Ambroxol: instructions for use
Production: MERCKLE, GmbH (Germany).
ATX Code: R05CB06 (Ambroxol).
Release form: tablets.
Dosage form: flat-cylindrical tablets of white or yellowish-white color with risk and a facet.
Clinico-pharmacological group: mucolytic and expectorant drug
Pharmacotherapeutic group: sputum thinner
Active ingredient: Ambroxol hydrochloride - 30 mg / mg
- calcium stearate;
- potato starch;
- lactose monohydrate;
- silica colloidal anhydrous.
A mucolytic (sputum-thinning) agent with expectorant, secretolytic and secretory-motive action. Due to the depolymerization of mucopolysaccharides contained in the sputum, the drug helps to reduce the viscosity of sputum, normalizes the ratio of serous and mucous components, increases the motor activity of ciliated epithelium, increases mukolytsiarny transport (removal of pathogenic agents) and facilitates the excretion of sputum from the respiratory tract. Having a direct effect on Clark's cells located in the bronchial tubes of the lungs, and on type II alveolar pneumocytes, Ambroxol contributes to the activation of surfactant (surfactant that prevents alveolar collapse on expiration).
The therapeutic effect occurs 30 minutes after taking the drug. Duration of action, depending on the dose taken - 6-12 hours.
When administered orally, Ambroxol is rapidly and almost completely absorbed from the gastrointestinal tract into the tissue, accumulating in the largest amounts in the lungs. Maximum concentration reaches in 1-3 hours.
The absolute bioavailability due to the biotransformation of the medicinal substance is reduced by about 1/3. Dibromantralic acid and glucuronides are excreted by the kidneys due to persistent metabolism.
Plasma protein binding is 80-90%. 90% of the drug is excreted in the form of metabolites, 10% - unchanged. Due to the high association with plasma proteins, a large initial volume of distribution and slow redistribution from tissues to blood, there is no significant excretion of the drug during forced diuresis and dialysis.
In severe liver pathologies, Ambroxol clearance is reduced by 20-40%. In severe renal impairment, the T1 / 2 metabolites of the drug increase.
Ambroxol can penetrate into the cerebrospinal fluid, pass through the placenta and pass into breast milk.
Indications for use
- Acute and chronic pathologies of the respiratory system, occurring in violation of the formation and discharge of sputum;
- Acute bronchitis ;
- Chronic bronchitis of unspecified etiology;
- Bronchial asthma;
- Chronic obstructive pulmonary disease (COPD);
- Respiratory distress syndrome in newborns and premature babies;
- Bacterial pneumonia of unspecified etiology.
The duration of treatment is chosen individually, taking into account the natural course of the pathological process. Without prescription, the drug is not recommended to take more than 4-5 days. During the period of use of the drug, plenty of drink is prescribed (dilution of sputum requires the ingestion of a large amount of liquid). Tablets should be taken after meals with water.
Children from 6 to 12 years old - ½ tablet (15 mg) 2-3 times a day;
Children over 12 years old and adult patients - 1 tablet (30 mg) 3 times a day. After 8-10 days, the dose should be reduced to two doses.
- : боли в животе, тошнота, рвота, диарея, запоры (от ≥0.1% до <1%); On the part of the digestive tract : abdominal pain, nausea, vomiting, diarrhea, constipation (≥0.1% to <1%);
- : кожная сыпь, зуд, крапивница , ангионевротический отек лица (от ≥0.1% до <1%); Allergic reactions : skin rash, itching, urticaria , angioedema of the face (from ≥0.1% to <1%);
- , в т. ч. анафилактический шок (<0.01%); Anaphylactic reactions , including anaphylactic shock (<0.01%);
- : головная боль, слабость, лихорадочное состояние (от ≥0.1% до <1%); General disorders : headache, weakness, fever (from ≥0.1% to <1%);
- : ринорея, пересыхание слизистой оболочки ротовой полости и дыхательных путей, дизурические расстройства, экзантематозные высыпания (от ≥0.1% до <1%). Other : rhinorrhea, drying of the mucous membrane of the mouth and respiratory tract, dysuric disorders, exanthematic lesions (≥0.1% to <1%).
Contraindications to use
- Hypersensitivity to the drug;
- Individual intolerance to fructose;
- Glucose and malabsorption;
- Isomaltose / sucrose deficiency;
- I trimester of pregnancy.
Patients with increased sputum formation (immotile cilia syndrome), impaired bronchial motor function, with exacerbation of gastric ulcer and 12 p. intestines, in the II and III trimester of pregnancy and in the period of lactation it is necessary to follow the rules of admission and precautions.
In severe renal and hepatic pathologies, Ambroxol tablets are taken at a lower dose, or longer intervals are maintained between doses.
To date, medicine does not have accurate data on the use of the drug in the first 28 weeks of pregnancy. In the II and III trimesters, the use of the drug should be carried out only with the permission of the doctor, after carefully weighing the ratio of the intended benefits of therapy for the mother and the potential risk to the fetus.
The use of Ambroxol tablets in women during breastfeeding is also not well understood. The decision on the appropriateness of taking medication is taken by the attending physician. This takes into account the risk to the child and the expected benefits to the mother.
When conducting experiments on animals, it was found that Ambroxol does not have a teratogenic effect (does not violate the processes of embryogenesis), is reabsorbed from human milk.
Interaction with other drugs
With simultaneous use of Ambroxol tablets with other antitussive drugs that inhibit the cough reflex, sputum stagnation can occur, leading to the development of fairly dangerous conditions. Therefore, such combinations of drugs should be chosen with extreme caution.
The combined use of Ambroxol and antibacterial drugs ( amoxicillin , erythromycin, cefuroxime and doxycycline) leads to a significant increase in the concentration of etiotropic components in bronchial secretions.
If there are changes on the part of the skin and mucous membranes, taking the drug should be stopped and consult a doctor.
Data on the impact on the ability to drive vehicles and control of various mechanisms is not available.
In case of overdose of the drug, intoxication was not detected. Possible development of diarrhea and the emergence of signs of nervous excitement. When taking excessively large doses, there may be a decrease in blood pressure, increased salivation, nausea and vomiting. In this situation, in the first 1-2 hours after using the drug, the victim should have a gastric lavage and, if necessary, use other methods of intensive therapy. Next, the patient is prescribed symptomatic treatment.
Terms of implementation
Ambroxol tablets are non-prescription drugs.
Store in a dark, protected from light and moisture, out of the reach of children, at a temperature not exceeding 25 C.
Ambroxol in tablet form is usable for 3 years from the date of issue. Use of the product after the expiration date indicated on the package is prohibited.
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Ambroxol tablet prices
Ambroxol tablets 30 mg, 40 pcs. - from 125r.