Usage
Ambroxol + Amoxycillin is prescribed for bacterial infections of the respiratory tract, particularly those accompanied by excessive mucus production. Conditions it is used for include:
- Acute bacterial sinusitis
- Acute exacerbations of chronic bronchitis
- Community-acquired pneumonia
- Other lower respiratory tract infections with excessive mucus secretion
Pharmacological Classification:
- Mucolytic (Ambroxol)
- Antibiotic (Amoxycillin)
Mechanism of Action:
Ambroxol works by thinning and loosening mucus in the airways, making it easier to cough up and clear the airways. Amoxycillin, a beta-lactam antibiotic, inhibits bacterial cell wall synthesis, leading to bacterial death and controlling the infection.
Alternate Names
There are no widely recognized alternate names for the combination. However, the individual components may have regional variations.
Brand Names: Numerous brand names exist depending on the region and manufacturer. Some examples may include Ambroclav, Moxamol.
How It Works
Pharmacodynamics:
- Ambroxol: Reduces mucus viscosity by breaking down mucopolysaccharide fibers and stimulating surfactant production. It also may have anti-inflammatory and antioxidant effects.
- Amoxycillin: Bactericidal against a wide range of Gram-positive and Gram-negative bacteria by inhibiting cell wall synthesis via binding to penicillin-binding proteins.
Pharmacokinetics:
- Ambroxol: Well-absorbed orally. Metabolized in the liver and excreted primarily in the urine.
- Amoxycillin: Well-absorbed orally. Partially metabolized in the liver and excreted primarily in the urine. Both drugs may achieve higher concentrations in bronchial secretions due to their physicochemical properties and transport mechanisms.
Mode of Action: See “Mechanism of Action” above. Ambroxol acts on mucus, Amoxycillin on bacterial cell walls. No direct receptor binding, enzyme inhibition, or neurotransmitter modulation is primarily involved.
Elimination Pathways: Primarily renal excretion for both drugs.
Dosage
Standard Dosage
Adults:
Dosage and frequency depend on the severity of the infection and the specific formulation. Common dosages range from 500mg to 875mg of Amoxicillin every 8 to 12 hours, combined with 15mg to 30mg of Ambroxol 2-3 times/day. Maximum daily dose for Amoxicillin should not generally exceed 6g.
Children:
Dosage is typically based on weight and age, and liquid formulations (syrups, suspensions) are often preferred for children. Consulting standardized pediatric dosing charts is crucial.
Special Cases:
- Elderly Patients: Generally, standard adult dosages are used unless renal impairment is present. Close monitoring is recommended.
- Patients with Renal Impairment: Amoxycillin dosage adjustment is necessary depending on creatinine clearance (CrCl). Consult dosage guidelines for specific recommendations based on CrCl ranges.
- Patients with Hepatic Dysfunction: Caution is advised, and dosage adjustments may be considered, especially for Ambroxol.
- Patients with Comorbid Conditions: Careful assessment and dosage adjustments might be needed for patients with conditions like diabetes, cardiovascular diseases, or other relevant comorbidities.
Clinical Use Cases
Dosage guidelines provided above generally apply to the clinical use cases you mentioned (intubation, surgical procedures, mechanical ventilation, ICU use, emergency situations). However, dosage adjustments based on individual patient factors and disease severity are crucial in these settings. Consult specific protocols and guidelines for managing infections in these clinical scenarios.
Dosage Adjustments
Dosage modification is necessary in cases of renal/hepatic dysfunction, metabolic disorders, and suspected genetic polymorphisms affecting drug metabolism. Refer to specific guidelines based on the individual patient’s condition.
Side Effects
Common Side Effects:
Nausea, vomiting, diarrhea, abdominal discomfort, skin rash, itching.
Rare but Serious Side Effects:
Severe allergic reactions (anaphylaxis, angioedema), Stevens-Johnson syndrome, toxic epidermal necrolysis.
Long-Term Effects:
Generally, no long-term side effects are expected with short-term use. However, prolonged or repeated antibiotic use can disrupt gut microbiota and increase the risk of Clostridium difficile infection.
Adverse Drug Reactions (ADR):
See “Rare but Serious Side Effects”.
Contraindications
- Hypersensitivity to ambroxol, amoxycillin, or any penicillin or cephalosporin antibiotic.
- Severe hepatic impairment (for Ambroxol).
Drug Interactions
- Antibiotics: Ambroxol may increase the concentration of certain antibiotics (e.g., erythromycin, doxycycline, cefuroxime) in bronchial secretions.
- Antitussives: Concurrent use with cough suppressants can hinder mucus clearance.
- Allopurinol: May increase the risk of skin rash with Amoxicillin.
- Probenecid: May reduce the renal excretion of Amoxicillin, leading to increased serum levels.
- Methotrexate: Amoxicillin can increase Methotrexate levels.
- Oral Contraceptives: Amoxicillin may reduce the efficacy of oral contraceptives.
Pregnancy and Breastfeeding
Ambroxol and Amoxycillin are generally considered safe during pregnancy, especially in the second and third trimesters. However, benefits should outweigh the risks. Both drugs are excreted in breast milk; caution is advised during breastfeeding.
Drug Profile Summary
- Mechanism of Action: Ambroxol thins and loosens mucus; Amoxycillin inhibits bacterial cell wall synthesis.
- Side Effects: Common: GI upset, rash. Serious: Allergic reactions, severe skin reactions.
- Contraindications: Hypersensitivity to penicillins/cephalosporins.
- Drug Interactions: See “Drug Interactions”.
- Pregnancy & Breastfeeding: Generally safe, but caution advised.
- Dosage: See “Dosage” section.
- Monitoring Parameters: Respiratory status, signs of infection, adverse reactions.
Popular Combinations
Ambroxol is commonly combined with antibiotics like amoxicillin for respiratory infections with excessive mucus production.
Precautions
Assess for allergies, renal and hepatic function, and history of peptic ulcer disease before prescribing. Monitor for adverse drug reactions, particularly skin reactions. Caution in patients with severe renal impairment.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ambroxol + Amoxycillin?
A: The dosage varies depending on the age, weight, and condition of the patient. Refer to the “Dosage” section above for details. Always consult up-to-date guidelines and resources.
Q2: Can this combination be used in children?
A: Yes, but liquid formulations are usually preferred, and dosage should be carefully calculated based on weight and age.
Q3: What are the common side effects?
A: Nausea, vomiting, diarrhea, and skin rash are the most common side effects.
Q4: Are there any serious adverse reactions to watch out for?
A: Yes, severe allergic reactions (anaphylaxis, angioedema) and severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) can occur, though rarely.
Q5: What are the contraindications?
A: Known hypersensitivity to penicillins, cephalosporins, or ambroxol is a contraindication.
Q6: Can I prescribe this to a pregnant woman?
A: Generally, the combination is considered safe during pregnancy, but the benefits should outweigh the potential risks. Consult current guidelines for specific recommendations.
Q7: Does this combination interact with other medications?
A: Yes, it can interact with other antibiotics, cough suppressants, allopurinol, probenecid, methotrexate, and others. See “Drug Interactions” section for more details.
Q8: How does Ambroxol work in this combination?
A: Ambroxol thins and loosens mucus, improving airway clearance and potentially facilitating the penetration of amoxicillin into the bronchial secretions.
Q9: What should I monitor in a patient taking this medication?
A: Monitor respiratory status, signs of infection, resolution of symptoms, and any potential adverse reactions.
Q10: Can it be administered intravenously?
A: While Amoxicillin can be administered intravenously, Ambroxol is generally administered orally or via inhalation. Intravenous formulations of Ambroxol may exist in some regions, but this is not a common route. Therefore, the combination is typically not administered intravenously.