drugs

Ambroxol of I.Randi

Generality

Ambroxol is an active ingredient with a mucolytic action used to fluidify and favor the elimination of thick and viscous mucus that forms in the airways in the presence of disorders and diseases.

Ambroxol belongs to the pharmacotherapeutic group of expectorants and mucolytics and is available in various pharmaceutical formulations suitable for oral, inhalation and rectal administration. It is an active ingredient considered safe and is used both in adults and in children (naturally, at the appropriate dosages).

Ambroxol - whose chemical name is trans-4 - [(2-amino-3, 5-dibromobenzyl) amino] cyclohexanol - is a derivative of bromexine (another active ingredient mucolytic).

Examples of Medicinal Specialties Containing Ambroxol

  • Ambroxol®
  • Broxol®
  • Fluibron®
  • Lintos®
  • Mucosolvan®
  • Zerinol Gola®

Therapeutic indications

When is the use of Ambroxol indicated?

The use of ambroxol is indicated to favor the fluidification, therefore the elimination, of the thick and viscous mucus that is formed in the presence of diseases of the airways of both acute and chronic nature.

Did you know that ...

Ambroxol is available in tablets to be dissolved in the mouth (Zerinol Gola®) with indications for the symptomatic treatment of acute pain of the oral and pharyngeal mucosa (sore throat). In these medicines, the concentration of active ingredient is generally lower than the concentrations used in the medicines used to thin the thick and viscous mucus mentioned above.

Warnings

Warnings and Precautions for the use of Ambroxol

Before taking any medicinal product based on ambroxol, it is advisable to inform your doctor if:

  • You suffer, or have suffered in the past, from peptic ulcer;
  • You are suffering from disorders or changes in renal function;
  • It is suspected or certain that you are pregnant.

Furthermore, it is recalled that, following the use of ambroxol-based medicines, the appearance of serious skin reactions has been reported. Therefore, if after the administration of the active ingredient in question skin rash appears, it is necessary to immediately stop the treatment with the drug and contact the doctor immediately.

Pharmacological Interactions

Interactions of Ambroxol with Other Drugs

At present, no clinically relevant drug interactions are known between ambroxol and other drugs. However, before starting treatment with the aforementioned active ingredient, it is advisable to inform your doctor if you are taking - or have recently been - any type of medication, including prescription-free medicines, over-the-counter medications and herbal products. .

Side effects

Side Effects Caused by the Assumption of Ambroxol

The intake of ambroxol - as happens with any other drug - can lead to the appearance of side effects, sometimes even serious ones. However, not all patients manifest them and not all of them manifest them in the same way, since each individual reacts differently to the administration of the active substance in question.

Therefore, the main side effects that may occur during ambroxol therapy will be described below.

Nervous system disorders

Taking ambroxol can cause headaches and dysgeusia.

Gastrointestinal disorders

Ambroxol therapy - especially when the active ingredient is administered orally - can cause:

  • Nausea and vomit;
  • Digestive difficulties (dyspepsia);
  • Abdominal pains;
  • Dry mouth and / or throat.

Skin and subcutaneous tissue disorders

Treatment with ambroxol can give rise to side effects on the skin, such as rash and hives. Furthermore, ambroxol can lead to the onset of adverse skin reactions, including very serious ones, such as:

  • Erythema multiforme;
  • Stevens-Johnson syndrome or toxic epidermal necrolysis;
  • Acute generalized exanthematous pustulosis.

Other Side Effects

Other side effects that may occur following the intake of ambroxol are:

  • Allergic reactions and anaphylactic reactions;
  • Hypoesthesia of the oral cavity and pharynx;
  • Bronchial obstruction.

Action mechanism

How does Ambroxol work?

Ambroxol is an active ingredient with mucolytic and mucoregulating properties . In fact, it acts by regulating the production of mucus, improving its quality and favoring its elimination from the airways.

More in detail, ambroxol carries out its function through:

  • The normalization of the viscosity of the mucus produced;
  • The regularization of the activity of the tubulo-acinar glands present in the airways;
  • The stimulation of the activity of serous glandular cells (secrete an aqueous liquid that favors the fluidization of mucus);
  • The increase in the frequency of the movements of the eyelashes present in the respiratory system, thus favoring the removal of the mucus;
  • The stimulus of class II pneumocytes to produce greater quantities of alveolar surfactant, an indispensable substance for maintaining the stability of the lung tissue avoiding its collapse.

The anesthetic effect that allows the use of ambroxol in the treatment of acute pain of the oral and pharyngeal mucosa, on the other hand, seems to be related to the ability of the same active principle to block the dependent voltage sodium channels. Furthermore, for information, we recall that - in in vitro studies - ambroxol has been shown to be able to exercise an anti-inflammatory activity.

Method of use and Posology

How to take Ambroxol

Ambroxol is available in different formulations suitable for administration for:

  • Oral route (tablets, effervescent tablets, granules for suspension / oral solution, oral spray, rubbery tablets, hard capsules and prolonged-release capsules);
  • Via rectal (suppositories);
  • Inhalation (solution to be sprayed with an aerosol appliance).

The dose of active ingredient to be taken may vary depending on the amount of thick and viscous mucus produced and depending on the type and severity of the respiratory disease that led to the appearance of the latter. However, indicatively, the doses of ambroxol administered to thin the mucus are the following:

  • Adults: 15-30 mg of ambroxol from two to three times a day;
  • Children over the age of 5-6: 15 mg of ambroxol twice a day;
  • Children between 2 and 5-6 years: 7.5-15 mg of ambroxol once or twice a day.

Clearly, those listed above are indicative dosages, for more information about the correct dosage of ambroxol for each patient it is necessary to seek medical attention and consult the package insert of the medicinal product prescribed by it.

Ambroxol in tablets to dissolve in the mouth

When ambroxol is prescribed in the form of tablets to be dissolved in the mouth for the treatment of acute pain of the oral and pharyngeal mucosa, it is generally recommended to take a pill as needed. Of course, the recommended daily dose (shown on the package insert) must never be exceeded.

Pregnancy and breastfeeding

Can Ambroxol be taken during pregnancy and during breastfeeding?

Since it is able to cross the placental barrier, the use of ambroxol is not recommended during pregnancy, especially in the first trimester of gestation. Furthermore, the use of the active ingredient and the medicines containing it is not recommended even during the breastfeeding phase.

The drug could be taken by pregnant women and breastfeeding mothers only in cases of actual need and only if prescribed by the doctor.

Contraindications

When the Ambroxol should not be used

The use of ambroxol must not be carried out:

  • In the presence of a known allergy to the same ambroxol;
  • In case of known allergy to any of the excipients present in the medicinal product to be used (the excipients may vary according to the pharmaceutical form);
  • In patients suffering from disorders, dysfunctions and liver and / or kidney diseases.

Furthermore, depending on the medicinal product and the concentration of the active ingredient contained in it, the use of ambroxol may be contraindicated, depending on the case, in children under the age of 2, 5-6 or 12 years (for for more information, it is necessary to read the illustrative leaflet of the medicinal product based on ambroxol which one intends to use).

Finally, it is recalled that the intake of ambroxol is generally contraindicated also in pregnancy and during lactation.