Ambrohexal

Ambroxol (trade name Ambroxol) is a mucolytic agent used to facilitate expectoration of mucus and secretions from the respiratory tract. It helps to thin and improve mucus discharge, which relieves cough in diseases of the upper and lower respiratory tract, such as bronchitis, tracheitis, bronchial asthma, obstructive pulmonary disease (OPD), bronchiectasis and other conditions accompanied by the formation and retention of mucus in the respiratory tract.

Indications Ambrohexala

1. Acute and chronic bronchitis
2. Pneumonia
3. Chronic obstructive pulmonary disease (COPD)
4. Bronchial asthma with difficulty in expectoration
5. Bronchiectasis
6. Cystic fibrosis

Release form

Ambroxol is available in various forms such as:

• Pills.
• Syrup.

Pharmacodynamics

1. Mucolytic action:

   • Ambroxol thins mucus, reducing its viscosity, making it easier to cough up.
   • This is achieved by influencing mucoproteins and mucopolysaccharides of sputum, as well as by stimulating hydrolyzing enzymes and increasing the production of surfactant.

2. Expectorant action:

   • Ambroxol increases the motor activity of the cilia of the respiratory tract epithelium, which promotes more effective removal of sputum from the respiratory tract.

3. Anti-inflammatory action:

   • Ambroxol has a mild anti-inflammatory effect, reducing inflammation in the airways and reducing irritation.

Pharmacokinetics

Suction:

• Oral absorption: Ambroxol is rapidly and almost completely absorbed from the gastrointestinal tract after oral administration.
• Bioavailability: Absolute bioavailability after oral administration is approximately 70-80% due to the first-pass effect in the liver.

Distribution:

• Plasma protein binding: The drug binds to plasma proteins by approximately 90%.
• Tissue distribution: Ambroxol is well distributed in tissues, especially in the lungs, which ensures its targeted action on the respiratory tract.
• Distribution volume: Approximately 552 l.

Metabolism:

• Hepatic metabolism: Ambroxol is metabolized in the liver, where it is converted to inactive metabolites, mainly through conjugation.
• Main metabolites: Dibromanthranilic acid and glucuronides.

Withdrawal:

• Urinary excretion: Approximately 90% of ambroxol is excreted in urine as metabolites. Less than 10% is excreted unchanged.
• Half-life: The half-life of ambroxol is approximately 10 hours.

Special patient groups:

• Renal impairment: In patients with severe renal impairment, the elimination of ambroxol metabolites may be delayed.
• Hepatic impairment: In patients with hepatic impairment, the metabolism of ambroxol may be slower, which may require dosage adjustment.

Dosing and administration

The dosage of Ambroxol may vary depending on the patient’s age and the severity of the condition. However, the generally recommended dose for adults and children over 12 years is 30 mg 2-3 times a day. For children aged 6 to 12 years, 15 mg 2-3 times a day is generally recommended. Children aged 2 to 6 years are recommended to take 7.5 mg 3 times a day.

The drug is taken during meals with a sufficient amount of liquid (for example, water).

Use Ambrohexala during pregnancy

Efficiency and safety

1. Stimulation of fetal lung maturity: Studies have shown that ambroxol can promote fetal lung maturation by increasing surfactant production, which reduces the risk of respiratory distress syndrome (RDS) in preterm infants. In one study, ambroxol was found to be as effective as betamethasone, but with fewer side effects (Wolff et al., 1987).
2. Prevention of RDS: Ambroxol has been used in several studies to prevent RDS in premature infants. The results showed that ambroxol reduced the incidence of RDS compared to placebo, confirming its effectiveness in this area (Wauer et al., 1982).
3. Antioxidant activity: Ambroxol also exhibits antioxidant properties, which helps reduce oxidative stress in tissues, including the placenta. This may be useful in reducing complications associated with oxidative stress during pregnancy (Chlubek et al., 2001).
4. Side effects and safety: Most studies have found no significant adverse effects in mothers or newborns with ambroxol. One study comparing ambroxol with betamethasone found no significant differences in the incidence of adverse effects between the two groups (Gonzalez Garay et al., 2014).
5. Dosage and Administration: In most studies, ambroxol was administered at a dosage of 1000 mg daily for 5 days, which was found to be effective in stimulating fetal lung maturity and reducing the risk of RDS (Vytiska-Binstorfer et al., 1986).

Contraindications

1. Hypersensitivity or allergic reaction to ambroxol or any other components of the drug.
2. Prolonged bleeding from the upper respiratory tract or pulmonary hemorrhage.
3. Conditions associated with impaired activity of the cilia of the respiratory epithelium (for example, bronchial asthma or chronic obstructive pulmonary disease).
4. Pregnancy (especially in the first trimester) and breastfeeding (data on safety during this period is limited, so use should only be for medical reasons and under the supervision of a physician).
5. Children under 2 years of age (in tablet form).

Side effects Ambrohexala

1. Gastrointestinal disorders: diarrhea, nausea, vomiting, unsatisfactory condition of the stomach.
2. Taste disturbances.
3. Allergic reactions: urticaria, itching, angioedema, allergic dermatitis.
4. Liver dysfunction.
5. Headache, weakness, increased sweating.

Overdose

Overdose of Ambroxol may lead to increased side effects such as nausea, vomiting, headache, increased secretion of the salivary glands and mucous membranes of the respiratory tract.

Interactions with other drugs

Main interactions:

1. Antitussives:

   • Cough suppressants (eg, codeine):
     • Concomitant use with antitussives may lead to difficulty in expectorating sputum, since suppression of the cough reflex can cause stagnation of sputum in the respiratory tract.

2. Antibiotics:

   • Amoxicillin, cefuroxime, erythromycin, doxycycline:
     • Ambroxol may increase the concentration of these antibiotics in bronchial secretions and sputum, which may enhance their therapeutic effect in the treatment of respiratory tract infections.

3. Theophylline:

   • Theophylline:
     • Concomitant use of ambroxol and theophylline may result in increased blood theophylline concentrations, increasing the risk of toxicity. Monitoring of theophylline levels is required when used together.

4. Nonsteroidal anti-inflammatory drugs (NSAIDs):

   • NSAIDs:
     • Concomitant use may increase the risk of gastrointestinal irritation and increased gastric acid secretion. Caution is required when taking concomitantly.

Special instructions:

1. Alcohol:

   • Drinking alcohol may increase the irritating effect of ambroxol on the gastric mucosa, which increases the risk of side effects.

2. Medicines that affect liver function:

   • Drugs that affect liver function may alter the metabolism of ambroxol, which requires caution when using them together.

3. Other mucolytic agents:

   • Concomitant use with other mucolytics may enhance the mucus-thinning effect, which may be beneficial but requires an assessment of the overall therapeutic regimen.