Compound
One Ambrobene tablet contains 30 mg of ambroxol , lactose in the form of monohydrate (Lactose monohydrate), corn starch (Maidis amylum), magnesium stearate (Magnesium stearate), anhydrous colloidal silicon dioxide (Silicium dioxide).
One sustained-release capsule contains 75 mg ambroxol , microcrystalline cellulose (Cellulose microcrystalline), Avicel PH 102 and PC 581, triethyl citrate, methacrylic acid ethyl acrylate copolymer msds, hypromellose (Pharmacoat 603; Hypromellose), anhydrous colloidal silicon dioxide. The composition of the shell covering the capsule includes: gelatin, titanium dioxide, dyes (iron oxide red, yellow and black).
100 ml of syrup contains 0.3 grams of ambroxol, sorbitol (Sorbitol) liquid 70%, propylene glycol (Propylene glycol), saccharin (Saccharin), water, raspberry flavoring.
100 ml of solution for oral administration and inhalation includes 0.75 grams of ambroxol , potassium sorbate (Potassium sorbate); hydrochloric acid (Acidum hydrochloricum), water.
2 ml of solution for intravenous administration contains 15 mg of ambroxol , citric acid monohydrate (Acid citric monohydrate), sodium chloride (Sodium chloride), sodium hydrophosphate heptahydrate (Sodium hydrophosphate heptahydrate), water.
Release form
Ambrobene has 5 release forms:
- pills;
- injection solution for intravenous administration;
- retard capsules;
- syrup;
- solution for inhalation and p/os administration.
The tablets are biconvex, round in shape. Their color is white, there is a mark on one side. One package of the drug can contain 2 or 5 blisters of 10 Ambrobene tablets.
The body of retard gelatin capsules is colorless, transparent, the cap is brown, the contents are white or slightly yellowish granules. One package of the drug contains 1 or 2 blisters of 10 capsules.
Syrup is a colorless (or slightly yellowish) transparent liquid with a raspberry odor. In pharmacies it is sold in 100 ml glass bottles. Each bottle is sealed with a jet cap and closed with a plastic screw cap. Each pack comes with a measuring cup.
The solution for inhalation and oral administration is a clear, odorless liquid that can be either colorless or light yellow with a slightly brownish tint. The solution is sold in glass bottles of 40 or 100 ml. Each bottle is sealed with a dropper stopper and closed with a plastic screw cap. Each pack contains a measuring cup.
The solution for injection into a vein is a clear, colorless or slightly yellowish liquid. It is produced in 2 ml ampoules of dark glass (first type), 5 ampoules in a plastic tray, 1 tray per package.
General description of the drug
The active ingredient is ambroxol; each capsule contains 75 mg.
The capsule shell consists of a gelatinous mass, which is colored white and brown. Inside the capsules are granules that can be white or light yellow.
The drug is produced in 10 capsules, which are placed in a plastic blister and packaged in a cardboard box. Each package contains a detailed annotation in Russian. The medication is sold in pharmacies without a doctor's prescription.
The medicine should be stored in a cool, dry place, at a temperature not exceeding 25 degrees. The shelf life, subject to storage conditions, is 5 years.
Pharmacodynamics and pharmacokinetics
Ambroxol is a substance that is a metabolite of Bromhexine . Its action is aimed at stimulating prenatal (intrauterine) lung development: the use of the drug increases the synthesis and secretion of pulmonary surfactant , and also blocks its breakdown.
Ambrobene has secretomotor , expectorant and secretolytic effects , activates the function of serous gland cells , which are localized in the bronchial mucosa , increases the amount of mucous secretion and stimulates the release of surfactant in the alveoli and bronchi , helps restore the disturbed balance of the mucous and serous components of sputum.
Ambroxol increases the activity of hydrolyzing enzymes , stimulates the release of lysosomes Clara cells located in and the function of the cilia of the ciliated epithelium , due to which sputum is liquefied and the mucociliary transport of pathological secretions is improved.
In preclinical studies, it was found that ambroxol has an antioxidant effect . When used simultaneously with antibiotics Doxycycline , Amoxicillin , Erythromycin and Cefuroxime , it increases the concentration of the latter in bronchial secretions and sputum.
The effect after using the drug develops approximately half an hour after taking p/os (orally) and approximately 10 minutes to half an hour after rectal administration. The duration of the therapeutic effect is dose-dependent and varies from 6 to 12 hours.
When taken p/os, ambroxol is almost completely absorbed from the digestive tract . Cmax is reached after 1-3 hours. Due to first-pass metabolism, the absolute bioavailability of ambroxol after taking p/os is reduced by about a third.
The resulting metabolites ( glucuronides and dibromoanthranilic acid ) are excreted by the kidneys .
The substance binds approximately 80-90% to blood plasma proteins
Ambroxol penetrates the placental barrier and into the cerebral spinal fluid , and is also excreted in the milk of a nursing woman.
The half-life from plasma is 7-12 hours. The total half-life of the substance and its metabolites is about 22 hours. The drug is mainly excreted by the kidneys in the form of metabolic products of ambroxol (about 90%), and only less than 10% of the substance is excreted in its pure form.
Indications for use and action
The drug is prescribed for diseases of the respiratory tract that are accompanied by impaired formation and discharge of sputum: bronchitis (acute, chronic, obstructive), bronchial asthma, pneumonia, cystic fibrosis, tracheitis and bronchiectasis.
"Ambroxol" helps to increase the production of sputum, reduce its viscosity and faster excretion. It begins to have an effect after half an hour and lasts from 6 to 24 hours.
In addition, ambroxol stimulates the formation of surfactant in both adults and newborns. This property of the drug allows it to be used for nursing premature infants with respiratory distress syndrome. Ambrobene is most often used as part of combination and complex therapy. Combines with many drugs. When treated with ambroxol in combination with the antibiotics amoxicillin, cefuroxime, erythromycin and doxycycline, their concentration in sputum increases.
Contraindications
The use of Ambrobene is contraindicated in case of hypersensitivity to the components of the drug, as well as in the first trimester of pregnancy.
Additional contraindications for tablets:
- hypolactasia;
- lactase deficiency;
- glucose-galactose malabsorption;
- age up to 6 years.
Retard capsules are prohibited for children under 12 years of age.
Ambrobene syrup is not prescribed for:
- sucrose-isomaltose malabsorption;
- glucose-galactose malabsorption;
- fructose intolerance.
The medicine is prescribed with caution:
- with the syndrome of immotile cilia ( primary ciliary dyskinesia ) - a genetically determined hereditary abnormality in the development of the structure and function of the ciliated epithelium of the respiratory tract ;
- during pregnancy (in the 2nd and 3rd trimesters);
- during breastfeeding;
- during periods of exacerbation of stomach ulcers or duodenal ulcers (for dosage forms intended for oral administration).
renal function or have been diagnosed with serious liver . In this case, the dose of medication for them should be smaller, and the intervals between doses should be longer.
Peculiarities
Before you start using Ambrobene tablets, you should carefully read the instructions for use.
In this case, it is necessary to pay attention to certain features:. "Ambrobene" is an over-the-counter medicine and is sold freely in pharmacies.
If you have any questions, it is advisable to consult a doctor
The use of the medicine in the first three months of pregnancy is contraindicated, since there is no reliable information about the absence of negative effects on the fetus. In the second and third trimester, taking the medicine is possible only after the permission of the doctor, who carefully weighs all the risks. The same applies to taking pills during lactation. According to the instructions for Ambrobene tablets, for children under two years of age the drug is prescribed only by a medical specialist on an individual basis. Ambrobene is not recommended to be taken simultaneously with medications that suppress cough, as this can lead to stagnation of pathological secretions in the respiratory tract. If a negative process occurs in the liver or kidneys, the medication is prescribed with extreme caution and with constant monitoring of the functioning of the organs. On average, therapy using Ambrobene tablets for children (according to the instructions for use) lasts four to five days. When prolonging treatment, it is important to consult a medical specialist. The combined use of Ambrobene and antibacterial agents increases the content of the latter in pathological secretions, thereby increasing the rate of elimination of infection in the respiratory system. The medicine does not affect the speed of patient reactions, so its use is allowed for people whose work requires increased concentration.
"Ambrobene" is an over-the-counter drug that is sold freely in pharmacies. If you have any questions, it is advisable to consult a doctor.
Side effects
Side effects associated with taking tablets, syrup and extended-release capsules:
- allergic reactions (including skin rashes, itching, shortness of breath, urticaria , angioedema of the face);
- headache;
- increased weakness;
- fever;
- anaphylactic reactions (in extremely rare cases);
- stomach ache;
- nausea;
- constipation/diarrhea;
- vomit;
- increased dryness of the mucous membranes of the respiratory tract and oral cavity;
- rhinorrhea;
- exanthema;
- dysuria.
When using Ambrobene solution for inhalation and oral administration, the following may develop:
- hypersensitivity reactions;
- anaphylactic reactions;
- disorders of taste perception;
- stomach ache;
- increased dryness of the mucous membranes of the throat and mouth;
- dyspepsia;
- vomit;
- diarrhea.
Ambrobene solution for injection into a vein can provoke:
- allergic and anaphylactic reactions;
- fever;
- high intensity headaches;
- feeling very tired;
- stomach ache;
- venous edema;
- weakness;
- nausea and vomiting.
Excess of dosage and negative reactions
Ambrobene is a safe medicine that is well tolerated by patients. The occurrence of adverse reactions or complications is rare. Problems progress due to improper use of the drug and overdose.
Exceeding the recommended amount of ambroxol does not cause specific symptoms.
Typical symptoms:
- nausea;
- weakness;
- headache.
In case of severe drug poisoning, gastric lavage and a temporary pause in taking the drug are performed.
Possible adverse reactions:
- fatigue;
- allergic manifestations such as urticaria or facial swelling;
- dry mouth;
- abdominal discomfort, pain, nausea, vomiting;
- constipation or diarrhea.
Sometimes the secretion of mucus from the nose sharply increases, and dysuria—impaired urination—progresses.
Instructions for use of Ambrobene
The duration of therapy in any dosage form is determined individually and depends on the characteristics of the disease. The maximum duration of treatment with Ambrobene without a doctor's prescription is five days.
The mucolytic effect of the drug occurs provided that the patient consumes large amounts of fluid. Therefore, during treatment with the drug, the patient should drink as much as possible.
All dosage forms intended for p/os should be taken after meals, with the drops pre-mixed with water, tea or fruit juice. It is recommended to take tablets and capsules with plenty of water; the instructions prohibit chewing them.
Ambrobene tablets: instructions for use
The optimal dose for children 6-12 years old is half a tablet 2 or 3 times a day.
Patients over 12 years of age should take the drug 1 tablet three times a day in the first 2-3 days. If the expected effect is not observed, adult patients are allowed to increase the single dose to 2 tablets, the frequency of use of the drug is 2 times a day.
From the 3rd or 4th day of treatment, it is advisable to take 1 tablet of 30 mg twice a day.
Ambrobene capsules: instructions for use
The daily dose of the drug in this dosage form is 1 capsule (75 mg).
Ambrobene syrup: instructions for use
For children, syrup is dosed depending on age. Thus, at the age of up to 24 months, it is recommended to drink 2.5 ml (0.5 measuring cup) twice a day; at the age of 24 months to 6 years - 2.5 ml three times a day; at the age of 6-12 years - 5 ml two or three times a day (according to indications).
Patients over 12 years of age should take cough syrup 10 ml three times a day for the first 2-3 days. If necessary, adult patients are allowed to increase the dose to 20 ml twice a day.
Starting from 3-4 days, treatment is continued by taking 20 ml of syrup per day, the dose is divided into 2 doses.
Instructions for use of Ambrobene for inhalation and orally
The dose of the solution for taking p/os is calculated as follows:
- 2 ml/day. in 2 doses - for children up to 24 months;
- 3 ml/day. in 3 doses - for children from 24 months to 6 years;
- 4-6 ml/day. in 2 or 3 doses (2 ml per dose) - for children 6-12 years old;
- 12 ml/day. in 3 doses - for patients over 12 years of age in the first 2-3 days of treatment (if therapy is ineffective, the dose is increased to 16 ml/day with a frequency of applications 2 times a day);
- 8 ml/day. in 2 doses - for patients over 12 years of age, from 3-4 days of treatment.
When using Ambrobene for inhalation, the use of any modern equipment is allowed, with the exception of steam inhalers.
Inhalations with saline are carried out, for which, immediately before the procedure, the drug is mixed with an isotonic NaCl solution and heated to body temperature. To achieve optimal air humidification, it is recommended to take solutions in a 1:1 ratio.
It should be remembered that taking a deep breath during inhalation therapy provokes cough points, so inhalations are carried out while trying to breathe as usual. Patients diagnosed with bronchial asthma should undergo the procedure after taking bronchodilators .
How to perform inhalations for patients of different age groups:
- for children under 24 months, one or two procedures per day using 1 ml of inhalation solution are indicated;
- for children from 24 months to 6 years of age, procedures are carried out with the same frequency, but using twice the dose of the drug;
- for all other categories of patients, a single dose of Ambrobene solution for inhalation is 2-3 ml, the frequency of procedures is the same - 1 or 2 times a day.
Ambrobene solution: instructions for use
The solution is injected into the vein slowly (for at least 5 minutes), stream or drip, using as a solvent any basic solution whose pH does not exceed 6.3 (isotonic NaCl solution, Ringer-Locke solution, five percent glucose solution are suitable for this purpose ).
The daily dose depends on the patient’s weight; it is measured at the rate of 30 mg per 1 kg of body weight and evenly distributed over 4 administrations per day.
After the disappearance of acute symptoms, it is considered advisable to switch to taking the drug in other dosage forms.
General characteristics of the drug Ambroxol
A mucolytic drug that has an expectorant, secretolytic and secretomotor effect. As a result of the process of converting the polymer into a monomer in pathological secretions, the medication helps reduce the viscosity of sputum, and also normalizes the ratio of serous and mucous substances, increases the motor activity of ciliated epithelial tissue, enhances the elimination of harmful organisms and facilitates the elimination of pathological secretions from the respiratory organs. At the same time, Ambroxol has a direct effect on Clark cells, which are located in the bronchioles of the lungs.
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The drug helps activate surfactants that prevent the alveoli from collapsing during exhalation.
When tablets are taken orally, the active substance is instantly and completely absorbed from the gastrointestinal tract into the tissues, accumulating in the greatest quantities in the lungs. The maximum concentration is reached after approximately three hours. The cost of the medicine is 70 rubles.
Overdose
Signs of intoxication with an overdose of ambroxol have not been established. There is evidence that exceeding the recommended dose provokes diarrhea and nervous agitation .
Ambroxol is well tolerated when taken orally at a dose of 25 mg per kilogram of body weight per day.
A severe overdose can cause increased salivation , nausea, vomiting, and decreased blood pressure .
In case of serious overdose, intensive therapy is indicated: stimulation of vomiting and gastric lavage. These activities should be carried out in the first hour or two after taking the drug. Further treatment is symptomatic.
Interaction
The simultaneous use of antitussive drugs and ambroxol suppresses the cough reflex , which in turn can provoke stagnation of secretions.
Ambroxol, when used simultaneously with Erythromycin, Amoxicillin, Doxycycline and Cefuroxime, increases the concentration of these antibacterial drugs in sputum and bronchial secretions.
When administering ambroxol into a vein, solutions should be used as solvents whose pH does not exceed 6.3. For ambroxol, this indicator is 5, so too large a difference in pH values can provoke precipitation of the base of the substance.
special instructions
In exceptional cases, when using the drug, severe dermatological reactions may occur, including and Stevens-Johnson syndromes . If changes appear on the skin or mucous membranes, you should urgently consult a doctor and stop treatment with Ambrobene.
The calorie content of the syrup is 2.6 kcal/gram of sorbitol. One 5 ml measuring cup contains 2.1 grams of sorbitol, which is equivalent to 0.18 XE (bread units).
Sorbitol has the ability to have a mild laxative effect.
For what cough is Ambrobene prescribed?
Ambrobene is a mucolytic and, like all drugs with mucolytic action , it is advisable to prescribe it for dry cough , which is caused by diseases of the lower respiratory tract.
The medicine optimizes the functioning of epithelial cells and dilutes the pathological secretion, thereby facilitating its expectoration.
If the patient's cough is wet, profuse and productive, there is no need to prescribe drugs to thin the sputum.
Analogs
Level 4 ATX code matches:
Mukolik
Abrol
Ambrosan
Bronchorus
ACC 100
ACC 200
ACC Long
ACC
Mukolwan
Lazolvan
Bromhexine 8
Bromhexine 8 Berlin-Chemie
Bromhexine
Bronchobos
Carbocisteine
Erdomed
Pulmozyme
Pectolvan C
Halixol
Acetylcysteine
Structural analogues of Ambrobene: Ambroxol , Bronchoxol , Bronchorus , Lazolvan , Lazongin , Medox , Neo-Bronchol , Ambrolor , Suprima-Kof , Halixol .
Analogues by mechanism of action are: Ascoril , Acestin , Acetylcysteine , ACC , Bromhexine , Bronchosan , Bronchobos , Joset , Cashnol , Libexin Muco , N-AC-Ratiopharm , Pulmozim , Sinupret , Solvin , Fluditek , Fluifort , Fluimucil , Erdomed , Cofasma , Bronchostop .
Ambrobene for children
Why are tablets and syrup prescribed to children? The use of the drug is indicated for the treatment of respiratory tract diseases that occur in acute or chronic form.
Tablets can be prescribed to a child only upon reaching the age of six, capsules - no earlier than from 12 years of age. The optimal dosage form for children is Ambrobene syrup. However, it should be remembered that for children under 2 years of age, syrup, solution for intravenous administration and solution for p/os and inhalation are prescribed exclusively according to doctor’s indications.
The most important property of Ambrobene is the ability to stimulate the formation of surfactant - a substance that is necessary to ensure normal lung . And it is this property that makes the drug valuable for babies who have problems with the lungs .
Ambrobene is prescribed to newborns, infants and children up to one year old in order to normalize the production of surfactant and prevent the alveoli of the lungs , as well as to prevent bronchitis , which is often complicated by ARVI , from becoming chronic.
The dosage regimen and optimal duration of treatment are determined by the attending physician, taking into account the nature of the disease and the age of the small patient.
In the video advertising of the Ambrobene brand, the emphasis is placed on the fact that the drug is made in Germany, which in itself is a guarantor of its high quality and effectiveness.
The main message of the advertisement is that the standards according to which Ambrobene is created are in no way inferior to the high quality standards and those user characteristics, thanks to which German cars, toys and household appliances have long and firmly earned the recognition of consumers in different countries of the world.
And the manufacturer’s claims about the effectiveness of its product are confirmed by numerous positive reviews about Ambroben for children: according to most mothers, the product is one of the best today, since it works really well and helps the child cope with a severe cough.
What are these pills for?
What to use Ambrobene tablets for is indicated in the instructions; the drug has expectorant properties, therefore it is prescribed for pathologies with the formation of thick, difficult-to-clear sputum. The intensity of cough decreases in the following diseases:
- bronchitis;
- laryngitis;
- tracheitis;
- pharyngitis;
- pneumonia.
And this is not a complete list. The instructions for Ambrobene tablets recommend to alleviate the condition and help get rid of unpleasant symptoms when it is difficult to cough and clear the respiratory tract. Ambroxol, the active substance of the drug, activates the serous cells of the bronchi, which secrete the secretion necessary for cleansing. If an excessive amount of sputum is produced, the active ingredient of the drug stimulates the movement of the cilia of the bronchial epithelium, prevents them from sticking together, this helps remove mucus.
The medicine can be prescribed for prophylaxis, so that after surgery or injury, the mucus formed does not stagnate in the bronchopulmonary system.
When treating diseases with antibiotics, Ambrobene enhances their beneficial effect on the body.
Ambrobene 75 mg is not a tablet, but a capsule. Instructions for use recommend prescribing the medicine to patients from the age of twelve. Ambrobene in capsule form has a long release period of the active substance.
Instructions for use recommend drinking plenty of fluids during therapy.
Ambrobene during pregnancy
To date, there is no reliable data on the safety of using Ambrobene during pregnancy (in particular, in the first 28 weeks). Studies conducted on animals did not reveal the teratogenic effect of ambroxol.
The use of the drug in the 2nd and 3rd trimesters is possible only as prescribed by a doctor and only after the potential benefits to the mother and possible risks to the fetus have been assessed.
Studies conducted on animals have established that ambroxol has the ability to pass into breast milk. However, the use of the drug in nursing women has not been studied enough, and therefore Ambrobene can be prescribed only after assessing the benefit/risk ratio for the mother and child.
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.
Reviews about Ambroben
Reviews of Ambrobene syrup, as well as reviews of tablets, solution for inhalation or solution for intravenous administration, are mostly positive. They are confirmed by fairly high ratings of the medicine on specialized forums, where people share their experience of using this or that medicine: on a five-point scale, Ambrobene is rated at 4.5-4.8 points.
The main advantages of the drug are:
- efficiency;
- performance;
- ease of use;
- tastes pleasant to the child;
- can be used from the first months of a child’s life;
- a large number of dosage forms (tablets, solution for intravenous administration, retard capsules, solution for inhalation and p/os administration, syrup), which allows you to choose the optimal one for yourself.
However, there are also neutral and negative reviews, which are related to the fact that the use of the drug did not produce as pronounced a result as expected.
Ambrobene price
The price of Ambrobene tablets is 54 UAH/165 rubles, extended-release capsules are 59 UAH/190 rubles. The price of Ambrobene syrup for children is 63 UAH/108 rubles. The price of Ambrobene for inhalation 40 ml is 38 UAH/127 rubles, a solution for inhalation 100 ml can be purchased for 62 UAH or 176 rubles.
- Online pharmacies in RussiaRussia
- Online pharmacies in UkraineUkraine
- Online pharmacies in KazakhstanKazakhstan
ZdravCity
- Ambrobene STOPTUSSIN tab.
4mg+100mg No. 20Teva Pharm.Predpr./Teva Operations Poland 260 RUR order - Ambrobene stoptussin cap. for oral administration 10 mlTeva Pharmaceutical
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Pharmacy Dialogue
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Pharmacy24
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PaniPharmacy
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