1. Disclaimer
The information provided in this commentary is intended solely for educational and professional reference purposes and does not replace medical advice, diagnosis, or treatment. Healthcare professionals should consult official prescribing information and local regulatory approvals before clinical use.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. By using this blog, you agree to assume personal responsibility for relying on the information provided.
2. Summary
XITHRONE is a branded formulation of azithromycin, a broad-spectrum macrolide (azalide) antibiotic widely used for the treatment of respiratory tract infections, skin and soft tissue infections, and selected sexually transmitted infections. It is characterized by extensive tissue penetration, intracellular accumulation, and a prolonged terminal half-life, enabling once-daily dosing and short treatment courses.
3. Brand Name
XITHRONE®
Brand availability and presentation may vary by country.
4. Category
- Pharmacological Class: Macrolide antibiotic (Azalide)
- Therapeutic Class: Antibacterial agent
5. Active Ingredient
Azithromycin
(usually present as azithromycin dihydrate)
6. Pharmaceutical Form & Strength
Based on available manufacturer data and standard azithromycin formulations:
Powder for Oral Suspension
- 200 mg / 5 mL
- Bottle sizes: 15 mL, 25 mL
Film-Coated Tablets
- 500 mg
- Packs of 3 or 5 tablets
Powder for Intravenous Infusion
- 500 mg vial (lyophilized powder)
Exact presentations should be verified locally.
7. Manufacturer & Marketing Authorization Holder
AMOUN Pharmaceutical Company (S.A.E.)
Cairo, Egypt
Marketing authorization status may differ between countries and should be confirmed with local regulatory authorities.
8. Mechanism of Action
Azithromycin binds to the 50S ribosomal subunit (23S rRNA) of susceptible bacteria, inhibiting RNA-dependent protein synthesis by blocking peptide translocation.
This results primarily in a bacteriostatic effect, although bactericidal activity may occur at higher intracellular concentrations against certain organisms.
9. Spectrum of Activity
Azithromycin demonstrates activity against:
Gram-positive bacteria
- Streptococcus pneumoniae
- Streptococcus pyogenes
- Methicillin-susceptible Staphylococcus aureus
Gram-negative bacteria
- Haemophilus influenzae
- Moraxella catarrhalis
- Neisseria gonorrhoeae
- Legionella pneumophila
Atypical pathogens
- Mycoplasma pneumoniae
- Chlamydia pneumoniae
- Chlamydia trachomatis
Local resistance patterns must be considered.
10. Pharmacokinetics
- Absorption: Oral bioavailability approximately 37%; peak levels within 2–3 hours
- Distribution: Extensive tissue distribution; tissue concentrations greatly exceed plasma levels
- Metabolism: Minimal hepatic metabolism; not a significant CYP450 inhibitor
- Elimination: Mainly biliary excretion as unchanged drug; minor renal elimination
- Terminal Half-Life: Approximately 68 hours, allowing once-daily dosing
11. Indications
- Upper respiratory tract infections (sinusitis, pharyngitis, tonsillitis)
- Lower respiratory tract infections, including community-acquired pneumonia
- Acute otitis media (pediatric patients)
- Skin and soft tissue infections
- Uncomplicated urethritis and cervicitis due to Chlamydia trachomatis
- Certain sexually transmitted infections
- Mycobacterial infections (only as part of combination therapy)
12. Administration
- Oral tablets/suspension: Once daily, with or without food
- Intravenous form: Administered only as slow IV infusion under medical supervision
Dosage depends on indication, age, body weight, and severity of infection
13. Method of Preparation
Oral Suspension
- Reconstitute with the specified volume of purified water
- Shake well before each dose
IV Infusion
- Reconstitute 500 mg vial with 4.8 mL sterile water for injection
- Further dilute to a final concentration of 1–2 mg/mL
- Do not administer as IV bolus or IM injection
14. Contraindications
- Hypersensitivity to azithromycin, erythromycin, or other macrolide/ketolide antibiotics
- History of cholestatic jaundice or hepatic dysfunction associated with prior azithromycin use
15. Warnings & Precautions
- QT interval prolongation and risk of serious cardiac arrhythmias
- Use with caution in patients with hepatic impairment
- Risk of Clostridioides difficile–associated diarrhea
- Possible exacerbation of myasthenia gravis
- Overuse may contribute to antimicrobial resistance
16. Drug Interactions
- Antacids (Al/Mg): Reduce peak concentration (separate dosing by ≥2 hours)
- Warfarin: Possible increased anticoagulant effect (monitor INR)
- Digoxin: Potential increase in serum digoxin levels
- Ergot derivatives: Risk of ergotism (avoid combination)
- QT-prolonging drugs: Increased arrhythmia risk
17. Side Effects
Common
- Diarrhea
- Nausea
- Abdominal pain
- Vomiting
Less Common
- Headache
- Dizziness
- Elevated liver enzymes
Rare but Serious
- Severe hypersensitivity reactions
- Hepatotoxicity
- Cardiac arrhythmias (including torsades de pointes)
18. Use in Special Populations
- Pregnancy: Generally considered safe when clinically indicated
- Lactation: Excreted in breast milk; use with caution
- Pediatrics: Approved with weight-adjusted dosing
- Elderly: Increased susceptibility to QT prolongation
- Renal impairment: Usually no dose adjustment required
- Hepatic impairment: Use with caution; monitor liver function
19. Storage Conditions
- Store below 25–30°C
- Protect from moisture and light
- Reconstituted oral suspension: use within manufacturer-specified period
- Keep out of reach of children
20. Additional Sections
Antibiotic Stewardship
Azithromycin should be prescribed only for confirmed or strongly suspected bacterial infections to minimize resistance development.
21. Frequently Asked Questions (FAQ)
Q: Can XITHRONE be taken once daily?
A: Yes. Its long half-life allows once-daily dosing.
Q: Does XITHRONE treat viral infections?
A: No. It is ineffective against viral illnesses such as influenza or the common cold.
Q: Should treatment be stopped when symptoms improve?
A: No. The full prescribed course should be completed.
22. References
- FDA Prescribing Information – Azithromycin
- DailyMed, U.S. National Library of Medicine
- British National Formulary (BNF)
- World Health Organization (WHO) – Azithromycin Monograph
- European Medicines Agency (EMA) – Azithromycin Product Information
