Ats-Fs
Producer: LLC Pharm Start Ukraine
Code of automatic telephone exchange: R05CB01
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredient: Acetylcysteinum; N - ацитил - L - cysteine.
Excipients: cellulose microcrystallic, lactoses monohydrate (tabletoza), starch corn, magnesium stearate, a covering for drawing a cover of Opadry II White.
Pharmacological properties:
ATs-FS rarefies a phlegm, it is connected with ability of sulphhydryl groups of active ingredient of Acetylcysteinum to terminate disulfide bridges of acid mucopolysaccharides of phlegms that leads to depolarization of mukoproteid and reduction of viscosity of slime. Drug keeps activity in the presence of purulent phlegms. Acetylcysteinum has the antioxidant action caused by existence of nucleophilic thiol SH group which easily gives hydrogen, neutralizing oxidizing radicals. At use of drug reduction of frequency and weight of aggravations at patients with chronic bronchitis and a mucoviscidosis is noted. The protective mechanism of Acetylcysteinum is based on ability of its reactive sulphhydryl groups to connect chemical radicals.
Acetylcysteinum promotes the strengthened synthesis of glutathione which is an important antioxidant factor of intracellular protection and provides support of functional activity and morphological integrity of a cell, promoting, thus, a detoxication of harmful substances. Action of Acetylcysteinum as antidote is explained by it at poisoning with paracetamol.
Acetylcysteinum is well absorbed at oral administration. In a liver drug is deacetylated to cysteine. In blood mobile balance of the free and connected by proteins of plasma Acetylcysteinum and its metabolites (cysteine, cystine, diacetylcysteinum) is observed. Owing to considerable effect of "the first passing" through a liver bioavailability of Acetylcysteinum makes about 10%. Acetylcysteinum gets into intercellular space, is distributed preferential in a liver, kidneys, lungs, a bronchial secret. After oral administration of 600 mg of Acetylcysteinum by healthy volunteers the maximum concentration in plasma is reached approximately in 1 hour and makes 15 mmol/l. Plasma elimination half-life - 2 hours. Acetylcysteinum and its metabolites are excreted from an organism preferential by kidneys.
Indications to use:
Treatment of acute and chronic pathology of bronchopulmonary system at the diseases which are followed by the increased formation of a phlegm with deterioration in expectoration.
Route of administration and doses:
ATs-FS is appointed inside to adults and children aged from 14 years on 200 mg by 2-3 times a day, to children aged from 6 up to 14 years - on 200 mg 2 times a day.
At treatment of a mucoviscidosis: the usual dose to children is more senior than 6 years makes on 200 mg 3 times a day. At a mucoviscidosis over 30 kg are allowed by the patient with body weight increase in a daily dose to 800 mg of Acetylcysteinum. Therapy is pochinat gradually, consistently selecting an effective dose.
Duration of use is determined by the doctor depending on disease severity and the clinical response to treatment. At acute uncomplicated forms of diseases duration of treatment makes no more than 5-10 days. Treatment of a mucoviscidosis, chronic bronchitis can last up to several months.
Drug is taken after food, swallow of a pill, without chewing, and wash down with enough water.
During treatment Acetylcysteinum recommends the additional use of liquid.
Features of use:
Appropriate security measures at use.
Patients with bronchial asthma and obstructive bronchitis of ATs-FS need to appoint with care under systematic control of bronchial passability and providing an effective drainage of a phlegm.
ATs-FS should appoint with care the patient with diseases of adrenal glands, with a renal and/or liver failure.
Drug contains lactose therefore patients with rare hereditary forms of intolerance of a galactose, insufficiency of lactase or a syndrome of glyukozo-galaktozny malabsorption should not apply ATs-FS.
At use of ATs-FS it is not necessary to allow contact of drug with metals and rubber.
Use during pregnancy or feeding by a breast.
During pregnancy and feeding by a breast expediency of purpose of ATs-FS is determined by the doctor taking into account assessment of the expected advantage for mother and possible risk for a fruit or the child.
Ability to influence speed of response at control of motor transport or work with other mechanisms.
Data on a negative impact of drug on speed of response at control of vehicles and other mechanisms are absent.
Children.
Drug is not appointed to children under 6 years (in this dosage form).
Side effects:
For the description of frequency of side effects use the following classification: very frequent (≥ 10%), frequent (≥ 1%, <10%), infrequent (≥ 0,1%, <1%), single (≥ 0,01%, <0,1%), rare (<0,01%).
General disturbances: infrequent - tachycardia, arterial hypotension, a headache, a ring/sonitus, fever.
Allergic reactions: infrequent - an itch, urticaria, a dieback, rash, a Quincke's disease. At use of Acetylcysteinum it was reported about separate cases of heavy reactions from skin (Stephens-Johnson's syndrome and a Lyell's disease), rare cases of developing of the bleedings most often connected with development of reactions of hypersensitivity were observed. Reported about isolated cases of anaphylactic reaction or even shock. In case of changes of skin or a mucous membrane it is necessary to see immediately a doctor and to stop use of ATs-FS.
From respiratory system: single - диспноэ, a bronchospasm (it is preferential at patients with hyperreactivity of bronchial system which is connected with bronchial asthma).
From a digestive tract: infrequent - heartburn, nausea, vomiting, abdominal pain, diarrhea, stomatitis.
In case of any undesirable phenomena it is necessary to consult to the doctor concerning a possibility of further use of drug.
Interaction with other medicines:
The concomitant use of ATs-FS with antibechics can increase stagnation of phlegms because of oppression of a tussive reflex.
Acetylcysteinum is not recommended to be applied along with antibiotics of a tetracycline row (except for doxycycline).
At simultaneous use with antibiotics (including tetracycline, ampicillin, Amphotericinum In, cephalosporins) their interaction with thiol group of Acetylcysteinum is possible that leads to decrease of the activity of both drugs. For safety of the patient between oral administration of ATs-FS and antibiotics it is necessary to adhere to not less two-hour interval.
The concomitant use of Acetylcysteinum with nitroglycerine can lead to strengthening of the vasodilating effect of nitroglycerine.
Acetylcysteinum eliminates a hepatotoxic action of paracetamol.
Contraindications:
Hypersensitivity to Acetylcysteinum and to other components of drug, a peptic ulcer of a stomach and duodenum in aggravation stages, pulmonary bleeding, a pneumorrhagia.
Overdose:
About cases of overdose of drug it was not reported.
Storage conditions:
To store in the place, unavailable to children, in original packaging at a temperature not above 25 °C.
Issue conditions:
Without recipe
Packaging:
On 10 tablets in the blister, on 2 blisters in a cardboard pack.