Treatment of acute and chronic respiratory diseases accompanied by violation of bronchial secretion and evacuation of secretions : including acute and chronic bronchitis, chronic obstructive pulmonary diseases, pneumonia, bronchiectatic disease, bronchial asthma, cystic fibrosis, laryngitis, tracheitis.
Active ingredients: acetylcysteine 200 mg, ambroxol hydrochloride 30 mg.
Excipients: lactose, monohydrate; povidone (K-30); anhydrous colloidal silicon dioxide; crospovidone; sodium lauryl sulfate; hydrogenated vegetable oil.
Pharmacological properties Pulmobriz
Ambroxol hydrochloride has a pronounced expectorant, mucolytic, anti-inflammatory, immunomodulatory, antioxidant and slight antitussive effect. It stimulates serous cells of the glands of the bronchial mucosa, increases the amount of serous secretion and thus changes the disturbed ratio of serous and mucous components. This leads to the normalization of the rheological parameters of sputum, reducing its viscosity and adhesive properties. Directly stimulates the motor activity of the ciliated epithelium of the bronchi, prevents its adhesion and improves mucociliary evacuation of sputum. Ambroxol increases the content of surfactant in the lungs by direct action on type II pneumocytes in the alveoli and on Clara cells in the bronchioles, and also prevents its destruction in pneumocytes. Ambroxol does not cause bronchial obstruction, but, on the contrary, improves the function of external respiration. It has been proven that ambroxol reduces the hyperreactivity of bronchial muscles in patients with asthma.
The local anesthetic effect of Ambroxol hydrochloride was observed in a rabbit eye model, which may be explained by the sodium channel blocking properties. In vitro studies have shown that ambroxol hydrochloride blocks neuronal sodium channels; binding was reversible and concentration dependent.
Ambroxol has an anti-inflammatory effect, which was found in vitro, antioxidant properties, stimulates local immunity and renewal of the natural surfactant layer. When taking ambroxol, patients’ complaints of cough and phlegm are significantly reduced in accordance with the intensity of treatment.
As a result of clinical trials involving patients with pharyngitis, a significant reduction in pain and redness in the throat with the use of ambroxol hydrochloride has been proven.
Pharmacological properties to rapidly relieve pain in the treatment of upper respiratory tract diseases have been observed in studies of the clinical efficacy of inhaled forms of ambroxol.
Acetylcysteine is a mucolytic and expectorant active ingredient. Due to the free sulfhydryl group, it breaks the bisulfide bonds of mucopolysaccharides of sputum, which leads to a decrease in the viscosity of bronchial secretions. Increases mucociliary clearance. It has an antioxidant effect due to its ability to bind free radicals. Increases the synthesis of glutathione, which is an important factor in detoxification; due to this property, acetylcysteine is used to treat acute poisoning with paracetamol, phenols, aldehydes and other substances.
Treatment of acute and chronic diseases of the respiratory tract, accompanied by impaired bronchial secretion and evacuation of secretions: including in acute and chronic bronchitis, chronic obstructive pulmonary diseases, pneumonia, bronchiectasis, bronchial asthma, cystic fibrosis, laryngitis, tracheitis.
- Hypersensitivity to ambroxol, acetylcysteine or other components of the drug.
- Peptic ulcer of the stomach and duodenum in the acute stage.
- Hemoptysis, pulmonary hemorrhage, severe exacerbation of bronchial asthma.
Application during pregnancy or lactation
The drug is not recommended for use in the first trimester of pregnancy.
There is no relevant data on the teratogenic effect of ambroxol hydrochloride and acetylcysteine on the fetus, therefore, it is possible to use the drug in the II-III trimesters of pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus.
Since ambroxol hydrochloride and acetylcysteine pass into breast milk, it is undesirable to take the drug during breastfeeding. If necessary, the appointment of the drug should stop breastfeeding.
There is no evidence of harmful effects on fertility.
Method of administration and dosage
Doses for adults and children over 12 years old: 1 tablet 3 times a day.
Do not exceed the recommended dose.
The duration of treatment should not exceed 5-7 days without consulting a doctor.
For use in children over 12 years of age.
- From the immune system: hypersensitivity reactions, including anaphylactic reactions, anaphylactic shock and angioedema.
- Skin and subcutaneous tissue disorders: itching, urticaria, rash, eczema; severe skin lesions (erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell’s syndrome), acute generalized exanthematous pustulosis).
- From the gastrointestinal tract: nausea, decreased sensitivity in the mouth, heartburn, vomiting, diarrhea, dyspepsia, abdominal pain, dry mouth, dry throat, stomatitis, bad breath, salivation.
- From the respiratory system: decreased sensitivity in the pharynx, shortness of breath (as a hypersensitivity reaction), bronchospasm (mainly in patients with hyperresponsiveness of the bronchial system, associated with bronchial asthma), rhinorrhea.
- From the hearing organs: ringing in the ears.
- From the nervous system: headache, dysgeusia (taste disorder).
- From the side of the cardiovascular system: tachycardia, arterial hypotension.
- General disorders: fever, reactions from the mucous membranes.
With the use of acetylcysteine, bleeding was very rarely reported, most often they were associated with the development of hypersensitivity reactions; cases of anemia, hemorrhage.
There have been cases of a decrease in platelet aggregation, but there is no clinical confirmation of this.
Storage conditions Pulmobriz
Keep out of the reach of children in the original packaging at a temperature not exceeding 25 ° C.