Ambrobene solution for oral administration and inhalation 7.5 mg/ml 40 ml
Pharmacological action Mucolytic and expectorant drug.
Ambroxol, an active metabolite of bromhexine, improves the rheological properties of sputum, reduces its viscosity and adhesive properties, facilitating its removal from the respiratory tract.
Ambroxol stimulates the activity of the serous cells of the bronchial lining glands, the production of enzymes that break down the bonds between sputum polysaccharides, the formation of surfactant and the direct activity of the bronchial cilia, preventing their adhesion.
After oral administration, the therapeutic effect occurs within 30 minutes and lasts for 6-12 hours (depending on the dose taken).
When administered parenterally, the effect of the drug occurs quickly and lasts for 6-10 hours.
Pharmacokinetics
Suction and distribution
When administered parenterally, ambroxol quickly penetrates into tissues. The highest concentration is found in the lungs. Cmax in blood plasma is achieved after 1-3 hours.
About 80% of the drug is bound to plasma proteins. Ambroxol penetrates the blood-brain barrier and the placental barrier and is excreted in breast milk.
Metabolism and excretion
The drug is metabolized in the liver by conjugation to form pharmacologically inactive metabolites.
About 90% of ambroxol is excreted in the urine: 90% of them in the form of metabolites and 10% unchanged.
Pharmacokinetics in special clinical situations
For severe liver diseases
Ambroxol clearance decreases by 20-40%.
For severe renal impairment
T1/2 of ambroxol and its metabolites increases.
Indications for the use of the drug AMBROBENE
All forms of the drug are used for diseases of the respiratory tract with the release of viscous sputum and difficulty in its discharge:
- acute and chronic bronchitis;
- pneumonia;
- bronchial asthma;
- bronchiectasis;
— as part of complex therapy to stimulate the synthesis of surfactant in respiratory distress syndrome in premature infants and newborns (solution for injection).
Dosage regimen
The drug should be taken orally after meals with a sufficient amount of liquid (a glass of water, tea or juice).
Tablets
: Adults and children over 12 years of age
are prescribed 1 tablet 3 times a day in the first 2-3 days. (90 mg/day). Subsequently, they switch to taking the drug twice a day, 1/2 tablet/day. (30 mg/day).
Children aged 6 to 12 years
in the first 2-3 days, 1/2 tablet is prescribed 2-3 times a day. (30-45 mg/day). Subsequently, they switch to taking the drug twice a day, 1/2 tablet/day. (30 mg/day).
Retard capsules
for adults and children over 12 years of age
are prescribed 1 capsule/day. (75 mg/day).
Syrup
should be taken using a measuring cup: 1 ml of syrup contains 3 mg of ambroxol.
Children under 2 years of age
Prescribe the drug 2.5 ml of syrup 2 times a day. (15 mg/day).
Children aged 2 to 6 years
prescribe the drug 2.5 ml of syrup 3 times a day. (22.5 mg/day).
Children aged 6 to 12 years
Prescribe the drug 5 ml of syrup 2-3 times a day. (30-45 mg/day).
Adults and children over 12 years of age
during the first days, 10 ml of syrup 3 times a day. (90 mg/day). Subsequently, 10 ml of syrup 2 times a day. (60 mg/day).
Ambrobene in syrup form is the most convenient dosage form for treating pediatric patients.
Solution for oral administration and inhalation
It should be taken orally using a measuring cup: 1 ml of solution contains 7.5 mg of ambroxol.
Children under 2 years of age
Prescribe the drug 1 ml of solution 2 times a day. (15 mg/day).
Children aged 2 to 6 years
Prescribe the drug 1 ml of solution 3 times a day. (22.5 mg/day).
Children aged 6 to 12 years
Prescribe the drug 2 ml of solution 2-3 times a day. (30-45 mg/day).
Adults and teenagers
in the first 2-3 days, 4 ml of solution is prescribed 3 times a day. (90 mg/day). In the following days - 4 ml 2 times a day. (60 mg/day).
When using Ambrobene in the form of inhalations
use any modern equipment (except steam inhalation). Before inhalation, the drug should be mixed with a 0.9% sodium chloride solution (for optimal air humidification it can be diluted in a ratio of 1:1) and heated to body temperature. Inhalations should be carried out in normal breathing mode so as not to provoke coughing shocks.
Patients with bronchial asthma should use bronchodilators before inhaling ambroxol to avoid nonspecific irritation of the respiratory tract and their spasm.
Children under 2 years of age
inhale 1 ml of solution 1-2 times a day. (7.5-15 mg/day).
Children aged 2 to 6 years
inhale 2 ml of solution 1-2 times a day. (15-30 mg/day).
Adults and children over 6 years of age
inhale 2-3 ml of solution 1-2 times a day. (15-45 mg/day).
Injection
should be administered intravenously (slow stream or drip). The solvent used is 0.9% sodium chloride solution, 5% dextrose solution, Ringer-Locke solution or other basic solution with a pH not higher than 6.3.
For children
The drug is usually prescribed in a daily dose of 1.2-1.6 mg/kg body weight.
Children under 2 years of age
prescribed 1 ml (1/2 amp.) 2 times/day. (15 mg/day).
Children aged 2 to 6 years
prescribed 1 ml (1/2 amp.) 3 times/day. (22.5 mg/day).
Children over 6 years of age
Prescribe 2 ml (1 amp.) 2-3 times/day. (30-45 mg/day).
For adults
prescribed 1 amp. 2-3 times/day. (30-45 mg/day). In severe cases, the dose can be increased to 2 amp. 2-3 times/day. (60-90 mg/day).
For respiratory distress syndrome in newborns and premature infants
The daily dose of the drug is 30 mg and, as a rule, is divided into 4 separate injections.
Injections are stopped after the disappearance of acute manifestations of the disease and switch to oral administration of other dosage forms of Ambrobene .
Treatment of children under 2 years of age
should only be carried out under the supervision of a physician.
Drinking plenty of fluids is recommended while using the drug.
The duration of treatment depends on the characteristics of the disease. It is not recommended to use the drug without medical prescription for more than 4-5 days.
Side effect
From the digestive system:
rarely - salivation, gastralgia, nausea, vomiting, diarrhea, constipation.
From 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, exanthema.
With rapid intravenous administration:
intense headaches, feeling of fatigue and heaviness in the legs, numbness, increased blood pressure, shortness of breath, hyperthermia, chills.
Contraindications to the use of the drug AMBROBENE
- peptic ulcer of the stomach and duodenum;
- epileptic syndrome;
- children under 6 years of age (for tablets, retard capsules, solution for injection);
- children under 12 years of age (for retard capsules);
- hypersensitivity to the components of the drug.
Carefully _
The drug should be used in case of impaired renal function and severe liver disease, reducing the dose and increasing the time between doses of the drug (treatment in such cases should be carried out under the supervision of a doctor).
With extreme caution
and only under the supervision of a physician should
Ambrobene in cases of impaired bronchial motility and large volumes of secreted secretions in order to avoid the danger of stagnation of secretions in the bronchi.
Use of the drug AMBROBENE during pregnancy and breastfeeding
Since to date there is no reliable data on the negative effects of ambroxol on the fetus and newborn, the use of Ambrobene during pregnancy, especially in the first trimester, and during breastfeeding is possible only if the expected benefit to the mother outweighs the potential risk to the fetus.
Use for liver dysfunction
Carefully _
The drug should be used for severe liver diseases, reducing the dose and increasing the time between doses of the drug (treatment in such cases should be carried out under the supervision of a doctor).
Use for impaired renal function
With caution
the drug should be used in case of impaired renal function, reducing the dose and increasing the time between doses of the drug (treatment in such cases should be carried out under the supervision of a doctor).
Special instructions
There are no special instructions for the drug.
Overdose
Ambroxol is well tolerated when taken orally at a dose of up to 25 mg/kg/day.
Symptoms:
increased salivation, nausea, vomiting, decreased blood pressure.
Treatment:
gastric lavage in the first 1-2 hours after taking the drug, taking fat-containing foods.
Hemodynamic parameters should be monitored. If necessary, symptomatic therapy should be carried out. Drug interactions
The simultaneous use of Ambrobene with drugs that have antitussive activity (for example, containing codeine) is not recommended due to the difficulty of removing phlegm from the bronchi while reducing cough.
The simultaneous use of Ambrobene with antibiotics (including amoxicillin, cefuroxime, erythromycin, doxycycline) improves the flow of antibiotics into the pulmonary tract. This interaction with doxycycline is widely used for therapeutic purposes.
Ambrobene mixture cannot be used for injection with solutions having a pH higher than 6.3.
Conditions for dispensing from pharmacies
The drug in the form of tablets, retard capsules, solution for oral administration and inhalation, syrup is approved for use as an over-the-counter product.
The drug in the form of an injection solution is available with a prescription.
Storage conditions and periods
Retard tablets and capsules should be stored out of the reach of children under normal conditions. Shelf life: 5 years.
The solution for oral administration and inhalation should be stored at a temperature not exceeding 25°C. Shelf life: 5 years.
The shelf life of the syrup is 4 years.
List B. Solution for injection should be stored under normal conditions. Shelf life: 4 years.
Pharmacological properties of the drug Ambrobene
Mucolytic drug. It has a bronchosecretolytic and secretomotor (expectorant) effect. Ambrobene normalizes impaired bronchopulmonary secretion, improves the rheological parameters of sputum, reduces its viscosity and facilitates discharge from the bronchi. After oral administration, Ambrobene is almost completely absorbed from the gastrointestinal tract. The action begins after 30 minutes and lasts for 6–12 hours. Metabolized in the liver. The half-life is 8–10 hours. About 90% of the drug is excreted in the urine.
How to drink Ambrobene for a child
It is difficult for children under three years of age to swallow tablets, and during the first two years of life it is not at all possible. Therefore, special dosage forms have been developed for young patients: syrup and solution for inhalation.
If a child’s body reacts to sugar with rashes, for example on the cheeks, using syrup is not recommended. In this case, it is better to give preference to a solution for preparing inhalation. It is safer to inhale volatile particles with medicine because they do not require systemic administration and do not contain sugars or other flavoring additives.
There is a type of inhalation solution that can be taken orally. It tastes unpleasant, but if you mix the drug with tea or any other drink, the child can drink it without noticing the medicine. It is important not to exceed the recommended dosage on the package allowed for each age category.
Is it possible to use Ambrobene for a wet cough?
Ambrobene solution is recommended to be taken only for dry, unproductive cough. If the cough is wet, there is no point in taking mucolytics and expectorants, since the body copes on its own, armed with local immunity. It is not difficult to provide yourself with a natural wet cough - just drink more than 2 liters of warm liquid per day and breathe moist air. You can bring air parameters back to normal through frequent and regular ventilation or using special air humidifiers.
Lazolvan or Ambrobene: which is better
Lazolvan is a drug with mucolytic and expectorant action. It is based on the same ambroxol as Ambrobene. Lazolvan is produced in the form of syrup. When choosing a medicine to improve sputum rheology, you can focus on both the price and the preferred form of release. Without the opportunity to use Lazolval for inhalation, you can choose Ambrobene. The drugs are identical and are complete analogues of each other. In pharmacies, the cost of Lazolvan is often almost twice as high as the price of Ambrobene.
Composition and release form
The drug is available in several dosage forms:
- syrup for oral administration;
- solution for nebulizers;
- pills;
- capsules;
- solution for injection (in medical institutions).
The tablets contain the main active ingredient – ambroxol, 0.3 g, as well as auxiliary components:
- lactose (Lactose monohydrate);
- corn starch (Maidis amylum);
- magnesium stearate (Magnesium stearate);
- silica.
The tablets have a score in the center. They are convex on both sides and white. Packaged in blisters, each containing 10 pcs. One cardboard package can contain several blisters: from 2 pcs. up to 5 pcs.
Capsules are a form with an increased duration of action, they contain 0.75 g of ambroxol, in addition:
- triethyl citrate;
- hypromellose;
- silicon dioxide
The capsule itself consists of gelatin, dyes and titanium dioxide. The part covering the capsule is painted brown. Inside there are white or yellowish granules. Capsules are packaged in blisters, 10 pcs. in everyone. There can be 1 or 2 blisters in 1 cardboard package.
100 ml of syrup contains a dose equal to 1 tablet - 0.3 g of ambroxol. Raspberry flavoring gives the clear liquid a pleasant aroma and taste. The bottle is made of dark glass, which protects the contents from sunlight, and is equipped with a nozzle that makes dosing easier. The syrup is supplied with a plastic measuring cup with marks on the body.
100 ml of solution for inhalation contains 0.75 g of ambroxol. The liquid is colorless and odorless. Packaged in glass bottles with a drip nozzle, which facilitates dosing when preparing solutions in a nebulizer. The packaging includes a plastic measuring cup with marks and a scale on the walls.
2 ml of solution for injection includes 0.15 g of ambroxol. Sold in ampoules, each with a volume of 2 ml, made of dark glass. 1 cardboard package contains 5 ampoules in 1 pallet.
Is it possible to mix Berodual with Ambrobene?
Berodual is a drug that primarily affects the bronchi. It is indicated for patients with bronchial asthma and patients suffering from bronchospasm of various etiologies. In combination with Ambrobene, the maximum effect of removing pathogenic sputum can be achieved. However, in each specific case, it is necessary to consult a specialist who, knowing the medical history, will answer whether the patient can combine Berodual with Ambrobene or not. In case of individual intolerance to the components, the opposite effect may develop, which will worsen the patient’s condition. For example, if Berodual relaxes the muscles of the bronchi so that the cough reflex is reduced, taking Ambrobene will be contraindicated.
Special instructions for the use of Ambrobene
In case of impaired renal function and/or severe liver disease, Ambrobene is taken under constant medical supervision. Use during pregnancy and lactation . Despite the lack of reliable data on the effect of ambroxol on the fetus and child, the use of ambroxol is possible only after a thorough analysis of the benefit/risk ratio. Before using Ambrobene, you should stop breastfeeding. There is no experience with the use of syrup in premature and newborn babies. For children under 2 years of age, the use of syrup is only possible under medical supervision. 5 ml of syrup contains 2.1 g of sorbitol (corresponding to 0.175 XE) and is a source of 0.53 g of fructose (the syrup should not be administered to patients with fructose intolerance).
Side effects
Forms of the drug intended for systemic treatment, involving oral administration, may lead to the following symptoms:
- allergic skin reactions such as itching, urticaria, swelling of tissues on the face;
- fever;
- headache;
- nausea;
- weakness;
- gastrointestinal disorders.
The inhalation solution rarely causes impaired taste perception, as well as abdominal pain and anaphylactic reactions.
Taking multiple drugs at the same time
Antibacterial therapy, supplemented with Ambrobene, increases the concentration of antibacterial substances in secreted sputum.
The simultaneous use of Ambrobene with antitussives is strictly contraindicated. The liquid sputum produced should immediately leave the lungs and bronchi, thanks to the cough reflex. By suppressing a cough with means such as Sinekod, the patient dooms himself to the development of pneumonia associated with stagnation of mucus from the lungs, where a favorable environment is formed for the proliferation of pathogenic bacteria.
