Ambrobene oral solution 7.5mg ml bottle 100ml
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Active ingredients
Ambroxol
Release form
Solution
Composition
1 ml contains: ambroxol hydrochloride 7.5 mg .; Excipients: potassium sorbate - 1 mg, hydrochloric acid - 0.6 mg, purified water - 991.9 mg.
Pharmacological effect
Mucolytic agent with expectorant action. Stimulates the serous cells of the glands of the mucous membrane of the bronchi, increasing the content of mucous secretion and, thus, alters the disturbed ratio of serous and mucous components of sputum. This activates the hydrolyzing enzymes, and increases the release of lysosomes from Clara cells, which leads to a decrease in sputum viscosity. Ambroxol increases the content of surfactant in the lungs, which is associated with an increase in its synthesis and secretion in the alveolar pneumocytes, as well as a violation of its decay. Increases mucociliary transport of sputum. Slightly suppresses cough.
Pharmacokinetics
After oral administration, Ambroxol is almost completely absorbed from the gastrointestinal tract. Cmax in plasma is reached in approximately 0.5-3 hours. Does not cumulate. Plasma protein binding is about 90%; After ingestion and parenteral administration, Ambroxol is rapidly distributed in the tissues of the body, the highest concentration is determined in the lungs .; It penetrates the BBB and placental barrier, is excreted in breast milk .; Metabolized in the liver by conjugation to form pharmacologically inactive metabolites .; T1 / 2 makes 7-12 hours. It is removed mainly by kidneys in the form of metabolites - 90%, in not changed look - 5% .; T1 / 2 increases with severe chronic renal failure.
Indications
Acute and chronic diseases of the respiratory tract, accompanied by the release of viscous sputum (chronic bronchitis with broncho-obstructive syndrome, bronchial asthma, bronchiectasis). Respiratory distress syndrome in newborns and premature babies.
Contraindications
Peptic ulcer and duodenal ulcer, convulsive syndrome of various etiologies, I trimester of pregnancy, hypersensitivity to Ambroxol.
Use during pregnancy and lactation
Ambroxol is contraindicated in the first trimester of pregnancy.If necessary, use in the II and III trimesters should assess the potential benefit of therapy for the mother and the possible risk to the fetus .; If necessary, the use of ambroxol during lactation should decide on the termination of breastfeeding.
Dosage and administration
Inside adults and children over 12 years old - 30 mg 2-3 times per day; In the form of inhalation in adults and children over 5 years old - at 15-22.5 mg 1-2 times / day; Adults parenterally (v / m, v / v) - 15 mg, in severe cases - 30 mg 2-3 times per day; Children i / m - 1.2-1.6 mg / kg 3 times / day; in / in - 1.2-1.6 mg / kg / day; Children under the age of 2 years in / in - 15 mg / day, the multiplicity of the introduction - 2 times / day; Children from 2 to 5 years in / in - 22.5 mg / day, the multiplicity of the introduction - 3 times / day; Children older than 5 years - 30-45 mg / day, the frequency of administration - 2-3 times / day. For the treatment of respiratory distress syndrome in premature and newborn babies, Ambroxol is administered intravenously or intramuscularly at a dose of 10 mg / kg / day, the frequency of administration is 3-4 times / day, if necessary, the dose can be gradually increased to 30 mg / kg per day
Side effects
On the part of the digestive system: rarely - nausea, vomiting, diarrhea, abdominal pain .; Allergic reactions: skin rash, urticaria, angioedema .; Other: rarely - weakness, headache.
Overdose
Symptoms: Signs of intoxication with ambroxol overdose were not detected. There is information about nervous excitement and diarrhea. Ambroxol is well tolerated when taken orally at a dose of up to 25 mg / kg / day. In case of a severe overdose, excessive salivation, nausea, vomiting, lowering blood pressure are possible .; Treatment: Intensive care methods, such as induction of vomiting, gastric lavage, should be used only in cases of severe overdose, in the first 1-2 hours after taking the drug. Sympathetic treatment is indicated.
Interaction with other drugs
At simultaneous use with antitussive means separation of a sputum becomes difficult against reduction of cough; with amoxicillin, doxycycline, cefuroxime, erythromycin - increasing their penetration into the bronchial secret .; Ambroxol is compatible with drugs that inhibit generic activity.
special instructions
In patients with asthma, in order to avoid nonspecific irritation of the respiratory tract and their spasm before inhalation of ambroxol, bronchodilators can be used.