Active substanceBromhexine + Guaifenesin + SalbutamolBromhexine + Guaifenesin + Salbutamol
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  • Ascoril
    pills inwards 
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    syrup inwards 
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  • Dosage form: & nbsppills
    Composition:

    1 tablet contains:

    Active substances:

    Salbutamol sulfate, equivalent to salbutamol 2 mg

    Bromhexine hydrochloride 8 mg

    Guaifenesin 100 mg

    Excipients: calcium hydrophosphate, corn starch, methyl parahydroxybenzoate (methylparaben), propyl parahydroxybenzoate (propylparaben), talc purified, silicon dioxide colloid, magnesium stearate.

    Description:White, round, flat tablets with a facet and one-sided risk.
    Pharmacotherapeutic group:Expectorant combination
    ATX: & nbsp

    R.05.C   Expectorants (excluding combinations with antitussive drugs)

    Pharmacodynamics:

    The combined preparation has a bronchodilator, expectorant and mucolytic effect. Salbutamol - a bronchodilator, stimulates beta2-adrenoreceptors of bronchi, blood vessels and myometrium. Warns or eliminates spasm of the bronchi, reduces resistance in the airways, increases the vital capacity of the lungs.Causes the expansion of the coronary arteries, does not reduce blood pressure. Bromhexine - mucolytic agent, has an expectorant and antitussive effect. Increases the serous component of bronchial secretion; activates the cilia of the ciliated epithelium, reduces the viscosity of the sputum, increases its volume and improves withdrawal. Guaifenesin - mucolytic agent, reduces the surface tension of the bronchopulmonary structures; stimulates the secretory cells of the bronchial mucosa that produce neutral polysaccharides, depolymerises acidic mucopolysaccharides, reduces the viscosity of sputum, activates the ciliary arm of the bronchi, facilitates the removal of sputum and facilitates the transition of non-productive cough to productive.

    Pharmacokinetics:

    Salbutamol: when absorbed, absorption is high. Eating reduces the absorption rate, but does not affect bioavailability. Connection with plasma proteins - 10%. Penetrates through the placenta.

    It is subjected to presystemic metabolism in the liver and in the intestinal wall, by means of phenol sulfotransferase is inactivated to 4-o-sulfate ether. The half-life (T1 / 2) is 3.8-6 hours.It is excreted by the kidneys (69-90%), mainly in the form of an inactive phenol sulfate metabolite (60%) for 72 hours and with bile (4%). The bioavailability of orally administered Salbutamol is about 50%.

    Bromhexine: when ingested almost completely (99%) is absorbed in the gastrointestinal tract (GIT) for 30 minutes. Bioavailability is low (the effect of primary "passage" through the liver). Penetrates through the placental and blood-brain barrier. In the liver it is demethylated and oxidized, metabolized to pharmacologically active ambroxol. T1 / 2 -15 h (due to slow reverse diffusion from tissues). It is excreted by the kidneys. With chronic renal failure, excretion of metabolites is impaired. With multiple applications can cumulate.

    Guaifenesin: absorption from the gastrointestinal tract - fast (after 25-30 minutes after ingestion). T1 / 2 -1h. Penetrates into tissues containing acidic mucopolysaccharides.

    Approximately 60% of the injected drug is metabolized in the liver. It is excreted by lungs (with phlegm) and kidneys both in unchanged form and in the form of inactive metabolites.

    Indications:

    As a part of the combined therapy of acute and chronic bronchopulmonary diseases, accompanied by the formation of a hard-to-separate viscous secretion:

    bronchial asthma;

    tracheobronchitis;

    obstructive bronchitis; pneumonia;

    emphysema of the lungs;

    whooping cough;

    pneumoconiosis;

    pulmonary tuberculosis, etc.

    Contraindications:

    - Hypersensitivity to the components of the drug;

    - pregnancy, lactation;

    - tachyarrhythmia, myocarditis;

    - heart defects;

    - Decompensated diabetes mellitus;

    - thyrotoxicosis;

    - glaucoma;

    - hepatic or renal insufficiency;

    - peptic ulcer of the stomach and duodenum in the stage of exacerbation;

    - gastric bleeding;

    - arterial hypertension;

    - children's age till 6th years.

    Carefully:

    Carefully prescribe to patients with diabetes mellitus, peptic ulcer of the stomach and duodenum in the remission stage.

    Pregnancy and lactation:

    During pregnancy, use of the drug is not recommended.

    If it is necessary to treat the drug during lactation, breastfeeding should be discontinued.

    Dosing and Administration:

    Inside. Adults and children over 12 years of age are prescribed 1 tablet 3 times / day.

    Children aged 6 to 12 years old are ½ or 1 tablet 3 times / day.

    Children under the age of 6 years are advised to use the "Ascoril Expectorant" syrup.

    Side effects:

    According to the World Health Organization (WHO), undesirable effects are classified according to their frequency of development as follows: 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); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

    From the immune system: rarely: hypersensitivity reactions. frequency unknown: anaphylactic reactions, including anaphylactic shock, angioedema and itching.

    From the central nervous system: rarely: headache, dizziness, increased nervous excitability, sleep disturbance, drowsiness, tremor, convulsions.

    From the side of the cardiovascular system: rarely: heart palpitations, collapse.

    From the respiratory system of the chest and mediastinum: rarely: bronchospasm.

    From the gastrointestinal tract OKKT): rarely: nausea, vomiting, diarrhea, exacerbation of peptic ulcer of the stomach and duodenum.

    From the side of the kidneys and the urinary system:rarely: it is possible to stain the urine pink.

    From the skin and subcutaneous tissues: rarely: a rash, hives.

    frequency unknown: severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustules associated with ambroxol use (ambroxol is a metabolite of bromhexine).

    Overdose:

    Symptoms: increased manifestations of side effects.

    Treatment: symptomatic therapy.

    Interaction:

    Other beta-2-adrenomimetic agents and theophylline increases the effect of salbutamol and increases the likelihood of side effects.

    Ascoril is not prescribed concomitantly with drugs containing codeine, and other antitussive agents, as this makes it difficult to move away diluted sputum. Included in the composition of the drug Ascoril bromohexine contributes to the penetration of antibiotics (erythromycin, cephalexin, oxytetracycline) into the lung tissue.

    It is not recommended to use Ascoril at the same time as nonselective beta-adrenergic receptor blockers, such as propranolol.

    The drug Ascoril salbutamol It is not recommended for patients who receive monoamine oxidase inhibitors (MAO).

    Diuretics and preparations of glucocorticosteroids increase the hypokalemic effect of salbutamol.

    It is not recommended to take alkaline drink simultaneously with Ascoril.

    Special instructions:

    There are reports of severe skin reactions, such as erythema multiforme, Stevens-Johnson syndrome (SDS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (OGEP) associated with the use of ambroxol. Because the ambroxol is a metabolite of bromhexine, the risk of anaphylactic and severe skin reactions may be considered for bromhexine. If symptoms of a progressive skin reaction occur (sometimes associated with damage to the mucous membranes: mouth, throat, nose, eyes, genitals), stop using Ascoril immediately and consult a doctor.

    Guaifenesin stains urine in pink. It is not recommended to take alkaline drink simultaneously with the drug.

    Form release / dosage:

    Pills.

    Packaging:

    For 10 tablets in a contour mesh package made of a light protective film of PVC - aluminum foil.1, 2 or 5 packages together with the instruction for use are placed in a cardboard box.

    Storage conditions:

    In dry, the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years. Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-003332/09
    Date of registration:30.04.2009 / 21.04.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:Glenmark Pharmaceuticals Co., Ltd.Glenmark Pharmaceuticals Co., Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspGLENMARK IMPEX LLCGLENMARK IMPEX LLCRussia
    Information update date: & nbsp19.09.2017
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