Usage
Acebrophylline + Azithromycin is prescribed for lower respiratory tract infections, such as acute bacterial exacerbations of chronic bronchitis and community-acquired pneumonia, where both an antibiotic (Azithromycin) and a bronchodilator/mucolytic (Acebrophylline) are clinically indicated.
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Pharmacological Classification:
- Acebrophylline: Bronchodilator, Mucolytic
- Azithromycin: Macrolide Antibiotic
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Mechanism of Action: Acebrophylline relaxes the smooth muscles of the airways, widening them, and improving airflow. It also reduces mucus viscosity, making it easier to cough up. Azithromycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit of bacteria, thus impeding bacterial growth.
Alternate Names
This combination is marketed under various brand names, including Rtlide. It is important to distinguish between brand names and the generic constituents: Acebrophylline and Azithromycin.
How It Works
- Acebrophylline:
- Pharmacodynamics: Relaxes bronchial smooth muscle and improves mucociliary clearance.
- Pharmacokinetics: Well-absorbed orally, metabolized in the liver, excreted primarily renally.
- Azithromycin:
- Pharmacodynamics: Binds to the 50S ribosomal subunit, inhibiting bacterial protein synthesis.
- Pharmacokinetics: Rapidly absorbed orally, distributes widely into tissues, prolonged half-life, hepatic elimination.
Dosage
Standard Dosage
Adults:
Azithromycin is typically administered as a 500mg dose on the first day, followed by 250mg daily for the next four days. Acebrophylline is often prescribed at 100mg twice daily. However, dosages can vary depending on the specific product used. Always consult the specific product literature.
Children:
The dosage for children is determined by body weight and should be decided by a physician. Azithromycin is often dosed at 10-30mg/kg as a single daily dose or divided into multiple doses over 3-5 days. Acebrophylline’s pediatric dosing also varies by age and weight, and is generally not recommended for children under 12.
Special Cases:
- Elderly Patients: Dosage adjustments may be necessary based on renal and hepatic function.
- Patients with Renal Impairment: Azithromycin requires dosage adjustment in patients with severe renal dysfunction (GFR < 10 mL/min). Acebrophylline should be used with caution.
- Patients with Hepatic Dysfunction: Azithromycin should be used with caution in patients with hepatic impairment. Acebrophylline dosage may need adjustment.
- Patients with Comorbid Conditions: Careful evaluation is necessary, especially for patients with cardiovascular disease, diabetes, or hyperthyroidism.
Clinical Use Cases
The combination of Acebrophylline and Azithromycin is generally not recommended for clinical settings such as intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. Specific protocols usually dictate drug selection in these cases.
Dosage Adjustments
Dosage adjustments are based on patient-specific factors, including renal and hepatic function, age, and concomitant medications. Always refer to the product’s prescribing information and consider clinical guidelines.
Side Effects
Common Side Effects:
- Nausea, vomiting, diarrhea
- Abdominal pain
- Headache, dizziness
Rare but Serious Side Effects:
- Severe allergic reactions (anaphylaxis, angioedema)
- Hepatotoxicity
- Cardiac arrhythmias (including QT prolongation with Azithromycin)
- Clostridium difficile-associated diarrhea
Long-Term Effects:
Chronic complications from prolonged use of this specific combination are not well-documented. However, long-term antibiotic use can contribute to antibiotic resistance.
Adverse Drug Reactions (ADR):
Clinically significant ADRs requiring immediate intervention include severe allergic reactions, hepatotoxicity, and cardiac arrhythmias.
Contraindications
- Hypersensitivity to Acebrophylline, Azithromycin, or any macrolide antibiotic.
- History of cholestatic jaundice/hepatic dysfunction associated with prior macrolide use.
- Concomitant use with Pimozide.
Drug Interactions
- Acebrophylline: May interact with other xanthine derivatives, certain antihypertensives, and some diuretics.
- Azithromycin: Interacts with Warfarin, Digoxin, certain antacids, and certain statins. Theophylline levels can be increased by azithromycin. The combined use of Acebrophylline (which contains theophylline) and Azithromycin may increase the effects of azithromycin and lead to side effects. Additional interactions include those with furosemide, allopurinol, cimetidine, ciprofloxacin, erythromycin, amoxicillin, doxycycline, diltiazem, verapamil, isoprenaline, thiabendazole, ketoconazole, fluoxetine, corticosteroids (e.g. prednisone), and oral contraceptives (e.g. ethinylestradiol)
- Food and Lifestyle Factors: Alcohol should be avoided while taking Azithromycin. Smoking may decrease the effectiveness of Acebrophylline.
Pregnancy and Breastfeeding
The safety of this combination during pregnancy and lactation has not been established. Pregnant or breastfeeding women should consult their doctor before using this medication. Azithromycin is generally considered safe during pregnancy, but should only be used if the benefits outweigh the risks.
Drug Profile Summary
- Mechanism of Action: Acebrophylline: Bronchodilator, mucolytic. Azithromycin: Macrolide antibiotic inhibiting bacterial protein synthesis.
- Side Effects: Nausea, vomiting, diarrhea, abdominal pain, headache, dizziness; rarely: severe allergic reactions, hepatotoxicity, cardiac arrhythmias.
- Contraindications: Hypersensitivity, history of cholestatic jaundice/hepatic dysfunction with prior macrolide use, concomitant use with Pimozide.
- Drug Interactions: See Drug Interactions Section.
- Pregnancy & Breastfeeding: Consult a physician.
- Dosage: See Dosage Section.
- Monitoring Parameters: Liver function tests, renal function, ECG (for QT prolongation with Azithromycin).
Popular Combinations
While Azithromycin is sometimes combined with bronchodilators in fixed-dose combinations, Acebrophylline + Azithromycin is less common than Azithromycin’s combination with other bronchodilators.
Precautions
- General Precautions: Evaluate renal and hepatic function, monitor for adverse reactions.
- Specific Populations: Use with caution in pregnant/breastfeeding women, elderly patients, and those with comorbid conditions.
- Lifestyle Considerations: Avoid alcohol while taking Azithromycin. Smoking may decrease the effectiveness of Acebrophylline.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Acebrophylline + Azithromycin?
A: See Dosage Section. Dosing varies depending on the patient’s age, weight, renal and hepatic function, and the severity of the infection. Always consult the product’s specific prescribing information.
Q2: What are the common side effects?
A: Common side effects include nausea, vomiting, diarrhea, abdominal pain, headache, and dizziness.
A: Serious side effects include severe allergic reactions (anaphylaxis, angioedema), hepatotoxicity, and cardiac arrhythmias (including QT prolongation).
Q4: Can this combination be used during pregnancy or breastfeeding?
A: Consult a physician. The safety of this combination during pregnancy and breastfeeding hasn’t been fully established.
Q5: What are the contraindications for using this medicine?
A: Contraindications include hypersensitivity to either drug, a history of cholestatic jaundice/hepatic dysfunction with prior macrolide use, and concomitant use with Pimozide.
Q6: What other medications interact with this combination?
A: See Drug Interactions Section.
Q7: What precautions should be taken while using this drug?
A: Evaluate renal and hepatic function, monitor for adverse reactions, and use with caution in pregnant/breastfeeding women, elderly patients, and those with comorbid conditions. Avoid alcohol while taking Azithromycin and consider the impact of smoking on Acebrophylline’s effectiveness.
Q8: What is the mechanism of action of each component?
A: Acebrophylline relaxes bronchial smooth muscle and improves mucociliary clearance. Azithromycin inhibits bacterial protein synthesis.
Q9: Is this combination safe for children?
A: It’s not recommended for children under 12 years. Pediatric dosages for older children should be weight-based and determined by a physician.
Q10: What should I do if I miss a dose?
A: Take the missed dose as soon as remembered unless it is almost time for the next dose. Do not double the dose to make up for a missed one.
