ORVIS Broncho - instructions for use, dose, side effects, contraindications

Excipients: sodium chloride - 6.220 mg; sodium hydrogen phosphate dihydrate - 4,350 mg; citric acid monohydrate - 2,000 mg; benzalkonium chloride 0.225 mg; purified water - 989.705 mg.

Description:

Transparent from a colorless to brownish solution with a weak characteristic odor.

Pharmacotherapeutic group:Expectorant, mucolytic agent

ATX: & nbsp

R.05.C.B.06 Ambroxol

Pharmacodynamics:

Ambroxol is active N-detylated metabolite of bromhexine. Has a secreto-motor, secretolitic and expectorant action. Stimulates the work of bronchial glands, increases the motor activity of ciliated epithelium by influencing pneumocytes of type 2 in the alveoli and Clara cells in bronchioles, strengthens the formation of an endogenous surfactant, a surfactant, which ensures the sliding of the bronchial secretion in the airway lumen. Ambroxol increases the proportion of the serous component in the bronchial secret, improving its structure and contributing to a decrease in viscosity and dilution of sputum; as a result of which mucociliary transport (mucociliary clearance) improves. Strengthening mucociliary clearance improves the excretion of sputum from the bronchial tree and facilitates coughing.

On average, when administered orally, the effect of the drug occurs 30 minutes later, the duration of the action is 6-12 hours, depending on the dose taken.

Pharmacokinetics:

After oral administration ambroxol quickly and almost completely absorbed from the gastrointestinal tract. The maximum concentration (C_m_Oh) in the blood plasma for oral administration is achieved in 1-3 hours.The volume of distribution is 552 liters. In the therapeutic concentration range, binding to plasma proteins is 80-90%. The highest concentrations of the active component of the drug are observed in the lungs. Ambroxol penetrates through the placental and blood-brain barrier, excreted in breast milk. Approximately 30% of the oral dose taken is exposed to the effect of a primary pass through the liver. Studies on microsomes of the human liver showed that the isoenzyme CYP3A4 is the predominant isoform responsible for the metabolism of ambroxol to dibromoanthranilic acid. The remaining part of ambroxol is metabolized in the liver by conjugation with the formation of pharmacologically inactive metabolites. The terminal elimination half-life (T1 / 2) of ambroxol from the blood plasma is 10 hours. The total half-life of ambroxol and its metabolites is about 22 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 reason to select a dosage 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;

- bronchiectatic disease.

Contraindications:

Hypersensitivity to ambroxol or other components of the drug, pregnancy (I trimester), the period of breastfeeding.

Carefully:

Renal failure and / or severe hepatic impairment; peptic ulcer of the stomach and duodenum in the period of exacerbation; pregnancy (II-III trimester); violation of bronchial motility and increased secretion of mucus (with the syndrome of immobile cilia).

Pregnancy and lactation:

The use of the drug in the first trimester of pregnancy and during breastfeeding is contraindicated. The use of the drug in the II and III trimesters of pregnancy is possible only after a thorough assessment of the relationship between the benefits of treatment and the possible risks.

Dosing and Administration:

Ingestion (1 ml = 25 drops)

Adults and children over 12 years of age: the first 2-3 days by 4 ml (100 drops) 3 times a day (corresponding to 90 mg of ambroxol per day), then 4 ml 2 times a day (corresponding to 60 mg of ambroxol per day).

Children from 6 to 12 years: by 2 ml (50 drops) 2-3 times a day (corresponding to 30 or 45 mg ambroksola per day).

Children from 2 up to 6 years: 1 ml (25 drops) 3 times a day (corresponding to 22.5 mg of ambroxol per day).

Children up to 2 years: by 1 ml (25 drops) 2 times a day (corresponding to 15 mg ambroksola per day).

Children younger than 2 years of age, the drug is prescribed only under the supervision of a doctor.

The maximum daily intake for ingestion: for adults - 90 mg, for children 6-12 years - 45 mg, for children 2-6 years - 22.5 mg, for children up to 2 years - 15 mg.

The drug is used after eating, adding water, tea, milk or fruit juice.

During treatment, you need to consume a lot of fluids (water, tea, juice) to enhance the mucolytic effect of the drug.

Inhalation

Adults and children over 6 years of age: 1-2 inhalation for 2-3 ml (50-75 drops) solution per day (corresponding to 15-45 mg ambroksola per day).

Children until 6 years: 1-2 inhalations of 2 ml (50 drops) of solution per day (corresponding to 15-30 mg of ambroxol per day).

The drug can be used using any modern equipment for inhalation (except for steam inhalers). To achieve optimal humidification during inhalations, the preparation is mixed with 0.9% sodium chloride solution in a ratio of 1: 1.Since inhalation therapy can cause a deep inhalation of a cough, inhalation should be performed in the usual breathing mode. Before inhalation it is usually recommended to warm the inhalation solution to body temperature. Patients with bronchial asthma should be given inhalation after taking bronchodilators, to avoid nonspecific irritation of the respiratory tract and their spasm.

If the symptoms persist for 4-5 days after the start of treatment, it is recommended that you consult a doctor.

Side effects:

Possible side effects are given in the following gradation: very often (> 1/10), often (> 1/100 to <1/10), infrequently (> 1/1000 to <1/100), rarely (> 1/10000 to <1/1000), very rarely (<1/10000), is unknown (can not be estimated based on available data).

Disturbance of the gastrointestinal tract:

Often - nausea, decreased sensitivity in the mouth or throat;

Infrequently - indigestion, vomiting, diarrhea, abdominal pain;

Rarely - dryness of the mucous membrane of the mouth and pharynx;

Unknown - heartburn, constipation.

Disturbances from the respiratory system:

Rarely - dryness of the mucous membrane of the respiratory tract, rhinorrhea.

Disorders from the nervous system:

Often - dysgeusia (a violation of taste sensations).

Immune system disorders:

Rarely, hypersensitivity reactions, skin rashes, hives, itching, angioedema;

In isolated cases - anaphylactic reactions, including anaphylactic shock.

Disturbances from the skin and subcutaneous tissues:

Very rarely - toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome.

Other:

Unknown - adynamia, fever.

Overdose:

Specific symptoms of an overdose of ambroxol in humans are not described. Observed symptoms of overdose corresponded to known side effects of ambroxol used in recommended doses (nausea, vomiting, abdominal pain, diarrhea, indigestion).

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

Interaction:

With the simultaneous use of ambroxol and antitussive drugs as a result of suppressing the cough reflex, sputum discharge can be difficult.With simultaneous use with amoxicillin, doxycycline, cefuroxime, erythromycin ambroxol increases their concentration in the bronchial secretion.

Special instructions:

Ambroxol should not be combined with antitussive drugs that make it difficult to withdraw phlegm.

To maintain secretionolytic action during the period of application of the drug, it is necessary to ensure the intake of enough liquid in the body.

In patients with bronchial asthma ambroxol can strengthen cough.

The preparation contains benzalkonium chloride (preservative), which, when inhaled, can cause bronchospasm in sensitive patients with increased reactivity of the respiratory tract.

The drug should not be mixed with cromoglycic acid and alkaline solutions.

Patients who observe the hyponatric diet, it is necessary to take into account that 1 ml of the drug contains 10 mg of sodium. In the maximum daily dose (12 ml) for adults and children over 12 years old contains 120 mg of sodium.

There are isolated reports of the detection of Stevens-Johnson syndrome and the syndrome Lyell, coinciding with the appointment of ambroxol, however, there is no causal relationship with taking the drug. In most cases, they can be explained by the severity of the underlying disease and / or concomitant therapy. Have patients with Stevens-Johnson or Lyell syndrome in the early phase may appear temperature, pain in the body, rhinitis, cough and sore throat. With symptomatic treatment possibly erroneous administration of mucolytic agents, such as ambroxol hydrochloride. With the development of the above mentioned syndromes, it is recommended to stop ambroxol treatment and immediately seek medical help. In severe renal failure (creatinine clearance less than 30 ml / min), it is necessary to take into account the danger of accumulation of metabolites of ambroxol.

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

The drug does not affect the performance of potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions (driving, working with driving mechanisms, etc.).

Form release / dosage:

Solution for ingestion and inhalation 7.5 mg / ml.

Packaging:

To 50, 100 ml in bottles made of brown or orange glass for medicines, sealed with stoppers-droppers and caps screwed with the control of the first autopsy.Each bottle, together with instructions for use, is placed in a pack of cardboard. It is allowed to insert a measuring cup into a pack of cardboard.

Storage conditions:

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-004198

Date of registration:17.03.2017

Expiration Date:17.03.2022

The owner of the registration certificate:EVALAR, CJSC EVALAR, CJSC Russia

Manufacturer: & nbsp

EVALAR, CJSC Russia

Information update date: & nbsp13.04.2017

Illustrated instructions

Instructions

ORVIS® Bronho (ORVIS® Broncho)