ACC powder for solution for oral administration 100mg in bags №20

Name:
ACC por. dpr. inside 100 mg No. 20 Storage conditions The drug should be stored out of the reach of children at a temperature not exceeding 25 ° C. The shelf life of granules for oral solution (200 mg, 600 mg) is 3 years. The shelf life of granules for oral solution preparation (orange) is 4 years. The shelf life of the syrup is 2 years; after opening, the vial should be stored for no more than 18 days at a temperature not exceeding 25 ° C. Expiration date from the date of manufacture4 years
Description:
of goods Granules for oral solution preparation (orange) white, homogeneous, without agglomerates, with an orange smell. Pharmacological action Mucolytic drug. Acetylcysteine 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; otitis media. Use during pregnancy and lactation Due to insufficient data, the use of the drug during pregnancy is contraindicated. For syrup: the use of the drug during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus. 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. It is not recommended to prescribe the drug to patients with renal and / or hepatic insufficiency in order to avoid additional formation of nitrogenous compounds. 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). When prescribing the drug to patients on a diet aimed at limiting sodium intake, it should be taken into account that 1 ml of ACC® syrup contains 41.02 mg of sodium. There is no need for special precautions when destroying an unused ACC® preparation. Instructions for patients with diabetes In the treatment of patients with diabetes, it must be taken into account that ACC® in the form of granules for oral solution (200 mg, 600 mg, orange 100 mg and 200 mg) contain sucrose. ACC® in the form of granules for oral solution / orange / 100 mg and 200 mg: 1 sachet of 100 mg corresponds to 0.24 XE, 1 sachet of 200 mg – 0.23 XE. ACC® in the form of granules for oral solution 200 mg: 1 sachet corresponds to 0.21 XE. ACC® in the form of granules for oral solution 600 mg: 1 sachet corresponds to 0.17 XE. Influence on the ability to drive vehicles and control mechanisms Information about the effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions is not available. 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 under 2 years of age (syrup, granules for oral solution / orange / 100 mg and 200 mg); children’s age up to 6 years (granules for the preparation of a solution for oral administration of 200 mg); children’s age up to 14 years (granules for the preparation of a solution for oral administration 600 mg); fructose intolerance, tk. the drug contains sorbitol (granules for oral solution /orange/ 100 mg and 200 mg, granules for oral solution 200 mg and 600 mg); sucrase / isomaltase deficiency, glucose-galactose deficiency (granules for oral solution / orange / 100 mg and 200 mg, granules for oral solution 200 mg and 600 mg); hypersensitivity to acetylcysteine and other components of the drug. The drug should be used with caution in patients with a history of gastric 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. Method of application and doses Granules for the preparation of a solution for oral administration (orange) 100 mg and 200 mg, granules for the preparation of a solution for oral administration 200 mg Adults and adolescents over 14 years of age are recommended to prescribe the drug 200 mg 2-3 times / day. The daily dose is 400-600 mg. Children aged 6 to 14 years are recommended to take 100 mg 3 times / day or 200 mg 2 times / day. The daily dose is 300-400 mg. Children aged 2 to 5 years are recommended to take the drug 100 mg 2-3 times / day. The daily dose is 200-300 mg. In cystic fibrosis, children over the age of 6 years are recommended to take the drug 200 mg 3 times / day. The daily dose is 600 mg. Children aged 2 to 5 years – 100 mg 4 times / day. The daily dose is 400 mg. Patients weighing more than 30 kg with cystic fibrosis, if necessary, can increase the dose to 800 mg / 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. In case of long-term diseases, the duration of therapy is determined by the attending physician. The drug is taken orally after a meal. Additional fluid intake enhances the mucolytic effect of the drug. ACC® in the form of granules for oral solution (orange) 100 mg and 200 mg are dissolved in water, juice or cold tea. ACC® in the form of granules for oral solution 200 mg is dissolved with stirring in 1 glass of hot water and drunk as hot as possible. If necessary, you can leave the prepared solution for 3 hours. Granules for the preparation of a solution for oral administration 600 mg Adults and adolescents over 14 years of age are recommended to prescribe the drug at a dose of 600 mg (1 sachet) 1 time / 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. In case of long-term diseases, the duration of therapy is determined by the attending physician. The drug is taken orally after a meal. Additional fluid intake enhances the mucolytic effect of the drug. The granules are dissolved with stirring in 1 glass of hot water and drunk, if possible, hot. If necessary, you can leave the prepared solution for 3 hours. Syrup Adults and adolescents over 14 years of age are prescribed 10 ml of syrup 2-3 times / day (400-600 mg of acetylcysteine). Children aged 6 to 14 years – 5 ml of syrup 3 times / day or 10 ml of syrup 2 times / day (300-400 mg of acetylcysteine). Children aged 2 to 5 years are prescribed 5 ml of syrup 2-3 times / day (200-300 mg of acetylcysteine). In cystic fibrosis, children over the age of 6 years are recommended to take the drug 10 ml of syrup 3 times / day (600 mg of acetylcysteine); children aged 2 to 5 years – 5 ml of syrup 4 times / day (400 mg of acetylcysteine). With short-term colds, the duration of admission is 4-5 days. In chronic bronchitis and cystic fibrosis, the drug should be used for a longer time to prevent infections. In case of long-term diseases, the duration of therapy is determined by the attending physician. The drug is taken orally, after a meal. Additional fluid intake enhances the mucolytic effect of the drug. ACC® syrup is taken with a measuring syringe or a measuring cup, which is in the package. 10 ml of ACC® syrup corresponds to 1/2 measuring cup or 2 filled syringes. Using a measuring syringe 1. Open the vial cap by pushing it in and turning it counterclockwise. 2. Remove the plug with a hole from the syringe, insert it into the neck of the vial and press it in until it stops. The stopper is designed to connect the syringe to the vial and remains in the neck of the vial. 3. It is necessary to firmly insert the syringe into the stopper. Carefully turn the vial upside down, pull the syringe plunger down and draw up the required amount of syrup (ml). If air bubbles are visible in the syrup, press the piston all the way down, and then refill the syringe. Then return the vial 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 (in the buccal region, slowly, so that the child can swallow the syrup). While taking the syrup, the child should be in an upright position. 5. After use, rinse the syringe with clean water. Overdose Acetylcysteine at a dose of 500 mg / kg / day does not cause signs and symptoms of overdose. Symptoms: with an erroneous or deliberate overdose, such phenomena as diarrhea, vomiting, stomach pain, heartburn, nausea are observed. Treatment: symptomatic therapy. Side effectsAccording to WHO, adverse effects are classified according to their frequency of development as follows: very often (? <1/100), rare (?1/10,000, <1/1000) and very rare (<10,000), the frequency is unknown (the frequency of occurrence cannot be determined from 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: rarely - headache, fever; in isolated cases - the development of bleeding as a manifestation of a hypersensitivity reaction, a decrease in platelet aggregation. Composition Active substance: acetylcysteine 100 mg; Excipients: sucrose - 2829.5 mg, ascorbic acid - 12.5 mg, saccharin - 8 mg, orange flavor - 50 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 Granules for solution for oral administration (orange) white, homogeneous, without agglomerates, with an orange smell. 1 pack Active substance: acetylcysteine 100 mg; Excipients: sucrose - 2829.5 mg, ascorbic acid - 12.5 mg, saccharin - 8 mg, orange flavor - 50 mg. 3 g - sachets of combined material (20) - cardboard packs. Buy ACC powder for oral solution 100 mg in bags No. 20 Price for ACC powder for oral solution 100 mg in bags No. 20 Instructions for use for ACC powder for preparation solution for oral administration 100 mg in bags No. 20