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medicalmeds.eu Medicines Sekretolitiki and stimulators of motor function of respiratory tracts. АЦЦ® 100

ÇÛÛ® 100

Препарат АЦЦ® 100. Sandoz Gmbh (Сандоз Гмбх) Германия


Producer: Sandoz Gmbh (Sandoz Gmbh) Germany

Code of automatic telephone exchange: R05CB01

Release form: Firm dosage forms. Tablets.

Indications to use:


General characteristics. Structure:

АЦЦ®

Granules for syrup preparation (orange) 5 ml of ready syrup
active agent: 
Acetylcysteinum of 100 mg
excipients: methylparahydroxybenzoate; пропилпарагидроксибензоат; sorbitol; sodium citrate; fragrance orange 
ÇÛÛ® 100

Tablets sparkling 1 table.
active agent: 
Acetylcysteinum of 100 mg
excipients: ascorbic acid; citric acid anhydride; lactoses anhydride; Mannitolum; sodium citrate; Natrii hydrocarbonas; saccharin; fragrance blackberry 
ÇÛÛ® 200

Tablets sparkling 1 table.
active agent: 
Acetylcysteinum of 200 mg
excipients: ascorbic acid; citric acid anhydride; lactoses anhydride; Mannitolum; sodium citrate; Natrii hydrocarbonas; saccharin; fragrance blackberry 
АЦЦ®

Granules for preparation of solution for intake (orange) 1 pack ice. (3 g)
active agent: 
Acetylcysteinum of 100 mg
  200 mg
excipients: sucrose; ascorbic acid; saccharin; fragrance orange 
Granules for preparation of solution for intake 1 pack ice. (3 g)
active agent: 
Acetylcysteinum of 200 mg
  600 mg
excipients: ascorbic acid; sukroza; saccharin; honey and lemon fragrances 
ATsTs® Long

Tablets sparkling 1 table.
active agent: 
Acetylcysteinum of 600 mg
excipients: citric acid — 625 mg; Natrii hydrocarbonas — 327 mg; sodium a carbonate — 104 mg; Mannitolum — 72,8 mg; lactose — 70 mg; ascorbic acid — 75 mg; sodium cyclomate — 30,75 mg; saccharinate sodium a dihydrate — 5 mg; citrate sodium a dihydrate — 0,45 mg; blackberry fragrance "B" — 40 mg 
Description of a dosage form
Granules for syrup preparation (orange): homogeneous granules, from white till yellowish color, without the agglomerated particles, with an orange smell.

Granules for preparation of solution for intake (orange): homogeneous granules, white color, without the agglomerated particles, with an orange smell.

Granules for preparation of solution for intake: white homogeneous granules, no more than 1,5 mm in size without agglomerates and mechanical impurity, with a smell of a lemon and honey.

Tablets are sparkling, 100 mg, 200 mg: white, round, flat tablets, with risky (200 mg), with a blackberry smell.

Tablets are sparkling, 600 mg: white, round tablets, with a facet, with risky on one party, with a smooth surface, with a blackberry smell. Outward of solution: at dissolution of 1 tab. in 100 ml of water receive colourless transparent solution with a blackberry smell.




Pharmacological properties:

Acetylcysteinum (AZZ) — mucolytic, an expectorant which is applied to depression of a phlegm at the diseases of respiratory system which are followed by formation of dense slime. Acetylcysteinum is derivative amino acids cysteine. AZZ works sekretolitichesk and increases motility of a respiratory path. The mucolytic effect of drug has the chemical nature. Due to existence of free sulphhydryl group Acetylcysteinum terminates disulfide bridges of acid mucopolysaccharides that leads to a depolymerization of mukoproteid of a phlegm. As a result of it viscosity of a phlegm decreases. Drug AZZ is active also concerning a purulent phlegm.
Drug AZZ has also antioxidant pneumotyre-tread properties which are caused by binding by its sulphhydryl groups of chemical radicals and, thus, their neutralization. Besides, AZZ promotes increase in synthesis of glutathione — an important factor of intracellular protection not only against toxins of an exogenous and endogenous origin, but also from a row cytotoxic substances. This feature of AZZ gives the chance to effectively apply it at acute poisonings with paracetamol and other toxic substances (aldehydes, phenols).
After oral administration Acetylcysteinum quickly and completely is soaked up and exposed to metabolism in a liver with formation of cysteine, pharmacological an active metabolite, and also diacetylcysteinum, cystine and further — the mixed disulfides. Bioavailability very low — about 10%. Cmax in a blood plasma is reached in 1–3 h after reception. Linkng with proteins of a blood plasma — about 50%. Acetylcysteinum is allocated with kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteinum).
T½ is defined, mainly, bystry biotransformation in a liver and makes about 1 h. In case of depression of function of a liver of T½ increases to 8 h.


Indications to use:

The acute and chronic diseases of bronchopulmonary system which are followed by the increased formation of a phlegm with deterioration in expectoration.


Route of administration and doses:

To adults and children 14 years are aged more senior: 400–600 mg of Acetylcysteinum the day (divided into 1–3 receptions).
To children at the age of 6–14 years: 400–600 mg of Acetylcysteinum the day (divided into 2–3 receptions).
To children at the age of 2–6 years: 200–400 mg of Acetylcysteinum the day (divided into 2 receptions).
Drug is recommended to be accepted after food. The sparkling tablet / contents of a bag is dissolved in ½ glasses of water, juice or cold tea. For strengthening of mucolytic effect of AZZ the additional use of liquid is recommended.
The term of treatment of chronic diseases is defined by the doctor depending on character or the course of a disease. At acute uncomplicated diseases Acetylcysteinum is used by 5–7 days.


Features of use:

Acetylcysteinum should be applied with care to patients with a peptic ulcer of a stomach and duodenum in the anamnesis, especially in case of the accompanying reception of other medicines which irritate a mucous membrane of a stomach. It was reported about separate heavy reactions from skin (Stephens's syndrome — Johnson and a Lyell's disease). Therefore in case of changes from skin or mucous membranes it is necessary to stop immediately use of drug and to consult with the doctor concerning the subsequent administration of drug. Acetylcysteinum should be applied with care to patients with OH because of possible development of a bronchospasm. At a bag contents rash in ware in preparation time of solution powder can get to air and irritate a mucous membrane of a nose owing to what there can be a reflex bronchospasm. Patients with diseases of a liver, kidneys need to appoint Acetylcysteinum with care in order to avoid accumulation of nitrogen-containing substances in an organism. Use of Acetylcysteinum causes fluidifying of a bronchial secret. If the patient cannot effectively cough up a phlegm, the postural drainage and a bronkhoaspiration are necessary. Acetylcysteinum influences metabolism of a histamine therefore patients should not appoint long therapy with intolerance of a histamine as it can lead to emergence of symptoms of intolerance (a headache, vasculomotor rhinitis, an itch).
Tablets sparkling contain compounds of sodium. The patients who are on an electrolyte-deficient diet with the low content of sodium have to consider it. Powder for peroral solution contains sucrose therefore patients should not appoint it with rare hereditary forms of intolerance of fructose, deficit of α-isomaltase or a syndrome of glyukozo-galaktozny malabsorption.
One bag of ATsTs 100 contains 2,8 g of sucrose (about 0,24 grain units — HE); one bag of ATsTs 200 contains 2,7 g of sucrose (about 0,23 HE). It should be considered when using drug at patients with a diabetes mellitus.
Use during pregnancy and feeding by a breast. For today there is no enough observations concerning use of drug during pregnancy and feeding by a breast therefore it is only possible to appoint drug during this period when the expected advantage for mother exceeds potential risk for a fruit or the child.
Children. Use at children aged 2 years are more senior.
Ability to influence speed of response at control of vehicles and work with other mechanisms. Does not influence.


Side effects:

For the description of frequency of side effects use such classification: very often (≥1/10), it is frequent (≥1/100, <1/10), infrequently (≥1/1000, <1/100), is rare (≥1/10 000, <1/1000), is very rare (<1/10 000).
From cardiovascular system: infrequently — tachycardia, arterial hypotension.
From a nervous system: infrequently — a headache.
From an acoustic organ: infrequently — a ring in ears.
General disturbances: infrequently — fever.
From respiratory system: seldom — диспноэ, a bronchospasm (it is preferential at patients with hyperreactivity of bronchial system which is associated with OH), a rhinorrhea.
From a GIT: infrequently — heartburn, dyspepsia, stomatitis, abdominal pain, nausea, vomiting, diarrhea.
It was reported about separate heavy reactions from skin (Stephens's syndrome — Johnson and a Lyell's disease). At use of Acetylcysteinum it was very seldom reported about developing of bleedings which were most often connected with development of reactions of hypersensitivity. In many researches oppression of aggregation of thrombocytes was noted, however it does not have clinical confirmation. It was very seldom reported about cases of a Quincke's edema, a face edema, anemia, a hemorrhage, anaphylactic reactions or even shock.


Interaction with other medicines:

Simultaneous use of Acetylcysteinum with antibechics can increase stagnation of a phlegm because of oppression of a tussive reflex.
At simultaneous use with such antibiotics as tetracycline (except for doxycycline), ampicillin, Amphotericinum In, cephalosporins, aminoglycosides their interaction with thiol group of Acetylcysteinum is possible that leads to decrease of the activity of both drugs. Therefore the interval between use of these drugs has to make not less than 2 h. It does not concern a tsefiksim and a lorakarbef. Absorbent carbon reduces efficiency of Acetylcysteinum. It is not recommended to dissolve in one glass Acetylcysteinum with other drugs. Acetylcysteinum reduces expressiveness of a hepatotoxic action of paracetamol.
Acetylcysteinum synergism with bronchial spasmolytics is noted.
Acetylcysteinum can be the donor of cysteine and increase the level of glutathione which promotes a detoxication of free radicals of oxygen and certain toxic substances in an organism. The concomitant use of nitroglycerine and Acetylcysteinum can lead to strengthening of vazodilatatorny effect of nitroglycerine.
During contact with metals or rubber sulfides with a characteristic smell therefore for dissolution of drug it is necessary to use glasswares are formed.


Contraindications:

Hypersensitivity to Acetylcysteinum or other components of drug. A peptic ulcer of a stomach and duodenum in an aggravation stage, a pneumorrhagia, pulmonary bleeding.


Overdose:

Still cases of heavy and life-threatening side effects, even are not revealed at extreme overdose.
Symptoms: nausea, vomiting, diarrhea.
Treatment: symptomatic.


Storage conditions:

In densely closed tuba at a temperature not above 25 °C.


Issue conditions:

Without recipe


Packaging:

Granules for syrup preparation (orange) 100 mg / 5 ml. On 30 or 60 g of granules in a bottle of dark glass. 1 фл. with a measured spoon in a cardboard pack. The bottle has a circular tag and is corked by the plastic screw-on cover with a control ring of the first opening and the pressurizing laying inside. On an upper surface of a cover the scheme of opening of a bottle is put.

Tablets are sparkling, 100 mg, 200 mg. According to 20 or 25 tab. in a tuba aluminum or plastic. On 1 tuba according to 20 tab. either on 2 or on 4 tubas according to 25 tab. in a cardboard box. According to 4 tab. in strips from 3-layer material: paper/PE/aluminium. On 15 strips in a cardboard box.

Granules for preparation of solution for intake orange, 100 mg, 200 mg. On 3 g of granulate in bags from 3-layer material (aluminum/paper/polythylene). On the 20 or 50 pack ice. in a cardboard pack.

Granules for preparation of solution for intake, 200 mg, 600 mg. On 6, 10 or 20 pack ice. in cardboard packaging.

Tablets are sparkling, 600 mg. According to 6, 10 or 20 tab. in tubas from polypropylene. On 1 tuba in a cardboard pack.



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