When dealing with colds and coughs, many people try to buy medicine as quickly as possible. A popular remedy for coughs and runny noses are Ambrobene tablets. Before taking this medicine, you should carefully read the instructions and strictly follow the recommendations. Overdose and abuse of the drug can seriously harm your health.
What does the medicine consist of?
The active ingredient is abroxol hydrochloride. One tablet contains 30 mg of this substance. In addition, the tablets contain additional microelements:
- colloidal anhydrous silicon dioxide - 1.8 mg;
- magnesium stearate - 2.41 mg;
- lactose monohydrate - 169.46 mg;
- corn starch - 36.33 mg.
The round white tablets have a slightly convex surface on both sides. There is a score line on one side of each tablet. The package contains 2 or 5 blisters, each containing 10 tablets.
In what forms is it available?
The doctor can prescribe the medicine to the patient in the most suitable form of release. "Ambrobene" is available in 5 different forms:
- pills;
- solution for inhalation and oral administration;
- syrup;
- capsules;
- solution for intravenous injection.
These release forms differ from each other in the dosage of the active substance, as well as additional substances.
Ambrobene syrup
Release form
Syrup: a clear, colorless to slightly yellow solution with a raspberry odor.
Compound
Active ingredients : ambroxol hydrochloride (0.30 g/100 ml).
Excipients : liquid sorbitol 70%; propylene glycol; raspberry flavor; saccharin; purified water .
Pharmacological group
Mucolytic and expectorant drug. Secretolytics and stimulants of motor function of the respiratory tract.
Action
Mucolytic agent with expectorant action. Ambroxol increases the secretion of the glands of the respiratory tract, stimulates the activity of the villi of the respiratory tract, and enhances the formation of surfactant in the lungs. Ambroxol is a metabolite of bromhexine.
Ambroxol - description of the substance
The effect occurs 30 minutes after administration and lasts 6-12 hours.
Indications
Acute and chronic diseases of the respiratory tract, accompanied by impaired formation and discharge of sputum.
Contraindications and restrictions
- Hypersensitivity to ambroxol or one of the excipients;
- Pregnancy (first trimester);
- Sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.
Carefully:
- impaired bronchial motor function and increased sputum production (with immotile cilia syndrome);
- pregnancy (II–III trimester), lactation period;
- peptic ulcer of the stomach and duodenum during an exacerbation;
- impaired renal function or severe liver disease.
Application and dosage
Inside , after meals, using the included measuring cup.
Children: up to 2 years old - 1/2 measuring cup (2.5 ml syrup) 2 times a day (15 mg ambroxol per day); from 2 to 6 years - 1/2 measuring cup (2.5 ml syrup) 3 times a day (22.5 mg ambroxol per day); from 6 to 12 years - 1 measuring cup (5 ml of syrup) 2-3 times a day (30-45 mg of ambroxol per day).
Adults and children over 12 years of age: in the first 2-3 days of treatment - 2 measuring cups (10 ml of syrup) 3 times a day (90 mg of ambroxol per day). If therapy is ineffective, adults can increase the dose to 4 measuring cups (20 ml of syrup) 2 times a day (120 mg of ambroxol per day). In the following days, you should take 2 measuring cups (10 ml of syrup) 2 times a day (60 mg of ambroxol per day).
It is not recommended to take Ambrobene for more than 4-5 days without a doctor's prescription.
The mucolytic effect of the drug occurs when taking large amounts of fluid, so drinking plenty of fluids is recommended during treatment.
Side effect
Rarely (from ≥0.1% to <1%) - allergic reactions (urticaria, skin rash, angioedema of the face, shortness of breath, itching), fever, weakness, headache; very rarely (<0.01%) - anaphylactic reactions, incl. anaphylactic shock. Rarely - nausea, abdominal pain, vomiting, diarrhea, constipation, dry mucous membrane of the oral cavity and respiratory tract, exanthema, rhinorrhea, dysuria.
special instructions
It should not be combined with antitussive drugs that impede the removal of sputum.
Severe skin reactions, such as Stevens-Johnson syndrome and Lyell's syndrome, have been observed extremely rarely when using Ambrobene. If there is a change in the skin or mucous membranes, you must immediately consult a doctor and stop taking the drug.
In children under 2 years of age, the drug can only be used as prescribed by a doctor.
Caloric content is 2.6 kcal/g sorbitol. Sorbitol may have a mild laxative effect. One measuring cup (5 ml of syrup) contains 2.1 g of sorbitol, which corresponds to 0.18 XE.
Storage
At a temperature not exceeding 25 °C. Keep out of the reach of children. Shelf life - 5 years, after opening - 1 year.
Production
- Teva Pharmaceutical Enterprises Ltd (Israel);
- Merkle GmbH (Germany).
Package
100 ml with a measuring cup (cup) in a cardboard pack or in a dark glass bottle.
Recipe
Available without a prescription.
How it affects the body
This medicine thins mucus in the bronchi and lungs and stimulates its rapid elimination from the body. Under the influence of the drug, sputum does not increase in volume, but loses its viscosity. The bonds between molecules are broken, and sputum is easily coughed up. "Ambrobene" refers to expectorant and mucolytic drugs.
The tablets begin to act half an hour after taking them. Depending on their quantity, the effect lasts 6–12 hours. The antioxidant properties of Ambrobene have been proven.
The active substance is excreted by the kidneys. Ambroxol easily enters the spinal fluid. It is able to penetrate into the fetus through the placenta, as well as into breast milk. It is completely eliminated from the body within 22 hours.
Ambrobene, 30 mg, tablets, 20 pcs.
Inside, inhalation, i.v.
The duration of treatment is selected individually depending on the course of the disease. It is not recommended to take Ambrobene for more than 4-5 days without a doctor's prescription.
The mucolytic effect of the drug occurs when taking large amounts of liquid. Therefore, drinking plenty of fluids is recommended during treatment.
Pills
Inside
, after eating, swallow whole, without chewing, with plenty of liquid.
Children from 6 to 12 years old:
1/2 table 2–3 times a day (15 mg ambroxol 2–3 times a day).
Adults and children over 12 years old:
in the first 2–3 days of treatment - 1 tablet. 3 times a day (30 mg ambroxol 3 times a day). If therapy is ineffective, adults can increase the dose to 2 tablets. 2 times a day (120 mg ambroxol per day). In the following days you should take 1 tablet. 2 times a day (30 mg ambroxol 2 times a day).
Extended release capsules
Inside
, after eating, swallow whole, without chewing, with plenty of liquid.
Adults and children over 12 years old:
1 caps. per day (75 mg ambroxol per day).
Syrup
Inside
, after eating, using the included measuring cup.
For children:
up to 2 years - 1/2 measuring cup (2.5 ml syrup) 2 times a day (15 mg ambroxol per day); from 2 to 6 years - 1/2 measuring cup (2.5 ml syrup) 3 times a day (22.5 mg ambroxol per day); from 6 to 12 years - 1 measuring cup (5 ml of syrup) 2-3 times a day (30-45 mg of ambroxol per day).
Adults and children over 12 years old:
in the first 2-3 days of treatment - 2 measuring cups (10 ml of syrup) 3 times a day (90 mg of ambroxol per day). If therapy is ineffective, adults can increase the dose to 4 measuring cups (20 ml of syrup) 2 times a day (120 mg of ambroxol per day). In the following days, you should take 2 measuring cups (10 ml of syrup) 2 times a day (60 mg of ambroxol per day).
Solution for oral administration and inhalation
Inside
, after meals, add to water, juice or tea using the included measuring cup.
For children:
up to 2 years - 1 ml of the drug 2 times a day (15 mg ambroxol per day); from 2 to 6 years - 1 ml of the drug 3 times a day (22.5 mg ambroxol per day); from 6 to 12 years - 2 ml of the drug 2-3 times a day (30-45 mg ambroxol per day).
Adults and children over 12 years old:
in the first 2-3 days of treatment - 4 ml of the drug 3 times a day (90 mg ambroxol per day). If therapy is ineffective, adults can increase the dose to 8 ml of the drug 2 times a day (120 mg ambroxol per day). In the following days, you should take 4 ml of the drug 2 times a day (60 mg ambroxol per day).
Inhalation.
When using the drug Ambrobene in the form of inhalations, you can use any modern equipment (except for steam inhalers). Before inhalation, the drug is mixed with a 0.9% sodium chloride solution (for optimal air humidification, it can be diluted in a 1:1 ratio) and heated to body temperature. Since during inhalation therapy, a deep breath can provoke coughing impulses, inhalations should be carried out in normal breathing mode. Patients with bronchial asthma can be recommended to carry out inhalation after taking bronchodilator drugs.
1 ml of solution contains 7.5 mg of ambroxol.
For children:
up to 2 years - 1 ml of solution 1-2 times a day (7.5-15 mg ambroxol per day); from 2 to 6 years - 2 ml of solution 1-2 times a day (15-30 mg ambroxol per day).
Adults and children over 6 years old:
2–3 ml of solution 1–2 times a day (15–45 mg ambroxol per day).
Solution for intravenous administration
IV
, slowly, stream or drip. The solvent used is 0.9% sodium chloride solution, 5% glucose solution, Ringer-Locke solution or another basic solution with a pH not higher than 6.3.
The daily dose is 30 mg/kg, evenly distributed over 4 administrations per day.
The solution should be administered intravenously, slowly, over at least 5 minutes.
Injections are stopped after the acute manifestations of the disease disappear and the patient switches to oral administration of other dosage forms of the drug.
In what cases is it recommended to take
There are a number of diseases and conditions for which the doctor prescribes Ambrobene:
- bronchitis;
- cystic fibrosis;
- pneumonia;
- bronchial asthma;
- inflammatory processes in the respiratory tract;
- acute respiratory infections and acute respiratory viral infections.
Chronic and acute diseases of the respiratory tract, in which the mechanism of clearing the lungs of phlegm is disrupted, are successfully treated with the drug "Ambrobene".
Side effects
Tablets, syrup and capsules may cause unwanted side effects:
- itching and rash on the skin;
- swelling on the face;
- hives;
- dry mouth and mucous membranes;
- anaphylactic shock (extremely rare);
- weakness;
- profuse runny nose;
- headache;
- nausea, vomiting;
- diarrhea or constipation;
- abdominal pain;
- fever;
- urination disorder.
Solutions for inhalation and injection sometimes provoke other side effects:
- anaphylactic reactions, up to shock;
- impaired taste sensations;
- pain and discomfort in the abdomen;
- vomiting and diarrhea;
- swelling of the veins.
The patient must take care of his health, strictly adhere to the dosage and follow the instructions for use.
Buy Ambrobene solution for internal use and for inhalation 7.5 mg/ml 100 ml in pharmacies
Trade name:
Ambrobene
International nonproprietary or chemical name:
ambroxol
Dosage form:
solution for oral administration and inhalation, 7.5 mg/ml
Composition 100 ml of the drug contains:
active ingredient: ambroxol hydrochloride 0.750 g;
excipients: potassium sorbate 0.100 g, hydrochloric acid (25%) 0.060 g, purified water 99.190 g.
Description
A clear, colorless to slightly yellowish-brown solution.
Pharmacotherapeutic group:
mucolytic expectorant.
pharmachologic effect
Pharmacodynamics.
Ambroxol is a benzylamine metabolite of bromhexine. It differs from bromhexine in the absence of a methyl group and the presence of a hydroxyl group in the para-trans position of the cyclohexyl ring. It has secretomotor, secretolytic and expectorant effects.
After oral administration, the effect occurs within 30 minutes and lasts for 6-12 hours (depending on the dose taken).
Preclinical studies have shown that ambroxol stimulates the serous cells of the glands of the bronchial mucosa. By activating ciliated epithelial cells and reducing the viscosity of sputum, ambroxol improves mucociliary transport.
Ambroxol activates the formation of surfactant, having a direct effect on type 2 alveolar pneumocytes and Clara cells of the small airways.
Studies on cell cultures and in vivo studies on animals have shown that ambroxol stimulates the formation and secretion of a substance (surfactant) active on the surface of the alveoli and bronchi of the embryo and adult.
Also, preclinical studies have proven the antioxidant effect of ambroxol. Ambroxol, when used together with antibiotics (amoxicillin, cefuroxime, erythromycin, doxycycline), increases their concentration in sputum and bronchial secretions.
Pharmacokinetics.
When taken orally, ambroxol is almost completely absorbed from the gastrointestinal tract. The maximum concentration is reached 1-3 hours after oral administration. Due to first-pass metabolism, the absolute bioavailability of ambroxol after oral administration is reduced by approximately ⅓. The resulting metabolites (such as dibromanthranilic acid, glucuronides) are eliminated in the kidneys. Plasma protein binding is about 85% (80-90%). The plasma half-life ranges from 7 to 12 hours. The total half-life of ambroxol and its metabolites is approximately 22 hours.
It is excreted mainly by the kidneys in the form of metabolites - 90%, less than 10% is excreted unchanged.
Given the high binding to plasma proteins, large volume of distribution and slow redistribution from tissues to blood, significant elimination of ambroxol does not occur during dialysis or forced diuresis.
In patients with severe liver disease, the clearance of ambroxol is reduced by 20-40%. In patients with severe renal impairment, the half-life of ambroxol metabolites increases.
Ambroxol penetrates into the cerebrospinal fluid and through the placental barrier, and is also excreted into breast milk.
Indications for use
Acute and chronic diseases of the respiratory tract, accompanied by impaired formation and discharge of sputum.
Contraindications
Hypersensitivity to ambroxol or one of the excipients; pregnancy (first trimester).
Carefully
Impaired bronchial motor function and increased sputum production (with fixed cilia syndrome), peptic ulcer of the stomach and duodenum during an exacerbation, pregnancy (II-III trimester), breastfeeding period.
Patients with impaired renal function or severe liver disease should take Ambrobene with extreme caution, observing long intervals between doses or taking the drug in a lower dose.
Use during pregnancy and breastfeeding
Pregnancy. There is insufficient data regarding the use of ambroxol during pregnancy. In particular, this applies to the first 28 weeks of pregnancy. Animal studies have not revealed a teratogenic effect.
The use of Ambrobene during pregnancy (II-III trimester) is possible only as prescribed by a doctor, after a thorough assessment of the risk/benefit ratio.
Breastfeeding period. Animal studies have shown that ambroxol passes into breast milk. Due to insufficient study of the use of the drug in women during breastfeeding, the use of Ambrobene is possible only as prescribed by a doctor, after a thorough assessment of the risk/benefit ratio.
Directions for use and doses
Use of the drug internally
The drug is taken orally after meals, adding to water, juice or tea using the supplied measuring cup.
Children under 2 years of age should take 1 ml of the drug 2 times a day (15 mg ambroxol per day).
Children from 2 to 6 years old should take 1 ml of the drug 3 times a day (22.5 mg ambroxol per day).
Children from 6 to 12 years old should take 2 ml of the drug 2-3 times a day (30 - 45 mg ambroxol per day).
Adults and children over 12 years of age should take 4 ml of the drug 3 times a day (90 mg ambroxol per day) in the first 2-3 days of treatment. If therapy is ineffective, adults can increase the dose to 8 ml of the drug 2 times a day (120 mg ambroxol per day). In the following days, you should take 4 ml of the drug 2 times a day (60 mg ambroxol per day).
Use of the drug in the form of inhalations
When using the drug Ambrobene in the form of inhalations, you can use any modern equipment (except for steam inhalers). Before inhalation, the drug is mixed with a 0.9% sodium chloride solution (for optimal air humidification, it can be diluted in a 1:1 ratio) and heated to body temperature. Since during inhalation therapy, a deep breath can provoke coughing impulses, inhalations should be carried out in normal breathing mode. Patients with bronchial asthma can be recommended to carry out inhalation after taking bronchodilator drugs.
For inhalation, the following dosages are used (1 ml of solution contains 7.5 mg of ambroxol):
children under 2 years of age: 1 ml of solution 1-2 times a day (7.5-15 mg ambroxol per day);
children from 2 to 6 years: 2 ml of solution 1-2 times a day (15-30 mg ambroxol per day);
children over 6 years of age and adults: 2-3 ml of solution 1-2 times a day (15-45 mg ambroxol per day).
The duration of treatment is selected individually depending on the course of the disease. It is not recommended to take Ambrobene for more than 4-5 days without a doctor's prescription.
The mucolytic effect of the drug occurs when taking large amounts of fluid, so drinking plenty of fluids is recommended during treatment.
Side effect
The incidence of side effects is classified according to the recommendations of the World Health Organization: very often - at least 10%; often – at least 1%, but less than 10%; infrequently - at least 0.1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - less than 0.01%.
From the immune system: uncommon - hypersensitivity reaction, frequency not established - anaphylactic reactions, including rash, itching, urticaria, angioedema, anaphylactic shock.
From the nervous system: often - impaired taste perception.
From the gastrointestinal tract: often – nausea; uncommon – dryness of the mucous membrane of the mouth and throat, vomiting, dyspepsia, abdominal pain, diarrhea.
Overdose
Symptoms There were no signs of intoxication with an overdose of ambroxol. There are reports of nervous agitation and diarrhea.
Ambroxol is well tolerated when taken orally at doses up to 25 mg/kg/day.
In case of severe overdose, increased salivation, nausea, vomiting, and decreased blood pressure are possible.
Treatment. Intensive therapy methods, such as inducing vomiting and gastric lavage, should be used only in cases of severe overdose, in the first 1-2 hours after taking the drug. Symptomatic treatment is indicated.
Interaction with other drugs
With the simultaneous use of ambroxol and antitussives, stagnation of secretions may occur due to suppression of the cough reflex. Such combinations should be selected with caution.
When ambroxol is taken together with the antibiotics amoxicillin, cefuroxime, erythromycin and doxycycline, the concentration of the latter in sputum and bronchial secretions increases.
special instructions
It should not be combined with antitussive drugs that impede the removal of sputum.
In children under 2 years of age, the drug can only be used as prescribed by a doctor. Severe skin reactions, such as Stevens-Johnson syndrome and Lyell's syndrome, have been observed extremely rarely with the use of ambroxol. If there is a change in the skin or mucous membranes, you must immediately consult a doctor and stop taking the drug.
Impact on the ability to drive vehicles and machinery
There have been no studies on the effect of Ambrobene on the ability to drive vehicles and operate machinery. If side effects develop, caution should be exercised when performing actions that require increased concentration and speed of psychomotor reactions.
Release form
Solution for oral administration and inhalation 7.5 mg/ml.
40 or 100 ml of the drug in a dark glass bottle, sealed with a dropper stopper and a plastic screw cap. One bottle with instructions for use and a measuring cup is placed in a cardboard box, on which protective stickers can additionally be applied.
Storage conditions
Store at a temperature not exceeding 25 ºС.
Keep out of the reach of children!
Best before date
5 years.
After opening the bottle, the drug is suitable for use for 1 year.
Do not use after the expiration date.
Vacation conditions
Available without a prescription.
Contraindications
Despite its harmlessness, Ambrobene has many contraindications. "Ambrobene" in all forms of release is prohibited from taking in the following conditions:
- first trimester of pregnancy;
- hypersensitivity to the active substance and (or) to other components.
Other contraindications depend on the form of release of the medicine. Capsules should not be given to children under 12 years of age. Tablets are prohibited in a number of cases:
- disturbances in the absorption of galactose and glucose - GGM syndrome, malabsorption;
- lactase deficiency;
- lactose intolerance;
- children under 6 years old;
You should not drink syrup if you have the following health problems:
- fructose intolerance;
- GGM syndrome
- malabsorption (intolerance) of sucrose and isomaltose;
Ambrobene should be taken with great caution for many conditions and diseases:
- exacerbation of stomach ulcers and duodenal ulcers;
- serious kidney and liver diseases (it is necessary to reduce the dose of the medicine and increase the time intervals between doses);
- primary ciliary dyskinesia;
- second and third trimester of pregnancy;
- breastfeeding period.
Caution when taking tablets must be strictly observed: do not increase the dose without the doctor's permission and do not take the drug too often.
Ambrobene 30 mg No. 20 tab.
Instructions for medical use of the drug Ambrobene Trade name Ambrobene® International nonproprietary name Ambroxol Dosage form Tablets, 30 mg Composition One tablet contains the active substance: ambroxol hydrochloride 30.0 g, excipients: lactose monohydrate, corn starch, magnesium stearate, colloidal silicon dioxide anhydrous. Description Tablets, white, round, with a biconvex surface, scored on one side, height (3.4 ± 0.3) mm, diameter (9.0 ± 0.2) mm. Pharmacotherapeutic group Expectorants. Mucolytics. ATC code R 05CB 06 Pharmacological properties Pharmacokinetics After oral administration, Ambroxol is almost completely absorbed from the gastrointestinal tract. The maximum plasma concentration of the drug occurs after 1-3 hours. Protein binding 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 production and expectoration of sputum is impaired: - acute and chronic bronchitis, pneumonia - bronchial asthma with difficulty in sputum discharge - bronchiectasis. Directions for use and dosage: Ambrobene® tablets are taken orally after meals with sufficient water. Swallow whole without chewing. Adults: in the first 2-3 days, 1 tablet 3 times a day, then 1 tablet 2 times or 1/2 tablet 3 times a day. Children 6-12 years old: 1/2 tablet 2-3 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 Rarely - gastralgia, nausea, vomiting - hypersensitivity reactions (skin rash, facial swelling, dyspnea, itching) - fever Very rarely - allergic reactions, including anaphylactic shock. Contraindications - hypersensitivity to ambroxol and/or other components of the drug - first trimester of pregnancy - children under 6 years of age Drug interactions With the simultaneous use of Ambrobene® and: - antitussive drugs - it may be difficult to remove phlegm 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 Despite the fact that to date there is no reliable data on the negative effects of Ambrobene on the fetus and infants, the use of Ambrobene® 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. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms Does not affect Overdose Symptoms: agitation, diarrhea, increased salivation, vomiting and hypotension Treatment: symptomatic therapy. Release form and packaging 10 tablets in a blister pack made of polyvinyl chloride film and printed aluminum foil. 1 or 2 contour packages together with instructions for medical use in the state and Russian languages are placed in a cardboard box. Storage conditions Store at a temperature not exceeding 25˚C. Keep out of the reach of children! Shelf life: 5 years Do not use after expiration date! Dispensing conditions Without a prescription, Germany Registration certificate holder "ratiopharm GmbH", Germany Address of the organization that accepts claims from consumers on the quality of products (products) in the territory of the Republic of Kazakhstan "ratiopharm Kazakhstan" LLP, 050000, Almaty, Al-Farabi Ave. 13, BC Nurly-Tau, 1B, office 305, phone/68/73/75, Fax, email
Overdose symptoms
Cases of Ambrobene poisoning due to overdose have not been recorded. If the dose is sharply exceeded, diarrhea and restlessness may occur. The maximum daily dose should not exceed 25 mg per 1 kg of human weight.
Signs of a severe overdose:
- decrease in pressure;
- vomiting and nausea;
- increased salivation.
If these symptoms appear, then in the first 1–2 hours after taking the medicine, the patient should rinse the stomach.