Cofisme (Cofasma)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceBromhexine + Guaifenesin + SalbutamolBromhexine + Guaifenesin + Salbutamol
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    • Dosage form: & nbsp
    cyrup
    Composition:

    10 ml of syrup contain:

    Active substances:

    Salbutamol sulfate is equivalent to salbutamol 2.0 mg.

    Bromhexine hydrochloride 4.0 mg.

    Guaifenesis 100.0 mg.

    Excipients: levomenthol 1.0 mg, propylene glycol 2050.0 mg, aspartame 60.0 mg, sodium benzoate 20.0 mg, citric acid 40.0 mg, sodium citrate dihydrate 22.8 mg, dye sunset yellow - 0,15 mg, pineapple flavor - 0,01 ml, hypromellose - 70,0 mg, purified water - up to 10 ml.

    Description:An orange liquid with a pineapple smell.
    Pharmacotherapeutic group:Expectorant combined
    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 beta-2-adrenergic receptors 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 (ZHEL). Causes the expansion of the coronary arteries, does not reduce blood pressure (BP). Bromhexine - mucolytic agent, exerts an expectorant 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

    Suction and distribution

    After ingestion, absorption is high. Bioavailability of the ingested salbutamol is about 50%. Eating reduces the absorption rate, but does not affect bioavailability.

    Connection with plasma proteins - 10%. Penetrates through the placental barrier.

    Metabolism and excretion

    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.

    Half-life (T1/2) - 3.8-6 hoursIt is excreted in urine (69-90%), mainly in the form of an inactive phenol sulfate metabolite (60%) for 72 hours and with bile (4%).

    Bromhexine

    Suction and distribution

    When ingested almost completely (99%) is absorbed in the gastrointestinal tract for 30 minutes. Bioavailability is low (the effect of "first passage" through the liver). Penetrates through the placental barrier and the blood-brain barrier (BBB).

    Metabolism and excretion

    In the liver it is demethylated and oxidized, metabolized to pharmacologically active ambroxol.

    T1/2 -15 h (due to slow back diffusion from tissues). It is excreted by the kidneys. With chronic renal failure, excretion of metabolites is impaired. With multiple applications can cumulate.

    Guaifenesin

    Suction and distribution

    Absorption from the gastrointestinal tract is rapid (after 25-30 minutes after ingestion). Penetrates into tissues containing acidic mucopolysaccharides.

    Metabolism and excretion

    Approximately 60% of the injected drug is metabolized in the liver. T1/2 - 1 h. 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;

    - acute and chronic bronchitis; - emphysema of the lungs;

    - chronic obstructive pulmonary disease;

    - tracheobronchitis;

    - pneumonia;

    - pneumoconiosis;

    - pulmonary tuberculosis;

    - whooping cough.

    Contraindications:

    - Fenylketonuria;

    - tachyarrhythmia

    - myocarditis;

    - tachycardia;

    - heart defects (including aortic stenosis);

    Decompensated diabetes mellitus;

    - thyrotoxicosis;

    - glaucoma;

    - hepatic and / or renal insufficiency;

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

    - gastric bleeding;

    - pregnancy;

    - lactation period;

    - hypersensitivity to the components of the drug.

    Carefully:

    With caution appoint the drug to patients with hyperthyroidism, diabetes, severe cardiovascular disease, hypertension, peptic ulcer of the stomach and duodenal ulcer in remission.

    Do not use Cofisma in combination with beta-blockers.

    Pregnancy and lactation:Contraindicated use of this drug during pregnancy and lactation.
    Dosing and Administration:

    Inside, adults and children over 12 years are prescribed 10 ml (2 teaspoons) 3 times / day.

    Children under the age of 6 years - 5 ml (1 teaspoon) 3 times / day, from 6 to 12 years - 5-10 ml (1-2 teaspoons) 3 times / day.

    Side effects:

    From the central nervous system: tremor of hands, muscle cramps. When used in high doses - headache, dizziness, increased nervous excitability, sleep disturbance, snotty.

    From the gastrointestinal tract: nausea, vomiting, diarrhea, exacerbation of gastric ulcer and duodenal ulcer, increased activity of "liver" transaminases.

    From the cardiovascular system: tachycardia, lowering of arterial pressure, peripheral vasodilation, collapse.

    From the side of the urinary system: staining the urine in pink. Allergic reactions: skin rash, hives, paradoxical bronchospasm.

    Overdose:

    Symptoms: it is possible to intensify the manifestations of the described side effects.

    Treatment: if necessary, conduct symptomatic therapy.

    Interaction:
    With the simultaneous use of beta-adrenomimetics and theophylline and others, xanatines increase the likelihood of developing tachyarrhythmias. It is not recommended to administer monoamine oxidase inhibitors and tricyclic antidepressants with inhibitors. they increase the effect of salbutamol, can lead to a sharp drop in blood pressure. Incompatible with nonselective beta-blockers. Diuretics and glucocorticosteroids increase hypokalemic effect of salbutamol. Do not administer concomitantly with drugs containing codeine and other antitussive agents (making it difficult for sputum to pass away). Included in the preparation bromohexine contributes to the penetration of antibiotics (erythromycin, cephalexin, oxytetracycline) into the lung tissue.
    Special instructions:Guaifenesin stains urine in pink. It is not recommended to take alkaline drink simultaneously with the drug.
    Effect on the ability to drive transp. cf. and fur:Given the profile of side effects (dizziness, drowsiness and others) it is recommended during treatment to refrain from driving, from practicing other potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:
    Syrup.
    Packaging:
    For 100 ml or 200 ml of preparation in a plastic bottle of dark color with a screwed aluminum cover with the control of the first opening. One bottle, complete with a dispensing cap and instructions for use, is placed in a cardboard box.
    Storage conditions:
    Store in a well-closed vial at a temperature not exceeding 25 ° C. Do not freeze. Keep out of the reach of children.
    Shelf life:
    2 years. Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-002796
    Date of registration:29.12.2014 / 04.08.2016
    Expiration Date:29.12.2019
    The owner of the registration certificate:Agio Pharmaceuticals Ltd.Agio Pharmaceuticals Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspAgio Pharmaceuticals Ltd.Agio Pharmaceuticals Ltd.
    Information update date: & nbsp05.02.2018
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