of AЦЦ® the junior
the International unlicensed
name Acetylcysteinum Dosage Form Solution for intake 20mg/ml
of 1 ml of solution for intake contains
active agent: Acetylcysteinum of 20 mg,
excipients: methylparahydroxybenzoate, Natrium benzoicum, dinatrium edetat, sodium saccharin, sodium of a karmelloz, sodium of hydroxide of 10% solution, cherry fragrance, water purified.
Transparent, colourless, slightly viscous solution, with a cherry smell.
Expectorant drugs. Mucolytics. Acetylcysteinum.
The ATX R05 CB01 code
Pharmacokinetics Later properties of intake Acetylcysteinum is quickly absorbed from digestive tract and metabolized in a liver in cysteine, pharmacological an active metabolite and also in diacetylcysteinum, cystine and various mixed disulfides.
Because of high effect of the first passing through a liver, bioavailability of Acetylcysteinum it is very low (about 10%).
The maximum concentration in plasma are reached in 1-3 h. The maximum concentration in plasma of a metabolite of cysteine makes about 2 µmol/l. Linking of Acetylcysteinum with proteins of plasma makes about 50%.
Acetylcysteinum is removed through kidneys almost only in the form of inactive metabolites (inorganic sulfates, diacetylcysteinum).
Elimination half-life in plasma makes about 1 hour and generally is defined by hepatic biotransformation. Therefore the abnormal liver function leads to lengthening of elimination half-life up to 8 hours.
Acetylcysteinum is derivative amino acids cysteine. Acetylcysteinum possesses sekretolitichesky and sekretomotorny action in airways. Acetylcysteinum breaks disulfide bridges between mukopolisakharidny chains and possesses the depolymerizing action on DNA chains (at a purulent phlegm). Thanks to these mechanisms the viscosity of a phlegm decreases.
The alternative mechanism of Acetylcysteinum is based on ability of its reactive sulfhydryl group to connect chemical radicals and it to neutralize them.
Acetylcysteinum promotes increase in synthesis of glutathione that is important for a detoxification of toxic agents. Is antidote in poisonings with paracetamol.
At preventive use Acetylcysteinum has protective action concerning frequency and weight of exacerbations of bacterial infections that was established at patients with chronic bronchitis and a mucoviscidosis.
Sekretolitichesky therapy in acute and chronic diseases of bronchial tubes and lungs which are followed by disturbance of education and removal of a phlegm.
The route of administration and a dosage
the Drug ATsTs® the junior represents solution for intake after a meal.
The drug ATsTs® the junior is taken by means of the measured syringe which is in packing.
10 ml of solution correspond to 2 filled measured syringes.
Adults and teenagers aged from 14 years: on 10 ml of solution 3 times a day (600 mg of Acetylcysteinum a day are equivalent).
Children and teenagers aged from 6 up to 14 years: on 10 ml of solution 2 times a day (400 mg of Acetylcysteinum a day are equivalent).
Children aged from 2 up to 5 years: on 5 ml of solution 2-3 times a day (200-300 mg of Acetylcysteinum a day are equivalent).
In short-term catarrhal diseases duration of a course is 4-5 days. In long diseases the course of therapy is defined by the doctor.
Use of the measured syringe:
Open a bottle cover, having pressed on it and having turned counterclockwise,
Remove from the syringe a stopper with an opening and insert it into a neck of a bottle and press against the stop. The stopper is intended for connection of the syringe with a bottle and remains in a bottle neck,
Densely insert the syringe into a stopper. Carefully turn a bottle upside down, pull the syringe piston down and gain necessary quantity of milliliters of solution. If in solution vials of air are visible, press the piston against the stop then fill the syringe anew. Return a bottle to a starting position and take out the syringe.
Solution should be poured out of the syringe on a spoon or directly in a mouth to the child (to the zashchechny area, slowly, so that the child could swallow solution properly), during intake of solution the child has to be in vertical position (a standing position / sitting),
After use wash the syringe with clear water.
not often (≥1/1000, & lt, 1/100)
– allergic reactions (itching, urticaria, skin rash, a bronchospasm, a Quincke’s edema)
– arterial hypotension
– a headache
– stomatitis, an abdominal pain, diarrhea, vomiting, heartburn, nausea
Seldom (≥1/10000, & lt, 1/1000)
– an asthma, a bronchospasm mainly at patients with hyperreactivity of the bronchial system connected with bronchial asthma
Very seldom (& lt, 1/10,000)
– bleedings and hemorrhages which are partially connected with hypersensitivity reactions
– anaphylactic reactions, up to an acute anaphylaxis
– Stephens-Johnson’s syndrome, a Lyell’s disease
It is unknown
the Contraindication face edema
– hypersensitivity to Acetylcysteinum or excipients of drug
– intolerance of a galactose and lactose
– a glucose galactose sprue
– a renal failure
– a liver failure
– the children’s age up to 2 years
Simultaneous use of Acetylcysteinum and antibechics can cause dangerous secretory stagnation owing to reduction of a tussive reflex. This option of combination therapy has to be defined by the attending physician.
For achievement of the best therapeutic effect the oral antibiotics (penicillin, tetracyclines and aminoglycosides) have to be entered separately, with a two-hour time interval.
Use of activated carbon in high doses can weaken effect of Acetylcysteinum.
Simultaneous use of nitroglycerine and Acetylcysteinum should be carried out under control of the doctor as strengthening of vasodilating effect and inhibiting effect on aggregation of thrombocytes is possible.
The junior is not recommended to dissolve other medicines in drug AЦЦ® solution.
Acetylcysteinum can influence colorimetric quantification of definition of salicylates.
Acetylcysteinum can affect results of the analysis of ketone bodies in the analysis of urine.
It is necessary to be careful at drug AЦЦ® use the junior at patients with bronchial asthma, with ulcer of stomach or duodenum in the anamnesis.
During drug AЦЦ® use the junior emergence of heavy skin allergic reactions (Stephens-Johnson’s syndrome, a Lyell’s disease) was seldom or never observed. In case of skin allergic reactions the patient should stop immediately administration of drug of AЦЦ® the junior and to see a doctor.
Patients with intolerance of a histamine should take the drug AЦЦ® the junior solution short courses, because of influence on metabolism of the histamine possible emergence of symptoms of intolerance (for example, a headache, cold, an itching).
Use of an atsetiltsistin can lead to fluidifying of a phlegm in bronchial tubes and to some increase in its volume. At an insufficient tussive reflex are applied: postural drainage or aspiration.
1 ml of solution contains 1.78 mmol (41.02 mg) of sodium. It should be taken into account when prescribing the drug ATsTs® the junior to the patients keeping to a diet with the low content of sodium (low-salt diet).
Pregnancy and the period of a lactation
Use of drug during pregnancy and in the period of a lactation perhaps in cases when the expected advantage of therapy for mother exceeds potential risk for a fruit and the child.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
the Drug ATsTs® the junior does not affect ability to run the vehicle or potentially dangerous mechanisms.
Symptoms: nausea, vomiting, diarrhea.
The form of release and packing
On 100 ml of solution for intake place in the bottle of dark III glass corked by the white polypropylene twisting cover with control of the first opening and the chlorbutyl condensing membrane.
On 1 bottle complete with the measured syringe (it is graduated from 0.5 to 5 ml) from polypropylene and the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions at a temperature not above 25 °C.
After the first opening of a bottle: to store at a temperature from 2 °C to 8 °C (in the fridge) no more than 11 days.
To store out of children’s reach!
not to use a period of storage after expiry date.
To Develop prescription status Without prescription
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