Composition, structure and packing
Tablets are white, round, biconvex, with one-sided separation mark.
1 tab. ambroxol hydrochloride 30 mg.
Excipients: lactose, corn starch, magnesium stearate, silicon dioxide highly dispersed. Retard capsules with an opaque upper part brown and transparent colorless lower part, the contents of capsules - from white to slightly yellowish pellets.
1 capsule. ambroxol hydrochloride 75 mg.
Excipients: microcrystalline cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, methylhydroxypropylcellulose, eudragit RS 30D, trietiltsitrat, colloidal silicon besieged, gelatin, titanium dioxide, iron oxide (yellow, red, black). Solution for oral and inhalation transparent, colorless to slightly yellowish, odorless.
1 ml ambroxol hydrochloride 7.5 mg.
Excipients: potassium sorbate, hydrochloric acid, purified water.
Syrup: Clear, colorless to slightly yellowish, odorless. 5 ml ambroxol hydrochloride 15 mg Excipients: sorbitol liquid (noncrystallizing), propylene glycol, raspberry flavor, saccharin, purified water.
Injection solution is transparent, from colorless to slightly yellowish, odorless.
1 amp. ambroxol hydrochloride 15 mg.
Other ingredients: citric acid monohydrate, sodium chloride, disodium monogidrogenfosfat geptagidrat, water d / and.
Clinico-pharmacological group: mucolytic and expectorant drug.
Pharmacological action
Mucolytic and expectorant drug. Ambroxol - the 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 bronchial glands of the shell, the formulation of enzymes that break down the relationship between polysaccharides of sputum, the formation of surfactant and direct the activity of the cilia of the bronchi, preventing them from sticking together. Once inside the therapeutic effect after 30 minutes and lasts for 6-12 hours (depending on the applied dose). When a parenteral drug effect comes quickly and lasts for 6-10 hours
Pharmacokinetics
Absorption and distribution
When parenteral administration ambroxole rapidly penetrates into tissue. The highest concentration found in the lungs. Cmax plasma levels achieved after 1-3 hours with plasma protein binds approximately 80% of the drug. Ambroxol penetrates through the BBB and placental barrier, excreted in breast milk.
Metabolism and excretion
The drug is metabolized in the liver by conjugation with the formation of pharmacologically inactive metabolites. About 90% of ambroxol excreted in the urine: 90% of them in the form of metabolites and 10% unchanged.
Pharmacokinetics in special clinical situations
In severe liver clearance ambroxol decreases by 20-40%. In severely impaired renal function increases T1 / 2 ambroxol and its metabolites.
Statement
All forms of the drug used for respiratory diseases with separation of viscous sputum and difficulty of its separation of:
Acute and chronic bronchitis;
pneumonia;
asthma;
bronchiectasis;
in the complex therapy to stimulate the synthesis of surfactant for respiratory distress syndrome in premature infants and neonates (injection).
Dosage regimen
The drug, taken orally after meal with plenty of liquid (a glass of water, tea or juice). Tablets for adults and children over the age of 12 years in the first 2-3 days appoint 1 tab. 3 times / day (90 mg / day). In a further move to 2-single dose of the drug for 1 / 2 tab. / day (30 mg / day).
Children aged 6 to 12 years in the first 2-3 days appoint 1 / 2 tab. 2-3 times / day (30-45 mg / day). In a further move to half-board receiving the drug for 1 / 2 tab. / day (30g/sut). Retard capsules for adults and children over the age of 12 years, appoint 1 kaps. / day after dinner (75 mg / day). The syrup should be taken with measuring cup: 1 ml of syrup contains 3 mg of ambroxol.
Children under 2 years prescribers to 2.5 ml of syrup two times a day (15 mg / day).
Children aged 2 to 6 years prescribers of 2.5 ml of syrup 3 times / day (22.5 mg / day). Children aged 6 to 12 years prescribed the drug to 5 ml of syrup 2-3 Rza / day (30-45 mg / day).
Adults and children over the age of 12 years during the first days of 10 ml of syrup 3 times / day (90 mg / day). In the subsequent 10 ml of syrup two times a day (60 mg / day). Ambrobene in syrup form for oral administration is the most convenient dosage form for treatment of childhood.
Solution for oral and inhalation should be taken by mouth with measuring cup: 1 ml solution contains 7.5 mg of ambroxol.
Children under 2 years of prescribers and 1 mL 2 times / day (15 mg / day).
Children aged 2 to 6 years of prescribed medication to 1 ml 3 times / day (22.5 mg / day).
Children aged 6 to 12 years prescribed the drug for 2 mL 2-3 times / day (30-45 mg / day).
Adults and teenagers in the first 2-3 days appoint to 4 ml 3 times / day (90 mg / day). In the next few days - to 4 mL 2 times / day (60 mg / day). In applying Ambrobene by inhalation using any modern equipment (except steam inhalation).
Before inhalation of the drug should be mixed with 0.9% sodium chloride solution (for optimal humidification can be diluted in a ratio of 1:1) and heated to body temperature. Inhalation should be done in the usual mode of breathing, not to provoke cough shock.
Patients with asthma to avoid non-specific respiratory irritation and spasm before the inhalation of ambroxol should be used bronchodilators.
Children under 2 years ingaliruyut to 1 ml 1-2 times / day (7.5-15 mg / day).
Children aged 2 to 6 years ingaliruyut to 2 mL 1-2 times / day (15-30 mg / day).
Adults and children over the age of 6 years ingaliruyut of 2-3 ml 1-2 times / day (15-45 mg / day). Solution for injection should be administered in / in (slow jet or drip). The solvent used 0.9% sodium chloride solution, 5% dextrose, Ringer-Locke or any other base solution with a pH no higher than 6.3.
Children are usually prescribe medication in a daily dose rate of 1.2-1.6 mg / kg body weight.
Children under the age of 2 years appoint 1 ml (1 / 2 amp.) 2 times / day (15 mg / day). Children aged 2 to 6 years appoint 1 ml (1 / 2 amp.) 3 times / day (22.5 mg / day).
Children under the age of 6 appointed to 2 ml (1 amp.) 2-3 times / day (30-45 mg / day). Adults appoint an amp. 2-3 times / day (30-45 mg / day). In severe cases, the dose may be increased to 2 amp. 2-3 times / day (60-92 mg / day).
In respiratory distress syndrome in newborn and premature babies daily dose is 30 mg, usually divided into 4 separate introduction. Injection stopped after the disappearance of acute manifestations of the disease and pass on the ingestion of other medicines Ambrobene.
Treatment of children under 2 years should be undertaken only under medical supervision. The drug should drink plenty of liquids.
Duration of treatment depends on the characteristics of the disease. Do not use the drug without a doctor's appointment more than 4-5 days.
Side effect
On the part of the digestive system: rarely - salivation, stomachalgia, nausea, vomiting, diarrhea, constipation.
On the part of the respiratory system: rarely - dry mouth and respiratory tract, running nose.
Allergic reactions: very rare - rash, angioedema person, respiratory failure, temperature reaction with chills, in some cases - contact dermatitis, anaphylactic shock.
Other: weakness, headache, dysuria, rash.
With the rapid i / in the introduction: intense headaches, tiredness and heaviness in the legs, numbness, increased blood pressure, dyspnea, pyrexia, chills.
Contraindications
ulcer of the stomach and duodenum;
epileptic syndrome;
children under 6 years (for tablets, capsules retard, solution for injection);
children under the age of 12 years (for capsules retard);
Hypersensitivity to the drug's components.
With care use in patients with renal dysfunction and severe liver disease, reducing the dose and increasing the time between taking the drug (treatment in such cases should be under the supervision of a physician).
With great caution and only under medical supervision should be applied Ambrobene with dysmotility bronchi and large amounts of allocated secret to avoid the risk of stagnation secretion in the bronchi.
Pregnancy and lactation
Since so far there are no reliable data on negative influence of ambroxol on the fetus and newborn Ambrobene use during pregnancy, especially in the I trimester and during breast-feeding is possible only when the intended benefits to the mother outweighs the potential risk to the fetus.
Application for violations of liver function
Sostorozhnostyu use in patients with severe liver disease, reducing the dose and increasing the time between taking the drug (treatment in such cases should be under the supervision of a physician).
Application for violations of renal function
Sostorozhnostyu use in patients with renal failure, reducing the dose and increasing the time between taking the drug (treatment in such cases should be under the supervision of a physician).
Cautions
Special instructions to the drug is not available.
Overdose
Ambroxol is well tolerated when administered at a dose of 25 mg / kg / day.
Symptoms: increased saliva, nausea, vomiting, decrease blood pressure.
Treatment: gastric lavage in the first 1-2 h after drug administration, reception of fat-containing products.
Should monitor hemodynamics. If necessary, carry symptomatically.
Drug Interactions
The simultaneous use of Ambrobene with drugs, possessing antitussive activity (such as those containing codeine), is not recommended because of difficulties removing phlegm from the bronchial tubes in the background to reduce coughing.
The simultaneous use of Ambrobene with antibiotics (including amoxicillin, cefuroxime, erythromycin, doxycycline) improves the flow of antibiotics into the pulmonary route.
Such interaction with doxycycline is widely used for therapeutic purposes. Do not use for injection mixture Ambrobene with solutions having pH above 6.3.
Terms and Conditions of storage
The tablets, capsules, retard, and injection (List B) should be stored out of reach of children under normal circumstances. Solution for oral and inhalation should be stored out of reach of children at or above 25 ° C.
Expiration of tablets, capsules retard and solution for oral and inhalation - 5 years.
Expiration date syrup and solution for injection - 4 years.
Tablets are white, round, biconvex, with one-sided separation mark.
1 tab. ambroxol hydrochloride 30 mg.
Excipients: lactose, corn starch, magnesium stearate, silicon dioxide highly dispersed. Retard capsules with an opaque upper part brown and transparent colorless lower part, the contents of capsules - from white to slightly yellowish pellets.
1 capsule. ambroxol hydrochloride 75 mg.
Excipients: microcrystalline cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, methylhydroxypropylcellulose, eudragit RS 30D, trietiltsitrat, colloidal silicon besieged, gelatin, titanium dioxide, iron oxide (yellow, red, black). Solution for oral and inhalation transparent, colorless to slightly yellowish, odorless.
1 ml ambroxol hydrochloride 7.5 mg.
Excipients: potassium sorbate, hydrochloric acid, purified water.
Syrup: Clear, colorless to slightly yellowish, odorless. 5 ml ambroxol hydrochloride 15 mg Excipients: sorbitol liquid (noncrystallizing), propylene glycol, raspberry flavor, saccharin, purified water.
Injection solution is transparent, from colorless to slightly yellowish, odorless.
1 amp. ambroxol hydrochloride 15 mg.
Other ingredients: citric acid monohydrate, sodium chloride, disodium monogidrogenfosfat geptagidrat, water d / and.
Clinico-pharmacological group: mucolytic and expectorant drug.
Pharmacological action
Mucolytic and expectorant drug. Ambroxol - the 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 bronchial glands of the shell, the formulation of enzymes that break down the relationship between polysaccharides of sputum, the formation of surfactant and direct the activity of the cilia of the bronchi, preventing them from sticking together. Once inside the therapeutic effect after 30 minutes and lasts for 6-12 hours (depending on the applied dose). When a parenteral drug effect comes quickly and lasts for 6-10 hours
Pharmacokinetics
Absorption and distribution
When parenteral administration ambroxole rapidly penetrates into tissue. The highest concentration found in the lungs. Cmax plasma levels achieved after 1-3 hours with plasma protein binds approximately 80% of the drug. Ambroxol penetrates through the BBB and placental barrier, excreted in breast milk.
Metabolism and excretion
The drug is metabolized in the liver by conjugation with the formation of pharmacologically inactive metabolites. About 90% of ambroxol excreted in the urine: 90% of them in the form of metabolites and 10% unchanged.
Pharmacokinetics in special clinical situations
In severe liver clearance ambroxol decreases by 20-40%. In severely impaired renal function increases T1 / 2 ambroxol and its metabolites.
Statement
All forms of the drug used for respiratory diseases with separation of viscous sputum and difficulty of its separation of:
Acute and chronic bronchitis;
pneumonia;
asthma;
bronchiectasis;
in the complex therapy to stimulate the synthesis of surfactant for respiratory distress syndrome in premature infants and neonates (injection).
Dosage regimen
The drug, taken orally after meal with plenty of liquid (a glass of water, tea or juice). Tablets for adults and children over the age of 12 years in the first 2-3 days appoint 1 tab. 3 times / day (90 mg / day). In a further move to 2-single dose of the drug for 1 / 2 tab. / day (30 mg / day).
Children aged 6 to 12 years in the first 2-3 days appoint 1 / 2 tab. 2-3 times / day (30-45 mg / day). In a further move to half-board receiving the drug for 1 / 2 tab. / day (30g/sut). Retard capsules for adults and children over the age of 12 years, appoint 1 kaps. / day after dinner (75 mg / day). The syrup should be taken with measuring cup: 1 ml of syrup contains 3 mg of ambroxol.
Children under 2 years prescribers to 2.5 ml of syrup two times a day (15 mg / day).
Children aged 2 to 6 years prescribers of 2.5 ml of syrup 3 times / day (22.5 mg / day). Children aged 6 to 12 years prescribed the drug to 5 ml of syrup 2-3 Rza / day (30-45 mg / day).
Adults and children over the age of 12 years during the first days of 10 ml of syrup 3 times / day (90 mg / day). In the subsequent 10 ml of syrup two times a day (60 mg / day). Ambrobene in syrup form for oral administration is the most convenient dosage form for treatment of childhood.
Solution for oral and inhalation should be taken by mouth with measuring cup: 1 ml solution contains 7.5 mg of ambroxol.
Children under 2 years of prescribers and 1 mL 2 times / day (15 mg / day).
Children aged 2 to 6 years of prescribed medication to 1 ml 3 times / day (22.5 mg / day).
Children aged 6 to 12 years prescribed the drug for 2 mL 2-3 times / day (30-45 mg / day).
Adults and teenagers in the first 2-3 days appoint to 4 ml 3 times / day (90 mg / day). In the next few days - to 4 mL 2 times / day (60 mg / day). In applying Ambrobene by inhalation using any modern equipment (except steam inhalation).
Before inhalation of the drug should be mixed with 0.9% sodium chloride solution (for optimal humidification can be diluted in a ratio of 1:1) and heated to body temperature. Inhalation should be done in the usual mode of breathing, not to provoke cough shock.
Patients with asthma to avoid non-specific respiratory irritation and spasm before the inhalation of ambroxol should be used bronchodilators.
Children under 2 years ingaliruyut to 1 ml 1-2 times / day (7.5-15 mg / day).
Children aged 2 to 6 years ingaliruyut to 2 mL 1-2 times / day (15-30 mg / day).
Adults and children over the age of 6 years ingaliruyut of 2-3 ml 1-2 times / day (15-45 mg / day). Solution for injection should be administered in / in (slow jet or drip). The solvent used 0.9% sodium chloride solution, 5% dextrose, Ringer-Locke or any other base solution with a pH no higher than 6.3.
Children are usually prescribe medication in a daily dose rate of 1.2-1.6 mg / kg body weight.
Children under the age of 2 years appoint 1 ml (1 / 2 amp.) 2 times / day (15 mg / day). Children aged 2 to 6 years appoint 1 ml (1 / 2 amp.) 3 times / day (22.5 mg / day).
Children under the age of 6 appointed to 2 ml (1 amp.) 2-3 times / day (30-45 mg / day). Adults appoint an amp. 2-3 times / day (30-45 mg / day). In severe cases, the dose may be increased to 2 amp. 2-3 times / day (60-92 mg / day).
In respiratory distress syndrome in newborn and premature babies daily dose is 30 mg, usually divided into 4 separate introduction. Injection stopped after the disappearance of acute manifestations of the disease and pass on the ingestion of other medicines Ambrobene.
Treatment of children under 2 years should be undertaken only under medical supervision. The drug should drink plenty of liquids.
Duration of treatment depends on the characteristics of the disease. Do not use the drug without a doctor's appointment more than 4-5 days.
Side effect
On the part of the digestive system: rarely - salivation, stomachalgia, nausea, vomiting, diarrhea, constipation.
On the part of the respiratory system: rarely - dry mouth and respiratory tract, running nose.
Allergic reactions: very rare - rash, angioedema person, respiratory failure, temperature reaction with chills, in some cases - contact dermatitis, anaphylactic shock.
Other: weakness, headache, dysuria, rash.
With the rapid i / in the introduction: intense headaches, tiredness and heaviness in the legs, numbness, increased blood pressure, dyspnea, pyrexia, chills.
Contraindications
ulcer of the stomach and duodenum;
epileptic syndrome;
children under 6 years (for tablets, capsules retard, solution for injection);
children under the age of 12 years (for capsules retard);
Hypersensitivity to the drug's components.
With care use in patients with renal dysfunction and severe liver disease, reducing the dose and increasing the time between taking the drug (treatment in such cases should be under the supervision of a physician).
With great caution and only under medical supervision should be applied Ambrobene with dysmotility bronchi and large amounts of allocated secret to avoid the risk of stagnation secretion in the bronchi.
Pregnancy and lactation
Since so far there are no reliable data on negative influence of ambroxol on the fetus and newborn Ambrobene use during pregnancy, especially in the I trimester and during breast-feeding is possible only when the intended benefits to the mother outweighs the potential risk to the fetus.
Application for violations of liver function
Sostorozhnostyu use in patients with severe liver disease, reducing the dose and increasing the time between taking the drug (treatment in such cases should be under the supervision of a physician).
Application for violations of renal function
Sostorozhnostyu use in patients with renal failure, reducing the dose and increasing the time between taking the drug (treatment in such cases should be under the supervision of a physician).
Cautions
Special instructions to the drug is not available.
Overdose
Ambroxol is well tolerated when administered at a dose of 25 mg / kg / day.
Symptoms: increased saliva, nausea, vomiting, decrease blood pressure.
Treatment: gastric lavage in the first 1-2 h after drug administration, reception of fat-containing products.
Should monitor hemodynamics. If necessary, carry symptomatically.
Drug Interactions
The simultaneous use of Ambrobene with drugs, possessing antitussive activity (such as those containing codeine), is not recommended because of difficulties removing phlegm from the bronchial tubes in the background to reduce coughing.
The simultaneous use of Ambrobene with antibiotics (including amoxicillin, cefuroxime, erythromycin, doxycycline) improves the flow of antibiotics into the pulmonary route.
Such interaction with doxycycline is widely used for therapeutic purposes. Do not use for injection mixture Ambrobene with solutions having pH above 6.3.
Terms and Conditions of storage
The tablets, capsules, retard, and injection (List B) should be stored out of reach of children under normal circumstances. Solution for oral and inhalation should be stored out of reach of children at or above 25 ° C.
Expiration of tablets, capsules retard and solution for oral and inhalation - 5 years.
Expiration date syrup and solution for injection - 4 years.
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