Thoraxol Solution pills Dispersible 30mg, 10pcs

Composition

For 1 tablet:

Active ingredient:  ambroxol hydrochloride 30.0 mg. Auxiliary substances:  cellulose microcrystalline 249,5 mg crospovidone of 20.0 mg, aspartame 20,0 mg, flavor blackcurrant 6.5 mg, sodium fumarate 3.5 mg, sodium saccharin 4.0 mg, citric acid 15,0 mg, silica colloidal anhydrous 1.5 mg

Pharmacological action of

Ambroxol has sekretomotornym, secretolytic and expectorant action: stimulates the serous cells of the glands of the bronchial mucosa, increases the content of mucous secretion and secretion of surfactant (surfactant) in the alveoli and bronchi; normalizes the disturbed ratio of serous and mucous components of sputum. Activating hydrolyzing enzymes and increasing the release of lysosomes from Klara cells reduces the viscosity of sputum. Increases motor activity of cilia of the ciliated epithelium. Increases mucus flow and transport (mucociliary clearance). Increased mucociliary clearance improves sputum discharge and eases coughing. Pharmacokinetics Ambroxol is characterized by rapid and almost complete absorption from the gastrointestinal tract (GIT) with a linear dose dependence in the therapeutic range of concentrations. Bioavailability is 70-80%. The maximum concentration (Cmax) in blood plasma with oral use is reached after 0.5-3 hours. In the therapeutic range of concentrations, plasma protein binding is approximately 90%. The transfer of ambroxol from the blood to the tissues when administered orally is rapid. The highest concentrations of the active component of the drug are observed in the lungs. Penetrates through the blood-brain barrier, placental barrier, is excreted in breast milk. Approximately 30% of the administered oral dose is exposed to the effect of primary passage through the liver. Studies on human liver microsomes have shown that CYP4 is the predominant isoform responsible for ambroxol metabolism. The remainder of ambroxol is metabolized in the liver to inactive metabolites. The half-life (T 1/2) of ambroxol is 10 hours. Excreted by the kidneys: 90% in the form of metabolites,10% unchanged. There was no clinically significant effect of age and gender on the pharmacokinetics of ambroxol, so there is no reason to adjust the dose for these signs.

Indications

Acute and chronic diseases of the respiratory tract with the release of viscous sputum: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease, bronchial asthma with difficulty expectorating sputum, bronchiectatic disease.

Contraindications

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

With caution

Violation of the motor function of the bronchi and increased sputum formation (with fixed cilia syndrome), peptic ulcer of the stomach and duodenum 12 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 at a lower dose. Use during pregnancy and lactation Ambroxol penetrates the placental barrier. The drug is not recommended for use during the first trimester of pregnancy. If ambroxol should be used in the second-third trimesters of pregnancy, the potential benefit to the mother should be evaluated with possible risk to the fetus. During breastfeeding, the drug is contraindicated, since it is excreted in breast milk.

Side effects

Gastrointestinal disorders: heartburn, dyspepsia, diarrhea, nausea, vomiting, pain in the upper abdomen, decreased sensitivity in the mouth or pharynx, dry mouth and throat, dysgeusia (violation of taste sensations). Allergic reactions: allergic reactions (including anaphylactic shock), angioedema, skin rash (exanthema), urticaria, pruritus, and other allergic reactions. Stevens-Johnson syndrome, Lyell’s syndrome. Other: adynamia, fever.

Interaction

When used with antitussive medications, sputum discharge may be difficult as a result of suppression of the cough reflex. When used concomitantly with amoxicillin, cefuroxime, and erythromycin, ambroxol increases their concentration in the bronchial secretions. No clinically significant adverse drug interactions have been reported.

How to take, course of use and dosage

Inside. Tablets are dissolved in a small amount of water (about 20 ml) to obtain a suspension, you can also swallow whole, divide into parts, wash down with water. You can take tablets regardless of food intake. Adults and children over 12 years of age: 30 mg (1 tablet of 30 mg or 1/2 tablet of 60 mg) 3 times a day. If necessary, to enhance the therapeutic effect, you can prescribe 60 mg (2 tablets of 30 mg or 1 tablet of 60 mg) 2 times a day. Children from 6 to 12 years: 15 mg (1/2 tablet 30 mg) 2-3 times a day, pre-dissolved in a small amount of water. Children from 2 to 6 years: 7.5 mg (1/4 tablet 30 mg) 3 times a day, pre-dissolved in a small amount of water. Children under 2 years of age: 7.5 mg (1/4 tablet 30 mg) 2 times a day, pre-dissolved in a small amount of water. It is not recommended to take ambroxol without a doctor’s prescription for more than 4-5 days.

Overdose

Symptoms: heartburn, dyspepsia, diarrhea, nausea, vomiting, upper abdominal pain. With a severe overdose, a decrease in blood pressure is possible. Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; taking fat-containing products, symptomatic therapy.

Special instructions

Ambroxol should not be taken simultaneously with antitussive medications that may inhibit the cough reflex. Ambroxol should be used with caution in patients with a weakened cough reflex or impaired mucociliary transport due to the possibility of sputum accumulation. In seriously ill patients, dilute sputum aspiration should be performed. In patients with asthma, ambroxol may worsen coughing. Do not take ambroxol immediately before bedtime. Patients with severe skin lesions-Stevens-Johnson syndrome or Lyell’s syndrome-may experience fever, body aches, rhinitis, cough, and sore throat in the early phase. With symptomatic treatment, it is possible to mistakenly prescribe mucolytic agents, such as ambroxol hydrochloride. There are isolated reports of Stevens-Johnson syndrome and Lyell’s syndrome being detected at the same time as the drug was prescribed; however, there is no causal relationship with the drug intake. If the above-mentioned syndromes develop, it is recommended to stop treatment and immediately seek medical help. If renal function is impaired, ambroxol should be used only on the recommendation of a doctor.

Influence on the ability to drive motor vehicles and work with mechanisms

The effect on the ability to drive vehicles and control mechanisms is still unknown.

Storage conditions

At a temperature not exceeding 25 °C. Keep out of reach of children. Store contour cell packaging in a cardboard box (pack).

Shelf

life is 3 years. Do not use after the expiration date.

Active ingredient

Ambroxol

Dosage form

Tablets