Usage
Ambroxol + Roxithromycin is prescribed for respiratory tract infections with thick mucus. It is used in acute and chronic bronchitis, community-acquired pneumonia, pharyngitis, tonsillitis, sinusitis, and other respiratory infections.
Pharmacological Classification:
- Ambroxol: Mucolytic, expectorant.
- Roxithromycin: Macrolide antibiotic.
Mechanism of Action:
Ambroxol breaks down thick mucus, making it easier to cough up. Roxithromycin inhibits bacterial protein synthesis, stopping bacterial growth. The addition of ambroxol improves roxithromycin’s effectiveness.
Alternate Names
No widely recognized alternate names exist for this combination. Several brand names are available (see below).
How It Works
Pharmacodynamics:
Ambroxol increases airway surfactant, promoting ciliary activity. It also reduces mucus viscosity aiding in its clearance. Roxithromycin binds to the bacterial 50S ribosomal subunit, inhibiting protein synthesis and halting bacterial growth.
Pharmacokinetics:
Roxithromycin: Absorbed orally, reaching peak concentration within 2 hours. Metabolized by the liver (CYP3A4), excreted in bile and feces.
Ambroxol: Well-absorbed orally, metabolized in the liver, excreted mainly in urine.
Drug interaction studies have shown that combining ambroxol and roxithromycin leads to no significant pharmacokinetic interaction.
Mode of Action:
Ambroxol increases surfactant production in the lungs promoting mucociliary clearance. Roxithromycin binds to the 50S ribosomal subunit of bacteria, inhibiting protein synthesis.
Elimination Pathways:
Roxithromycin: Primarily hepatic excretion via bile and feces.
Ambroxol: Primarily renal excretion.
Dosage
Standard Dosage
Adults:
Roxithromycin 150 mg + Ambroxol 60 mg twice daily or Roxithromycin 300 mg + Ambroxol 60 mg once daily, taken with meals, usually for 5-10 days.
Children:
Roxithromycin 50 mg + Ambroxol 30 mg thrice daily, taken with meals. Dosage adjustment may be needed based on weight and age. Pediatric use should be under strict medical supervision.
Special Cases:
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Elderly Patients: Standard dosage guidelines are often followed, with close monitoring for adverse events. Dose reduction might be considered in cases of severe comorbidities.
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Patients with Renal Impairment: Dosage adjustment necessary depending on the creatinine clearance rate.
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Patients with Hepatic Dysfunction: Roxithromycin dosage should be reduced in moderate to severe hepatic dysfunction. Ambroxol dosage might also need adjustments.
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Patients with Comorbid Conditions: Careful evaluation and dosage adjustments are essential in patients with diabetes, cardiovascular disease, or other significant comorbidities.
Clinical Use Cases
Dosage adjustments for specific clinical scenarios are generally not indicated, but patient-specific factors should be considered.
Dosage Adjustments
Dose modifications depend on renal or hepatic function.
Side Effects
Common Side Effects:
Nausea, vomiting, diarrhea, stomach pain, altered taste, dry mouth, dizziness, fatigue, and headache.
Rare but Serious Side Effects:
Severe allergic reactions (rash, itching, swelling), difficulty breathing, skin reactions, liver dysfunction (jaundice).
Long-Term Effects:
No specific long-term effects have been reported with short-term usage.
Adverse Drug Reactions (ADR):
Severe allergic reactions, Stevens-Johnson syndrome, and toxic epidermal necrolysis.
Contraindications
Hypersensitivity to Roxithromycin, Ambroxol or macrolide antibiotics. Concomitant use with ergot alkaloids (ergotamine, dihydroergotamine). Severe hepatic impairment. Pregnancy (first trimester).
Drug Interactions
Roxithromycin interacts with terfenadine, astemizole, cisapride, pimozide, statins, theophylline, bromocriptine, ergot alkaloids, and some CYP3A4 inhibitors/inducers (ketoconazole, itraconazole). Ambroxol interacts with some antibiotics (amoxicillin), increasing their lung concentrations.
Pregnancy and Breastfeeding
Avoid in the first trimester of pregnancy. Consult a physician if benefits outweigh risks. Use with caution during breastfeeding; potential neonatal exposure through breastmilk exists.
Drug Profile Summary
- Mechanism of Action: Ambroxol: Mucolytic, increases surfactant. Roxithromycin: Macrolide antibiotic, inhibits bacterial protein synthesis.
- Side Effects: Nausea, vomiting, diarrhea, stomach pain, dizziness, allergic reactions.
- Contraindications: Hypersensitivity, concomitant use with ergot alkaloids, severe hepatic impairment.
- Drug Interactions: CYP3A4 inhibitors/inducers, certain antibiotics, antihistamines.
- Pregnancy & Breastfeeding: Avoid during the first trimester. Use with caution during breastfeeding.
- Dosage: Adults: Roxithromycin 150 mg + Ambroxol 60 mg BID. Children: Consult physician and adjust per age/weight.
- Monitoring Parameters: Liver function tests, ECG (for patients at risk of QT prolongation).
Popular Combinations
This combination itself is a common pairing for respiratory infections.
Precautions
Assess for hypersensitivity, hepatic/renal dysfunction before use. Caution in patients with QT prolongation risk. Monitor for adverse events.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ambroxol + Roxithromycin?
A: Adults: Roxithromycin 150 mg + Ambroxol 60 mg twice daily. Children: Dosage needs to be adjusted according to weight/age under medical supervision.
Q2: What are the common side effects?
A: Nausea, vomiting, diarrhea, stomach upset, taste changes, dizziness.
Q3: Can this medication be used during pregnancy?
A: Avoid during the first trimester. In the second and third trimesters, only if the benefits outweigh the risks, after consulting a physician.
Q4: What are the contraindications?
A: Hypersensitivity to the drugs, concomitant use with ergot alkaloids, severe liver disease.
Q5: Are there any drug interactions I should be aware of?
A: Yes, it interacts with certain antibiotics, antihistamines, and some other medications metabolized by CYP3A4. Provide a complete medication history to your physician.
Q6: Can I take this medication with food?
A: Yes, it is recommended to take this medication with food to reduce gastrointestinal side effects.
Q7: How does Ambroxol + Roxithromycin work?
A: Ambroxol thins and loosens mucus. Roxithromycin kills bacteria causing the infection.
Q8: How long should I take this medication?
A: Typically 5–10 days, but the duration should be as prescribed by your physician.
Q9: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember, unless it is almost time for the next dose. Do not double the dose.
Q10: Can I drink alcohol while taking this medication?
A: It is generally advised to avoid alcohol while taking this medication due to the potential for increased drowsiness and other side effects.
