Ambrobene injection solution 15mg, 2 ml No. 5

Ambrobene - solution for injection is used for diseases of the respiratory tract with the release of viscous sputum and with difficulty in sputum discharge in cases where it is necessary to obtain a quick therapeutic effect or it is impossible to take the drug inside:

• acute and chronic bronchitis, pneumonia;

• bronchial asthma;

• bronchiectasis.

• stimulation of surfactant synthesis in respiratory distress syndrome in premature infants and newborns (as part of complex therapy).

Ambrobene injection solution is administered intravenously (slowly by stream or drip). The solvent used is 0.9% sodium chloride solution, 5% dextrose solution, Ringer-Locke's solution or other basic solution with a pH not higher than 6.3. Adults are usually prescribed one ampoule 2-3 times a day (30-45 mg), in severe cases, the dose can be increased: 2 ampoules 2-3 times a day (60-90 mg). For children, the drug is prescribed in a daily dose at the rate of 0.0012-0.0016 g per 1 kg of body weight.

Usually, children under 2 years of age are prescribed 1 ml (1/2 ampoule) 2 times a day (15 mg / day); children from 2 to 6 years old - 1 ml (1/2 ampoule) 3 times (22.5 mg / day); children over 6 years old - 2 ml (1 ampoule) 2-3 times (30-45 mg / day).

For respiratory distress syndrome in newborns and premature infants: the daily dose of Ambrobene is 30 mg, which is usually divided into 4 separate injections.

Injections are stopped after the disappearance of acute manifestations of the disease and are switched to the ingestion of other dosage forms of Ambrobene.

The duration of treatment is determined by the attending physician.

2 ml of injection solution contains:
Active ingredient:
ambroxol hydrochloride 15.0 mg
Excipients:
citric acid monohydrate, sodium chloride, disodium monohydrogen phosphate heptahydrate, water for injection.

Absolute contraindications:

• hypersensitivity to ambroxol and / or other components of the finished dosage form;

• peptic ulcer of the stomach and duodenum;

• epileptic syndrome.

Relative contraindications:
If the functional capacity of the kidneys is limited and / or in severe liver diseases, Ambrobene should be used with extreme caution, reducing the dose used and increasing the time between doses of the drug (usually in these cases, treatment is carried out under the supervision of a physician).

With extreme caution and only under the supervision of a physician, Ambrobene should also be used in cases of impaired motility of the bronchi and with large volumes of secreted secretions (the risk of stagnation of secretions in the bronchi).

APPLICATION DURING PREGNANCY AND DURING BREASTFEEDING:

Despite the fact that until now there is no reliable data on the negative effect of ambroxol on the fetus and infants, Ambrobene can be used during pregnancy, especially in the first trimester, and during lactation only after a careful analysis of the benefit / risk ratio by the attending physician.

Trade name of the drug: Ambrobene

International Non-Proprietary Name (INN): Ambroxol

Dosage form:

injection

Description of the dosage form: transparent, colorless to slightly yellowish solution in 2 ml brown glass ampoules.

Composition:

2 ml of injection solution contains:
Active ingredient:
ambroxol hydrochloride 15.0 mg
Excipients:
citric acid monohydrate, sodium chloride, disodium monohydrogen phosphate heptahydrate, water for injection.

Pharmacotherapeutic group:

mucolytic agent. ATC code: R05CB06.

Pharmacological action:
Ambroxol (active metabolite of bromhexine) is a mucolytic drug that improves the rheological properties of sputum, reduces its viscosity and adhesive properties, which promotes its excretion 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 a surfactant and directly the activity of the bronchial cilia, preventing them from sticking together.

With parenteral administration, the action occurs quickly and lasts for 6-10 hours.

Pharmacokinetics:
When administered parenterally, Ambroxol rapidly penetrates into tissues. The highest concentration is found in the lungs. Plasma proteins bind about 80% of the drug.

Ambroxol crosses the blood-brain and placental barriers, is excreted in breast milk. The maximum concentration in blood plasma is reached after 1-3 hours, T 1/2 in plasma fluctuates within 7-12 hours, and the total T 1/2 in plasma (ambroxol and its metabolites) reaches 22 hours.

The drug is metabolized in the liver by conjugation to form pharmacologically inactive metabolites. About 90% of ambroxol is excreted by the kidneys: 90% as metabolites and 10% unchanged.

In severe liver diseases, the clearance of ambroxol decreases by 20-40%, in severe renal dysfunction, the half-life of ambroxol and its metabolites increases.

Indications for use:

Ambrobene - solution for injection is used for diseases of the respiratory tract with the release of viscous sputum and with difficulty in sputum discharge in cases where it is necessary to obtain a quick therapeutic effect or it is impossible to take the drug inside:

• acute and chronic bronchitis, pneumonia;

• bronchial asthma;

• bronchiectasis.

• stimulation of surfactant synthesis in respiratory distress syndrome in premature infants and newborns (as part of complex therapy).

Contraindications:

Absolute contraindications:

• hypersensitivity to ambroxol and / or other components of the finished dosage form;

• peptic ulcer of the stomach and duodenum;

• epileptic syndrome.

Relative contraindications:
If the functional capacity of the kidneys is limited and / or in severe liver diseases, Ambrobene should be used with extreme caution, reducing the dose used and increasing the time between doses of the drug (usually in these cases, treatment is carried out under the supervision of a physician).

With extreme caution and only under the supervision of a physician, Ambrobene should also be used in cases of impaired motility of the bronchi and with large volumes of secreted secretions (the risk of stagnation of secretions in the bronchi).

APPLICATION DURING PREGNANCY AND DURING BREASTFEEDING:

Despite the fact that until now there is no reliable data on the negative effect of ambroxol on the fetus and infants, Ambrobene can be used during pregnancy, especially in the first trimester, and during lactation only after a careful analysis of the benefit / risk ratio by the attending physician.

Method of administration and dosage:

Ambrobene injection solution is administered intravenously (slowly by stream or drip). The solvent used is 0.9% sodium chloride solution, 5% dextrose solution, Ringer-Locke's solution or other basic solution with a pH not higher than 6.3. Adults are usually prescribed one ampoule 2-3 times a day (30-45 mg), in severe cases, the dose can be increased: 2 ampoules 2-3 times a day (60-90 mg). For children, the drug is prescribed in a daily dose at the rate of 0.0012-0.0016 g per 1 kg of body weight.

Usually, children under 2 years of age are prescribed 1 ml (1/2 ampoule) 2 times a day (15 mg / day); children from 2 to 6 years old - 1 ml (1/2 ampoule) 3 times (22.5 mg / day); children over 6 years old - 2 ml (1 ampoule) 2-3 times (30-45 mg / day).

For respiratory distress syndrome in newborns and premature infants: the daily dose of Ambrobene is 30 mg, which is usually divided into 4 separate injections.

Injections are stopped after the disappearance of acute manifestations of the disease and are switched to the ingestion of other dosage forms of Ambrobene.

The duration of treatment is determined by the attending physician.

Side effects:

Occasionally, weakness, headache, dry mouth and respiratory tract, salivation, rhinorrhea, gastralgia, nausea, vomiting, diarrhea, constipation, dysuria, exanthema may occur.

In very rare cases, allergic reactions may occur (skin rash, angioedema of the face, respiratory failure, temperature reaction with chills). There is a report that in some cases allergic contact dermatitis was observed, and in one case the occurrence of anaphylactic shock was observed.With rapid intravenous administration, intense headaches, a feeling of fatigue and heaviness in the legs, numbness, blood pressure, shortness of breath, hyperthermia, chills can be provoked ...

Interaction with other medicinal products:

Simultaneous use with drugs with antitussive activity (for example, containing codeine) is not recommended due to the difficulty in removing sputum from the bronchi against the background of a decrease in cough.

Simultaneous administration with antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) improves the flow of antibiotics into the pulmonary tract. This interaction with doxycycline is widely used for therapeutic purposes.

Cannot be used for injection of a mixture of Ambrobene with solutions having a pH above 6.3.

Overdose:

Symptoms: increased salivation, nausea, vomiting, decreased blood pressure.
Treatment: it is necessary to monitor hemodynamic parameters and conduct, if necessary, symptomatic therapy.

Release form:

Ampoules of brown glass containing 2 ml of injection solution are placed in a plastic bed, 5 pieces each; 1 plastic tray with consumer information in a cardboard box.

Storage conditions:

Store under normal conditions (List B).
Keep out of the reach of children!

Shelf life:

4 years.
Do not use after the expiration date!

Terms of dispensing from pharmacies:

Dispensed by prescription.

Distributor: 'ratiopharm GmbH', Germany

Manufacturer:

103001 Moscow, 'Merkle GmbH', Germany