AZZ longum
Producer: Sandoz Gmbh (Sandoz Gmbh) Germany
Code of automatic telephone exchange: R05CB01
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
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. 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:
AZZ Longum — mucolytic, the expectorant applied to fluidifying of a phlegm at the diseases of respiratory system which are followed by formation of dense slime. Acetylcysteinum is derivative amino acids cysteine. The mucolytic effect of drug has the chemical nature. At the expense of the AZZ free sulphhydryl group Longum terminates disulfide bridges of acid mucopolysaccharides that leads to a depolymerization of mukoproteid of a phlegm and reduction of viscosity of slime and promotes expectoration and an otkhozhdeniye of a bronchial secret. AZZ Longum keeps activity in the presence of a purulent phlegm.
Acetylcysteinum has also antioxidant pneumotyre-tread properties that is caused by binding by its sulphhydryl groups of chemical radicals and, thus, their neutralization. Besides, drug promotes increase in synthesis of glutathione — an important factor of intracellular protection not only against oxidizing toxins of an exogenous and endogenous origin, but also from a number of cytotoxic substances. This feature of AZZ Longum gives the chance to effectively apply the last at paracetamol overdose.
After oral administration Acetylcysteinum is quickly and completely soaked up and metabolized 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 — 50%. Acetylcysteinum is allocated with kidneys in the form of inactive metabolites (inorganic sulfates, diacetylcysteinum).
T½ is defined mainly by 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:
Treatment of the acute and chronic diseases of bronchopulmonary system demanding reduction of viscosity of a phlegm, improvement its otkhozhdeniye and expectorations.
Route of administration and doses:
To adults and children 14 years are aged more senior appoint 600 mg (1 tablet) of 1 times a day.
To children 14 years and in cases when the dose has to be distributed on several receptions are aged younger, apply Acetylcysteinum in other dosage form or the corresponding dosage.
Drug is accepted after food. To dissolve a tablet in a glass of water and to drink solution as soon as possible. In some cases in connection with existence in composition of drug of the stabilizer — ascorbic acid it is possible to leave the prepared solution approximately on 2 h until its use. The additional use of liquid strengthens mucolytic effect of drug.
The term of treatment of chronic diseases is determined by the doctor depending on character and the course of a disease. At acute uncomplicated diseases of AZZ Longum is applied by 5–7 days.
Features of use:
It is recommended to take with caution drug to patients with stomach ulcer and a duodenum in the anamnesis, especially in case of a concomitant use of other medicines which irritate a mucous membrane of a stomach.
There are separate messages on heavy reactions from skin (Stephens's syndromes — Johnson and Layell) at reception of Acetylcysteinum 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 of its rather further use.
It is necessary to appoint with care Acetylcysteinum sick OH because of possible development of a bronchospasm.
Patients with diseases of a liver, kidneys should 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 is not capable to cough up effectively a phlegm, it is necessary to carry out a postural drainage and a bronkhoaspiration.
Tablets sparkling contain compounds of sodium. It should be considered to patients who are on an electrolyte-deficient diet with the low content of sodium.
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).
Drug contains lactose therefore to patients with rare hereditary forms of intolerance of a galactose, insufficiency of lactase or a syndrome of glyukozo-galaktozny malabsorption it is not necessary to use drug.
Use during pregnancy or feeding by a breast. During pregnancy and feeding by a breast use of Acetylcysteinum is possible only if the estimated advantage for mother exceeds potential risk for a fruit or the child.
Ability to influence speed of response at control of vehicles or other mechanisms. Does not influence.
Children. Apply at children aged 14 years are more senior.
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 skin: infrequently — allergic reactions (an itch, urticaria, a dieback, eczema, rash, a Quincke's disease).
From an acoustic organ: infrequently — a ring in ears.
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, an abdominal pain, nausea, vomiting, diarrhea, an unpleasant smell from a mouth.
General disturbances: often — fever.
It was reported about separate heavy reactions from skin (Stephens's syndromes — Johnson and Layell). At use of Acetylcysteinum it was very seldom reported about developing of bleedings which were most often connected with development of reactions of hypersensitivity. Noted cases of decrease in aggregation of thrombocytes, however that does not have clinical confirmation. It was very seldom reported about a Quincke's edema, a face edema, anemia, a hemorrhage, anaphylactic reactions (including an acute anaphylaxis).
Interaction with other medicines:
Use together with Acetylcysteinum of antibechics can increase stagnation of a phlegm because of reduction of a tussive reflex.
At simultaneous use with such antibiotics as tetracyclines (excepting 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 reception 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 toxics in an organism.
The concomitant use of nitroglycerine and Acetylcysteinum can lead to strengthening of vasodilating 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:
There are no data on overdose cases at oral administration of Acetylcysteinum.
Symptoms: nausea, vomiting, diarrhea.
Therapy: symptomatic treatment.
Storage conditions:
In the dry, protected from light place, at a temperature not above 30 °C. It is dense to tube to close after capture of a tablet. To store in the place, unavailable to children. Drug ATsTs® period of validity Longum 3 years.
Issue conditions:
Without recipe
Packaging:
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.
Tablets are sparkling, 600 mg. According to 6, 10 or 20 tab. in tubas from polypropylene. On 1 tuba in a cardboard pack.