Toraxol Solution Tablets, 30 mg 10 pcs

Ambroxol has secretomotor, secretolytic and expectorant action: it stimulates serous glands cells of bronchial mucosa, increases the content of mucous secretion and release of surfactant (surfactant) in alveoli and bronchi; normalizes the disturbed ratio of serous and mucous components of sputum. By activating hydrolyzing enzymes and increasing the release of lysosomes from the clara cells, it reduces the viscosity of sputum. Increases motor activity of the cilia of the atomizing epithelium. Increases the flow and transport of mucus (mucociliary clearance). Increased mucociliary clearance improves sputum discharge and facilitates cough.
Pharmacokinetics
Ambroxol is characterized by rapid and almost complete absorption from the gastrointestinal tract (GIT) with a linear dependence on the dose in therapeutic concentration range.
Bioavailability is 70-80%. Maximal concentration (Cmax) in blood plasma is reached after 0.5-3 hours when administered orally. In the therapeutic range of concentrations binding to plasma proteins is approximately 90%.
Transition of ambroxol from blood to tissues during oral administration occurs rapidly.
The highest concentrations of the active component of the drug are observed in the lungs. It penetrates through the blood-brain barrier, placental barrier, excreted with breast milk.
About 30% of the administered oral dose is subjected to the effect of primary passage through the liver. Studies on human liver microsomes have shown that CYPCA4 is the predominant isoform responsible for ambroxol metabolism. The remainder of ambroxol is metabolized in the liver to inactive metabolites. The half-life (T1/2) of ambroxol is 10 hours. Renal excretion: 90% as metabolites, 10% unchanged.
No clinically significant effect of age and sex on ambroxol pharmacokinetics was found, so there is no reason to adjust the dose by these characteristics.

Indications

Active ingredient

How to take, the dosage

Interaction

Special Instructions

Ambroxol should not be taken simultaneously with anti-cough drugs that may inhibit the cough reflex.
Ambroxol should be used with caution in patients with impaired cough reflex or impaired mucociliary transport due to the possibility of sputum accumulation.
In severely ill patients dilute sputum should be aspirated.
In patients with bronchial asthma, ambroxol may increase cough.
Ambroxol should not be taken immediately before bedtime.
In patients with severe skin lesions, Stevens-Johnson syndrome or Lyell syndrome, fever, body pain, rhinitis, cough and sore throat may occur in the early phase. Mucolytic agents such as ambroxol hydrochloride may be prescribed incorrectly in symptomatic treatment. There have been single reports of Stevens-Johnson syndrome and Lyell syndrome coinciding with the prescription of the drug; however, there is no causal relationship with the drug administration.
In the development of the above syndromes it is recommended to stop treatment and seek medical attention immediately.
In renal function disorders ambroxol should be used only on the recommendation of the doctor.

The effect on the ability to drive and operate machinery is not known to date.

Contraindications

Hypersensitivity to ambroxol or to one of the excipients; phenylketonuria; pregnancy (first trimester); lactation.
Childhood under 12 years of age (for dispersible tablets 60 mg).

Bronchial motor dysfunction and increased sputum formation (in immobile cilia syndrome), gastric and duodenal ulcer during exacerbation, pregnancy (II-III trimester).
Patients with impaired renal function or severe liver disease should take ambroxol with extreme caution, observing long intervals between doses of the drug or taking the drug in a smaller dose.
Use during pregnancy and breast-feeding
Ambroxol penetrates through the placental barrier. The drug is not recommended to use during the first trimester of pregnancy. If it is necessary to use ambroxol in the II-III trimesters of pregnancy, the potential benefit to the mother with a possible risk to the fetus should be evaluated.
During breastfeeding, the drug is contraindicated because it is excreted with the breast milk.

Side effects

Overdose

Similarities