Acetylcysteine powder for solution for oral administration 0.2 g in bags No. 20

Name:
Acetylcysteine por.d/prig.r-ra d/pr.vn.0.2g in pack.in pack No. 20
Description:
White or almost white powder. A yellowish tint is allowed. The main active ingredientAcetylcysteine Release formPowder for the preparation of a solution Pharmacological action Mucolytic agent, dilutes sputum, increases its volume, facilitates sputum separation. The action is associated with the ability of free sulfhydryl groups of acetylcysteine to break intra- and intermolecular disulfide bonds of sputum acid mucopolysaccharides, which leads to depolymerization of mucoproteins and a decrease in sputum viscosity (in some cases this leads to a significant increase in sputum volume, which requires aspiration of bronchial contents). Retains activity in purulent sputum. Does not affect immunity. Increases the secretion of less viscous sialomucins by goblet cells, reduces the adhesion of bacteria to the epithelial cells of the bronchial mucosa. Stimulates the mucous cells of the bronchi, the secret of which lyses fibrin. It has a similar effect on the secret formed in inflammatory diseases of the upper respiratory tract. It has an antioxidant effect due to the presence of the SH-group, which is able to neutralize electrophilic oxidative toxins. It also has some anti-inflammatory action (due to the suppression of the formation of free radicals and active oxygen-containing substances responsible for the development of inflammation in the lung tissue). Indications for use Respiratory diseases accompanied by the formation of viscous sputum that is difficult to separate, for example, acute and chronic bronchitis, tracheitis, laryngitis, bronchial asthma and (as an additional therapy) cystic fibrosis. Dosage and administration Apply orally after meals. The contents of 1 packet are dissolved in 1/2 cup (approximately 100 ml) of warm drinking water immediately before taking. After preparing the solution, it should be drunk as soon as possible. Additional fluid intake enhances the mucolytic effect of the drug. Acute and chronic diseases of the bronchopulmonary system: adults and children over the age of 12 years, 200 mg 3 times a day. Children aged 6 to 12 years: 200 mg 2 times a day. In acute uncomplicated diseases, the drug is used for no more than 4-5 days without medical supervision. Long-term treatment: 400-600 mg per day, divided into several doses or as a single dose. The duration of treatment is a maximum of 3-6 months. Cystic fibrosis (cystic fibrosis): adults and children from 6 years old – 200 mg 3 times a day or 600 mg 1 time a day. If there is no effect after two weeks of treatment, the diagnosis should be reviewed and a possible malignant disease of the respiratory tract excluded. If a dose is missed, it should be taken as soon as possible and the next dose at the usual time. However, if the next dose is due, the missed dose should not be taken. You should not compensate for the missed dose by increasing the dose at the next dose. Elderly patients: dose adjustment is not required. Patients with impaired liver and kidney function: dose adjustment is not required. Use during pregnancy and lactation Pregnancy Limited data on the use of the drug during pregnancy have not shown an adverse effect on the course of pregnancy or on the health of the fetus or newborn. There is no experience of epidemiological studies. Animal studies have not revealed direct or indirect toxic effects on pregnancy, embryonic development, fetal development and/or postnatal development. Use during pregnancy with caution only if the benefit to the mother outweighs the risk to the fetus. Lactation Data on the intake of acetylcysteine in breast milk are not available. Acetylcysteine should not be used during breastfeeding unless clearly needed. Precautions Do not mix the drug with other drugs. When working with a medicinal product, it is necessary to use glassware, avoid contact with metals and rubber (the formation of sulfides with a characteristic odor is possible), oxygen, and easily oxidizing substances. The drug should be used with caution in patients suffering from bronchial asthma. This is due to the fact that when preparing the solution, reflex bronchospasm may occur due to the fact that the powder, when it is poured out of the bag into the dishes, can enter the air. In the event of hypersensitivity reactions or bronchospasm, the drug should be stopped immediately and appropriate measures should be taken. The combined use of acetylcysteine and antitussive drugs is not recommended. The simultaneous use of antitussive drugs can lead, through inhibition of the cough reflex and physiological self-cleaning of the airways, to the accumulation of secretions 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), vomiting. When taking acetylcysteine, mainly at the beginning of treatment, it is possible to thin the bronchial secretion and increase its volume. If the patient cannot effectively cough up sputum on their own, postural drainage and bronchoaspiration may be used. The presence of a slight sulfuric odor is the characteristic odor of the active substance. The composition of the drug includes aspartame (a derivative of phenylalanine), which is dangerous for patients with phenylketonuria. The medicinal product contains lactose. In patients with rare hereditary galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption, the use of the drug is not recommended. Interaction with other drugs Acetylcysteine is pharmaceutically incompatible with antibiotics (cephalosporins, penicillins, erythromycin, tetracyclines), proteolytic enzymes. It reduces their absorption, so they should be taken no earlier than 2 hours after taking acetylcysteine. Mixing solutions of acetylcysteine with solutions of antibiotics and proteolytic enzymes can cause drug inactivation. Simultaneous use of acetylcysteine with antitussives may increase sputum stagnation due to suppression of the cough reflex. The combined use of acetylcysteine and nitroglycerin may enhance the vasodilating and antiplatelet effects of the latter. The simultaneous use of activated charcoal during intoxication may reduce the effect of acetylcysteine. Effects on diagnostic methods Acetylcysteine may interfere with the colorimetric analysis of salicylates. Acetylcysteine may affect the results of the determination of ketone bodies in the analysis of urine. Contraindications hypersensitivity to acetylcysteine or any of the excipients of the drug; children under 6 years of age; active peptic ulcer. Composition Each package contains the active substance: acetylcysteine (N-acetyl-L-cysteine) – 0.2 g; excipients: flavor “Lemon PX1548”, aspartame, lactose monohydrate. Overdose In volunteers who received acetylcysteine at a dose of 11.6 g / day for 3 months, there were no serious side effects. Oral doses of acetylcysteine up to 500 mg/kg body weight did not cause any toxic effects. Symptoms: diarrhea, heartburn, nausea, vomiting, stomach pain. Treatment: symptomatic. If you experience severe symptoms of an overdose, consult a doctor. Side effectEstimation of undesirable effects is based on the following data on the frequency of occurrence: very often (?1/10), often (?1/100 to <1/10), infrequently (?1/1000 to <1/100), rarely (? 1/10000 to <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data). Allergic reactions: infrequently: hypersensitivity; very rarely: anaphylactoid and anaphylactic reactions, anaphylactic shock, angioedema, angioedema. In very rare cases, severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome may occur. On the part of the skin and subcutaneous tissues: infrequently: urticaria, rash, itching; very rare: swelling of the face. From the nervous system: infrequently: headache. From the senses: infrequently: tinnitus. From the side of the cardiovascular system: infrequently: tachycardia, lowering blood pressure; very rarely: hemorrhages. From the gastrointestinal tract: infrequently: abdominal pain, vomiting, nausea, diarrhea, stomatitis; rarely: dyspepsia. From the respiratory system: rarely: bronchospasm, shortness of breath; unknown: airway obstruction. Other: often: hyperthermia. Laboratory tests: unknown: decreased platelet aggregation. In predisposed patients, hypersensitivity reactions from the skin and respiratory system may occur, in patients with bronchial hyperreactivity and bronchial asthma, bronchospasm may occur (see section "Precautions"). Very rarely, serious skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome have been reported in temporal association with the use of acetylcysteine. In most of these cases, the simultaneous use of at least one other drug was reported, which increased the risk of developing the described skin reactions. If changes occur in the skin and mucous membranes, immediately stop treatment and seek medical advice from specialists. Various studies have shown a decrease in platelet aggregation during the use of acetylcysteine. The clinical significance of this is unclear. Exhaled air may acquire an unpleasant odor, probably as a result of the elimination of hydrogen sulfide from the preparation. In case of adverse reactions, including those not listed in this leaflet, you should consult a doctor. Storage conditions Store in a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Acetylcysteine powder for oral solution 0.2g in bags No. 20 inside 0.2 g in packages No. 20