Bromhexine tablets 8mg №10×5

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Bromhexine tab 8mg №50
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Pills of white color, flat cylindrical, with a bevel. Composition One tablet contains: active substance – bromhexine hydrochloride – 8 mg; excipients: sucrose, lactose monohydrate, potato starch, stearic acid 95, microcrystalline cellulose type 101. Pharmacotherapeutic group Means used for coughs and colds. Expectorants, excluding combinations with antitussives. Mucolytics. ATX code: R05CB02. Pharmacological properties Pharmacodynamics Mucolytic (secretolytic) agent, has an expectorant and weak antitussive effect. Reduces sputum viscosity (depolymerizes mucoprotein and mucopolysaccharide fibers, increases the serous component of bronchial secretion), activates ciliated epithelium, increases volume and improves sputum discharge. Stimulates the production of endogenous surfactant, which ensures the stability of alveolar cells during respiration. The effect appears after 2-5 days from the start of treatment. Pharmacokinetics Absorption: When administered orally, Bromhexine is almost completely (99%) absorbed from the gastrointestinal tract within 30 minutes. Cmax in the blood is reached approximately 1 hour after taking the drug. Distribution: low bioavailability (about 20%) due to the effect of “first pass” through the liver. Binding to blood proteins is high and is 80-90% (95% on average), penetrates the blood-brain and placental barriers. 2 hours after ingestion, the accumulation of bromhexine in the lung tissue is recorded, exceeding the plasma level by 1.5-4.5 times. Metabolism: in the liver, bromhexine undergoes demethylation and oxidation, and is metabolized to the pharmacologically active ambroxol. Excretion: the half-life (T?) is 15 hours due to slow reverse diffusion from tissues. Excreted by the kidneys. After oral administration of radioactive labeled bromhexine, 97.4 ± 1.9% of the dose was found in the urine, of which less than 1% is unchanged substance. In chronic renal failure, excretion of metabolites is impaired. Total clearance 800 ml/min; determined solely by hepatic blood flow. In severe liver failure, the clearance of bromhexine decreases, and in chronic liver failure, the clearance of its metabolites decreases. After repeated dosing, no signs of accumulation were found. The cumulation coefficient is 1.1. The pharmacokinetics of bromhexine in the elderly or in patients with hepatic or renal insufficiency has not been studied. There is limited experience with this drug in these patient populations. Due to the slower excretion of bromhexine in patients with severe liver and kidney disease, it is recommended to increase the interval between its use. Pharmacokinetic interactions No interaction studies have been conducted with oral anticoagulants and digoxin. Co-administration of ampicillin, oxytetracycline or erythromycin does not affect the pharmacokinetics of bromhexine. Indications for use Secretolytic therapy of acute and chronic bronchopulmonary diseases, accompanied by disorders in the formation and transport of sputum. Contraindications Hypersensitivity to bromhexine and / or to any auxiliary component of the drug, including lactose and sucrose, peptic ulcer of the stomach and 12 duodenal ulcer in the acute phase, pregnancy (I trimester), lactation, children’s age (up to 3 years ). Dosing and Administration Tablets should be taken orally, after meals, with plenty of liquid. Adults and adolescents over 14 years of age are prescribed 1-2 tablets (8-16 mg) 3 times a day. Children and adolescents from 6 to 14 years old, as well as persons weighing less than 50 kg, 1 tablet (8 mg) 3 times a day. Children under 6 years of age should take dosage forms with a lower dosage. Children under 6 years of age should take lower dosage forms of Bromhexine and only on the advice of a doctor. The therapeutic effect may appear on the 4th-6th day of treatment. The course of treatment is from 4 to 28 days (determined individually depending on the indications and the course of the disease). Patients with renal insufficiency or impaired liver function are prescribed lower doses or increase the interval between doses. Side effects To describe side effects, the following designations are used for the probability of their occurrence, depending on the total number of cases of use: very often (? 1/10); often (from? 1/100 to <1/10); infrequently (from? 1/1000 to <1/100); rarely (from? 1/10000 to <1/1000); very rarely (<1/10000); unknown (it is not possible to establish a frequency based on the available data). Immune system disorders: rarely: hypersensitivity reactions (rash, Quincke's edema, shortness of breath, itching, urticaria), bronchospasm; unknown: angioedema and itching, anaphylactic reactions, including anaphylactic shock. Skin and subcutaneous tissue disorders: rarely: skin rash, urticaria; unknown: severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis). In the early stages of Stevens-Johnson syndrome, non-specific flu-like symptoms such as fever, body aches, runny nose, cough, and sore throat may develop. Therefore, in the presence of these symptoms, if this is not explained by the course of the underlying disease, the use of drugs Bromhexine should be discontinued. Respiratory, thoracic and mediastinal disorders: rare: bronchospasm; unknown: shortness of breath (as a sign of a hypersensitivity reaction). Disorders from the gastrointestinal tract: infrequently: with prolonged use, nausea, vomiting, dyspepsia, exacerbation of peptic ulcer of the stomach and duodenum, diarrhea are possible. General disorders: infrequently: fever. Reporting Suspected Adverse Reactions Health professionals are encouraged to send information about any suspected adverse reactions and drug inefficacy to: Republican Unitary Enterprise "Center for Expertise of Tests in Healthcare", www.rceth.by. Interaction with other drugs Bromhexine is not prescribed simultaneously with drugs that suppress the cough center (including codeine), as this makes it difficult to expectorate liquefied sputum (accumulation of bronchial secretions in the airways). Bromhexine promotes the penetration of antibiotics (amoxicillin, erythromycin, cephalexin, oxytetracycline), sulfanilamide drugs into the lung tissue in the first 4-5 days of antimicrobial therapy. The combined use of bromhexine with certain non-steroidal anti-inflammatory drugs (for example, salicylates, phenylbutazone or butadione) can cause irritation of the gastric mucosa. Incompatible with alkaline solutions. Bromhexine should be used with caution in debilitated patients, as well as in patients with mechanical bronchial constriction (difficulty expectorating bronchial secretions) or bronchial diseases accompanied by excessive accumulation of secretions, as well as in case of renal and / or liver failure and gastric bleeding in history. There are reports of the possibility of developing severe skin reactions, such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis when taking bromhexine. It is necessary to immediately stop taking the drug if symptoms of a progressive skin reaction (including those associated with the development of blisters and lesions of the mucous membranes) appear. During treatment, it is necessary to take a sufficient amount of liquid, which enhances the expectorant effect of bromhexine. In children, treatment should be combined with postural drainage or chest vibration massage, which facilitates the removal of secretions from the bronchi. In case of gastric ulcer, as well as indications of gastric bleeding in history, the drug should be used under medical supervision. In case of impaired renal and hepatic function, the drug should be used with caution, reducing its dose for admission or increasing dosing intervals. With prolonged treatment, it is recommended to monitor liver function. The drug contains lactose and sucrose. Patients with congenital intolerance to galactose, fructose, Lapp lactase deficiency or glucose-galactose malabsorption syndrome, as well as patients with sucrase-isomaltase deficiency, should not take this drug. Pregnancy, lactation, fertility Bromhexine can cross the placental barrier. In animal studies, no direct or indirect negative effects on fertility, pregnancy, fetal / embryo development have been established. However, the experience of using Bromhexine in pregnant women is limited, the use of the drug is not recommended during the first trimester of pregnancy, in the second or third trimester, use is possible after a thorough assessment of the benefits and possible risks. Since bromhexine is excreted in breast milk, its use during lactation is not recommended. Studies of the effect of bromhexine on fertility have not been conducted. Available preclinical studies show no change in fertility with the use of bromhexine. Influence on the ability to drive vehicles and other mechanisms There is no evidence of a negative effect of bromhexine on the ability to drive vehicles and other mechanisms. OverdoseSymptoms: dyspeptic disorders, incl. nausea, vomiting, diarrhea. In children over the age of 2 years, an overdose was observed when taking more than 60-80 mg of bromhexine or 6 mg / kg (corresponding to 7-10 tablets). When taking bromhexine at a dose of up to 40 mg, overdose symptoms in young children were not observed. Cases of poisoning with the development of impaired consciousness, ataxia, diplopia, metabolic acidosis and tachypnea are described. Treatment: artificial vomiting, gastric lavage (in the first 1-2 hours after ingestion), symptomatic therapy. In addition, due to pharmacokinetic characteristics (large volume of distribution, high percentage of plasma protein binding), dialysis or forced diuresis do not significantly affect the elimination of bromhexine. Packing: 10 tablets in a blister pack made of PVC film and aluminum foil. 5 blister packs, together with the leaflet, are placed in a pack of cardboard (No. 10x5). Storage conditions Store in a place protected from light and moisture, at a temperature not exceeding 25 ° C. Keep out of the reach of children. Shelf life 3 years. Do not use the medicine after the expiration date. Conditions for dispensing from pharmaciesWithout a prescription. Buy Bromhexine tablets 8mg No. 10x5 Price for Bromhexine tablets 8mg No. 10x5