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

Excipients: methylparahydroxybenzoate 1.3 mg; propyl parahydroxybenzoate 0.2 mg; sodium metabisulphite - 0.20 mg; citric acid - 2.5 mg; sodium hydroxide 1.0 mg; water 993, 3 mg.

Description:A clear, colorless solution.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

It has secretory, secretolitic and expectorant action, stimulates serous cells of the glands of the bronchial mucosa, increases the content of mucous secretion and the release of surfactant (surfactant) in the alveoli and bronchi, normalizes the disturbed ratio of serous and mucous components of sputum. By activating hydrolysing enzymes and enhancing the release of lysosomes from Clara cells, reduces the viscosity of sputum. Increases the motor activity of the ciliated epithelium, increases mucociliary transport, facilitates the excretion of phlegm from the respiratory tract.

On average, the effect of taking ambroxol inside comes in 30 minutes and lasts 6-12 hours, depending on the amount of a single dose.

Pharmacokinetics:

Ambroxol after ingestion quickly and almost completely absorbed. Time to reach the maximum concentration (TC_m_Oh) after oral administration is 1-3 hours.

Metabolised in the liver with the formation of metabolites, excreted through the kidneys (dibromantranilic acid, glucuronides).

Binding to plasma proteins is approximately 85%. The half-life (T_1/2) from the blood plasma is 7-12 hours. T_1/2ambroxol and its metabolites is approximately 22 hours. 90% of ambroxol is excreted through the kidneys in the form of metabolites. In unchanged form, less than 10% of ambroxol is excreted through the kidneys.

Due to high binding to proteins and a large volume of distribution, as well as slow reverse penetration from tissues into the blood, during dialysis or forced diuresis, no significant removal of ambroxol occurs. Clear ambroxol in patients with severe hepatic insufficiency is reduced by 20-40 %. In severe renal failure T_1/2metabolites of ambroxol is increased. Ambroxol penetrates the placental barrier and into the mother's milk.

Indications:

Acute and chronic diseases of the respiratory tract with the release of viscous sputum:

- acute and chronic bronchitis;

- pneumonia;

- chronic obstructive pulmonary disease (COPD);

- bronchial asthma with difficulty in sputum discharge;

- bronchiectatic disease;

- treatment and prevention of respiratory distress syndrome

Contraindications:

- increased sensitivity to ambroxol or to any of the components of the drug;

- pregnancy (I trimester);

- the period of breastfeeding.

Carefully:Hepatic failure, renal insufficiency, peptic ulcer of stomach and duodenum, pregnancy (II-III trimester).

Pregnancy and lactation:

The drug is contraindicated for use during the first trimester of pregnancy. Use of Ambroghexal® during pregnancy (II-III trimester) is possible only if the intended benefit to the mother exceeds the potential risk to the fetus or baby.

Ambroxol penetrates the placental barrier. Animal studies have shown that the drug does not affect embryo-fetal development, childbirth and postnatal development.

Ambroxol is excreted in small amounts in breast milk, therefore, when taking Ambroghexal®, it is necessary to resolve the issue of stopping breastfeeding.

Dosing and Administration:

Ambrohexal® should be taken orally after meals in diluted form with tea, fruit juices, milk or water.

1 ml of Ambrohexal® (20 drops) contains 7.5 mg of ambroxol hydrochloride.

Adults and children over 12 years of age: 4 ml (80 drops) first 2-3 days 3 times a day (90 mg ambroxol hydrochloride per day), then 4 ml (80 drops) twice a day (60 mg ambroxol hydrochloride per day).

Children from 5 to 12 years: 2 ml (40 drops) 2-3 times a day (30-45 mg of ambroxol hydrochloride per day).

Children from 2 to 5 years: 1 ml (20 drops) 3 times a day (22.5 mg of ambroxol hydrochloride).

Children under 2 years: 1 ml (20 drops) 2 times a day (15 mg of ambroxol hydrochloride).

Children under 2 years of age Ambrohexal® are prescribed only under the supervision of a doctor. Mucolytic effect is enhanced by the use of liquid. Therefore, you need to consume enough fluids, especially during treatment.

Application for inhalation:

Adults and children over 5 years of age: it is recommended to inhalate 1-2 times a day for 2-3 ml (40-60 drops, which corresponds to 15-45 mg of ambroxol hydrochloride);

Children under 5 years of age: it is recommended to inhalate 1-2 times a day for 2 ml (40 drops, which corresponds to 15-30 mg ambroksol hydrochloride).

Inhalation solution. The inhalation solution can be used using any modern inhalation equipment (except steam inhalers). The drug is mixed with saline, to achieve the optimal level of air humidification in the respirator, the drug can be diluted in a ratio of 1: 1.Since inhalation therapy can cause a deep breath to cause coughing, inhalation should be performed in the usual breathing mode. Before inhalation it is usually recommended to warm the inhalation solution to body temperature. Patients with bronchial asthma can be recommended to perform inhalation after taking bronchodilators.

The duration of therapy depends on the severity of the disease and is determined by the attending physician.

Without a doctor's recommendation, you should not take Ambroghexal® for longer than 4-5 days.

Side effects:

According to the World Health Organization (WHO), unwanted effects are classified according to their frequency of development as follows: very often (≥1/10), often (from ≥1 / 100 to <1/10), infrequently (from ≥1 / 1,000 to <1/100), rarely (from ≥1 / 10,000 to <1 / 1,000), very rarely (<1 / 10,000); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

Allergic reactions

rarely: skin rash, hives;

frequency is unknown: anaphylactic reactions, including anaphylactic shock, angioedema, skin itching and other hypersensitivity reactions.

From the gastrointestinal tract

often: nausea,

infrequently: vomiting, diarrhea, dyspepsia and abdominal pain.

From the nervous system

often: change in taste.

Other

often: decreased sensitivity in the oral cavity or pharynx,

infrequently: dry mouth;

frequency is unknown: dryness of the mucous membranes of the respiratory tract.

Overdose:

Symptoms: nausea, vomiting, diarrhea, gastralgia, indigestion.

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

Interaction:

Simultaneous application with antitussive drugs leads to difficulty in withdrawing sputum against the background of a decrease in cough. Increases penetration into the bronchial secret amoxicillin, cefuroxime, erythromycin and doxycycline.

Special instructions:

Ambroxol should not be taken concomitantly with antitussive drugs, which can inhibit cough reflex, for example, with codeine, tk. this can make it difficult to remove diluted sputum from the bronchi.

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 the performance of respiratory gymnastics due to difficulty in withdrawing sputum; severe patients should perform aspiration of diluted sputum.

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 toxic epidermal necrolysis - in the initial stage of development of which an influenza-like condition may occur, with symptoms such as fever, body pain, rhinitis, cough, sore throat. With symptomatic treatment, it is possible to erroneously administer mucolytic agents, such as ambroxol hydrochloride.

There are isolated reports of the detection of Stevens-Johnson syndrome and toxic epidermal necrolysis, coinciding with the appointment of the drug. However, there is no causal relationship with taking the drug.

With the development of the above mentioned syndromes, it is recommended to stop treatment and immediately consult a doctor.

In connection with the presence in the sodium metabisulphite (preservative) may develop reactions of hypersensitivity (especially in patients with bronchial asthma),which are manifested in the form of vomiting, diarrhea, bronchospasm attacks, impaired consciousness or anaphylactic shock.

These reactions can occur very individually, as well as lead to life-threatening consequences.

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

Ambrohexal® does not adversely affect the ability to drive or operate machinery.

Form release / dosage:

Solution for ingestion and inhalation 7.5 mg / ml.

Packaging:

50 ml or 100 ml in a bottle of a dropper of dark glass (dropper in the form of a plastic dissector), with a plastic screw cap and a ring of the first opening. A bottle with a measuring cup of polypropylene in a cardboard box together with instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C, in a place protected from light.

Keep medicinal product out of the reach of children.

Shelf life:

4 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N012596 / 02

Date of registration:14.03.2008

Date of cancellation:2017-08-25

The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia

Manufacturer: & nbsp

LICHTENHELDT, GmbH Pharmazeutische Fabrik Germany

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp25.08.2017

Illustrated instructions

Instructions

Ambroghexal® (Ambrohexal®)