Fluimucil

General characteristics. Structure:

Active ingredient: 100 mg of Acetylcysteinum in 1 ml of solution.

Excipients: dinatrium эдетат, sodium hydroxide, water for injections.

Pharmacological properties:

Pharmacodynamics. Mucolytic means, liquefies a phlegm, increases its volume, facilitates department of a phlegm. Action is connected with ability of free sulphhydryl groups 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 a viscosity/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.

Protects alfa1-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. At intravenous administration of 600 mg of Acetylcysteinum the maximum concentration in plasma makes 300 mmol/l, plasma elimination half-life - 2 hours. The general clearance is equal to 0,21 l/h/kg, and distribution volume at the plateau is equal to 0,34 l/kg.

In a liver it is deacetylated to cysteine. In blood mobile balance of the free and connected with proteins of plasma Acetylcysteinum and its metabolites (cysteine, cystine, diacetylcysteinum) is observed. Acetylcysteinum gets into intercellular space, is preferential distributed in a liver, kidneys, lungs, a bronchial secret.

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.

Preparation for a bronkhoskopiya, bronchography, aspiration drainage. For washing of abscesses, the nasal courses, Highmore's bosoms, a middle ear; processings of fistulas, a surgery field at operations on a nasal cavity and a mastoid.

Route of administration and doses:

It is inhalation. For aerosol therapy in the ultrasonography devices spray 3-9 ml of 10% of solution, in devices with the distribution valve - 6 ml of 10% of solution. Inhalation duration - 15-20 min.; frequency rate - 2-4 times a day. At treatment of acute states the average duration of therapy - 5-10 days; at long therapy of chronicities a course of treatment - up to 6 months.

Owing to high safety of drug the frequency of acceptance and relative size of a dose can be changed by the doctor in acceptance limits, depending on a condition of sick and therapeutic influence. There is no need of change of an adult dose in case of use of drug for treatment of children. In case of strong sekretolitichesky action the secret is sucked away, and the frequency of inhalations and a daily dose are reduced. Intratrakhealno. For washing of a bronchial tree at medical bronkhoskopiya use 1-2 ampoules or more in day depending on clinical indications.

Locally. Dig in in outside acoustical pass and the nasal courses of 150-300 mg (1,5-3 ml) on 1 procedure.

Parenterally. Enter in/in (more preferable kapelno or slowly struyno - within 5 min.) or in oil. The adult - on 300 mg (3 ml) 1-2 times a day. Children are from 6 to 14 years old - on 150 mg (1,5 ml) 1-2 times a day. To children under 6 years oral administration of drug is preferable. The daily dose for children is younger than 6 years - 10 mg/kg of body weight, to children aged till 1 year in/in introduction of Acetylcysteinum perhaps only according to "vital" indications in the conditions of a hospital. Duration of treatment has to be established by results of change of a condition of the patient.

High local and general portability of drug allows to conduct long courses of treatment.

For in/in introductions solution is in addition diluted by 0.9% with NaCl solution or 5% dextrose solution in the ratio 1:1. Duration of therapy is defined individually (no more than 10 days).

At patients 65 years are more senior - use minimum effective doses.

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.

Patients with bronchial asthma and obstructive bronchitis should appoint Acetylcysteinum with care under systematic control of bronchial passability. At superficial administration of drug in oil and with hypersensitivity there can be an easy and quickly taking place burning in this connection it is recommended to administer the drug deeply in a muscle.

The ampoule of Fluimucil is opened before the use. The opened ampoule can be stored in the refrigerator within 24 hours, during this time drug can be used only for inhalations.

Solution of Fluimucil should not adjoin to rubber and metal surfaces.

Side effects:

At aerosol therapy: reflex cough, irritation of respiratory tracts, rhinorrhea; seldom - stomatitis, a bronchospasm.

At introduction in oil - burning in the place of an injection, skin rash, a small tortoiseshell; at prolonged treatment - an abnormal liver function and/or kidneys.

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.

Pharmaceutical it is incompatible with other solutions of medicines. The concomitant use of Acetylcysteinum and nitroglycerine can lead to strengthening of vasodilating action of the last.

Acetylcysteinum eliminates toxic effects of paracetamol.

Contraindications:

Hypersensitivity, peptic ulcer of a stomach and duodenum in aggravation stages, the lactation period.

With care - the Peptic ulcer of a stomach and a 12-perstny gut in remission stages, a gullet varicosity, a pneumorrhagia, pulmonary bleeding, bronchial asthma (at in introduction risk of development of a bronchospasm), diseases of adrenal glands, a liver and/or renal failure, arterial hypertension, children's age up to 6 years. To children aged till 1 year in/in introduction of Acetylcysteinum perhaps only according to "vital" indications in the conditions of a hospital.

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 from 15 °C - up to 25 °C. To store in the place, unavailable to children. A period of validity - 5 years. Not to use after the period of validity specified on packaging.

Issue conditions:

Without recipe

Packaging:

Solution for injections and inhalations of 100 mg/ml. Ampoules of 3 ml of orange glass with a tag for incision. On 5 ampoules in the plastic pallet with the instruction on a medical use place in a pack cardboard.