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Ambrolitin

Препарат Амбролитин. Sopharma (АО Софарма) Болгария


Producer: Sopharma (JSC Sofarm) Bulgaria

Code of automatic telephone exchange: R05CB06

Release form: Liquid dosage forms. Syrup.

Indications to use: Bronchitis.


General characteristics. Structure:

Active agent: Ambroxol hydrochloride of 15 mg / 5 ml

Other ingredients: sorbite (E 420), citric acid monohydrate, methylparahydroxybenzoate (Е 218), пропилпарагидроксибензоат (Е 216), glycerin, propylene glycol, sodium saccharin, fragrance crimson, the water purified.




Pharmacological properties:

Active ingredient of drug — Ambroxol is an active metabolite of Bromhexine, has mucolytic and sekretolitichesky effect, increases secretion of glands of respiratory tracts. Ambroxol strengthens release of pulmonary surfactant and stimulates tsiliarny activity therefore department of slime and its removal (mukotsiliarny clearance) is facilitated. Thus, activation of secretion of liquid and increase in mukotsiliarny clearance facilitate slime removal, promote expectoration, improve breath.
Absorption of Ambroxol takes place in a GIT quickly and almost completely. Cmax in a blood plasma after intake is reached in 0,5–3 h. In the therapeutic range about 90% of drug contacts proteins of a blood plasma.
At oral administration distribution of Ambroxol in fabric comes from blood quickly and is sharply expressed, with high concentration of active ingredient in lungs.
Ambroxol is metabolized mainly in a liver by conjugation.
The age and floor do not exert clinically significant impact on Ambroxol pharmacokinetics therefore there is no need for any dose adjustment.
90% of Ambroxol are allocated with kidneys. Does not accumulate at a renal failure. Ambroxol gets into breast milk.


Indications to use:

Sekretolitichesky therapy at the acute and chronic bronchopulmonary diseases which are followed by hypersecretion of a viscous phlegm and disturbance of transport of slime.


Route of administration and doses:

Syrup is recommended to be applied orally during food.
Adults and children are aged more senior than 12 years: on 10 ml of syrup 3 times a day during the first 2–3 days. Then children can lower a dose to 10 ml 2 times a day.
Children aged up to 12 years: children of 6-12 years — 15 mg (5 ml) 2–3 times a day; children at the age of 2–6 years — 7,5 mg (2,5 ml) 3 times a day; children from 1 year to 2 years — 7,5 mg (2,5 ml) 2 times a day.
More than 5 days without consultation of the doctor are not recommended to use drug.


Features of use:

Ambroxol with care is applied at heavy abnormal liver functions and kidneys. At such disturbances it is recommended to carry out treatment using lower dose (a half of a usual dose for adults) within no more than 4-5 days.
Ambrolitin syrup contains sorbite of 35 g / 100 ml. At use each of them (5 ml) contains 1,75 g of sorbite in the recommended doses. Patients with rare hereditary intolerance of fructose should not accept this drug. It can also cause irritation of a mucous membrane of a stomach and easy laxative effect.
If during 5-day treatment by Ambroxol the condition of the patient did not change or worsened, it is necessary to see a doctor for therapy review.
Ambrolitin syrup contains excipients marked пропилпарагидроксибензоат which can cause allergic reactions (perhaps, the slowed-down type).
Drug contains glycerin which use in high doses can be harmful. Glycerin can cause a headache, irritation of a mucous membrane of a stomach and diarrhea.
Use during pregnancy and feeding by a breast. Ambroxol gets through a placental barrier. It is not recommended to use drug in the I trimester of pregnancy. In II and the III trimester of pregnancy drug is used only when the expected advantage for mother exceeds potential risk for a fruit.
Ambroxol gets into breast milk, but at its use in therapeutic doses its impact on the baby is improbable. Ambroxol is not recommended to be applied during feeding by a breast.
Children. Ambrolitin, syrup of 15 mg / 5 ml, appoint to children aged from 1 year.
Ability to influence speed of response at control of vehicles or work with other mechanisms. Does not influence.


Side effects:

From a GIT: dyspepsia, heartburn, it is rare — nausea, vomiting, an abdominal pain, diarrhea, is very rare — hypersalivation, a lock.
From respiratory system: dryness of a mucous membrane of upper respiratory tracts.
General disturbances: rash, urticaria, an itch, a Quincke's disease, anaphylactic reactions (including an acute anaphylaxis) and allergic reactions.
It was very seldom reported about heavy skin reactions: Stephens's syndrome — Johnson, the Lyell's disease connected using mucolytic means, such as Ambroxol. Generally they could be explained with weight of a current of a basic disease or simultaneous use of other drug.
At emergence of any side reactions it is necessary to ask immediately for medical care and to stop treatment by Ambroxol.


Interaction with other medicines:

At simultaneous use with Ambroxol concentration of antibiotics (amoxicillin, a tsefuroksim, erythromycin) in a bronchopulmonary secret and in tissues of lungs increases.
Simultaneous use of Ambroxol with the medicines oppressing cough is not recommended.
There are no messages on clinical undesirable interactions with other medicines.


Contraindications:

Hypersensitivity to Ambroxol or other components of drug.


Overdose:

There are no messages on overdose cases. In case of use in the doses exceeding recommended it is necessary to see a doctor. Symptomatic treatment.


Storage conditions:

In original packaging (in the dry, protected from light place) at a temperature not above 25 °C. Not to freeze.


Issue conditions:

According to the recipe


Packaging:

Syrup of 15 mg / 5 ml фл. 100 ml.



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