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.
Ambrobene solution for oral administration and inhalation 7.5 mg/ml, 100 ml
Registration Certificate Holder
Teva Pharmaceutical Industries (Israel)
Dosage form
Medicine - Ambrobene
Description
Solution for oral administration and inhalation
transparent, colorless to light yellow with a brown tint, odorless.
1 ml
ambroxol hydrochloride 7.5 mg
Excipients
: potassium sorbate - 1 mg, hydrochloric acid - 0.6 mg, purified water - 991.9 mg.
40 ml - dark glass bottles with a dropper stopper (1) complete with a measuring cup - cardboard boxes. 100 ml - dark glass bottles with a dropper stopper (1) complete with a measuring cup - cardboard boxes.
Indications
Injection
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 orally:
- acute and chronic bronchitis;
- pneumonia;
- bronchial asthma;
- bronchiectasis;
- stimulation of surfactant synthesis during respiratory distress syndrome in premature infants and newborns (as part of complex therapy).
The solution for oral administration and inhalation
is used for diseases of the respiratory tract with the production of viscous sputum and difficulty in sputum discharge:
- acute and chronic bronchitis;
- pneumonia;
- bronchial asthma;
- bronchiectasis.
Contraindications for use
- peptic ulcer of the stomach and duodenum;
- epileptic syndrome;
- hypersensitivity to ambroxol and/or other components of the drug.
with caution
in case of impaired renal function and/or 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 physician).
With extreme caution
and only under the supervision of a physician should Ambrobene be used 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.
pharmachologic effect
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.
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 sputum 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.
Dosage regimen
Solution for oral administration and inhalation
taken orally after meals with a sufficient amount of liquid (water, juice, tea) 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
the drug is prescribed 1 ml of solution 3 times/day (22.5 mg/day).
Children aged 6 to 12 years
prescribe the drug 2 ml of solution 2-3 times/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 / 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/day (7.5-15 mg/day).
Children aged 2 to 6 years
inhale 2 ml of solution 1-2 times/day (15-30 mg/day).
Adults and children over 6 years of age
inhale 2-3 ml of solution 1-2 times/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 switched 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.
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.
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; One case of anaphylactic shock was recorded. 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.
Storage conditions
The solution for oral administration and inhalation should be stored at a temperature not exceeding 25°C.
Best before date
Shelf life: 5 years.
The solution for injection should be stored under normal conditions. Shelf life: 4 years.
Use during pregnancy and breastfeeding
Restrictions during pregnancy - With caution. Restrictions when breastfeeding - With caution. 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 only possible if there is an expected benefit for the mother outweighs the potential risk to the fetus.
Use for renal impairment
Restrictions for impaired renal function - With caution.
Carefully _
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).
Use for liver dysfunction
Restrictions for liver dysfunction - With caution.
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 in children
Restrictions for children - With caution.
The drug in the form of tablets and injection solution is contraindicated for use in children under 6 years of age. The drug in the form of retard capsules is contraindicated for use in children under 12 years of age.
Treatment
of children under 2 years of age
should be carried out only under the supervision of a physician.
Terms of sale
The drug in the form of a solution for oral administration and inhalation is approved for use as an over-the-counter product.
The drug in the form of an injection solution is available with a prescription.
Contacts for inquiries
TEVA (Israel)
Teva LLC
115054 Moscow Valovaya st. 35 Business Tel.
Contraindications
Allergic reactions or intolerance to any component of the drug are grounds for refusing therapy and prescribing an alternative remedy.
Tablets are not prescribed to people with:
- lactase deficiency;
- hypolactasia;
- children under 6 years old.
Due to the fact that Ambrobene syrup has a sweet taste, it is not prescribed to patients with:
- fructose intolerance;
- malabsorption of glucose, galactose, sucrose, isomaltose.
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.
Carefully
Patients with congenital syndrome of slow-moving cilia of the respiratory tract epithelium should take the drug strictly under the supervision of medical personnel. This is explained by the significantly reduced activity of the receptors responsible for the cough reflex, which makes it impossible to timely remove rapidly produced mucus, leading to complications.
Tablets, capsules and syrup are not prescribed to patients with acute gastric or duodenal ulcers.
People with reduced kidney and liver function during treatment should be under the supervision of specialists who are ready to provide timely assistance if necessary.
Ambrobene - solution for inhalation for cough
Ambrobene is based on the substance ambroxol. It is a mucolytic and at the same time has an expectorant effect. It is reasonable to use Ambroxol in the form of a solution, syrup or tablets for dry cough. Any respiratory disease accompanied by inflammation of the mucous membranes of the respiratory tract will be accompanied by a cough. If it is dry, the inflammation only intensifies. For recovery, it is necessary that the mucous membranes of the affected respiratory tract produce a sufficient amount of mucus. When it leaves the body with a cough, it removes all pathogenic microorganisms, speeding up the healing process.
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.
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.
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.
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.
How much Ambrobene to add to the inhaler
For inhalations, the calculations proposed for each age group are used:
- children under two years old are advised to add 1 ml of solution;
- for patients from 2 to 6 years old, increase the single dose to 2 ml;
- children over 6 years old are given 2.5 ml up to 12 years of age;
- Patients over 12 years of age add 3 ml of the drug to the inhaler.
In addition to Ambrobene, a physiological solution, which is sodium chloride, is poured into the nebulizer container. If you don’t have saline solution in its original packaging at home, you can prepare it yourself by dissolving a teaspoon of salt in a liter of clean water.
How the drug works
This drug helps with coughs with sputum that is difficult to clear. After all, it has a mucoltic and expectorant effect. Ambroxol, which is in the drug, is an analogue of bromhexine. The active substance is able to increase the mucous volume of the bronchi and easily remove phlegm.
In addition, the drug has an antioxidant effect. When taken together with antibiotics (macrolides, penicillins), Ambroxol increases their secretion in the bronchi.
Entering the digestive tract, the drug immediately begins to act. After about an hour, it is completely absorbed into the blood. Then it enters the bronchi and lungs, facilitating breathing, diluting mucus and quickly removing it from there.
It is excreted by the kidneys after about eleven hours. The drug also passes through the placenta and into breast milk. This should be taken into account by pregnant and nursing mothers. The therapeutic effect of the drug begins within half an hour and lasts from six to twelve hours, depending on the type.
How long can you drink Ambrobene?
Treatment of respiratory infections with Ambrobene can be continued for no longer than 5 days. This is justified by the fact that during this time viral infections cease their pathogenic effect, the body manages to form a reliable army of antibodies and produce a large amount of interferon, due to which the patient’s condition returns to normal. The persistence of symptoms after the 5th day of treatment indicates that the disease was caused by bacteria, so you need to consult a specialist to prescribe an antibiotic.
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.
Ambrobene 1 ml: how many drops?
Each package of solution for the preparation of inhalations has a glass bottle equipped with a dropper and a measuring cup. By turning the bottle over, you can accurately measure the required number of milliliters. 1 ml of Ambrobene contains 10-12 drops. It is important to consider not only the amount of the drug, but also to maintain the concentration when preparing a solution for the nebulizer. You must first pour 4 ml of saline solution into the device’s container, then add 1 to 3 ml of Ambrobene, depending on the age of the patient.
