azithromycin/ambroxol

Action and Spectrum

Actions and Spectrum: 

Action:  

azithromycin is an antibiotic which belongs to the macrolide class. It generally works by inhibiting the growth of bacteria, primarily by interfering with their protein synthesis. It does this by binding to the bacterial ribosomes, essential for protein production in bacteria. This action ultimately leads to the suppression of bacterial growth and the resolution of bacterial infections. 

ambroxol is a mucolytic and expectorant medication. Its primary action is to help thin and loosen mucus in the airways, makes it easier to cough up and also clear from the respiratory tract. This can relieve individuals with respiratory conditions characterized by thick and sticky mucus, such as bronchitis, chronic obstructive pulmonary disease (COPD), and asthma. ambroxol also has some anti-inflammatory properties that can help reduce airway inflammation. 

Spectrum:  

azithromycin is the effective against a wide range of the bacterial infections, both Gram-positive and Gram-negative bacteria. It is generally used to treat respiratory tract infections, skin and also soft tissue infections, sexually transmitted infections and other bacterial infections. azithromycin is often prescribed for respiratory infections like bronchitis, pneumonia, and sinusitis. 

ambroxol is not an antibiotic and does not have antibacterial properties. Instead, it alleviates the symptoms associated with respiratory conditions where excessive mucus production and congestion are problematic. It helps improve mucus clearance, reduce coughing, and make breathing more comfortable for individuals with respiratory issues. 

Drug Interaction

Adverse Reaction

Frequency not defined 

Vomiting 

Angioedema 

Rash 

Dizziness 

Urticaria 

Nausea 

Epigastric pain 

Headache 

Fever 

Black Box Warning

Black Box Warning: 

None 

Contraindication / Caution

Contraindication/Caution: 

Contraindication 

azithromycin: 

• Allergy: azithromycin should not be taken if allergic to azithromycin or other macrolide antibiotics, such as erythromycin or clarithromycin. 
• Liver Dysfunction: Individuals with severe liver dysfunction should use azithromycin cautiously, as it can affect liver function. 
• QT Prolongation: azithromycin can prolong the QT interval on an electrocardiogram (ECG), which may lead to an irregular heart rhythm. It should be used cautiously in individuals with a history of arrhythmias, heart disease, or electrolyte imbalances. 
• Myasthenia Gravis: azithromycin can exacerbate the symptoms of myasthenia gravis, a neuromuscular disorder, and should be avoided in individuals with this condition. 
• Drug Interactions: azithromycin might interact with other medications, particularly those that affect the heart’s electrical activity.  

ambroxol: 

• Hypersensitivity: ambroxol should not be used by individuals who are hypersensitive or allergic to ambroxol or its components. 
• Pregnancy and Lactation: ambroxol during pregnancy and breastfeeding should be cautiously approached, and a healthcare provider’s advice should be sought. The safety of ambroxol during these periods is not well-established. 
• Liver or Kidney Impairment: Individuals with severe liver or kidney impairment may need dose adjustments or should avoid ambroxol.  
• Peptic Ulcer: ambroxol may exacerbate symptoms in individuals with peptic ulcers, so it should be used cautiously. 
• Children: Special care should be taken when giving ambroxol to children, and it should only be done under the guidance of a healthcare provider and in appropriate dosage forms. 
• Ciliary Dyskinesia: ambroxol may not be suitable for individuals with primary ciliary dyskinesia due to its mucolytic properties potentially interfering with ciliary function. 

Caution 

azithromycin: 

• Cardiac Issues: azithromycin can affect the heart’s electrical activity and may lead to an irregular heartbeat, particularly in individuals with a history of heart problems or those taking medications that prolong the QT interval. You must inform your healthcare provider if you have any cardiac issues. 
• Liver Function: While azithromycin is generally considered safe for most people, individuals with pre-existing liver conditions should be cautious when using it. Dose adjustments may be necessary in severe cases of liver dysfunction. 
• Kidney Function: azithromycin is primarily eliminated through the liver and kidneys. Patients with impaired kidney function may need dose adjustments. Monitoring kidney function during treatment is advisable. 
• Allergic Reactions: While rare, severe allergic reactions to azithromycin can occur.  
• Myasthenia Gravis: azithromycin might worsen the symptoms of myasthenia gravis, a neuromuscular disorder. Use it cautiously or avoid it if you have this condition. 

ambroxol: 

• Respiratory Conditions: ambroxol primarily treats respiratory conditions characterized by excessive mucus production. While it can help relieve symptoms, it does not treat the underlying cause. Ensure that the underlying condition is appropriately diagnosed and treated. 
• Pediatric Use: ambroxol should be used with caution in children, and a healthcare provider should determine the appropriate dosage form and dose based on the child’s age and weight. 
• Pregnancy and Breastfeeding: The safety of ambroxol during pregnancy and breastfeeding is not well-established.  
• Gastric Ulcers: ambroxol may exacerbate symptoms in individuals with peptic ulcers. Use it cautiously in such cases. 
• Ciliary Dyskinesia: In rare cases, ambroxol’s mucolytic properties could interfere with the ciliary function in individuals with primary ciliary dyskinesia. Careful monitoring may be necessary. 
• Allergic Reactions: Although rare, allergic reactions to ambroxol can occur. If you experience signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, difficulty breathing), seek immediate medical attention. 

Pregnancy / Lactation

Pregnancy consideration:  

US FDA pregnancy category: Not assigned. 

Lactation:   

Excreted into human milk: Not known. 

Pregnancy category: 

• Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 
• <b>Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 
• Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    
• Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    
• Category X: Drugs listed in this category outweigh the risks over benefits. Hence, these categories of drugs need to be avoided by pregnant women.    
• Category N: There is no data available for the drug under this category. 

Pharmacology

Pharmacology: 

azithromycin is a macrolide antibiotic with a mechanism of action that involves binding to bacterial ribosomes, thereby inhibiting protein synthesis and ultimately suppressing bacterial growth. It exhibits the broad spectrum of activity against various Gram-positive and Gram-negative bacteria and is commonly used to treat respiratory and other bacterial infections.

In contrast, ambroxol is a mucolytic and expectorant agent that facilitates the thinning and loosening of mucus in the respiratory tract by enhancing mucociliary clearance and reducing mucus viscosity. It is utilized primarily to alleviate symptoms associated with respiratory conditions characterized by excessive mucus production, like bronchitis and chronic obstructive pulmonary disease. When combined under medical supervision, azithromycin and ambroxol can address bacterial infection and mucus-related symptoms in certain respiratory conditions. 

Pharmacodynamics: 

Mechanism of action: azithromycin, an antibiotic, inhibits bacterial protein synthesis by typically binding to the 50S ribosomal subunit of bacterial ribosomes, effectively halting the production of bacterial proteins. This interference disrupts bacterial growth and can lead to cell death, making it effective against a broad spectrum of bacteria. ambroxol, a mucolytic and expectorant medication, acts on the respiratory tract by reducing the viscosity of mucus, enhancing mucociliary clearance, and exerting anti-inflammatory effects. It thins and loosens mucus, promotes the movement of cilia to clear mucus from the airways, and reduces airway inflammation, providing relief for individuals with respiratory conditions characterized by excessive mucus production and coughing, such as bronchitis and chronic obstructive pulmonary disease (COPD). 

Pharmacokinetics: 

Absorption 

azithromycin is well-absorbed from the gastrointestinal tract when taken orally, with an oral bioavailability of approximately 37%. Food can affect its absorption, with higher absorption rates when taken with food, which may reduce gastrointestinal side effects. 

ambroxol is well-absorbed from the gastrointestinal tract when taken orally. It reaches peak plasma concentrations within 1 to 3 hours after oral administration. 

Distribution 

azithromycin has a relatively large volume of distribution, indicating that it distributes well into various body tissues and fluids. It can penetrate respiratory tissues, making it practical for respiratory tract infections. It also reaches high concentrations in the skin, which is helpful for skin and soft tissue infections. 

ambroxol is distributed throughout the body, with a particular affinity for lung tissue, where it exerts its mucolytic and expectorant effects. It also crosses the placenta and can be found in breast milk. 

Metabolism 

azithromycin undergoes limited metabolism in the liver, with most of the drug being excreted unchanged. It is primarily metabolized by hepatic cytochrome P450 enzymes, specifically CYP3A4. 

ambroxol undergoes extensive metabolism in the liver to form various metabolites, which are then excreted in the urine. The exact metabolic pathways and metabolites can vary among individuals. 

Elimination and Excretion 

azithromycin is primarily excreted in the bile and eliminated in the feces. Only a small portion (approximately 6%) is excreted as an unchanged drug in the urine. 

The primary route of excretion for ambroxol and its metabolites is through the urine, with a minor portion being eliminated in the feces. The elimination half-life of ambroxol is relatively short, usually around 7 to 12 hours in adults. 

Adminstartion

Administration: 

The administration of azithromycin and ambroxol depends on the specific formulation and your healthcare provider’s instructions. These medications come in various forms, such as tablets, capsules, syrups, and injections. Always follow your healthcare provider’s prescribed dosage and instructions.  

azithromycin: 

• Tablets or Capsules: azithromycin tablets or capsules should be taken by mouth with a full glass of water. You can take them with or without food, although taking them with food may help reduce stomach upset. 
• Oral Suspension: If prescribed an oral suspension (liquid form), measure the dose carefully using the provided measuring device (e.g., oral syringe or measuring cup). Shake the suspension well before each use. You can take it with or without food. 
• Extended-Release Tablets: Some formulations of azithromycin are extended-release.  
• Intravenous (IV) Injection: azithromycin can be administered intravenously in healthcare. This form is typically used for severe infections or when oral administration is impossible. Healthcare professionals will administer the IV form. 
• Dosage and Duration: The dosage and also duration of azithromycin treatment will vary depending on the type and severity of the infection.  

ambroxol: 

• Oral Liquid/Syrup: ambroxol is commonly available in oral liquid or syrup form. Measure the dose carefully using the provided measuring device (e.g., oral syringe or measuring cup). You can usually take ambroxol with or without food. 
• Tablets or Capsules: ambroxol is also available in tablet or capsule form. Take these forms with a full glass of water. You may take them with or without food. 
• Dosage: The appropriate ambroxol dosage varies depending on age, weight, and the severity of the respiratory condition. Follow your healthcare provider’s recommended dosage, and do not exceed the prescribed amount. 
• Duration: The duration of ambroxol treatment depends on the specific condition you are treating. Follow your healthcare provider’s instructions regarding how long to take the medication. 
• Inhalation: In some cases, ambroxol may be used in nebulizer solutions for inhalation therapy. If prescribed for inhalation, follow the specific instructions your healthcare provider provides. 
• Children: Use pediatric formulations and carefully follow the dosage recommendations based on the child’s age and weight. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: azithromycin/ambroxol 

Why do we use azithromycin/ambroxol? 

The combination of azithromycin and ambroxol is sometimes prescribed for treating respiratory infections, particularly those characterized by excessive mucus production and coughing. These medications have different mechanisms of action, and when used together, they can address multiple aspects of respiratory conditions. However, it’s essential to note that the use of combination medications should be done under the supervision and prescription of a healthcare provider.  

Respiratory Tract Infections: 

Bronchitis: The combination may be prescribed for acute or chronic bronchitis, as it can help reduce inflammation in the bronchial tubes (azithromycin) and thin and loosen mucus (ambroxol), making it easier to cough up. 

Pneumonia: In cases of bacterial pneumonia, azithromycin can target the underlying infection, while ambroxol can aid in clearing mucus from the lungs. 

Sinusitis: This combination may be used to treat sinusitis, as azithromycin can combat bacterial infections, and ambroxol can alleviate congestion and facilitate mucus drainage. 

Pharyngitis and Tonsillitis: azithromycin can be effective for bacterial throat infections, and ambroxol can help soothe the throat and reduce coughing. 

Chronic Obstructive Pulmonary Disease (COPD): 

The combination may be prescribed for individuals with COPD, a chronic lung condition often involving chronic bronchitis and emphysema. azithromycin can help reduce the frequency of exacerbations caused by bacterial infections, while ambroxol can assist in managing mucus production. 

Cystic Fibrosis: 

In individuals with cystic fibrosis, a genetic disorder characterized by thick and sticky mucus production, the combination of azithromycin and ambroxol may improve mucus clearance and reduce the risk of bacterial lung infections. 

Other Respiratory Conditions: 

This combination might be considered for other respiratory conditions where antibacterial and mucolytic effects are needed to manage symptoms effectively.