Thoraxol Solventshn Tablets - instructions for use, dose, side effects, contraindications

Excipients: cellulose microcrystalline 249.5 mg, crospovidone 100,0 mg, aspartame 20.0 mg, black currant flavor 6.5 mg, sodium stearyl fumarate 3.5 mg, sodium saccharinate 4.0 mg, citric acid 15.0 mg, silicon dioxide colloid 1.5 mg.

Active substance: Ambroxol hydrochloride 60.0 mg.

Excipients: cellulose microcrystalline 544.5 mg, crospovidone 100,0 mg, aspartame 20.0 mg, black currant flavor 6.5 mg, sodium stearyl fumarate 7.0 mg, sodium saccharinate 4.0 mg, citric acid 15.0 mg, silicon dioxide colloid 3.0 mg.

Description:

Round, flat tablets of white or white with a yellowish tint of color, with the smell of black currant. Allowed a slight marbling.

Dosage of 30 mg: with a cross-shaped risk on one side and chamfers on both sides.

Dosage of 60 mg: with a risk on one side and chamfers from two sides.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

Ambroxol has secretory, secretory and expectorant action: it stimulates serous cells of the glands of the mucous membrane of the bronchi, increases the content of mucous secretions and the release of surfactant (surfactant) in the alveoli and bronchi; normalizes the disturbed ratio of serous and mucous components of sputum. By activating hydrolysing enzymes and by increasing the release of lysosomes from Clara cells, reduces the viscosity of sputum. Increases the motor activity of the cilia of the ciliated epithelium.Strengthens the current and transport of mucus (mucociliary clearance). Strengthening mucociliary clearance improves sputum discharge and facilitates coughing.

Pharmacokinetics:

For ambroksola 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 (Cmah) in blood plasma for oral intake is achieved after 0.5 - 3 hours. In the therapeutic concentration range, binding to plasma proteins is approximately 90%.

The transfer of ambroxol from the blood to the tissue with oral administration occurs rapidly. The highest concentrations of the active component of the drug are observed in the lungs. Penetrates through the blood-brain barrier, placental barrier, excreted in breast milk.

Approximately 30% of the administered oral dose is subjected to the effect of a primary pass through the liver. Studies on microsomes of the human liver have shown that CYP3A4 is the predominant isoform responsible for the metabolism of ambroxol. The rest of the ambroxol is metabolized in the liver to inactive metabolites. The half-life (T1/2) of ambroxol is 10 hours. It is excreted by the kidneys: 90% in the form of metabolites, 10% in unchanged form.

There is no clinically significant effect of age and sex on the pharmacokinetics of ambroxol, so there is no basis for dose adjustment for these features.

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 in sputum discharge, bronchiectasis.

Contraindications:

Hypersensitivity to ambroxol or to one of the excipients; phenylketonuria; pregnancy (I trimester); lactation period.

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

Carefully:

Disturbance of motor function of the bronchi and increased sputum production (with the syndrome of immobile cilia), peptic ulcer of the stomach and duodenum during the exacerbation, pregnancy (II-III trimester).

Patients with impaired renal function or severe liver disease should take ambroxol with extreme caution, observing large intervals between doses of the drug or taking the drug in a smaller dose.

Pregnancy and lactation:

Ambroxol penetrates the placental barrier. The drug is not recommended for use during the first trimester of pregnancy. If it is necessary to use ambroxol in II-III trimesters of pregnancy should be evaluated for potential benefits to the mother with a possible risk to the fetus.

During the period of breastfeeding, the drug is contraindicated because it is excreted in breast milk.

Dosing and Administration:

Inside. The tablets are dissolved in a small amount of water (about 20 ml) to obtain a suspension, can also be swallowed whole, divided into parts, washed down with water. You can take the pill regardless of the meal.

Adults and children over 12 years: 30 mg (1 tablet 30 mg or 1/2 tablet 60 mg) 3 times a day.

If necessary, 60 mg (2 tablets 30 mg or 1 tablet 60 mg) can be administered twice a day to enhance the therapeutic effect.

Children from 6 to 12 years: 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: 7.5 mg (1/4 tablet 30 mg) 3 times a day, previously dissolved in a small amount of water.

Children under 2 years: 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 the appointment of a doctor for more than 4-5 days.

Side effects:

Gastrointestinal disorders: heartburn, dyspepsia, diarrhea, nausea, vomiting, pain in the upper abdomen, decreased sensitivity in the mouth or throat, dry mouth and throat, dysgeusia (a 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.

Overdose:

Symptoms: heartburn, indigestion, diarrhea, nausea, vomiting, pain in the upper abdomen. With severe overdose, it is possible to lower blood pressure.

Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after taking the drug; reception of fat-containing products, symptomatic therapy.

Interaction:

When used with antitussive drugs, it may be difficult for sputum to escape as a result of suppressing the cough reflex. With simultaneous use with amoxicillin, cefuroxime, erythromycin ambroxol increases their concentration in the bronchial secretion.No clinically relevant adverse interactions with other drugs have been reported.

Special instructions:

Ambroxol should not be taken concomitantly with antitussive drugs that can inhibit cough reflex.

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

In seriously ill patients, aspiration of diluted sputum should be performed.

In patients with bronchial asthma ambroxol can strengthen cough.

Do not take ambroxol just before bed.

In patients with severe skin lesions - Stevens-Johnson syndrome or Lyell's syndrome - in the early phase, fever, body pain, rhinitis, cough and sore throat may appear. With symptomatic treatment, it is possible to erroneously administer mucolytic agents, such as ambroxol hydrochloride. There are isolated reports of the detection of Stevens-Johnson syndrome and Lyell's syndrome, coinciding with the appointment of the drug; but there is no causal relationship with taking the drug.

With the development of the above syndromes, it is recommended to stop treatment and immediately seek medical help.

In case of impaired renal function ambroxol should be used only on the advice of a doctor.

Effect on the ability to drive transp. cf. and fur:

The impact on the ability to drive vehicles and control mechanisms is not known to this day.

Form release / dosage:

Tablets are dispersible 30 mg, 60 mg.

Packaging:

For 10, 20, 30 and 50 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

By 10, 20, 30, 40, 50, 60 or 100 tablets in cans of polymeric for medicines. One jar or 1, 2, 3, 4, 5, 6 or 10 contour squares, together with the instructions for use, are placed in a cardboard package (bundle).

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-002265

Date of registration:04.10.2013

The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Information update date: & nbsp22.09.2015

Illustrated instructions

Instructions

Thoraxol Solidshn Tablets (Toraxol Solution Tablets)