Ambroxol - instructions for use, dose, side effects, contraindications

Excipients: Benzoic acid 0.0100 g, hyietolose 0.0075 g, sorbitol - 2.5000 g, glycerol 0.700 g, propylene glycol 0.100 g, sodium saccharinate 0.0015 g, raspberry flavor 0.0025 g, water up to 5 ml.

5 ml of syrup contains:

active substance: Ambroxol hydrochloride 0.0300 g

Excipients: benzoic acid 0.0100 g, hyiethellosis 0.0075 g, sorbitol - 2.5000 g, glycerol 0.700 g, propylene glycol 0.100 g, sodium saccharinate 0.0015 g, apricot flavors 0.0025 g, water up to 5 ml.

Description:

Dosage of 15 mg / 5 ml - slightly viscous transparent, colorless liquid with the smell of raspberry. Dosage 30 mg / 5 ml - slightly viscous transparent, slightly yellowish liquid with the smell of apricot.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

Ambroxol possesses a secreto-motor, secretolitic and expectorant action: it stimulates serous cells of the glands of the mucosa bronchi, increases the maintenance of a mucous secret and allocation of a surfactant (surfactant) in alveoli and bronchuses; normalizes the disturbed ratio of serous and mucous components of sputum. By activating hydrolysing enzymes and by increasing the release of lysosomes from Clara cells, reduces the viscosity of sputum. Increases the motor activity of the cilia of the ciliated epithelium. Strengthens the current and transport of mucus (mucociliary clearance). Strengthening mucociliary clearance improves sputum discharge and facilitates coughing.

Pharmacokinetics:

For ambroksola characterized by rapid and almost complete absorption from the gastrointestinal tract (GIT) with a linear dose dependence in the therapeutic range of concentrations. Bioavailability is 70-80%. The maximum concentration (Cmah) in the blood plasma for oral intake of syrup is achieved through 1,5-4 hours. In the therapeutic concentration range, binding to plasma proteins is approximately 90%.

The transfer of ambroxol from the blood to the tissue with oral administration occurs rapidly. The highest concentrations of the active component of the drug are observed in the lungs. Penetrates through the blood-brain barrier, placental barrier, excreted in breast milk.

Approximately 30% of the administered oral dose is subjected to the effect of "primary passage" through the liver. Studies on microsomes of the human liver showed that the isoenzyme CYP3A4 is the predominant isoenzyme responsible for metabolism of ambroxol. The rest of the ambroxol is metabolized in the liver to inactive metabolites. Half-life (T_1/2) of ambroxol is about 10 hours. It is excreted by the kidneys: 90% in the form of metabolites, 10% in unchanged form.

There is no clinically significant effect of age and sex on the pharmacokinetics of ambroxol, so there is no basis for dose adjustment for these features.

Indications:Acute and chronic diseases of the respiratory tract with the release of viscous sputum: acute and chronic bronchitis, pneumonia,chronic obstructive pulmonary disease, bronchial asthma with difficulty in sputum discharge, bronchiectasis.

Contraindications:

Hypersensitivity to ambroxol or to one of the excipients;

pregnancy (I trimester); lactation period.

Intolerance to fructose, tk. the preparation contains sorbitol.

Carefully:

Disturbance of motor function of the bronchi and increased sputum production (with the syndrome of immobile cilia), peptic ulcer of the stomach and duodenum during the exacerbation, pregnancy (II-III trimester).

Patients with impaired renal function or severe liver disease should take ambroxol with extreme caution, observing large intervals between doses of the drug or taking the drug in a smaller dose.

Pregnancy and lactation:

Ambroxol penetrates the placental barrier. The drug is not recommended for use during the first trimester of pregnancy. If it is necessary to use ambroxol in II-III trimesters of pregnancy should be evaluated for potential benefits to the mother with a possible risk to the fetus.

During the period of breastfeeding, the drug is contraindicated because it is excreted in breast milk.If it is necessary to use the drug, breastfeeding should be discontinued.

Dosing and Administration:

Syrup should be taken orally after eating, using the supplied measuring cup (measuring spoon). The mucolytic effect of the drug is manifested when receiving a large amount of fluid. Therefore, during treatment is recommended to drink abundantly. The drug should not be taken immediately before bedtime.

Syrup 15 mg / 5 ml:

5 ml of syrup contains 15 mg of ambroxol.

Adults and children over 12 years of age

During the first 2-3 days take 10 ml of syrup 3 times a day, then the dose should be reduced to 10 ml of syrup 2 times a day.

Children from 6 to 12 years old

5 ml of syrup 2-3 times a day.

Children from 2 to 6 years old

2.5 ml of syrup 3 times a day.

Children under 2 years of age

2.5 ml of syrup 2 times a day.

Syrup 30 mg / 5 ml:

5 ml of syrup contains 30 mg of ambroxol.

Adults and children over 12 years of age

During the first 2-3 days take 5 ml of syrup 3 times a day, then the dose should be reduced to 5 ml of syrup 2 times a day.

Children from 6 to 12 years old

2.5 ml of syrup 2-3 times a day.

Children from 2 to 6 years old

For 1.25 ml of syrup 3 times a day.

Children under 2 years of age

For 1.25 ml of syrup 2 times a day.

The maximum daily intake for adults is 120 mg ambroxol; the maximum daily dose for children from 6 to 12 years - 45 mg ambroksola; for children from 2 to 6 years - 22.5 mg ambroksola; for children under 2 years of age - 15 mg ambroxol.

The duration of treatment is selected individually, depending on the course of the disease. Not it is recommended that ambroxol without the appointment of a doctor more than 4-5 days.

Side effects:

The incidence of adverse events is classified according to Rthe World health organizations: is characterized as very often - no less than 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0,1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely, including individual reports - less than 0.01%.

Disorders from the gastrointestinal tract: infrequently nausea, decreased sensitivity in the oral cavity or pharynx, dyspepsia, vomiting, diarrhea, abdominal pain, dry mouth and throat.

Immune system disorders, lesions of the skin and subcutaneous fabrics: rarely - skin rash, hives; anaphylactic reactions (including anaphylactic shock) *, angioedema, * itching *, hypersensitivity *; very rarely - Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis).

Disorders from the nervous system: infrequently - dysgeusia (a violation of taste sensations).

* - these adverse reactions were observed with a wide application of the drug; with 95% probability, the incidence of these adverse reactions is infrequent 0.1% -1.0%, but possibly less frequently; the exact frequency is difficult to assess, since they were not noted during clinical trials.

Overdose:

Symptoms: heartburn, indigestion, nausea, vomiting, pain in the upper abdomen.

Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; symptomatic therapy.

Interaction:

When used with antitussive drugs, it may be difficult for sputum to escape as a result of suppressing the cough reflex. With simultaneous use with amoxicillin, cefuroxime, erythromycin ambroxol increases their absorption into the bronchial secret. No clinically relevant adverse interactions with other drugs have been reported.

Special instructions:

Ambroxol should not be taken concomitantly with antitussive drugs that can inhibit cough reflex.

Ambroxol should be used with caution in patients with a weakened cough reflex or disturbed mucociliary transport due to the possibility of sputum congestion.

Patients receiving ambroxol, do not recommend performing respiratory gymnastics; In seriously ill patients, aspiration of diluted sputum should be performed.

In patients with bronchial asthma ambroxol can strengthen cough.

Do not take ambroxol just before bed.

In patients with severe skin lesions - Stevens-Johnson syndrome or Lyell's syndrome - in the early phase, fever, body pain, rhinitis, cough and sore throat may appear. With symptomatic treatment, it is possible to erroneously designate mucolytic agents, such as ambroxol. There are isolated reports of the detection of Stevens-Johnson syndrome and Lyell's syndrome, coinciding with the appointment of ambroxol; However, there is no causal relationship with the use of ambroxol.

With the development of the aforementioned syndromes,Mend to cease treatment and seek medical help immediately.

In case of impaired renal function ambroxol should be used only on the advice of a doctor.

Syrup Ambroxol (30 mg / 5 ml, 15 mg / 5 ml) contains 10 g of sorbitol in terms of the maximum recommended daily dose.

Patients with a rare hereditary intolerance to fructose should not take this drug.

Sorbitol can also have a mild laxative effect.

Effect on the ability to drive transp. cf. and fur:

The impact on the ability to drive vehicles and control mechanisms is not known to this day.

Form release / dosage:

Syrup 15 mg / 5ml, 30 mg / 5ml.

Packaging:

To 100 ml of syrup in the bottles of glass of orange glass ukuporennyh plastic stoppers or caps aluminum or without capping, with plastic covers.

For 100 ml of syrup in polymeric bottles with lids.

A label is attached to the vial on the basis of a self-adhesive film or a label of label paper.

Each bottle, along with instructions for use, as well as a measuring cup or measuring spoon, is placed in a cardboard package (bundle).

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-002739

Date of registration:02.12.2014

Expiration Date:02.12.2019

The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Information update date: & nbsp01.08.2017

Illustrated instructions

Instructions

Ambroxol (Ambroxol)