with a blackberry smell; there may be a slight sulfuric odor; reconstituted solution - colorless transparent with blackberry odor; There may be a slight sulfur odor. 1 tab. Active substance: acetylcysteine 200 mg Excipients: anhydrous citric acid - 558.5 mg, sodium bicarbonate - 200 mg, anhydrous sodium carbonate - 100 mg, mannitol - 60 mg, anhydrous lactose - 70 mg, ascorbic acid - 25 mg, sodium saccharinate - 6 mg, sodium citrate - 0.5 mg, blackberry flavor "B" - 20 mg. 20 pcs. - plastic tubes (1) - cardboard packs. Buy ACC 200 effervescent tablets 200mg No. 20 No. 1