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Ambrohexal solution for inhalation instructions for use

Ambrohexal solution for inhalation instructions for use

Production: LICHTENHELDT, GmbH Pharmazeutische Fabrik (Germany)

ATX Code: R05CB06 (Ambroxol)

Release form: solution for inhalation

Dosage Form: clear, colorless liquid

Clinico-pharmacological group: mucolytic and expectorant drug

Pharmacotherapeutic group: sputum thinner

Composition

Active ingredient: Ambroxol hydrochloride - 7.5 mg / ml

Auxiliary components : sodium disulfate, sodium hydroxide, propyl para-hydroxybenzoate, citric acid, purified water.

Packaging

Bottle-dropper dark glass, 50 ml (1), measuring cup, cardboard pack.

Pharmacodynamics

Ambrohexal is an organic compound with expectorant, secretolytic and secretive motor action. Due to the depolymerization of mucopolysaccharides contained in the sputum, associated with a rupture in the molecules of disulfide bonds, the drug helps to reduce the viscosity of sputum, normalizing the ratio of the serous and mucous components, increases the motor activity of the ciliated epithelium, increases mucolytic transport (removal of pathogenic agents) and facilitates the removal of sputum from the respiratory tract. By having a direct effect on Clark's cells located in the bronchial tubes of the lungs and alveolar pneumocytes of type II, Ambrohexal contributes to the activation of surfactant (surfactant that prevents the alveoli from collapsing on expiration).

The therapeutic effect occurs 30 minutes after taking the drug. Duration of action, depending on the dose taken - 6-12 hours.

Pharmacokinetics

After ambrohexal inhalation, the degree of absorption of the drug is 25-30% of the injected dose. Most concentrated in the lungs. It decomposes with the formation of metabolites excreted by the kidneys (glucuronides, dibromantranilic acid).

Plasma protein binding is 80-90%. 90% of the drug is excreted in the form of metabolites by the kidneys, 10% - unchanged. Due to the high association with plasma proteins, a large initial volume of distribution and slow redistribution from tissues into the blood, during the hemodialysis process and with forced diuresis, the drug is not released.

In severe liver disease, Ambrohexal clearance is reduced by 20-40%. In severe renal impairment, the T1 / 2 metabolites of the drug increase.

Ambrohexal is able to penetrate into the cerebrospinal fluid, pass through the placenta and pass into breast milk.


Indications for use

  • Acute and chronic pathologies of the respiratory system, occurring in violation of the formation and discharge of sputum;
  • Acute bronchitis ;
  • Chronic bronchitis of unspecified etiology;
  • Bronchiectasis;
  • Bronchial asthma;
  • Chronic obstructive pulmonary disease (COPD);
  • Bacterial pneumonia, not classified elsewhere;
  • Treatment and prevention of respiratory distress syndrome.

Dosage

1 milliliter - 20 drops.

Children over 5 years old and adults are prescribed inhalations 1-2 times a day (2-3 ml, 40-60 drops).

Children up to 5 years old inhalation 1-2 times a day, 2 ml (40 drops).

The procedure is carried out using an inhaler (special device for inhalation).

Side effect

On the part of the digestive tract: abdominal pain, nausea, vomiting, diarrhea, constipation (≥0.1% to <1%);

Allergic reactions: skin rash, itching, urticaria , angioedema of the face (from ≥0.1% to <1%);

Anaphylactic reactions, including anaphylactic shock (<0.01%);

General disorders: headache, weakness, fever (from ≥0.1% to <1%);

Other disorders: rhinorrhea, drying of the mucous membrane of the mouth and respiratory tract, dysuric disorders, exanthematic rash, change in taste sensations (from ≥0.1% to <1%).


Contraindications

  • Hypersensitivity to the drug;
  • I trimester of pregnancy.

Patients with increased sputum formation (immobile cilia syndrome), impaired bronchial motor function, exacerbation of gastric ulcer and 12 p. guts, in the II and III trimester of pregnancy and during lactation, the drug is used very carefully.

Special care should be exercised in case of severe renal and hepatic pathologies. In this situation, the solution for inhalation should be taken in a smaller dose, or between intervals the methods are kept for longer intervals.

To date, medicine does not have accurate data on the use of the drug in the first 28 weeks of pregnancy. In the II and III trimesters, the use of the drug should be carried out only with the permission of the doctor, after carefully weighing the ratio of the intended benefits of therapy for the mother and the potential risk to the fetus.

The use of the solution for inhalation during breastfeeding of the child is also insufficiently studied. Therefore, the decision on the appropriateness of taking the drug should be made by the attending physician, taking into account the risk to the child and the expected benefit to the mother.

When conducting experiments on animals, it was found that Ambrohexal does not have a teratogenic effect (does not violate the processes of embryogenesis), is reabsorbed from human milk.

Special indications when using

With extreme caution should be used in patients with a weakened cough reflex or impaired mucociliary transport, as in this situation, inhalation can cause sputum accumulation. Also during the period of treatment is not recommended to perform breathing exercises. In patients with asthma while using the drug may increase cough.

Patients with impaired tolerance to fructose before proceeding to inhalation, you should consult with your doctor.

Data on the impact on the ability to drive vehicles and control of various mechanisms is not available.

Interaction with other drugs

With the simultaneous use of Ambrohexal injectable solution with antitussives, inhibiting the cough reflex, sputum stagnation can occur, leading to the development of fairly dangerous conditions. Therefore, such combinations should be chosen with extreme caution.

With the combined use of Ambrohexal and antibacterial drugs ( amoxicillin , erythromycin, cefuroxime and doxycycline) there is a significant increase in the concentration of etiotropic components in the bronchial secretions.

Terms of sale of the drug

Ambrohexal inhalation solution refers to non-prescription drugs.

Storage conditions

Store in a dark, out of reach of children, at a temperature not exceeding 25 C.

Shelf life

Ambrohexal inhalation solution is suitable for use within 4 years from the date of issue. Use of the product after the expiration date indicated on the package is prohibited.

Analogs of Ambrohexal

  • Ambrobene
  • Lasolvan
  • Bronchoxol
  • Bronchovern

Prices for solution for inhalation Ambrohexal

Ambrohexal solution for ingestion and inhalation 50ml - from $ 100.

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