Fluimucil
Producer: Zambon S.P.A. (Zambon S.P.A.) Italy
Code of automatic telephone exchange: R05CB01
Release form: Firm dosage forms. Tablets are sparkling.
General characteristics. Structure:
Active ingredient: 600 mg of Acetylcysteinum.
Excipients: citric acid, Natrii hydrocarbonas, aspartame, fragrance lemon.
Pharmacological properties:
Pharmacodynamics. Mucolytic means, liquefies a phlegm, increases its volume, facilitates department of a phlegm. Action is connected with ability of vobodny sulphhydryl ipynn of Acetylcysteinum to break off inside - and intermolecular disulfide bridges of acid mucopolysaccharides of a phlegm that leads to a depolymerization of mucoproteins and reduction of viscosity of a phlegm. Keeps activity at a purulent phlegm.
Increases secretion of less viscous sialomutsin scyphoid cells, reduces adhesion of bacteria on epithelial cells of a mucous membrane of bronchial tubes. Stimulates mucous cells of bronchial tubes which secret lyses fibrin. Has similar effect on the secret which is formed at inflammatory diseases of ENT organs. Has the antioxidant effect caused by existence of the SH group capable to neutralize electrophilic oxidizing toxins. Acetylcysteinum easily gets in a cell, is deacetylated to L-cysteine from which intracellular glutathione is synthesized.
Glutathione - high-reactive tripeptide, powerful antioxidant, the cytoprotector catching endogenous and exogenous free radicals and toxins. Acetylcysteinum warns exhaustion and promotes increase in synthesis of the intracellular glutathione participating in oxidation-reduction processes of cells thus promoting a detoxication of harmful substances. Action of Acetylcysteinum as an antidote at poisoning with paracetamol is explained by it.
The alpha protects 1 antitrypsin (elastase inhibitor) from the inactivating influence of HOC1 - the oxidizer developed by myeloperoxidase of active phagocytes. Possesses also antiinflammatory action (due to suppression of formation of the free radicals and active oxygen-containing agents responsible for development of an inflammation in pulmonary fabric).
Pharmacokinetics. Fluimucil is well absorbed at oral administration. It is immediately deacetylated to cysteine in a liver. In blood mobile balance of the free and connected with proteins of plasma Acetylcysteinum and its metabolites (cysteine, cystine, diacetylcysteinum) is observed. Because of high effect of "the first passing" through a liver bioavailability of Acetylcysteinum makes about 10%. Acetylcysteinum gets into intercellular space, is preferential distributed in a liver, kidneys, lungs, / a bronchial secret.
The maximum concentration in plasma is reached in 1-3 h after oral administration and makes 15 mmol/l, communication with proteins of plasma - 50%. T1/2 - about 1 h, at cirrhosis increases to 8 h. It is removed by kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteinum), an insignificant part is allocated in not changed look through intestines. Gets through a placental barrier.
Indications to use:
Disturbance of an otkhozhdeniye of a phlegm: bronchitis, tracheitis, a bronchiolitis, pneumonia, a bronchoectatic disease, a mucoviscidosis, abscess of lungs, emphysema of lungs, laryngotracheitis, intersticial diseases of lungs, a lung atelectasis (owing to obstruction of bronchial tubes a mucous stopper). Catarral and purulent otitis, antritis, sinusitis (simplification of an otkhozhdeniye of a secret).
Removal of a viscous secret from respiratory tracts at posttraumatic and postoperative states.
Route of administration and doses:
Inside. Adult: 1 tablet of sparkling 600 mg is dissolved in 1/3 glasses of water and accepted once a day.
Duration of a course of treatment should be estimated individually. At acute diseases duration of a course of treatment makes from 5 to 10 days; at treatment of chronic diseases - up to several months (according to the recommendation of the doctor).
Features of use:
Use of drug at pregnancy and in the period of a lactation. Drug at pregnancy is appointed only if the estimated advantage for mother exceeds potential risk for a fruit. In case of need purposes of drug in the period of a lactation it is necessary to stop breastfeeding.
Patients with bronchial asthma and obstructive bronchitis should appoint Acetylcysteinum with care under systematic control of bronchial passability. Drug contains aspartame therefore its use for patients with a fenilketonuriya is not recommended.
Presence of a light sulfuric smell is a characteristic smell of active ingredient.
At dissolution of Acetylcysteinum it is necessary to use glasswares, to avoid contact with metal and rubber surfaces.
Side effects:
Are in rare instances possible: nausea, heartburn, feeling of overflow of a stomach, vomiting, diarrhea, skin rash, itch, small tortoiseshell, nasal bleedings, sonitus.
At reception of Acetylcysteinum cases of development of a bronchospasm, a collapse, stomatitis, decrease in aggregation of thrombocytes are described.
Interaction with other medicines:
The combined use of Acetylcysteinum with antibechics can increase stagnation of a phlegm because of suppression of a tussive reflex.
At simultaneous use with such antibiotics as tetracyclines (excepting doxycycline), ampicillin, Amphotericinum In, their interaction with thiol group of Acetylcysteinum is possible that leads to decrease of the activity of both drugs. Therefore the interval between receptions of these drugs has to make not less than 2 hours.
The concomitant use of Acetylcysteinum and nitroglycerine can lead to strengthening of vasodilating and dezagregantny action of the last. Acetylcysteinum eliminates toxic effects of paracetamol.
Contraindications:
Hypersensitivity to Acetylcysteinum, a peptic ulcer of a stomach and duodenum in aggravation stages, children's age up to 18 years, the lactation period.
With care: peptic ulcer of a stomach and 12-perstny gut, gullet varicosity, pneumorrhagia, pulmonary bleeding, fenilketonuriya, bronchial asthma, diseases of adrenal glands, liver and/or renal failure, arterial hypertension.
Overdose:
Acetylcysteinum at reception in a dose of 500 mg/kg/day does not cause signs and symptoms of overdose.
Storage conditions:
To store at a temperature not above 25 °C. To store in the places unavailable to children. A period of validity - 3 years. Not to use after the period of validity specified on packaging.
Issue conditions:
Without recipe
Packaging:
Tablets sparkling 600 mg. On 2 or 10 tablets in a blister strip packaging (blister) from the laminated aluminum foil [polyamide - aluminum - polyethylene / polyethylene - aluminum]. On 1 or 2 blisters (on 10 tablets) or on 5 or 10 blisters (on 2 tablets) together with the application instruction place in a cardboard pack.