AMBROBENE ORAL SOLUTION 7.5MG/ML BOTTLE 40ML

Dosage form

Solution for oral administration and inhalation

Composition

1 ml of oral and inhalation solution contains:
Active ingredients
Ambroxol hydrochloride 7.5 mg.
Excipients
Potassium sorbate, hydrochloric acid, purified water.

Packing

In a bottle of dark glass 40 ml solution. In packing 1 bottle with a stopper-dropper complete with a measuring cup.

Mechanism of action

Ambrobene is a mucolytic and expectorant drug.
Ambroxol - the active metabolite of Bromhexine improves the rheological properties of sputum, reduces its viscosity and adhesive properties, contributing to its removal from the respiratory tract.
Ambroxol stimulates the activity of serous cells of the glands of the bronchial membrane, the production of enzymes that break down the bonds between sputum polysaccharides, the formation of surfactant and the activity of the cilia of the bronchi directly, preventing them from sticking together.
After ingestion, the therapeutic effect occurs after 30 minutes and lasts for 6-12 hours (depending on the dose taken).

Indications and usage

For diseases of the respiratory tract with the release of viscous sputum and the difficulty of its discharge:
Acute and chronic bronchitis.
Pneumonia.
Bronchial asthma.
Bronchiectasis.

Contraindications

Peptic ulcer and duodenal ulcer.
Epileptic syndrome.
Hypersensitivity to the drug.
With caution should use the drug in violation of kidney function and severe liver disease, reducing the dose and increasing the time between taking the drug (treatment in such cases should be carried out under medical supervision).
With extreme caution and only under the supervision of a physician, Ambrobene should be used in violation of the motility of the bronchi and large volumes of secreted secretion in order to avoid the danger of a congestion of the secretion in the bronchi.

Pregnancy and Breastfeeding

Since so far there are no reliable data on the negative effects of ambroxol on the fetus and newborn, it is possible to use Ambrobene during pregnancy, especially in the first trimester, and during breastfeeding only in the case when the intended benefit to the mother outweighs the potential risk to the fetus.

Dosage and administration

The drug should be taken orally after a meal with a sufficient amount of liquid (a glass of water, tea or juice).
Treatment of children under 2 years should be carried out only under the supervision of a physician.
Solution for oral administration and inhalation should be taken with a measuring cup: 1 ml of the solution contains 7.5 mg of ambroxol.
Children under the age of 2 years prescribed the drug in 1 ml of solution 2 times / day. (15 mg / day.).
Children aged 2 to 6 years, appoint the drug to 1 ml of solution 3 times / day. (22.5 mg / day.).
Children aged 6 to 12 years, appoint the drug to 2 ml of solution 2-3 times / day. (30-45 mg / day.).
In adults and adolescents in the first 2-3 days, 4 ml of the solution is prescribed 3 times / day. (90 mg / day.). In the following days - 4 ml 2 times / day. (60 mg / day.).
When using Ambrobene in the form of inhalation, any modern equipment is used (except steam inhalation). Before inhalation, the drug should be mixed with a 0.9% solution of sodium chloride (for optimal moistening of the air can be diluted in a 1: 1 ratio) and heated to body temperature. Inhalation should be carried out in the mode of normal breathing, so as not to provoke cough tremors.
In patients with bronchial asthma, in order to avoid non-specific irritation of the respiratory tract and their spasm, bronchodilators should be used before inhalation of ambroxol.
Children under the age of 2 years inhale 1 ml of solution 1-2 times / day. (7.5-15 mg / day.).
In children aged 2 to 6 years old, 2 ml of the solution is injected 1-2 ml / day. (15-30 mg / day.).
Adults and children over the age of 6 years are inhaled with 2-3 ml of solution 1-2 times / day. (15-45 mg / day.).
During the use of the drug is recommended to drink plenty of water.
The duration of treatment depends on the characteristics of the course of the disease. It is not recommended to use the drug without medical prescription for more than 4-5 days.

Adverse reactions

From the digestive system
Rarely - salivation, gastralgia, nausea, vomiting, diarrhea, constipation.
On the part of the respiratory system
Rarely - dry mouth and respiratory tract, rhinorrhea.
Allergic reactions
Very rarely - skin rash, angioedema of the face, respiratory failure, temperature reaction with chills; in some cases - contact dermatitis, anaphylactic shock.
Other
Weakness, headache, dysuria, rash.

Special notes

Specific instructions for the drug is not provided.
Application for violations of the liver
The drug should be used with caution in severe liver diseases, reducing the dose and increasing the time between taking the drug (treatment in such cases should be carried out under medical supervision).
Application for violations of kidney function
With caution should use the drug in violation of kidney function, reducing the dose and increasing the time between doses of the drug (treatment in such cases should be carried out under medical supervision).

Drug interactions

The simultaneous use of Ambrobene with drugs that have antitussive activity (for example, containing codeine) is not recommended because of the difficulty of removing sputum from the bronchi against the background of a decrease in cough.
The simultaneous use of Ambrobene with antibiotics (including Amoxicillin, cefuroxime, Erythromycin, doxycycline) improves the flow of antibiotics into the pulmonary route. This interaction with Doxycycline is widely used for therapeutic purposes.

Overdosage

Ambroxol is well tolerated when taken orally at a dose of up to 25 mg / kg / day.
Symptoms: increased saliva, nausea, vomiting, decreased blood pressure.
Treatment: gastric lavage in the first 1-2 hours after taking the drug, taking fat-containing products. Hemodynamic parameters should be monitored. If necessary, symptomatic therapy should be carried out.

The drug should be stored at a temperature not higher than 25 ° C.

Ambrobene