Ambroxol: What Is It and What's It For?
Ambroxol is a drug from the category of mucolytics. It’s a drug derived from bromhexine (bromhexine hydrochloride), an expectorant used in the treatment of disorders associated with excessive and viscous mucus.
It’s found in the form of tablets and in oral syrups, in which it is the most common active ingredient. There are generic forms of ambroxol, but it is also sold under other names in pharmacies, such as Dinobroxol ®, Motosol ®, Mucibron ®, Mucosan ® and Naxpa ®.
Some similar drugs that contain bromhexine as an active ingredient are Normitos ®, Bisolvon ®, Pulmosan Forte ®, and Vasican ®, among others. If you want to know more about this pharmacological group of mucolytics and expectorants, keep reading.
What is ambroxol used for?
Mucus is the first line of defense for various epithelia in the human body. These secretions are part of the primary biological barriers against the entry of pathogens, along with saliva, skin, and tears. For its part, mucus is made up of a mixture of glycoproteins, proteoglycans, and high concentrations of antibodies.
The type of mucus that’s produced in the lower respiratory tract is often called phlegm. This barrier is synthesized by the goblet cells of the alveolar and tracheobronchial epithelium. In normal situations, it is secreted in very low amounts.
When the production of phlegm and mucus is excessive due to the presence of foreign bodies in the respiratory tree, its excretion is complicated and the body tries to eliminate it through coughs and expectorations. These clinical signs are addressed by medicine with 2 types of drugs:
- Mucolytics: These act on the viscosity of bronchial secretions, disintegrating them and facilitating their expulsion. Ambroxol falls into this category.
- Expectorants: These increase the water volume of mucous secretions causing them to become fluid. In turn, they enhance the ciliary movements of the respiratory tree.
Mechanism of action
Ambroxol is a mucolytic-type drug that works by relieving symptoms of excessive phlegm production in various chronic and acute respiratory conditions. Its general mechanism of action can be divided into the following points:
- Breaking of chemical bonds in phlegm, which reduces its viscosity and promotes its expectoration.
- Stimulation in the production of mucus.
- Stimulation of type II pneumocytes, cells that secrete lung surfactant. The surfactant acts as an anti-glue factor, reducing the adherence of mucus to the bronchial wall. With this, ambroxol dissolves the plug formed by phlegm and favors the mobilization and secretion of mucus.
- Inhibition of neuronal Na + channels. In experimental studies, this ability has been shown to help reduce severe sore throats.
- Reduction of inflammation of the throat tissue.
Beyond these uses in flu and catarrhal conditions, professional sources have shown that ambroxol could increase the activity of the lysosomal enzyme glucocerebrosidase. Therefore, its prescriptions as a therapeutic agent for Gaucher disease and Parkinson’s disease are being explored.
Ambroxol is used to treat phlegm secretion in acute and chronic respiratory conditions.
The drug is rapidly absorbed orally. If ambroxol is taken on an empty stomach, the maximum concentration of the active ingredient is reached 2 1/2 hours after ingestion. Its bioavailability is 60% and the half-life is calculated at 8 hours. The vast majority of the drug is eliminated as non-toxic metabolites via the kidneys.
How is ambroxol administered?
Ambroxol is presented in the form of tablets to be taken orally and in mucolytic syrups, the latter being the most common route of administration. Next, we present the dosage of this drug and active principle with the help of the commercial leaflets of the most important variants.
Ambroxol CINFA 15 mg / 5 ml ® (Syrup)
As stated in the package insert, for every 5 milliliters of syrup there are 15 milligrams of the active substance ambroxol hydrochloride. Dosage can be summarized in the following list:
- Adults: 1 measure of 10 milliliters of syrup, 3 times a day. This translates to a total of 30 milliliters a day.
- Children over 5 years: 1 measure of 5 milliliters of syrup, 2-3 times a day.
- Children 2 to 5 years: 1 measure of 2.5 milliliters, 3 times a day.
The syrup comes with a measuring cup, so it’s easy to set the average dose.
Ambroxol NORMON 3 mg/ml ® (Syrup)
This medicine belongs to a different pharmaceutical brand than the previous one, but its concentration is the same (3 mg/ml = 15 mg / 5 ml). The dosage is the same.
The use of this drug isn’t permitted in children under 2 years of age.
Mucosan 30 mg ® (tablets)
This variant comes in the form of tablets to be taken orally. Each box contains 20 round white pills with a groove on one of its sides. The dosage can be summarized in the following points:
- Adults: 1 tablet of 30 milligrams 3 times a day. This means 90 milligrams of Ambroxol every 24 hours.
- Dose with enhanced therapeutic effect: 2 tablets (60 milligrams) divided into 2 different doses 12 hours apart. The maximum dose is therefore 120 milligrams per day.
These tablets should be taken with plenty of fluids. It’s recommended to drink an extra glass of water after each dose and plenty of water during treatment.
Who cannot take this medicine?
The contraindications of this drug are very limited, as it’s an active compound that is very well tolerated by the vast majority of the general population. In adults, the administration of ambroxol should only be avoided in people who have shown allergic reactions to this compound or other similar mucolytics.
On the other hand, care must also be taken in people who have hypersensitivity to some of the drug’s excipients:
- Syrup excipients: Raspberry flavor, citric acid monohydrate, glycerol (E-422), hydroxyethylcellulose, benzoic acid, propylene glycol, 70% sorbitol (E-420), sodium saccharin (E-954) and purified water.
- Oral tablet excipients: Lactose, cornstarch, colloidal silica, and magnesium stearate.
Apart from the allergy to ambroxol or its excipients, it should be noted that the safety of this drug hasn’t been demonstrated in infants under 2 years of age. Therefore, its administration in this age group is completely contraindicated. Patients with broncho-motor deficiency should either not take it or take a reduced dosage.
Ambroxol and pregnancy
As indicated by the Vademecum medical portal, ambroxol is categorized in group C as far as consumption during pregnancy is concerned. Deleterious effects haven’t been shown in animal models, but there’s insufficient information in human fetuses. Therefore, its use isn’t recommended in pregnant mothers.
Possible side effects
Although the action of this drug is local and is well tolerated in almost all cases, ambroxol has certain side effects that should be known. We show them in the following list:
- Uncommon side effects (affects up to 1 in 100 people): Nausea, vomiting, stomach pain, and fever.
- Rare side effects (affects up to 1 in 1000 people): Hypersensitivity reactions, rash, and hives. These clinical signs indicate a need for immediate medical assistance.
- Symptoms of unknown frequency: Fatal anaphylactic reactions, angioedema (rapidly progressing swelling of the skin, subcutaneous tissues, or mucosa) and itching. Acute generalized exanthematous pustulosis is extremely rare after ingestion of this drug, but should also be reported.
If you experience any of these adverse effects or any other, consult your doctor or go to the emergency room.
What happens if I miss a dose?
In general, the dosage times of this drug are widely spaced, at intervals of 8 to 12 hours. For this reason, if you forget one of the doses, you can take the dosage later, even if it has been a few hours. However, if the next dose is approaching, you’d better skip the forgotten one.
What should I do in the case of an overdose?
Sources already cited emphasize that severe overdoses aren’t usually detected after the consumption of more Ambroxol than prescribed. If you drink more syrup than you should, the most common thing is to get mild symptoms, such as gastrointestinal disturbances, diarrhea, vomiting, skin rashes, and fatigue.
In cases of overdoses, make sure you go quickly to the emergency room, even if you aren’t extremely ill. In medical facilities – and if the condition is worrying – the digestive tract is usually flushed by inducing vomiting and administering activated carbon.
How should I store and dispose of this medicine?
Ambroxol in pill form doesn’t require any special storage criteria. You just have to keep the tablets in a high place and out of the reach of children. In addition to this consideration, in its syrup form it should be stored below 30 degrees Celsius.
We should emphasize that the drug shouldn’t be flushed down the toilet or put in the garbage in any of its formats.
Ambroxol: a safe and commonly used drug
Ambroxol syrups are sold in generic forms without a prescription. Its use is safe and has very few contraindications, so it can be ingested for a few days without any problem.
However, keep in mind that if you don’t get better in 5 days, it’s time to go to the doctor. Your condition may be bacterial and not viral. In these cases, the administration of specific antibiotics is required.It might interest you...
- Garcinuño, A. C., Alonso, I. C., Barbero, J. R., García, I. P., & Quirós, A. B. (2013, January). Prescripción de fármacos anticatarrales de uso sistémico a niños de 0-13 años. Un problema no resuelto. In Anales de Pediatría (Vol. 78, No. 1, pp. 43-50). Elsevier Doyma.
- de Mey C, et al. (2008), “Efficacy and safety of ambroxol lozenges in the treatment of acute uncomplicated sore throat”, Arzneimittelforschung, 58 (11): 557–68
- McNeill A, Magalhaes J, Shen C, Chau KY, Hughes D, Mehta A, Foltynie T, Cooper JM, Abramov AY, Gegg M, Schapira AH (May 2014). “Ambroxol improves lysosomal biochemistry in glucocerebrosidase mutation-linked Parkinson disease cells”. Brain. 137 (Pt 5): 1481–95.
- Prospecto de ambroxol cinfa 15mg/5ml, CIMA. Recogido a 17 de julio en https://cima.aemps.es/cima/dochtml/p/63626/Prospecto_63626.html
- Ambroxol, vademecum. Recogido a 17 de julio en https://www.iqb.es/cbasicas/farma/farma04/a120.htm
- Sistema Español de Farmacovigilancia de medicamentos de uso humano. Recogido a 17 de julio en https://www.aemps.gob.es/medicamentos-de-uso-humano/farmacovigilancia-de-medicamentos-de-uso-humano/
- Información necesaria sobre el punto SIGRE. Recogido a 17 de julio en https://www.sigre.es/