Ambrobene solution for oral administration and inhalation. Ambrobene use for children, instructions for use (solution for inhalation, for oral administration). Release form, composition and packaging
Instructions for medical use
medicine
Ambrobene ®
Tradename
Ambrobene ®
International nonproprietary name
Ambroxol
Dosage form
Solution 7.5 mg/ml, 40 and 100 ml
Compound
100 ml of solution contains
active substance: ambroxol hydrochloride 0.7500 g,
Excipients: potassium sorbate, hydrochloric acid 25% (for pH correction), water for injection
Description
A clear, colorless to slightly yellowish-brown solution.
Pharmacotherapeutic group
Expectorants. Mucolytics.
ATC code R05CB06
pharmachologic effect
Pharmacokinetics
After oral administration, Ambroxol is almost completely absorbed from the gastrointestinal tract. The maximum concentration in the blood plasma of the drug occurs after 1-3 hours. Binding to blood plasma proteins is about 85%. The half-life is approximately 22 hours. Excretion occurs through the kidneys 90% in the form of metabolites and 10% in the form of unchanged ambroxol.
Pharmacodynamics
Ambrobene ® normalizes altered bronchopulmonary secretion, improves the rheological parameters of sputum, reducing its viscosity, and facilitates the removal of sputum from the bronchi. Ambrobene ® promotes the activation of the surfactant system through a direct effect on type 2 pneumocytes in the alveoli and Clara cells, stimulates the formation and excretion of surface active material (surfactant) in the alveolar and bronchial region of the embryonic and adult lungs. In addition, the antioxidant effects of ambroxol have been established. After using Ambrobene ®, the concentration of antibiotics in sputum and bronchial secretions increases.
Indications for use
Ambrobene ® is used for the purpose of secretolytic therapy for acute and chronic bronchopulmonary diseases in which the secretion and expectoration of sputum is impaired:
Acute and chronic bronchitis, pneumonia
Bronchial asthma with difficulty in sputum discharge
Bronchiectasis.
Directions for use and doses
Ambrobene ® solution for oral administration and inhalation is dosed using the supplied dosage cup.
ORALLY (taken after meals with a sufficient amount of warm liquid, for example, tea or broth):
Adults and children over 12 years of age: in the first 2-3 days, 4 ml 3 times a day, then 4 ml 2 times or 2 ml 3 times a day.
Children from 6 to 12 years: 2 ml 2-3 times a day.
Children from 2-5 years: 1 ml 3 times a day.
Children under 2 years: 1 ml 2 times a day
INHALATION: the solution is inhaled using an inhaler.
Children under 2 years of age: 1 ml 1-2 inhalations per day.
Adults and children over 5 years of age: 2-3 ml, 1-2 inhalations per day.
The duration of treatment depends on the characteristics of the disease. It is not recommended to use Ambrobene ® without medical prescription for more than 4-5 days.
Side effects
Rarely
Dry mouth, gastralgia, nausea, vomiting
Weakness, headache
Hypersensitivity reactions (skin rash, facial swelling, dyspnea, itching)
Very rarely
Allergic reactions, including anaphylactic shock.
Contraindications
Hypersensitivity to ambroxol and/or other components of the drug
I trimester of pregnancy
Phenylketonuria
Peptic ulcer of the stomach and duodenum
Drug interactions
With the simultaneous use of Ambrobene ® and antitussive drugs, it may be difficult to remove mucus from the bronchi due to a decrease in the cough reflex.
special instructions
If the functional capacity of the kidneys is limited and/or with severe liver diseases, Ambrobene ® should be used with extreme caution, reducing the dose used and increasing the time between doses of the drug.
Pregnancy and lactation
There is no reliable data on the negative effect of Ambrobene ® on the fetus and infants; the use of the drug in the second and third trimesters of pregnancy and during lactation is possible only after a thorough analysis of the benefit/risk ratio by the attending physician.
Features of the influence on the ability to drive a vehicle or potentially dangerous mechanisms
Does not affect the ability to drive a vehicle or operate potentially dangerous machinery.
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.
Indications for use of the drug Ambrobene
Acute and chronic bronchitis, pneumonia, asthma with difficult sputum discharge, bronchiectasis.
Use of the drug Ambrobene
The drug is taken after meals; tablets, capsules are washed down with a sufficient amount of warm liquid (tea, broth).
Pills adults and children over 12 years of age are prescribed 1 tablet 3 times a day in the first 2-3 days, then 1 tablet 2 times a day or 1/2 tablet 3 times a day. Children aged 6 to 12 years are usually prescribed 1/2 tablet 2-3 times a day.
Retard capsules prescribed for adults and children over 12 years of age, 1 capsule daily.
Solution for oral administration and inhalation dose using the supplied dosing cup. Adults are prescribed orally in the first 2-3 days, 4 ml 3 times a day, then 4 ml 2 times or 2 ml 3 times a day. Children under 2 years of age are prescribed 1 ml 2 times a day; from 2 to 5 years - 1 ml 3 times a day; from 5 to 12 years - 2 ml 2-3 times a day. When performing inhalations, the solution is inhaled using an inhaler. Adults and children over 5 years of age are prescribed 1-2 inhalations per day, 2-3 ml; children under 5 years of age - 1-2 inhalations per day, 2 ml.
Syrup prescribed for adults in the first 2-3 days, 10 ml 3 times a day; then 10 ml 2 times or 5 ml 3 times a day. Children under 2 years of age (except newborns and premature infants) are prescribed 2.5 ml 2 times a day; from 2 to 5 years - 2.5 ml 3 times a day; from 5 to 12 years - 5 ml 2-3 times a day.
The duration of treatment with Ambrobene depends on the characteristics of the disease. The doctor decides on using the drug for longer than 4-5 days.
Contraindications to the use of the drug Ambrobene
Hypersensitivity to ambroxol or any other component of the drug, peptic ulcer of the stomach and duodenum, first trimester of pregnancy, breastfeeding, age up to 6 years (tablets), age up to 12 years (capsules).
Side effects of the drug Ambrobene
Rarely - general weakness, dyspepsia (stomach pain, diarrhea, nausea, vomiting), dysuria, rhinorrhea. In isolated cases - allergic reactions. There are reports of allergic contact dermatitis and anaphylactic reactions, but a clear connection with the use of ambroxol has not been established.
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).
Interactions of the drug Ambrobene
The simultaneous use of Ambrobene with antitussive drugs (for example, codeine) is not recommended due to the difficulty of sputum discharge from the bronchi when the cough reflex is suppressed.
The simultaneous use of Ambrobene with antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline) helps to increase their concentration in the lung tissue.
Ambrobene drug overdose, symptoms and treatment
Possible decrease in blood pressure, hypersalivation, nausea, vomiting. Treatment: symptomatic therapy, gastric lavage.
Storage conditions for the drug Ambrobene
Syrup, solution for oral use at temperatures up to 25 °C, tablets, capsules - at temperatures up to 30 °C.
List of pharmacies where you can buy Ambrobene:
- Saint Petersburg
A dry cough makes it difficult for a child to breathe and signals an inflammatory process. It is difficult to treat, since it does not lead to the discharge of sputum from the bronchi. To speed up recovery, it is necessary to provoke the release of mucus. Ambrobene cough syrup was created especially for this purpose. It quickly thins mucus, removes it from the lungs and removes the unpleasant symptoms of a dry cough.
Composition of the medicine
Ambrobene syrup with raspberry flavor can be used to treat children over one month old. This is a clear, slightly yellowish solution with expectorant properties. They are provided by ambroxol hydrochloride 0.30 g and auxiliary components:
- liquid sorbitol 70%;
- raspberry flavoring;
- propylene glycol;
- saccharin;
- water that has gone through several stages of purification.
The effectiveness of the drug is clinically proven and is due to ambroxol hydrochloride. This mucolytic stimulates the production of sputum, therefore it is in demand in the pharmaceutical industry. It is produced by synthesizing bromhexine and is used to create various drugs for dry cough.
Effect of the drug
Once inside, the active substances of the drug quickly penetrate into the blood and begin to act on serous cells, causing them to produce liquid secretions. At the same time, there is a positive effect on the cilia located on the inner surface of the bronchi. This forces them to carry out active oscillatory movements, bringing the accumulation of mucus out. Within half an hour after taking the syrup, it is easier for the child to cough.
Important! "Ambrobene" provides a persistent local anesthetic effect and reduces inflammation in the bronchi.
- Positive dynamics last from 6-12 hours.
- The highest concentration of the active substance is observed in plasma 1-3 hours after administration.
- The main part of the drug is excreted in the urine during the day.
Children's medicine "Ambrobene" comes in different forms. It can be purchased in tablets, capsules, inhalation injections and special drops for newborns. What form of release to use for treatment can only be decided by a pediatrician, having assessed the general condition of the child. For children older than one year, Ambrobene is most often prescribed in the form of syrup.
Indications for use
The drug is recommended for children suffering from dry cough. It is considered the most dangerous and debilitating for a child. Poor sputum discharge leads to bouts of barking cough at night, poor appetite, nervousness and moodiness.
"Ambrobene" significantly alleviates the condition of children with the following diseases:
- laryngitis;
- tracheitis;
- laryngotracheitis;
- pharyngitis;
- laryngopharyngitis.
As prescribed by a doctor, the syrup can be used for any inflammatory processes in the larynx, trachea and bronchi, accompanied by a dry cough. It speeds up recovery in acute and chronic bronchitis, and is effective in pneumonia, especially in combination with antibiotics.
Premature babies are given syrup if necessary under the strict supervision of a neonatologist. The active substance of the drug enhances the production of surfactant, a special substance necessary for the normal functioning of the lungs.
Side effects
Children's syrup has a powerful healing effect, so it should not be used uncontrolled. It is necessary to scrupulously follow the dosage prescribed by the doctor. It is selected individually for each baby and may differ from what is written in the instructions for use.
In case of overdose, undesirable effects may occur:
- nausea;
- stomach upset;
- vomit;
- dry mouth;
- loss of taste;
- skin rash, watery eyes;
- stomach ache.
Important! An overdose of Ambrobene excites the nervous system, disrupts bowel movements and lowers blood pressure. If a child drinks more than 25 mg of syrup per 1 kg of weight per day, stop treatment with the drug and immediately seek medical help.
Contraindications
"Ambrobene" - cough syrup for children - has contraindications for use. Their descriptions must be carefully studied. It is prohibited to take it if you experience:
- individual intolerance to the active substance of the drug;
- lack of sucrose in the body;
- fructose intolerance;
- stomach ulcer and other gastrointestinal pathologies;
- liver and kidney diseases;
- violation of the secretory function of the respiratory tract.
For bronchial asthma, the drug is prescribed with caution and taken only under the constant supervision of a doctor. Since the medicine contains sucrose, it may be contraindicated in diabetics.
How to use?
The medicine is dispensed at the pharmacy without a prescription. If the pediatrician has not prescribed an individual treatment regimen, you must adhere to the recommendations written in the instructions for use.
- From 2 to 6 years old, 2.5 ml of syrup should be taken three times a day.
- From 6 to 12 years - 5 ml of syrup three times a day.
- Children over 12 years of age and adults require 10 ml of syrup three times a day in the first three days of treatment. Starting from the fourth day, the dosage is reduced to 2 times a day.
Children under 2 years of age can only be given the drug according to an individual pediatrician’s regimen:
- Each package contains a plastic cup. It makes it convenient to measure liquid. Half a glass corresponds to 2 ml of product.
- The drug is taken after meals with clean water. This helps to thin the mucus and remove accumulated secretions.
- The course of therapy lasts from 5 to 7 days.
Ambrobene should be used in combination with other medications, since it alone is not able to eliminate the main cause of the disease and completely eliminate the inflammatory process in the lungs.
If no noticeable improvement is observed within several days of treatment, you should consult your pediatrician to adjust the syrup intake regimen.
Interaction with other drugs
The instructions for use of Ambrobene syrup for children state that it is not advisable to combine treatment with the drug with other antitussives. This can lead to suppression of the cough reflex and cause stagnation of phlegm in the bronchi.
The syrup should not be taken to eliminate a wet cough and should not be taken together with drugs that impede the passage of sputum.
If Ambrobene treatment is combined with erythromycin, amoxicillin, doxycycline, cefuroxime, the concentration of antibiotics in bronchial secretions increases.
Syrup storage
The drug "Ambrobene" is suitable for treating not only children, but also adults. It comes in a dark glass bottle with a capacity of 100 ml. The product goes on sale in a light pink cardboard box with the original manufacturer’s logo. Inside, in addition to the medicine, there is a detailed annotation and a measuring cup.
Each bottle has an expiration date engraved on it. It is 5 years from the date of manufacture. An opened bottle can be used for a year, provided that it is stored tightly closed with a lid in a cool, dark place.
Keep away from children!
Important! Never leave medicine on the table. Most often, an overdose occurs due to the fault of careless parents. Children, seeing a tempting bottle with tasty contents, can unscrew the cap in a matter of seconds, swallow half the bottle of syrup and get poisoned.
When buying medicine at a pharmacy, specify that you need syrup. Some parents have little understanding of the various dosage forms and acquire a solution with a bitter aftertaste, which is not advisable for small children. This solution is useful for inhalation with a nebulizer. The procedures remove phlegm well, dull coughing attacks and make breathing easier. They can be done for children only with the permission of a doctor.
Price and analogues
"Ambrobene" for cough is easy to buy in every pharmacy. Its price is low. On average across the country it varies from 130 to 180 rubles. In some pharmacy chains the cost is somewhat inflated and reaches 250 rubles.
There are many analogues on sale, produced on the basis of ambroxol hydrochloride, the active substance of Ambrobene. They all have a similar effect on the baby’s body and differ from each other in auxiliary components and price. 
The most famous drugs:
- "Flavamed"
- "Ambroxol".
- "AmbroHEXAL".
- "Ambrolan."
- "Bronchorus".
- "Ambroxol Vramed".
Separately, it is worth mentioning “Lazolvan”, a popular analogue of “Ambrobene”. Released in syrup form, the drug has a pleasant multi-fruit aroma that children like. It helps to get rid of a dry, debilitating cough and relieves spasms in bronchial asthma. The main difference between drugs is cost. "Lazolvan" is sold at a higher price. The minimum price at which it can be purchased is 250 rubles.
Video
One tablet contains
active substance: ambroxol hydrochloride 60.0 mg,
excipients: lactose monohydrate, corn starch, magnesium stearate, colloidal anhydrous silica.
Description
The tablets are white, round, with a biconvex surface, with a cross-shaped score on one side.
Pharmacotherapeutic group
Expectorants. Mucolytics. Ambroxol.
ATX code R05CB 06
Pharmacological properties
Pharmacokinetics
Suction. Absorption is high and almost complete, linearly dependent on the therapeutic dose. Maximum plasma concentration is achieved within 1 - 2.5 hours. Absolute bioavailability – 79%.
Distribution. Distribution is rapid and widespread, with highest concentrations in lung tissue. Distribution volume approximately 552 l. The binding to plasma proteins is approximately 90%.
Metabolism and excretion. Approximately 30% of an ingested dose undergoes a first-pass effect through the liver.
CYP3A4 is the main enzyme responsible for the metabolism of ambroxol, under the influence of which conjugates are formed, mainly in the liver.
The half-life is 10 hours. Total clearance: within 660 ml/min, renal clearance accounts for 83% of the total clearance. Excreted by the kidneys: 26% in the form of conjugates, 6% in free form.
Excretion is reduced in case of liver dysfunction, which leads to an increase in plasma levels by 1.3-2 times, but does not require dose adjustment.
Gender and age do not have a clinically significant effect on the pharmacokinetics of ambroxol and do not require dose adjustment.
Food intake does not affect the bioavailability of ambroxol hydrochloride.
Pharmacodynamics
Ambrobene® has a secretolytic and expectorant effect; stimulates the serous cells of the glands of the bronchial mucosa, increases the content of mucous secretion and the release of surfactant in the alveoli and bronchi; normalizes the disturbed ratio of serous and mucous components of sputum. By activating hydrolyzing enzymes and enhancing the release of lysosomes from Clara cells, it reduces the viscosity of sputum. Increases the motor activity of the cilia of the ciliated epithelium, increases the mucociliary transport of sputum. Increasing secretion and mucociliary clearance improves sputum production and relieves cough.
It has been proven that the local anesthetic effect of ambroxol is due to dose-dependent blockade of sodium channels of neurons. Under the influence of ambroxol, the release of cytokines from the blood, as well as from tissue mononuclear cells and polymorphonuclear cells, is significantly reduced.
Clinical studies on patients with sore throat have shown a significant reduction in sore throat and redness.
Indications for use
Secretolytic therapy of acute and chronic bronchopulmonary diseases characterized by impaired secretion and difficult sputum discharge
Directions for use and doses
Ambrobene® tablets are taken orally after meals with sufficient water. Swallow whole without chewing.
Adults and children over 12 years of age: In the first 2-3 days, ½ tablet Ambrobene® 60 mg 3 times a day (equivalent to 30 mg ambroxol hydrochloride 3 times a day). Then Ambrobene® 60 mg is taken ½ tablet 2 times a day (equivalent to 30 mg ambroxol hydrochloride 2 times a day).
The duration of treatment depends on the characteristics of the disease. It is not recommended to use Ambrobene® without medical prescription for more than 4-5 days.
Side effects
Gastrointestinal disorders
Often (≥ 1/100 -< 1/10):
Nausea, change in taste, decreased sensitivity in the mouth and pharynx (oral and pharyngeal hyposthesia)
Uncommon(≥ 1/1000 -< 1/100):
Vomiting, diarrhea, dyspepsia, abdominal pain, dry mouth
Rarely (≥ 1/10000 -< 1/1000):
Dry throat
Immune system disorders
Unknown:
Anaphylactic reactions, including anaphylactic shock
Disorders of the skin and subcutaneous tissue
Rarely(≥ 1/10000 -< 1/1000):
Rash, hives
Unknown:
Itching and other hypersensitivity reactions, angioedema.
Contraindications
Hypersensitivity to ambroxol and/or other components of the drug
Severe renal failure
Severe liver failure
I trimester of pregnancy
Rare hereditary galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption syndrome
Children's age up to 12 years
Drug interactions
No clinically significant adverse interactions with other drugs have been reported.
Combined use with antitussive drugs leads to difficulty in sputum discharge due to cough suppression.
Increases the penetration and concentration in bronchial secretions of amoxicillin, cefuroxime and erythromycin.
special instructions
Very rare cases of severe skin lesions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported with the use of ambroxol hydrochloride. They are mainly due to the severity of the underlying disease and concomitant treatment. In addition, in the early stages of Stevens-Johnson syndrome and toxic epidermal necrolysis, patients may show signs of the onset of a nonspecific disease, with the following symptoms: fever, pain throughout the body, rhinitis, cough and sore throat. The appearance of these signs may lead to unnecessary symptomatic treatment with cold medications. If skin lesions appear, the patient is immediately examined by a doctor, and ambroxol hydrochloride is stopped.
Pregnancy and lactation
Ambroxol hydrochloride penetrates the placental barrier. Preclinical studies have not shown direct or indirect negative effects on pregnancy, fetal development, childbirth or postnatal development.
It is not recommended to use Ambrobene® during the first trimester of pregnancy. Despite the fact that to date there is no reliable data on negative effects on the fetus and infants, the use of the drug in the second and third trimesters of pregnancy and during lactation is possible after a thorough analysis of the benefit/risk ratio by the attending physician.
