Ambroxol is the active l metabolite of bromhexine. It has sekretomotornym, sekretoliticheskim and expectorant action. It stimulates serous cells of glands of bronchial mucosa by increasing mucin content and thus changes the disturbed ratio of serous and mucous components of phlegm. Ambroxol content increases mucous secretion and release of surfactant (surfactant) in the alveoli and primo steroid bronchi. Increases motor activity of ciliated epithelium, increases mucociliary phlegm transport. On average, orally effect occurs within 30 minutes, the duration – 6-12 hours.
After ingestion ambroxol rapidly and almost completely absorbed from the gastrointestinal tract. The maximum plasma concentration (C max ) is achieved after approximately 1-3 hours. The resulting metabolites (such as dibromantranilovaya acid glucuronide) excreted by the kidneys. Distribution . Binding to plasma proteins – about 85% (80-90%). Ambroxol penetrates through the blood-brain and placental barriers and is excreted in breast milk. Metabolism . Ambroxol is metabolized in the liver by conjugation to form a pharmacologically inactive metabolites. Excretion . Because of the high degree of binding to plasma proteins and large distribution volume, and slow reverse distribution of tissue elimination significantly ambroxol blood by dialysis or forced diuresis not be expected.
Acute and chronic diseases of the respiratory tract, accompanied by violation of the secretion and transport of sputum:
- acute and chronic bronchitis;
- chronic obstructive pulmonary disease;
- bronchial asthma with obstruction of primo steroid sputum discharge;
- Hypersensitivity to ambroxol or other components of the preparation.
- Children up to age 6 years.
- dysmotility bronchi and formation of secretions in large quantities (for example, a rare syndrome of fixed cilia);
- renal failure or hepatic insufficiency;
- peptic ulcer and 12 duodenal ulcer.
Pregnancy and lactation
Use of the drug in the I trimester of pregnancy is contraindicated. In II and III trimester of pregnancy, the drug should be taken with caution.
Use of the drug during lactation is possible only if the expected benefit of treatment to the mother outweighs the potential risk to the infant.
Dosage and administration:
Tablets for oral use.
Tablets are taken after a meal, without chewing and drinking plenty of fluids. It is recommended to observe the following dosages: Children aged 6 to 12 years old : 2-3 times daily 1/2 tablet (respectively, 2-3 times 15 mg of ambroxol hydrochloride). Adults and children over 12 years : during the first 2- 3 days, take 3 times a day 1 tablet (respectively, 3 times 30 mg of ambroxol hydrochloride), then – 2 times a day 1 tablet (or 2 x 30 mg of ambroxol hydrochloride). If necessary for enhancing the therapeutic effect can be given 2 tablets 2 times a day (corresponding to 120 mg ambroxol hydrochloride / day). In renal failure, or severe liver disease should increase the interval between doses, or reduce the dose while taking the drug. The duration of the application is installed on an individual basis depending on the evidence and the disease. Without a doctor’s primo steroid appointment should not take more than 4-5 days.
Possible side effects are listed below in descending frequency of occurrence: Sometimes including isolated reports. Allergic reactions : sometimes – skin rash, urticaria, angioedema edema, pyrexia, dyspnea; very rarely – anaphylactic shock. From the digestive system : sometimes – diarrhea, dry mouth, constipation; long-term use – abdominal pain, nausea, vomiting. For the skin : very rarely – toxic epidermal necrolysis, Stevens-Johnson syndrome. Other : rarely – weakness, headache, rash, dysuria.
Symptoms of a person overdose have not been described.
There are: short-term anxiety, diarrhea, nausea, vomiting.
If a significant excess of the dose (more than 25 mg / kg / day) may decrease blood pressure, excessive salivation. Treatment : artificial vomiting, gastric lavage in the first 1 -2 hours after ingestion;reception of fat-containing products; symptomatic therapy.
Interaction with other drugs
the combined use ambroxol and antitussive drugs that suppress the cough reflex, due to the weakening of the cough reflex may be a risk of stagnation in the bronchi. Increases penetration in bronchial secretion of amoxicillin, cefuroxime, erythromycin and doxycycline.
Patients with severe renal insufficiency primo steroid should take into account the possibility of cumulation of ambroxol metabolites formed in the liver.
Necessary to ensure entry to the body fluid in sufficient quantity to maintain sekretoliticheskim action Ambroxol during ingestion.