Libexin Muco® (Libexin Muco®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceCarbocysteineCarbocysteine
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    • Dosage form: & nbspsyrup for children
    Composition:

    In 100 ml of syrup contains:

    active substance: carbocysteine ​​- 2,000 g;

    Excipients: sucrose - 70,000 g, methylparahydroxybenzoate crimson (Ponso 4R) (cochineal red A (E 124)) 0.005 g, raspberry aroma 1.00 ml, cherry flavor 0.50 ml, sodium hydroxide to pH 6.10 -6.30, purified water - up to 100 ml.

    One measuring spoonful of syrup (5 ml) contains 100 mg of carbocysteine, 3.5 g of sucrose and 13 mg of sodium.

    Description:

    Syrup-like liquid of red color.

    Pharmacotherapeutic group:Mucolytic agent
    ATX: & nbsp

    R.05.C.B.03   Carbocysteine

    Pharmacodynamics:

    Carbocysteine, being a mucolytic, exerts an effect on the gel phase of endobronchial secretion, rupturing the disulfide bridges of glycoproteins and, thus,reducing viscosity and increasing the elasticity of secretions. Carbocysteine activates sialic transferase - enzyme goblet cells of the bronchial mucosa, normalizes the proportion of acidic and neutral sialomutsinov promotes regeneration of the mucosa, normalizes its structure, activates the activity of the ciliary epithelium, restores the secretion of immunologically active IgA (specific protection), improves mucociliary clearance.

    Pharmacokinetics:

    Carbocysteine ​​is rapidly absorbed after oral administration, reaching a maximum serum concentration after 2 hours. Bioavailability is low (less than 10% of the dose) as a result of possible rapid passage through the liver.

    Half-life is about 2 hours. It is excreted mainly by the kidneys together with metabolites.

    Indications:
    • Acute and chronic bronchopulmonary diseases and diseases of upper respiratory tract accompanied by the formation of a viscous sputum (tracheitis, bronchitis, tracheobronchitis, bronchial asthma, bronchiectasis) and mucus (inflammation of the middle ear diseases of the nose and paranasal sinuses - rhinitis, otitis media, sinusitis ).
    • Preparation of the patient for bronchoscopy or bronchography.
    Contraindications:

    - Hypersensitivity to carbocysteine ​​or other components of the drug;

    - Stomach ulcer and duodenal ulcer in the stage of exacerbation;

    - chronic glomerulonephritis (in the phase of exacerbation), cystitis;

    - bVariability;

    - dEthnic age up to 2 years;

    Carefully:
    • Peptic ulcer of the stomach and duodenum in the anamnesis (see section "Special instructions").
    • Breastfeeding period. Older patients (see section "Special instructions").
    • Simultaneous reception of drugs that increase the risk of gastrointestinal bleeding (see section "Special instructions").
    Pregnancy and lactation:

    Pregnancy

    Due to insufficient clinical data, the use of Libexin Muco® in pregnant women is not recommended (see section "Contraindications").

    Breastfeeding period

    It is not known whether carbocysteine with breast milk.

    In the period of breastfeeding, the drug Libexin Muko® should be used with caution (see "With caution").

    Dosing and Administration:

    Inside.

    One measuring spoonful of syrup (5 ml) contains 100 mg of carbocysteine.

    Children aged 2 to 5 years: one measuring spoon (5 ml) 2 times a day (200 mg per day).

    Children over 5 years: one measuring spoon (5 ml) 3 times a day (300 mg per day).

    Treatment should not last more than 8 days without consulting a doctor.

    Side effects:

    Disorders from the gastrointestinal tract: nausea, diarrhea, epigastric pain, gastrointestinal bleeding, vomiting.

    Immune system disorders: allergic skin rash and anaphylactic reactions, including hives, angioedema; itching, exanthema, fixed drug rash.

    Disturbances from the skin and subcutaneous tissues: isolated cases of bullous dermatitis, such as Stevens-Johnson syndrome and erythema multiforme.

    General disorders: dizziness, weakness, malaise.

    Overdose:

    Symptoms: gastralgia, nausea, diarrhea.

    Treatment: symptomatic.

    Interaction:

    Carbocysteine ​​increases the effectiveness of glucocorticosteroid and antibacterial therapy for inflammatory diseases of the upper and lower respiratory tract. Potentsiruet broncholytic effect of theophylline.

    Action of carbocisteine ​​relieves antitussive and m-cholinoblocking drugs.

    Special instructions:Caution should be exercised when using Libexin Muco ® in elderly patients with peptic ulcer and duodenal ulcer, while taking drugs that increase the risk of developing gastrointestinal bleeding (see the section "With caution"). With the development of gastrointestinal bleeding should stop taking the drug.

    The ethanol content in the preparation is 1.64%, that is, 0.2 g of ethanol per measuring cup, which should be taken into account when using Libexin Muco ® for liver diseases, alcoholism, epilepsy, injuries or brain diseases.

    When prescribing Libexin Muco® to patients with diabetes mellitus or patients who observe a low-carb diet, it should be taken into account that 1 measuring cup of syrup (15 ml) contains 6 g of sucrose.

    When patients comply with a salt-free or low-salt diet, one should take into account that 1 measuring cup of syrup (15 ml) contains 97 mg of sodium.

    Since the preparation Libexin Muco® contains sucrose, its use is not recommended in patients with sugarase / isomaltase deficiency, fructose intolerance, glucose malabsorption / galactose syndrome.

    Effect on the ability to drive transp. cf. and fur:

    During drug treatment, care should be taken when driving vehicles and when engaging in other potentially hazardous activities due to the possibility of developing dizziness and weakness.

    Form release / dosage:

    Syrup for children, 20 mg / ml.

    Packaging:

    For 125 ml or 200 ml in a vial of colorless glass (type III), closed with a screwed aluminum cover with the control of the first opening.

    For 1 bottle together with a measuring spoon and instructions for use in a cardboard pack.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N013994 / 02
    Date of registration:25.04.2008 / 08.02.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:Sanofi-Aventis FranceSanofi-Aventis France France
    Manufacturer: & nbsp
    Representation: & nbspSanofi Aventis GroupSanofi Aventis Group
    Information update date: & nbsp04.03.2018
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