Orvis Broncho Ambroxol, 7.5 mg/ml 100 ml

Pharmacotherapeutic group: expectorant, mucolytic agent

ATC code: R05CB06

Pharmacological properties

Pharmacodynamics

Ambroxol is the active N-demethylated metabolite of bromhexine.

It has secretomotor, secretolytic and expectorant effects.

Stimulates bronchial glands, increases motor activity of the atomizing epithelium by influencing type 2 pneumocytes in alveoli and Clara cells in bronchioles, increases formation of endogenous surfactant – surfactant that ensures gliding of bronchial secretion in the airway lumen.

Ambroxol increases the proportion of the serous component in the bronchial secretion, improving its structure and contributing to the reduction of viscosity and liquefaction of sputum; as a result, mucociliary transport (mucociliary clearance) is improved.

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

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

Pharmacokinetics

After oral administration, ambroxol is quickly and almost completely absorbed from the gastrointestinal tract.

The maximum concentration (Cmax) in blood plasma with oral administration is reached after 1-3 hours. Distribution volume is 552 l. 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 through the placental and blood-brain barrier, is excreted with the breast milk.

About 30% of the oral dose taken is subject to the effect of primary passage through the liver.

The studies on human liver microsomes have shown that the CYP3A4 isoenzyme is the predominant isoform responsible for metabolizing ambroxol to dibromanthranilic acid.

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

The terminal elimination half-life (T1/2) of ambroxol from blood plasma is 10 hours.

The total half-life of ambroxol and its metabolites is about 22 hours. Excreted by the kidneys: 90% as metabolites, 10% unchanged.

There is no clinically significant effect of age and sex on pharmacokinetics of ambroxol; therefore, there is no reason to adjust the dosage according to these characteristics.

Indications

Orovis Broncho is used in the treatment of acute and chronic diseases with discharge of viscous sputum:

– chronic obstructive pulmonary disease

– acute and chronic bronchitis

– pneumonia<– bronchial asthma with sputum retention– bronchiectatic disease

Active ingredient

Ambroxol

Composition

1 ml of the solution contains

Active ingredient:

Ambroxol hydrochloride – 7.500 mg

Excipients:

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

How to take, the dosage

Oral administration (1 ml = 25 drops)

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

To children from 6 to 12 years old: 2 ml (50 drops) 2-3 times a day (corresponding to 30 or 45 mg ambroxol daily).

To children from 2 to 6 years old: 1 ml (25 drops) 3 times a day (corresponding to 22.5 mg ambroxol daily).

To children under 2 years old: 1 ml (25 drops) 2 times a day (corresponding to 15 mg ambroxol daily).

Children under 2 years old are prescribed the preparation only under the control of the physician.

Maximal daily dose for oral administration: For adults – 90 mg, for children 6-12 years old – 45 mg, for children 2-6 years old – 22.5 mg, for children under 2 years old – 15 mg.

The preparation is used after the meal adding it to water, tea, milk or fruit juice.

During the treatment it is necessary to drink a lot of liquids (water, tea, juice) to enhance the mucolytic effect of the preparation.

Inhalations

Adults and children over 6 years of age: 1-2 inhalations with 2-3 ml (50-75 drops) of the solution daily (which corresponds to 15-45 mg ambroxol daily).

To children under 6 years of age 1-2 inhalations 2 ml (50 drops) of the solution daily (which corresponds to
15-30 mg ambroxol daily).

The drug can be used with any modern equipment for inhalation (except for steam inhalers).

In order to achieve optimal hydration during inhalations the preparation is mixed with 0.9% sodium chloride solution in the ratio of 1:1.

Since during the inhalation therapy the deep inhalation may provoke coughing, the inhalation should be performed in the mode of normal breathing.

Before inhalation, it is usually recommended to warm the inhalation solution to body temperature.

Patients with bronchial asthma are recommended to inhale after taking bronchodilators to avoid non-specific irritation of the airways and their spasm.

If the disease symptoms persist for 4-5 days from the beginning of administration it is recommended to consult a doctor.

Interaction

When concomitant use of ambroxol and anti-cough drugs as a result of suppression of the cough reflex, sputum discharge may be difficult.

In concomitant use with amoxicillin, doxycycline, cefuroxime, erythromycin ambroxol increases their concentration in the bronchial secretion.

Special Instructions

Ambroxol should not be combined with cough suppressants that make it difficult to expectorate sputum.

In order to maintain the secretolytic action during the use of the drug it is necessary to provide the body with sufficient fluid intake.

In patients with bronchial asthma, ambroxol may increase coughing.

The drug contains benzalkonium chloride (a preservative), which when inhaled may cause bronchial spasm in sensitive patients with an overactive airway.

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

Patients on 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 old contains 120 mg of sodium.

There have been isolated reports of Stevens-Johnson syndrome and Lyell’s syndrome coinciding with the administration of ambroxol, but there is no causal relationship with the intake of the drug.

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

In patients with Stevens-Johnson or Lyell syndrome, fever, body pain, rhinitis, cough and sore throat may occur in the early phase.

In symptomatic treatment, mucolytic agents such as ambroxol hydrochloride may be mistakenly prescribed.

If the above syndromes develop, it is recommended that ambroxol treatment be discontinued and medical attention sought immediately.

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

The effect of the drug on the ability to drive vehicles and mechanisms

The drug has no effect on performance of potentially hazardous activities requiring increased concentration and quick psychomotor reactions (driving, operating moving mechanisms etc.).

Contraindications

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

With caution:

– Renal insufficiency and/or severe hepatic failure;

– Gastric and duodenal ulcer during exacerbation;

– pregnancy (II-III trimester);

– Bronchial motility disorders and increased mucus secretion (with immobile cilia syndrome).

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Side effects

Possible side effects are graded as follows: very frequently (> 1/10), frequently (> 1/100 to < 1/10), infrequently (> 1/1000 to < 1/100), rarely (> 1/10000 to < 1/1000), very rarely (< 1/10000), unknown (cannot be estimated based on available data).

Gastrointestinal tract disorders:

Frequently – nausea, decreased sensitivity in the mouth or pharynx;

Infrequently – dyspepsia, vomiting, diarrhea, abdominal pain;

Rarely – dryness of the mucous membrane of the oral cavity and pharynx;

Unknown – heartburn, constipation.

Respiratory system disorders:

Rarely – dryness of mucous membrane of airways, rhinorrhea.

Nervous system disorders:

Often – dysgeusia (taste disorders).

Immune system disorders:

Rarely – hypersensitivity reactions, skin rash, urticaria, pruritus, angioedema;

In single cases – anaphylactic reactions, including anaphylactic shock. Skin and subcutaneous tissue disorders:

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

Other:

Unknown – adynamia, fever.

Overdose

No specific symptoms of ambroxol overdose in humans have been described.

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

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

Similarities

Ambrohexal, Lazolvan, Halixol, Ambroxol, Ambrobene, Lazolvan Max, Asterisk, Asterisk for colds