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Ambroxol - Indications, Doses, and Mechanism of Action

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Ambroxol is used to treat coughs. Read the article further to know more about this drug.

Written by

Dr. Kinjal Shah

Medically reviewed by

Dr. Kaushal Bhavsar

Published At October 17, 2023
Reviewed AtOctober 17, 2023

Overview

Ambroxol is a member of the group of medications known as "mucolytic agents," also known as cough or sputum thinners, and is used to treat acute (short-term) and chronic (long-term) respiratory tract diseases, spasmodic bronchostenosis (bronchial narrowing), and abnormal bronchial mucus production in conditions like emphysema and bronchial asthma.

An ingredient in Ambroxol thins and loosens mucus (phlegm) in the nose, windpipe, and lungs. Ambroxol breaks down the acid mucopolysaccharide fibers that thin down and make sputum less viscous and thick, effectively removing sputum by coughing. A dry, annoying cough, hoarseness from laryngitis (swelling of the voice box), or a burning sensation in the chest from bronchitis are the earliest symptoms of acute respiratory illnesses (swelling of the lining of bronchial tubes). A dry, irritable cough and a wet, mucus-producing cough can be found in chronic respiratory disorders.

How Does Ambroxol Work?

Cough and respiratory tract infections are treated with the drug Ambroxol. As a mucolytic agent, it aids in dissolving and thinning down the mucus that builds up in the respiratory system.

Ambroxol works through several distinct mechanisms. Ambroxol primarily functions by boosting the lungs' synthesis of a chemical known as surfactant. A natural protein called surfactant aids in lowering the surface tension of the mucus, making it simpler to cough up.

Ambroxol also aids in promoting the creation of enzymes necessary for breaking down mucus. In particular, it raises the activity of lysosomal enzymes, which can degrade mucus in the respiratory tract and facilitate expulsion.

Ambroxol possesses antioxidant capabilities in addition to its mucolytic ones. Free radicals are scavenged, and reactive oxygen species (ROS), which cause the onset of lung illnesses, are prevented from being produced. Ambroxol can aid in symptom relief and improve respiratory health by thinning mucus and making it simpler to cough up.

Available Doses and Dosage for Ambroxol:

Ambroxol is available in several dosage forms, including syrups, tablets, capsules, and injections. The recommended dose of Ambroxol varies depending on the medication's form and the patient's age.

  1. Adults: Adults should take between two and three split doses of between 30 milligrams (mg) (one Ambroxol tablet) and 120 mg (four Ambroxol tablets) each day.

  2. Children Under Two Years: Twice daily, half a teaspoon of Ambroxol syrup

  3. Children Between the Ages of Two to Five Years: They should consume half a teaspoon of Ambroxol syrup thrice daily.

  4. Children Older Than Five Years: One to two teaspoons of Ambroxol syrup each day.

Storage

  1. Keep at a temperature of no more than 30 °C.

  2. Keep any medications out of children's reach.

Missed Dose:

Ambroxol should be taken as soon as a missed dosage is recollected. Skip the missing dosage if it is time for the next dose. To make up for a missing dosage, do not increase the medication.

Overdose:

In the event of an Ambroxol overdose, seek emergency care or call the doctor.

How Is It Delivered?

  1. 10, 1000 tablet boxes.

  2. Syrup comes in 60 ml (milliliter) and 120 ml bottles.

Directions for Using Ambroxol

The following are some general principles:

Syrup for Ambroxol:

  1. Before use, give the bottle a good shake.

  2. To measure the proper dose, use a measuring cup or spoon.

  3. Take the syrup immediately or after dilution with juice or water.

  4. To reduce gastrointestinal adverse effects, take the drug after meals.

  5. Never go above the specified dose or treatment time.

Tablet or Capsule Form of Ambroxol:

  1. With water, swallow the pills or capsules whole.

  2. To reduce gastrointestinal adverse effects, take the drug after meals.

  3. The pills or capsules should not be chewed or crushed.

  4. Never go above the specified dose or treatment time.

Injection of Ambroxol:

A healthcare practitioner often administers this kind of Ambroxol at a hospital or other medical facility.

Warnings

  1. Allergies: Ambroxol should not be taken if one is allergic to it or other drugs.

  2. Pregnancy and Nursing: Ambroxol should only be taken during pregnancy and nursing with a healthcare professional's approval and caution.

  3. Liver or Kidney Disease: Ambroxol should be used cautiously in patients with liver or kidney disease because it may result in complications.

  4. Interaction With Other Medications: Ambroxol may interact with other medications, especially antibiotics, so it is vital to inform the doctor about all the drugs one is taking.

  5. Children: Children under the age of two should take Ambroxol with care.

  6. Side Effects: Ambroxol's adverse effects might include a skin rash, headache, dizziness, and gastrointestinal problems.

Always adhere to the usage and dose guidelines given by the healthcare professional or on the medicine label. See the doctor if one has any concerns or questions about using Ambroxol. No matter the type of Ambroxol, do not go above the specified dose or treatment time without first talking to a doctor.

For Patients:

What Is Coughing?

  1. Coughing is a reflex activity that aids in clearing mucus, irritants, and foreign objects from the airways. The respiratory system's natural defense mechanism shields the lungs and throat from viruses and other dangerous things.

  2. The most common cause of coughing is an irritation or inflammation of the airways, which triggers a reflex action in the lungs and throat.

  3. Acute coughs persist briefly, but chronic coughs linger for several weeks or months. Several factors might contribute to their development, including respiratory infections, allergies, asthma, acid reflux, smoking, and exposure to environmental irritants.

What Is Ambroxol?

Ambroxol treats respiratory disorders that include thick or excessive amounts of phlegm (sputum) by breaking up, thinning, and clearing congestion. Due to its local numbing effects, Ambroxol is also used to treat sore throats. Within 30 minutes after taking it, Ambroxol begins to work. The sputum becomes thinner and less viscous due to the acid mucopolysaccharide fibers being broken down, making it easier to cough up and expel. Sputum volume ultimately drops, but its viscosity stays low as long as therapy is continued.

When and Why to Use Ambroxol?

The dose and frequency of administration of Ambroxol depend on the patient's age, weight, and the severity of the ailment being treated. Ambroxol is commonly given orally as a tablet or syrup. It is crucial to adhere to the dose and usage guidelines.

For the following ailments, Ambroxol may be prescribed:

  1. Ambroxol can be used to treat coughs brought on by respiratory tract diseases such as the flu, pneumonia, and the common cold.

  2. Ambroxol can treat coughs brought on by bronchitis, an inflammation of the bronchial tubes that causes coughing and breathing difficulties. Bronchitis can be acute or chronic.

  3. Ambroxol may be used to treat coughs brought on by chronic obstructive pulmonary disease (COPD), a progressive lung condition that makes breathing difficult.

How Effective Is Ambroxol?

In clinical research, Ambroxol helps lower cough frequency and ameliorating symptoms in people with respiratory disorders. As an illustration, a systematic review of randomized controlled trials on using Ambroxol in acute respiratory tract infections discovered that the drug effectively lowered cough frequency, enhanced sputum production, and lowered the severity of symptoms in patients with acute bronchitis.

Things to Inform the Doctor Before Taking Ambroxol.

Specifically, one should let the doctor know about the following:

  1. Medical History: Patients should be honest with their doctors about prior or present diseases, operations, or problems.

  2. Current Medications: Patients should let their doctor know whether they use prescription or over-the-counter drugs, vitamin tablets, dietary supplements, or herbal therapies.

  3. Allergies: Patients should inform their doctor if they have any drug, food, or other allergies.

  4. Individuals Who Are Expecting or Nursing: They should inform their doctor before taking Ambroxol because these conditions may make it unsafe for use.

  5. Adverse Effects: Patients using Ambroxol should let their doctor know if they have any side effects, such as allergic reactions, nausea, or vertigo.

  6. Additional Medical Problems: Patients with other health issues, such as liver or renal illness, should inform their doctor as these disorders may alter the Ambroxol dosage or safety.

What Are the Side Effects of Ambroxol?

Ambroxol can have negative effects on some people, just like any medicine. Ambroxol commonly has the following adverse effects:

  1. Nausea and vomiting.

  2. Diarrhea.

  3. Abdominal pain.

  4. Headache.

  5. Dizziness.

  6. Itching or skin rash.

  7. Breathing or swallowing challenges.

Ambroxol's less common side effects might be:

  1. Allergic symptoms such as swelling, hives, and breathing problems.

  2. Severe skin responses like peeling and blistering.

  3. Loss of flavor or changes in taste.

  4. Weakness or fatigue.

How to Take Ambroxol Medicine?

  1. Observe the Directions on the Label: When taking Ambroxol, read the directions on the label carefully. Speak with the healthcare practitioner or pharmacist to clarify how to use the drug or if there are any questions or concerns.

  2. Take With Water: Ambroxol must be consumed with a full glass of water. This may hasten the medication's dissolution and absorption by the body.

  3. Take With Meals: Ambroxol can be consumed with or without meals. However, consuming it with meals lessens the discomfort in the stomach.

  4. Do Not Crush: Ambroxol pills should not be chewed or mashed; they should only be consumed as a whole. This can facilitate the medication's absorption into the body.

For Doctors:

Pharmacology of Ambroxol

Mechanism of Action:

Ambroxol's pharmacology includes several different modes of action.

  1. Mucolytic Action: Ambroxol has a mucolytic effect, which means it promotes the synthesis of a protein called surfactant, which thins out and breaks down the mucus in the respiratory system. By lowering the mucus' surface tension, this surfactant makes it simpler for the body to cough up and expel the mucus.

  2. Anti-inflammatory Action: Ambroxol has been demonstrated to have anti-inflammatory characteristics, which may aid in reducing the inflammation that can develop in the respiratory system when respiratory diseases exist.

  3. Antioxidant Action: Ambroxol has been demonstrated to possess antioxidant capabilities, which may aid in defending the respiratory system against oxidative damage brought on by contaminants, smoking, or infections.

  4. Local Anesthetic Action: Ambroxol has a local anesthetic effect on the respiratory tract, which might assist in lessening coughing and airway discomfort.

Ambroxol is usually given orally, with a standard dose ranging from 30 mg to 120 mg per day, depending on the patient's age and health. With a half-life of around ten hours, it is quickly absorbed and disseminated throughout the body. Ambroxol metabolizes predominantly in the liver and is eliminated through the urine.

Metabolism:

  1. Ambroxol is primarily processed in the liver via several metabolic routes. Ambroxol is mainly metabolized through the processes of glucuronidation and oxidation.

  2. A glucuronic acid molecule is added to the medicine during glucuronidation to increase its water solubility and ease of excretion from the body. This procedure is carried out by an enzyme called UDP-glucuronosyltransferase (UGT). Many metabolites, such as Ambroxol-3-O-glucuronide, Ambroxol-4-O-glucuronide, and Ambroxol-4'-O-glucuronide, are created when Ambroxol is glucuronidated.

  3. Another metabolic process for Ambroxol is oxidation, which is principally controlled by the liver's cytochrome P450 (CYP) enzymes. Dibromo-dichloro-indophenol (DDI), which is further converted to dibromo-indophenol, is the primary oxidative metabolite of Ambroxol. Desmethyl-Ambroxol and Ambroxol quinone are two more insignificant oxidative metabolites of Ambroxol.

Excretion:

  1. Ambroxol and its metabolites are primarily eliminated in the urine after metabolism, with a minor quantity also leaving the body through the feces. Ambroxol has an elimination half-life of around ten hours; its total clearance is roughly 660 ml/min.

  2. Ambroxol has a straightforward metabolism, and the medication and its metabolites are primarily eliminated through the kidneys. Nevertheless, individuals with hepatic or renal impairment should exercise caution since these patients may have decreased ambroxol clearance.

Toxicity of Ambroxol

Clinical Toxicity

  1. Gastrointestinal Side Effects: Mild gastrointestinal symptoms, including nausea, vomiting, diarrhea, and stomach discomfort, are the most frequent side effects of Ambroxol.

  2. Hypersensitivity Reactions: Occasionally, Ambroxol can lead to hypersensitivity symptoms, including redness, itching, and anaphylaxis.

  3. Central Nervous System Effects: Ambroxol has been linked to a few unusual headaches, seizures, and dizziness in the central nervous system.

  4. Liver Injury: Rarely, Ambroxol can result in liver damage, including hepatitis and liver failure.

Non-clinical Toxicity

  1. Reproductive and Developmental Toxicity: Research on animals has revealed that Ambroxol may negatively affect fetal and reproductive development.

  2. Genotoxicity: Ambroxol has been demonstrated to be genotoxic in vitro, which indicates that it can harm DNA (deoxyribonucleic acid)).

  3. Carcinogenicity: Ambroxol has not been demonstrated to be carcinogenic in long-term animal investigations.

It is crucial to remember that Ambroxol has a generally low level of toxicity and that its effects are typically brought on by high dosages or continuous use. Patients with liver or renal disease and those who are pregnant or nursing should take Ambroxol with care.

Management of Toxicity

There are multiple processes involved in treating Ambroxol poisoning, including:

  1. Stabilization: Immediate stabilization is required if the patient displays severe symptoms, such as breathing difficulties or decreased blood pressure. This may entail supplying fluids to maintain blood pressure, offering respiratory support, and giving oxygen.

  2. Ambroxol Discontinuation: If a patient has overdosed on Ambroxol, the medication should be stopped immediately to avoid additional toxicity.

  3. Activated Charcoal: Activated charcoal can be used to lessen the absorption of the medication if the patient has consumed a substantial dose of Ambroxol.

  4. Symptomatic Management: Several drugs or therapies may be utilized to control the patient's symptoms, depending on the particular symptoms they are experiencing. For instance, bronchodilators can be used to treat respiratory distress, while antihistamines can be used to treat an allergic reaction.

  5. Monitoring: Individuals with Ambroxol toxicity need to be watched carefully to ensure their symptoms do not worsen and that their medication is working. Regular heart rate, blood pressure, and oxygen saturation monitoring are necessary.

  6. Supporting Care: In extreme situations, supportive treatment, such as mechanical breathing or hemodialysis, may be required to sustain the patient's critical functions while also assisting in removing the drug from the body.

Indications for Ambroxol

  1. Respiratory conditions that cause abnormal mucus production and acute and chronic difficulties expectorating (cough with mucus).

  2. Chronic obstructive pulmonary disease (COPD).

  3. Bronchiectasis (a condition in which the bronchial tubes are permanently damaged, enlarged, and thickened)

  4. Atelectasis pulmonalis (a condition in which there is a partial or complete lung collapse).

  5. Asthma makes it difficult to exhale.

Contraindications for Ambroxol

  1. Allergy to Ambroxol or any of its ingredients.

  2. Patients who have previously experienced adverse responses to drugs identical to Ambroxol.

  3. Ambroxol use is not advised during pregnancy or nursing.

  4. Ambroxol should only be used cautiously by patients with a history of gastrointestinal bleeding or peptic ulcers.

  5. Those with severe liver or renal illness should not use Ambroxol.

Drug Interactions of Ambroxol

Ambroxol can interact with other drugs, perhaps reducing their efficacy or raising the possibility of negative side effects. Ambroxol and some medications can interact in the ways listed below.

  1. Antibiotics: Amoxicillin and Erythromycin are two antibiotics that can cause Ambroxol to become more concentrated in the blood. This can raise the chance of adverse effects, and dose modification may be necessary.

  2. Antitussives: Ambroxol and antitussives (drugs that suppress cough) may have a negative impact on each other's efficacy.

  3. Bronchodilators: Ambroxol can make bronchodilators like Salbutamol and Theophylline work better. Dose modification may be necessary.

  4. Mucolytics: Ambroxol may raise the risk of negative effects when used with other mucolytics (drugs that help break down mucus).

  5. Anticoagulants: Ambroxol may intensify the anticoagulant effects of medications like Warfarin, raising the risk of bleeding. When using Ambroxol, patients taking anticoagulants should be closely watched.

  6. Concurrent Usage With Other Cough and Cold Medicines: Ambroxol may increase the risk of adverse effects when used with other cough and cold medicines, such as antihistamines or decongestants.

Other Specifications

Interactions With Ambroxol During Pregnancy

Ambroxol should not be used while pregnant, especially during the first trimester, unless required and if a healthcare professional has prescribed it. This is because there is minimal data on the safety of Ambroxol in pregnant women, and its effects on fetal development are not well known. Studies on animals have revealed some unfavorable effects on the fetus at large dosages. Hence, unless specifically instructed differently by their healthcare physician, it is advised that pregnant women should avoid using Ambroxol.

Interactions With Ambroxol During Breastfeeding

It is not advised to use Ambroxol during nursing. Ambroxol is known to enter breast milk, although it is unclear how it may affect the nursing infant. Hence, unless specifically instructed differently by their healthcare professional, it is advised that nursing women avoid using Ambroxol.

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Dr. Kaushal Bhavsar
Dr. Kaushal Bhavsar

Pulmonology (Asthma Doctors)

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