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

1 ml of syrup 3 mg / ml contains: active substance: ambroxol hydrochloride - 3.00 mg; Excipients: benzoic acid - 2.00 mg; sodium metabisulphite - 0.20 mg; citric acid monohydrate - 1.00 mg; sodium hydroxide - 0.92 mg; povidone - 25.00 mg; sorbitol 70% solution - 500.00 mg; glycerol 85% - 130.00 mg; sodium cyclamate - 4.00 mg; crimson flavoring - 2.00 mg; water purified to 1 ml - 473.58 mg.

Description:A syrupy transparent or almost transparent, colorless or slightly yellowish solution.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

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 surface-active substance (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 achieved in 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%. 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. The clearance of ambroxol in patients with severe hepatic insufficiency is reduced by 20-40%. In severe renal failure, the half-life of metabolites of ambroxol is increased. Ambroxol penetrates the placental barrier and into breast 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:

- Hypersensitivity to ambroxol or to any of the components of the drug;

- pregnancy (I trimester);

- Breastfeeding period

- intolerance to fructose.

Carefully:

Carefully the drug should be used in patients with peptic ulcer of the stomach and duodenum, as there may be an exacerbation of peptic ulcer, as well as in patients with renal and hepatic insufficiency, pregnancyII-III trimester).

Pregnancy and lactation:

The drug is contraindicated for use during the first trimester of pregnancy.

The 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. Ambroxol penetrates the placental barrier.

Animal studies have shown that the drug does not affect embryo-fetal development, childbirth and postnatal development. Extensive clinical studies after the 28th week of pregnancy showed no undesirable effects on the fetus.

Studies in animals have shown that ambroxol is excreted in breast milk, therefore, when taking Ambroghexal®, it is necessary to resolve the issue of stopping breastfeeding.

Preclinical studies showed no direct or indirect adverse effects on fertility.

Dosing and Administration:

Ambrohexal® should be taken orally after a meal. 1 measuring spoon of Ambrohexal® syrup (5 ml) contains 15 mg of ambroxol hydrochloride.

Adults and children over 12 years of age: 2 measuring spoons 2-3 times a day (60-90 mg ambroxol hydrochloride) in the first 2-3 days of administration, then 2 measuring spoons twice a day (60 mg ambroxol hydrochloride per day).

In severe cases, the dose is not reduced throughout the course of treatment. The maximum dose - 4 measuring spoons 2 times a day (120 mg of ambroxol hydrochloride per day).

Children from 5 to 12 years old: 1 scoop 2-3 times a day (30-45 mg ambroksol hydrochloride).

Children from 2 to 5 years: 1/2 teaspoonful 3 times a day (22.5 mg ambroxol hydrochloride).

Children under 2 years: 1/2 teaspoonful 2 times a day (15 mg ambroxol hydrochloride).

Children under 2 years of age Ambrohexal® are prescribed only under the supervision of a doctor.

During treatment it is necessary to use a lot of liquid (juices, tea, water) to enhance the mucolytic effect of the drug.

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 toThe undesirable effects of the World Health Organization (WHO) are classified according to their frequency of development as follows: very often (≥ 1/10), often (from ≥1 / 100 to <1/10), infrequently (from ≥1 / 1000 to < 1/100), rarely (from ≥1 / 10000 to <1/1000), very rarely (<1/10000); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

From the immune system:

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

From the gastrointestinal tract:

often: nausea, decreased sensitivity of the oral cavity and pharynx;

infrequently: heartburn, vomiting, diarrhea, indigestion and pain in the abdominal cavity, dry mouth.

From the nervous system:

often: a change in taste.

From the skin and subcutaneous tissues:

rarely: skin rash, hives;

frequency unknown: severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), and acute generalized exanthematous pustulosis).

Other:

frequency 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 to 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.

In the case of impaired bronchial motility and an increase in the amount of secretion (for example, a syndrome of immobile cilia), due to the danger of mucus accumulation, the drug can be taken only after consultation with the attending physician and with medical supervision.If the kidneys or liver function is severely impaired, lower concentrations should be used, or the interval between doses should be increased.

In patients with severe skin lesions - Stevens-Johnson syndrome or toxic epidermal necrolysis - an influenza-like condition may occur in the initial stage of development, with symptoms such as fever, body pain, rhinitis, cough and sore throat. In these situations, with symptomatic treatment, mistaken assignment of mucolytic agents, such as ambroxol hydrochloride, is possible. There are reports of the detection of multiform erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome) and acute generalized exanthematous pustules, coinciding with the appointment of the drug. Causal relationship with the drug is not established.

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

Patients with impaired renal function or with severe liver disease: application of Ambroghexal® is allowed only by prescription.

Guideline for patients with diabetes mellitus: 1 measuring spoon (5 ml of syrup) contains 2.525 g of sorbitol (0.21 XE).

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

Ambrohexal^® does not adversely affect the ability to drive or work with machinery.

Form release / dosage:Syrup 3 mg / ml.

Packaging:100 ml or 250 ml in a bottle of dark glass, equipped with a plastic dissector and a ring of the first opening. The bottle is complete with a measuring spoon in a cardboard box along with instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C in a dark place.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-007783/09

Date of registration:05.10.2009 / 23.07.2014

Expiration Date:Unlimited

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: & nbsp31.07.2017

Illustrated instructions

Instructions

Ambroghexal® (Ambrohexal®)