Bronhosan® (Bronchosan®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspdrops for oral administration
Composition:

100.0 g of the solution contains:

active substances: bromhexine hydrochloride 0.800 g, peppermint oil 0.0250 g, eucalyptus oil 0.0250 g, fennel oil 0.0750 g anise oil 0.0250 g, oregano oil 0.0250 g, levomenthol - 0.1500 g;

Excipients: potassium dihydrogen phosphate - 0.6000 g, sodium hydrophosphate - 0.0310 g, hydrochloric acid 35% 0.0390 g, sucrose 10,000 g, triethylene glycol 0.6000 g, polysorbate 80 0.400 g, ethanol 96% 36,000 g, purified water up to 100,000 g.

Description:

Transparent liquid, from colorless to light yellow color, with menthol odor.

Pharmacotherapeutic group:Expectorant mucolytic agent
ATX: & nbsp
  • Bromhexine
    • Pharmacodynamics:

    Combined drug, has mucolytic, expectorant, antispasmodic and antimicrobial action.

    Bromhexine - mucolytic (secretolithic) remedy, exerts an expectorant and weak antitussive effect. Reduces the viscosity of sputum (depolymerizes mukoproteinovye and mucopolysaccharide fibers, increases the serous component of the bronchial secret); activates ciliary epithelium, increases volume and improves sputum discharge. Stimulates the production of an endogenous surfactant providing stability alveolar cells in the process of breathing.

    Included in the preparation essential oils have anti-inflammatory, expectorant, antimicrobial act.

    Levomenthol has moderate spasmolytic, some antiseptic action.

    Pharmacokinetics:

    Ingestion bromohexine almost completely (99%) is absorbed within 30 minutes. The maximum concentration in the plasma is reached after about 1 hour. About 80% bromhexine is subjected to intensive metabolism due to the effect of the primary "passage" through the liver. In the plasma bromohexine binds to proteins, penetrates through blood-brain and placental barriers. In the liver bromohexine is demethylated and oxidized to form an active metabolite - ambroxol. Period half-life is 15 hours due to slow reverse diffusion from the tissues. It is excreted by the kidneys. In chronic renal failure, excretion of metabolites of bromhexine is impaired. With repeated use bromohexine can be cumulated.

    Indications:

    - Diseases of the respiratory tract, accompanied by embarrassment spitting viscous sputum: tracheobronchitis, acute and chronic bronchitis,including chronic obstructive bronchitis (including in combination with emphysema and bronchiectasis), pneumonia, bronchial asthma, pulmonary tuberculosis, pneumoconiosis, cystic fibrosis.

    - Sanitation of the bronchial tree in preoperative period and during the treatment and diagnostic intrabronchial manipulation, prevention of congestion in the bronchi of thick viscous sputum after surgery.

    Contraindications:

    - Hypersensitivity to the components of the drug;

    - Pregnancy;

    - the period of breastfeeding;

    - peptic ulcer of the stomach or duodenum, including in the anamnesis (the protective layer of the mucous membrane of the stomach and duodenum may be damaged by the action of bromhexine);

    - Children's age up to 3 years;

    - congenital intolerance fructose, glucose-galactose malabsorption or insufficiency of sucrose-isomaltase (due to content in the formulation of sucrose).

    Carefully:

    - Hepatic insufficiency, liver disease;

    - kidney failure;

    - fbleeding in the anamnesis;

    - zBone abolition accompanied by excessive accumulation of bronchial secretions;

    - alcoholism;

    - epilepsy, cerebral diseases, craniocerebral trauma;

    - dEthnic age (over 3 years).

    Dosing and Administration:

    Drops are taken inside before or after a meal in a small amount of water or on a piece of sugar, squeezed with enough water. The mucolytic effect of the Bronchosan® drug is enhanced by the intake of large amounts of liquid during the day.

    Adults and children over 12 years of age: 20 drops 4 times a day.

    Children from 6 to 12 years old: 15 drops 4 times a day.

    Children from 2 to 6 years: 10 drops 4 times a day.

    The course of treatment is 4-28 days. The duration of treatment depends on the clinical manifestation of the disease. In the absence of a positive effect when taking the drug for 5 days, it is recommended to consult a doctor.

    In case of severe impairment of kidney function, in agreement with the doctor, it is necessary to reduce the dose of the drug or increase the interval between doses.

    Side effects:

    The incidence of adverse reactions listed below was determined in accordance with the classification of the World Health Organization: very often (more than 1/10); often (from more than 1/100 to less than 1/10); infrequently (from more than 1/1000 to less than 1/100); rarely (from more than 1/10000 to less than 1/1000); very rarely (from less than 1/10000, including individual messages).

    Disorders from the gastrointestinal tract

    Infrequently: dyspeptic disorders, including nausea, vomiting.

    Rarely: exacerbation of peptic ulcer stomach and duodenum.

    Disturbances from the skin and subcutaneous tissues

    Rarely: erythema, edema.

    Immune system disorders

    Rarely: allergic reactions, including angioedema; In the literature, extremely severe cases of anaphylactic-type severe reactions have been very rarely reported, up to the development of anaphylactic shock.

    Laboratory and instrumental data

    Rarely: reversible increase in the activity of "hepatic" transaminases in the blood serum.

    Overdose:

    In case of an overdose, it is possible to increase dose-dependent adverse reactions; it is necessary to wash the stomach with the subsequent intake of activated carbon.

    Treatment: symptomatic.

    Interaction:

    Bromhexine, which is part of the drug Bronhosan®, promotes the penetration of certain antibiotics (amoxicillin, erythromycin, cephalexin, oxytetracycline), sulfonamide drugs in the bronchial secret in the first 4-5 days of antimicrobial therapy.

    It is not recommended to prescribe Bronchosan® simultaneously with medicines containing codeine, and other antitussive drugs, because of the inhibition of cough reflex difficulty evacuating diluted sputum.

    When combined with non-steroidal anti-inflammatory drugs (salicylates, phenylbutazone, oxybutazone), it is possible to intensify the irritating effect on the gastric mucosa.

    Bromhexine is incompatible with alkaline solutions.

    Special instructions:

    1 ml of Bronchosan ® contains 25 drops.

    It should be taken into account that Bronchosan®, drops for oral administration contain 34.56% of ethyl alcohol and 10% of sucrose (ie 100 g of solution contains 36 g of ethanol and 10 g of sucrose).

    Due to the presence of ethanol in the drug should be used with caution in patients with liver diseases, alcoholism, epilepsy, brain diseases, craniocerebral trauma. The content of absolute ethyl alcohol in grams and bread units (the preparation contains sucrose) in single and maximum daily doses of the drug.

    Age-specific and maximum daily doses

    The amount of absolute ethyl alcohol in grams

    amount bread units

    3-6 years old

    Single dose 10 drops

    < 0,13824

    <0,004

    The maximum daily dose of 40 drops

    <0,55296

    <0,016

    6-12 years old

    Single dose of 15 drops

    <0,20736

    <0,006

    The maximum daily dose of 60 drops

    <0,82944

    <0,024

    Adults and children over 12 years of age

    Single dose of 20 drops

    <0,27648

    <0,008

    The maximum daily dose of 80 drops

    <1,10592

    <0,032
    Effect on the ability to drive transp. cf. and fur:

    Due to the presence of ethanol in the preparation during the treatment period, it is necessary to refrain from management vehicles and occupations of other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Drops for oral administration.

    Packaging:

    For 25 ml in bottles of dark glass with a lid-dropper.

    Each vial with the instruction for use is placed in a cardboard box.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N013752 / 01
    Date of registration:20.12.2011 / 29.03.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:Zentiva as.Zentiva as. Czech Republic
    Manufacturer: & nbsp
    Saneca Pharmaceuticals a.s. The Slovak Republic
    Representation: & nbspZENTIVA PHARMA, LLCZENTIVA PHARMA, LLC
    Information update date: & nbsp19.04.2017
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