Orvis Broncho Ambroxol oral and inhalation solution 7.5mg/ml, 100ml

Composition

1 ml of the solution contains an Active ingredient: Ambroxol Hydrochloride-7,500 mgsupportable Substances: Sodium chloride-6,220 mg Sodium hydrophosphate dihydrate-4,350 mg Citric acid monohydrate-2,000 mg Benzalkonium chloride-0.225 mg Purified water-989.705 mg

Pharmacological action

Pharmacotherapeutic group: expectorant, mucolytic agent

ATX code: R05 CB 06

Pharmacological properties

Pharmacodynamics

Ambroxol is an active N-demethylated metabolite of Bromhexinee.

It has secretomotor, secretolytic and expectorant effects.

It stimulates the work of the bronchial glands, increases the motor activity of the ciliated epithelium by affecting type 2 pneumocytes in the alveoli and Klara cells in the bronchioles, increases the formation of endogenous surfactant – a surfactant that ensures the sliding of bronchial secretions in the lumen of the respiratory tract.

Ambroxol increases the proportion of the serous component in bronchial secretions, improving its structure and helping to reduce the viscosity and dilution of sputum; as a result, mucociliary transport (mucociliary clearance) improves.

Increased mucociliary clearance improves sputum removal from the bronchial tree and eases coughing.

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

Pharmacokinetics

After oral use, ambroxol is rapidly and almost completely absorbed from the gastrointestinal tract.

The maximum concentration (Cmax) in blood plasma with oral use is reached after 1-3 hours. The volume of distribution is 552 liters. In the therapeutic range of concentrations, binding to plasma proteins is

80-90%. The highest concentrations of the active component of the drug are observed in the lungs.

Ambroxol penetrates the placental and blood-brain barriers and is excreted in breast milk.

Approximately 30% of the oral dose received is affected by the primary passage through the liver.

Studies on human liver microsomes have shown that the CYP3A4 isoenzyme is the predominant isoform responsible for the metabolism of ambroxol to dibromanthranilic acid.

The remainder of ambroxol is metabolized in the liver by conjugation to form pharmacologically inactive metabolites.

The terminal plasma half-life (T 1/2) of ambroxol is 10 hours.

The total elimination half-life of ambroxol and its metabolites is about 22 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 select the dosage based on these signs.

Indications

ARVIS Broncho is used in the treatment of acute and chronic diseases with the release of viscous sputum: — chronic obstructive pulmonary disease-acute and chronic bronchitis-pneumonia— bronchial asthma with difficulty expectorating – bronchiectasis

Contraindications

Hypersensitivity to ambroxol or other components of the drug, pregnancy (I trimester), breast-feeding. With caution:  — Renal failure and / or severe hepatic insufficiency;— peptic ulcer of the stomach and duodenum in the period of exacerbation; – pregnancy (II-III trimester);- violation of bronchial motility and increased mucus secretion (with fixed cilia syndrome).

Side effects

Possible side effects are listed in the following gradation: very common (> 1/10), common (>>1/100 to >>< 1/10), uncommon (> 1/1000 to < 1/10), uncommon (>< 1/100), rare (> 1/10000 to < 1/100), rare (>< 1/1000), very rare (Gastrointestinal disorders: Often – nausea, decreased sensitivity in the oral cavity or pharynx; Infrequently-dyspepsia, vomiting, diarrhea, abdominal pain; Rarely-dryness of the oral and pharyngeal mucosa; Unknown-heartburn, constipation. Respiratory system disorders: Rarely – dryness of the mucous membrane of the respiratory tract, rhinorrhea. Disorders of the nervous system: Often-dysgeusia (violation of taste sensations). Immune system disorders: Rarely-hypersensitivity reactions, skin rash, urticaria, pruritus, angioedema;In rare cases-anaphylactic reactions, including anaphylactic shock. Skin and subcutaneous tissue disorders: Very rarely – toxic epidermal necrolysis (Lyell’s syndrome), Stevens-Johnson syndrome. Other services: Unknown – adynamia, fever.

Interaction

With the simultaneous use of ambroxol and antitussive drugs, as a result of suppression of the cough reflex, sputum discharge may be difficult. When used concomitantly with amoxicillin, doxycycline, cefuroxime, erythromycin, ambroxol increases their concentration in the bronchial secretions.

How to take, course of use and dosage

Oral use (1 ml = 25 drops)Adults and children over 12 years of age: for the first 2-3 days,4 ml (100 drops) 3 times a day (which corresponds to 90 mg of ambroxol per day), then 4 ml 2 times a day (which corresponds to 60 mg of ambroxol per day). Children from 6 to 12 years: 2 ml (50 drops) 2-3 times a day (which corresponds to 30 or 45 mg of ambroxol per day). Children from 2 to 6 years: 1 ml (25 drops) 3 times a day (which corresponds to 22.5 mg of ambroxol per day). Children under 2 years of age: 1 ml (25 drops) 2 times a day (which corresponds to 15 mg of ambroxol per day). For children under 2 years of age, the drug is prescribed only under the supervision of a doctor. The maximum daily dose when taken orally: for adults-90 mg, for children 6-12 years-45 mg, for children 2-6 years-22.5 mg, for children under 2 years-15 mg. The drug is used after a meal, adding to water, tea, milk or fruit juice. During treatment, it is necessary 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 inhalations of 2-3 ml (50-75 drops) of the solution per day (which corresponds to 15-45 mg of ambroxol per day). Children under 6 years of age: 1-2 inhalations of 2 ml (50 drops) of the solution per day (which corresponds to 15-30 mg of ambroxol per day). The drug can be used using any modern equipment for inhalation (except steam inhalers). To achieve optimal hydration during inhalation, the drug is mixed with 0.9% sodium chloride solution in a ratio of 1: 1. Since deep inhalation therapy can provoke coughing, inhalation should be carried out in normal breathing mode. Before inhalation, it is usually recommended to warm up the inhaled solution to body temperature. Patients with bronchial asthma are recommended to be inhaled after taking bronchodilators, in order to avoid non-specific irritation of the respiratory tract and their spasm. If symptoms persist for 4-5 days from the start of treatment, it is recommended to consult a doctor.

Overdose

Specific symptoms of ambroxol overdose in humans have not been described.

The observed overdose symptoms were consistent with the known side effects of ambroxol used at the recommended doses (nausea, vomiting, abdominal pain, diarrhea, dyspepsia).

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 combined with antitussive agents that make it difficult to remove sputum.

To maintain the secretolytic effect during the use of the drug, it is necessary to ensure that a sufficient amount of fluid enters the body.

In patients with asthma, ambroxol may worsen coughing.

The drug contains benzalkonium chloride (a preservative), which, when inhaled, can cause bronchospasm in sensitive patients with increased airway reactivity.

The drug is not recommended to be mixed with Cromoglicic acid and alkaline solutions.

Patients who follow a hyponatremic diet should take into account that 1 ml of the drug contains 10 mg of sodium. The maximum daily dose (12 ml) for adults and children over 12 years of age contains 120 mg of sodium.

There are isolated reports of the detection of Stevens-Johnson syndrome and Lyell’s syndrome, which coincided with the appointment of ambroxol, but there is no causal relationship with taking the drug.

In most cases, they can be attributed to the severity of the underlying disease and / or concomitant therapy.

Patients with Stevens-Johnson or Lyell 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.

If the above-mentioned syndromes develop, it is recommended to stop treatment with ambroxol and immediately seek medical help.

In severe renal insufficiency (creatinine clearance less than 30 ml/min), the risk of accumulation of ambroxol metabolites should be considered.

Effect of the drug on the ability to drive vehicles and mechanisms

The drug does not affect the performance of potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions (driving a car, working with moving mechanisms, etc. ).

Form of production

Solution for oral use and inhalation 7.5 mg / ml.

50,100 ml in bottles of brown or orange glass for medicines, capped with dropper stoppers and screw-on lids with the control of the first opening.

Each bottle together with the instructions for use is placed in a pack of cardboard.

It is allowed to put a measuring cup in a pack of cardboard.

Storage conditions

At a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

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

Active ingredient

Ambroxol

Dosage form

Oral powder