The instruction for medical use
of ACC medicine of Jotas Drink
the Trade name
of ACC of Jotas Drink
the International unlicensed
name Acetylcysteinum Dosage Form Powder for preparation of solution for intake of 600 mg
1 bag contains
active agent: Acetylcysteinum of 600 mg,
excipients: sucrose, ascorbic acid, sodium saccharin, fragrance the Lemon, fragrance Honey
Powder from white till yellowish color, with partial agglomeration of particles, with a smell of a lemon and honey.
Expectorant drugs. Mucolytics. Acetylcysteinum
the ATX R05 CB01 Code
Pharmacokinetics Later properties of intake Acetylcysteinum is quickly absorbed from the digestive tract (DT) 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%).
At the person the maximum concentration in plasma is reached in 1-3 h after administration of drug. The maximum concentration in plasma of a metabolite of cysteine makes about 2 µmol/l. Linking of Acetylcysteinum with protein of blood plasma makes about 50%.
Acetylcysteinum is removed through kidneys almost only in the form of inactive metabolites (inorganic sulfates, diacetylcysteinum).
The semi-elimination period in plasma is about 1 hour and generally is defined by hepatic biotransformation. Therefore the abnormal liver function leads to prolongation of the plasma period of semi-elimination up to 8 hours.
Acetylcysteinum gets through a placental barrier and it is found in umbilical blood. Data on ability to get into breast milk are not available.
Acetylcysteinum is derivative amino acids cysteine. Acetylcysteinum possesses sekretolitichesky and sekretomotorny action in airways. It 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 detoxication of toxic agents. It explains its action as antidote in poisonings with paracetamol.
At its preventive use it 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 all bronchopulmonary diseases which are followed by disturbance of education and removal of a phlegm, such as: acute and chronic bronchitis, obstructive bronchitis, bronchiolitis, bronchiectasia, pneumonia, laryngitis, tracheitis, bronchial asthma, mucoviscidosis, sinusitis, otitis of a middle ear.
The route of administration and a dosage
Adults and teenagers aged from 14 years are also more senior
On 1 bag of powder once a day (there correspond 600 mg of Acetylcysteinum a day).
Duration of treatment depends on type and disease severity. In cases of acute short-term catarrhal diseases, treatment lasts 5-7 days. In case of chronic bronchitis and a mucoviscidosis, treatment has to take longer span.
The maximum duration of a course of treatment – 3-6 months.
To dissolve contents of a bag in a glass of hot water, to mix, take hot after a meal.
– allergic reactions (itching, urticaria, skin rash, a bronchospasm, a Quincke’s edema, tachycardia, hypotonia)
– a headache
– a ring in ears
– stomatitis, an abdominal pain, diarrhea, vomiting, heartburn and nausea
– an asthma, a bronchospasm mainly at patients with hyperreactivity of the bronchial system connected with bronchial asthma
– the hemorrhages which are partially connected with hypersensitivity reactions
– anaphylactic reactions, up to an acute anaphylaxis
In various researches the decrease in aggregation of thrombocytes under the influence of Acetylcysteinum was proved. Now the clinical importance of this phenomenon is not established.
– hypersensitivity to Acetylcysteinum or any component of drug
– children’s age up to 14 years
– the period of pregnancy and a lactation
– the peptic ulcer of a stomach in an aggravation stage
Simultaneous use of Acetylcysteinum and antibechics can cause dangerous secretory stagnation owing to reduction of a tussive reflex. Therefore similar combinations should be selected with care.
Messages concerning an inactivation of antibiotics (semi-synthetic penicillin, tetracyclines, cephalosporins and aminoglycosides) as a result of simultaneous use of Acetylcysteinum or other mucolytic drugs are based only on laboratory trials in which significant substances directly mixed up. Despite this, for safety the oral antibiotics have to be entered separately, at least, with a two-hour time interval. It does not belong to a tsefiksim and a lorakarbef. There were no messages about incompatibility with such antibiotics as amoxicillin, doxycycline, erythromycin or triamfenikol and also tsefuroksy.
In cases of simultaneous administration of nitroglycerine (glycerin trinitrate) with Acetylcysteinum strengthening of its vasodilating effect and inhibiting effect on aggregation of thrombocytes was observed.
Acetylcysteinum is not compatible to the majority of the drugs containing metals and is inactivated by oxidizers.
Acetylcysteinum eliminates toxic effects of paracetamol.
during use of Acetylcysteinum the emergence of heavy skin reactions, such as Stephens-Johnson’s syndrome and Lyell’s disease was seldom or never observed. In case of changes from skin and mucous membranes the patient should stop immediately intake of Acetylcysteinum and to see a doctor.
It is necessary to be careful at treatment by Acetylcysteinum of the patients having bronchial asthma and patients with ulcer of stomach or duodenum in the anamnesis and also with risk of gastrointestinal bleeding (for example, a latent round ulcer or a varicosity of a gullet).
Presence of a light sulfuric smell is a characteristic smell of active ingredient.
At patients it is also necessary to be careful with intolerance of a histamine. At such patients it is necessary to avoid use of long therapeutic courses as Acetylcysteinum affects metabolism of a histamine and can cause intolerance symptoms (for example, a headache, cold, an itching).
It was reported about cases of strengthening of vasoconstrictive action and also inhibition of aggregation of thrombocytes at intake of nitroglycerine together with Acetylcysteinum.
The clinical value of this effect is not established.
The instruction for patients with diabetes: 1 bag of ACC of Jotas Drink supports 0.17 XE.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
of cases of toxic overdose of oral forms of Acetylcysteinum does not influence So far it was not observed.
Symptoms. At overdose there can be symptoms from digestive tract, such as nausea, vomiting and diarrhea. Children have a risk of emergence of hypersecretion.
Treatment. Symptomatic treatment.
A form of release and packing
On 3 g of powder in the thermosoldered three-layer bags from polyethylene, aluminum and paper.
On 6 bags together with 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 over 25C.
To store out of children’s reach!
Not to use a period of storage of 5 years after the expiry date specified on packing.
of Producer/Upakovshchik Lindopharm GmbH, Germany
of Neustrae 82, D-40721 Hilden, Germany
the Owner of the registration certificate
of Hexal AG, Germany
in Republic of Kazakhstan, Almaty, Luganskogo St. 96
to Develop the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of the products (goods) responsible for post-registration observation of safety of medicine Representative office of JSC Sandoz Pharmasyyutikals of of