Azithromycin Capsules 250mg
Composition:
Each capsule contains:
- Azithromycin (as Azithromycin Dihydrate) .........… 250mg
- Excipients .........… (as required)
Description:
Azithromycin is a broad-spectrum macrolide antibiotic that works by inhibiting bacterial protein synthesis. It is effective against a variety of Gram-positive, Gram-negative, and atypical bacteria.
Indications:
Azithromycin Capsules are indicated for the treatment of infections caused by susceptible organisms, including:
- Respiratory tract infections (e.g., pneumonia, bronchitis, pharyngitis, sinusitis)
- Skin and soft tissue infections
- Ear infections (acute otitis media)
- Sexually transmitted infections (e.g., chlamydia, gonorrhea)
- Helicobacter pylori-associated peptic ulcer disease (as part of combination therapy)
Dosage & Administration:
Adults & Adolescents (≥12 years):
- Standard dose: 500mg once daily for 3 days OR 500mg on Day 1, then 250mg once daily on Days 2-5
- Chlamydia trachomatis infections: Single dose of 1g (1000mg) once
- H. pylori eradication (as part of combination therapy): 500mg once daily for 3 days
Children (Under 12 years):
- Dose is weight-based: 10mg/kg/day for 3 days
- Alternative regimen: 10mg/kg on Day 1, then 5mg/kg on Days 2-5
Administration Instructions:
- Take 1 hour before or 2 hours after meals (food may reduce absorption).
- Swallow whole with water; do not crush or chew.
Contraindications:
- Hypersensitivity to Azithromycin, macrolide, or ketolide antibiotics
- Severe liver dysfunction
- History of cholestatic jaundice or hepatic dysfunction with prior Azithromycin use
Precautions:
- Use with caution in patients with liver or kidney impairment
- Monitor for QT prolongation, especially in patients with heart disease or taking other QT-prolonging drugs
- Avoid use in severe myasthenia gravis (may worsen symptoms)
- May cause Clostridioides difficile-associated diarrhea (CDAD)
Adverse Reactions:
- Common: Nausea, vomiting, diarrhea, abdominal pain, headache
- Serious: QT prolongation, arrhythmia, hepatotoxicity, severe allergic reactions (e.g., anaphylaxis, Stevens-Johnson Syndrome)
Drug Interactions:
- Increased risk of QT prolongation with antipsychotics, quinolones, and antiarrhythmic drugs
- May reduce effectiveness of live bacterial vaccines
- Increases the levels of warfarin, digoxin, cyclosporine - monitor closely
- Avoid simultaneous use with aluminum- or magnesium-containing antacids (may reduce absorption)
Overdose & Management:
- Symptoms: Severe nausea, vomiting, diarrhea, liver toxicity, hearing loss
- Treatment: Supportive care, symptomatic treatment (e.g., IV fluids, antiemetics)
Storage Conditions:
- Store at 20-25°C, protect from moisture and light
- Keep out of reach of children




