Acetesone powder for solution for oral administration 100mg in 3g bags №20

Name:
Acezone por.dprig.p-ra dpr.vn.100mg in pack.3g in pack No. 20
Description:
White or white with a yellowish tint powder with an orange smell. The main active ingredient Acetylcysteine Form of release powder Dosage 100 mg Indications for use Respiratory diseases accompanied by the formation of viscous, difficult to separate sputum: acute and chronic bronchitis, laryngitis, sinusitis, tracheitis, influenza, bronchial asthma and (as an additional treatment) cystic fibrosis. Dosage and administration Inside. Standard dose for acute diseases Children 2 to 12 years old: 100 mg 3 times a day or 200 mg 2 times a day. Adults and children over 12 years old: 200 mg 3 times a day or 600 mg at a time 1 time per day. The duration of the course of treatment should be set individually. In acute diseases, the duration of the course is from 5 to 10 days. Special dosing regimens Long-term treatment 400-600 mg per day, in one or more doses, the maximum duration of treatment is 3 to 6 months. With excessive secretion and, as a result, continued cough after 2 weeks of treatment, it is recommended to reconsider the diagnosis to exclude other diseases, for example, possible malignant diseases of the respiratory tract. Cystic fibrosis Adults and children from 6 years of age: 200 mg 3 times a day or 600 mg at a time 1 time per day. The contents of the package are dissolved in one glass of cold or warm water. The finished solution of the drug is not recommended to be mixed with other drugs. A slight sulfuric smell, which may appear when the package is opened, quickly disappears and does not affect the effectiveness of the drug. The drug is taken regardless of food intake, the interaction of the drug with food has not been reported. Patients with impaired liver and kidney function, as a rule, do not require dose adjustment of the drug. This group of patients is recommended to use the drug with caution under the strict supervision of a physician. Elderly age Given the favorable safety profile of acetylcysteine and the absence of a cumulative effect, dose adjustment in elderly patients is not required. In patients over 65 years of age, the lowest effective dose is recommended. If you miss the next dose of the drug, take the missed dose and then continue taking it according to the scheme. Do not take a double dose to make up for a forgotten dose. Use during pregnancy and lactation Pregnancy Limited data on the use of acetylcysteine during pregnancy do not indicate an adverse effect of this drug on the course of pregnancy, the health of the fetus or newborn. Epidemiological data are currently not available. Animal studies do not indicate a direct or indirect toxic effect of acetylcysteine on pregnancy and embryonic and / or postnatal development. As a precautionary measure, it is recommended that the drug be used with caution during pregnancy. The drug during pregnancy is prescribed only if the intended benefit to the mother outweighs the potential risk to the fetus. Lactation There are no data on the excretion of acetylcysteine in breast milk. Take the drug during lactation with caution, only after a thorough assessment of the benefit/risk ratio. If necessary, the use of the drug during lactation should decide on the termination of breastfeeding. Precautions It is recommended to take the drug with caution in patients with a history of gastric and duodenal ulcers, especially in the case of concomitant use of other drugs that irritate the gastric mucosa. There are isolated reports of severe skin reactions (Stevens-Johnson and Lyell syndromes) when taking acetylcysteine, therefore, in case of changes in the skin or mucous membranes, you should immediately stop using the drug and consult a doctor. Care should be taken to prescribe acetylcysteine to patients with bronchial asthma due to the possible development of bronchospasm. When pouring the contents of the package into the dishes during the preparation of the solution, the powder may enter the air and irritate the nasal mucosa, as a result of which reflex bronchospasm may occur. In patients with liver and kidney disease, acetylcysteine should be administered with caution to avoid the accumulation of nitrogen-containing substances in the body. The use of acetylcysteine causes liquefaction of bronchial secretions. If the patient is unable to effectively cough up sputum, postural drainage and bronchoaspiration are necessary. Acetylcysteine leads to inhibition of diamine oxidase (DAO) in vitro by 20-50%. Therefore, long-term therapy should not be given to patients with histamine intolerance, as this may lead to symptoms of intolerance (headache, vasomotor rhinitis, pruritus). The combined use of acetylcysteine and antitussive drugs is not recommended. The simultaneous use of antitussive drugs can lead to accumulation of secretion through inhibition of the cough reflex and physiological self-clearing of the airways with the risk of bronchospasm and upper respiratory tract infection. Caution should be exercised in patients at risk of gastrointestinal bleeding (eg, latent peptic ulcer or esophageal varices), as oral administration of acetylcysteine may cause vomiting. Due to the risk of bronchospasm in patients with bronchial asthma and bronchial hyperreactivity, caution is advised. If a hypersensitivity reaction or bronchospasm occurs, the use of the drug should be immediately discontinued and appropriate measures taken. Mucolytics can cause breathing problems in children under 2 years of age. Due to the physiological characteristics of the respiratory tract in this age group, the ability for physiological self-cleaning may be limited. Therefore, mucolytic agents should not be used in children under 2 years of age (see also the Contraindications section). The drug contains sucrose, so it should not be prescribed to patients with rare hereditary forms of fructose intolerance, sucrase-isomaltase deficiency or glucose-galactose malabsorption syndrome. One packet of ACECESONE 100 mg contains 2.8 g of sucrose (approximately 0.24 bread units), one packet of ACECESONE 200 mg contains 2.7 g of sucrose (approximately 0.23 bread units). This should be taken into account when using the drug in patients with diabetes mellitus. May cause damage to teeth with prolonged use (2 weeks or more). One packet of ACECESONE 100 mg contains 12.5 mg of ascorbic acid, one packet of ACECESONE 200 mg contains 25.0 mg of ascorbic acid, which is important to consider in patients taking other sources of vitamin C. This medicinal product contains sodium in an amount of less than 1 mmol (less than 23 mg) per sachet, i.e. practically “sodium-free”. Interaction with other drugs Interaction studies with other drugs have not been conducted in vivo. The simultaneous use of acetylcysteine and activated charcoal in the treatment of intoxication may reduce the effectiveness of oral acetylcysteine taken. In in vitro studies, cases of inactivation of antibiotics by acetylcysteine were noted when they were mixed. Therefore, the interval between taking antibiotics and acetylcysteine should be at least 2 hours. This does not apply to loracarbef. Simultaneous administration of acetylcysteine and nitroglycerin can lead to an increase in the vasodilating and antiplatelet action of the latter. If it is necessary to simultaneously use nitroglycerin and acetylcysteine, patients should be monitored for the possible development of hypotension, which can be severe, patients should be warned about the possibility of headaches. Simultaneous use of acetylcysteine with antitussives: see handed out “Precautions”. The simultaneous use of acetylcysteine and carbamazepine may lead to sub-therapeutic concentrations of carbamazepine. Acetylcysteine may interfere with colorimetric assays of salicylates and urinary ketones. Contraindications Hypersensitivity to acetylcysteine or any of the excipients of the drug. Children under 2 years old. Active peptic ulcer. Fructose intolerance, such as hereditary deficiency of fructose-1,6-diphosphatase (due to the presence of sucrose in the composition of the drug). Hyperoxaluria. Composition Each package contains: active substance: acetylcysteine – 100.0 mg and 200.0 mg; excipients: ascorbic acid, sodium saccharin (E954), sucrose, orange flavor (dextrose, flavoring component, anti-caking agent: E551 (5%), iodized table salt). Overdose No cases of drug overdose have been reported. The use of acetylcysteine in healthy volunteers at a daily dose of 11.6 g for three months did not cause any serious adverse reactions. Acetylcysteine, when taken at a dose of 500 mg / kg / day, does not cause signs and symptoms of overdose. Symptoms An overdose may be manifested by the following gastrointestinal symptoms: nausea, vomiting and diarrhoea. Treatment There is no specific antidote, treatment is symptomatic. Side effects Like all medicines, Acecazone can cause side effects, although not everyone gets them. Stop taking this medicine and get medical help right away if you experience any of these very rare side effects (may affect up to 1 in 10,000 people): a severe, life-threatening allergic reaction. Signs may include: rash, difficulty swallowing or breathing problems, swelling of the lips, face, throat, or tongue; heavy bleeding (hemorrhage); blisters, flaky, bleeding, flaking, or fluid-filled patches on any part of your skin. This includes your lips, eyes, mouth, nose, genitals, hands or feet. You may have a serious skin problem. The following adverse reactions have also been reported: Uncommon (may affect up to 1 in 100 people): stomatitis, abdominal pain, nausea, vomiting, diarrhea, heartburn, fever, tachycardia, hypotension, headache, tinnitus. Rare (may affect up to 1 in 1,000 people): dyspepsia, dyspnea, bronchospasm. Reporting adverse reactions If you experience any adverse reactions, it is recommended that you consult your doctor. This recommendation applies to any possible adverse reactions, including those not listed in the instructions for use of the medicinal product. You can also report adverse reactions to the adverse drug reactions (actions) information database, including reports of drug failures. By reporting adverse reactions, you help to get more information about the safety of the medicine. Storage conditions In a place protected from moisture and light at a temperature not exceeding 25 ° C. Store out of the reach of children. in packages 3g №20