Toraxol Solution 60mg tablets, No. 10

Diseases of the respiratory tract, accompanied by the release of viscous sputum and difficulty in passing sputum:

• acute and chronic bronchitis;

• pneumonia;

• bronchial asthma;

• bronchiectasis;

• COPD.

Inside.

The tablets are dissolved in a small amount of water (about 20 ml) to obtain a suspension, it can also be swallowed whole, divided into parts, washed down with water. You can take the tablets with or without food.

Adults and children over 12 years old: 30 mg (1 tablet 30 mg or 1/2 tablet 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 old: 15 mg (1/2 tablet 30 mg) 2-3 times a day, previously dissolved in a small amount of water.

Children from 2 to 6 years old: 7.5 mg (1/4 tablet 30 mg) 3 times a day, previously 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, previously 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

Active ingredient: Ambroxol hydrochloride 60.0 mg.

Excipients: microcrystalline cellulose 544.5 mg, crospovidone 40.0 mg, aspartame 20.0 mg, blackcurrant flavor 6.5 mg, sodium stearyl fumarate 7.0 mg, sodium saccharinate 4.0 mg, citric acid 15.0 mg, colloidal silicon dioxide 3.0 mg.

• Hypersensitivity to ambroxol or one of the excipients; phenylketonuria;

• pregnancy (I trimester);

• lactation period.

• Children under 12 years of age (for dispersible tablets 60 mg).

  Carefully

• Violation of the motor function of the bronchi and increased production of sputum (with immobile cilia syndrome), gastric ulcer and 12 duodenal ulcer during an 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

pharmachologic effect

Mucolytic and expectorant agent, is an active N-demethylated metabolite of bromhexine. It has a secretory, secretolytic and expectorant effect. Stimulates serous cells of the bronchial mucosa, increases the motor activity of the ciliated epithelium by acting on type 2 pneumocytes in the alveoli and Clara cells in the bronchioles, enhances the formation of endogenous surfactant - a surfactant that ensures the sliding of bronchial secretions in the airway lumen.

Ambroxol increases the proportion of the serous component in the bronchial secretion, improving its structure and helping to reduce the viscosity and dilute sputum; as a result of this, mucociliary transport is improved and the excretion of sputum from the bronchial tree is facilitated.

When ambroxol is taken orally, the effect, on average, occurs after 30 minutes and lasts 6-12 hours, depending on the single dose.

Pharmacokinetics

After oral administration, Ambroxol is rapidly and almost completely absorbed. Tmax is 1-3 hours. Plasma protein binding is approximately 85%. Penetrates through the placental barrier, excreted in breast milk. It is metabolized in the liver with the formation of metabolites (dibromantranilic acid, glucuronic conjugates), which are excreted by the kidneys. It is excreted mainly by the kidneys - 90% in the form of metabolites, less than 10% unchanged. T1 / 2 from plasma is 7-12 hours. T1 / 2 of ambroxol and its metabolites is approximately 22 hours.

Due to the high binding to proteins and high Vd, as well as the slow reverse penetration from tissues into the blood, during dialysis or forced diuresis, no significant excretion of Ambroxol occurs. Ambroxol clearance in patients with severe hepatic impairment is reduced by 20-40%. In severe renal failure, T1 / 2 of ambroxol metabolites increases.

Side effect

Allergic reactions: rarely - skin rash, urticaria, exanthema, swelling of the face, shortness of breath, itching, fever; frequency unknown - anaphylactic reactions, including anaphylactic shock, angioedema, pruritus, allergic contact dermatitis.

From the digestive system: often - nausea; infrequently - vomiting, diarrhea, dyspepsia, abdominal pain.

From the nervous system: often - dysgeusia.

Skin and subcutaneous tissue disorders: very rarely - toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome; frequency unknown - acute generalized eczematous pustulosis.

From the respiratory system: often - decreased sensitivity in the mouth or pharynx; rarely - dryness of the mucous membrane of the respiratory tract, rhinorrhea; in isolated cases - dryness of the pharyngeal mucosa.

Application during pregnancy and lactation

Ambroxol is contraindicated in the first trimester of pregnancy. If it is necessary to use it in the II and III trimesters, the potential benefit of therapy for the mother and the possible risk to the fetus should be assessed.

If it is necessary to use Ambroxol during lactation, the question of stopping breastfeeding should be resolved.

Application in children

Application is possible in accordance with the dosage regimen.

Use in elderly patients

The drug is approved for use in elderly patients

special instructions

Ambroxol should not be taken concurrently with antitussive drugs that can inhibit the cough reflex, such as codeine. this can make it difficult to remove the liquefied phlegm from the bronchi.

Ambroxol should be used with caution in patients with a weakened cough reflex or impaired mucociliary transport due to the possibility of sputum accumulation.

Patients taking ambroxol are not recommended to perform breathing exercises due to difficulty in sputum discharge. In critically ill patients, aspiration of liquefied sputum should be performed.

You should not take Ambroxol just before bed.

In patients with bronchial asthma, ambroxol may aggravate the cough.

Patients with severe skin lesions - Stevens-Johnson syndrome or toxic epidermal necrolysis - may experience a flu-like condition in the early phase: fever, body pains, rhinitis, cough, pharyngitis. With symptomatic therapy, it is possible to erroneously prescribe mucolytic agents such as ambroxol hydrochloride.

Drug interactions

Antitussives (for example, codeine) - due to the suppression of the cough reflex, sputum may accumulate in the lumen of the respiratory tract with difficulty in removing it (simultaneous use is not recommended).

Amoxicillin, doxycycline, cefuroxime, erythromycin - increased penetration of antibiotics into bronchial secretions.