AZOLID 500/MG FC TAB 3/FC TAB

Indications

Approved Uses

Azithromycin is indicated for susceptible infections including: community-acquired pneumonia; acute bacterial exacerbation of chronic bronchitis/COPD; acute bacterial sinusitis; pharyngitis/tonsillitis (when first-line agents are not appropriate); uncomplicated skin and skin structure infections; acute otitis media (pediatric); urethritis/cervicitis due to Chlamydia trachomatis and certain cases due to Neisseria gonorrhoeae (per local guidance/combination therapy); and chancroid (genital ulcer disease).

Dosage & Administration

Dosing by Condition

Typical adult oral regimens: CAP/pharyngitis/skin infections: 500 mg on Day 1 then 250 mg once daily Days 2-5 (or 500 mg daily x3 days for some indications per local labeling); acute bacterial sinusitis/AECB: 500 mg once daily for 3 days; chlamydial urethritis/cervicitis: 1 g PO single dose. Gonorrhea: azithromycin is not recommended as monotherapy; if used historically, higher single doses (e.g., 2 g) were used but current guidelines favor ceftriaxone-based therapy.

Initial Dose

500mg on Day 1 (for most respiratory and skin infections)

Maintenance Dose

250mg once daily on Days 2-5

Maximum Dose

500mg per day (oral); 2g as a single dose for specific indications such as gonorrhea

Children's Dosage

Acute otitis media: 30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg on Day 1 followed by 5 mg/kg/day on Days 2-5 (age ≥6 months). Acute bacterial sinusitis: 10 mg/kg once daily for 3 days (age ≥6 months). Community-acquired pneumonia: 10 mg/kg on Day 1 followed by 5 mg/kg once daily on Days 2-5 (age ≥6 months). Pharyngitis/tonsillitis: 12 mg/kg once daily for 5 days (age ≥2 years). Oral suspension preferred for pediatric use; 500 mg tablet for children able to swallow.

How to Take

Swallow tablet whole with a full glass of water. Can be taken with or without food.

Side Effects

Common Side Effects

Diarrhea, nausea, abdominal pain, vomiting, and headache (GI upset/loose stools/dyspepsia may also occur).

Side Effect Frequency

Common (≥1% to <10%): diarrhea, nausea, abdominal pain, vomiting. Uncommon (≥0.1% to <1%): dizziness, headache, rash. Rare/very rare but clinically important: QT prolongation/arrhythmias, hepatotoxicity, severe hypersensitivity (e.g., angioedema, SJS/TEN), and C. difficile-associated diarrhea/colitis.

Safety & Warnings

Age Restriction

Pediatric use is indication- and formulation-dependent: azithromycin is used in children ≥6 months for approved indications, but the 500 mg film‑coated tablet is generally intended for adults/adolescents or children able to swallow tablets; younger children typically require suspension with weight-based dosing.

Drug Interactions

Drug Interactions

Key interactions: aluminum/magnesium antacids (separate dosing), warfarin (monitor INR), digoxin (monitor levels/toxicity), ergotamine/dihydroergotamine (avoid), QT‑prolonging drugs (additive risk), cyclosporine (monitor levels), nelfinavir (increases azithromycin exposure); colchicine interaction is mainly a concern with macrolides that strongly inhibit CYP3A4/P‑gp-azithromycin is weaker but caution/monitoring is prudent especially in renal/hepatic impairment.

Interaction Severity

MAJOR: other QT-prolonging drugs (additive torsades risk) and ergot derivatives (ergotism-avoid). MODERATE: warfarin (monitor INR), digoxin (monitor for toxicity), cyclosporine (monitor levels). MINOR: aluminum/magnesium antacids can reduce peak levels-separate by ~2 hours.

Food Interaction

Tablets may be taken with or without food; taking with food can reduce gastrointestinal upset.

Alcohol Interaction

Safe

Special Populations

Children

Acute otitis media: 30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg on Day 1 followed by 5 mg/kg/day on Days 2-5 (age ≥6 months). Acute bacterial sinusitis: 10 mg/kg once daily for 3 days (age ≥6 months). Community-acquired pneumonia: 10 mg/kg on Day 1 followed by 5 mg/kg once daily on Days 2-5 (age ≥6 months). Pharyngitis/tonsillitis: 12 mg/kg once daily for 5 days (age ≥2 years). Oral suspension preferred for pediatric use; 500 mg tablet for children able to swallow.

Elderly

Standard adult dosing; no specific dose adjustment required, but monitor for QT prolongation and gastrointestinal side effects

Kidney Impairment

No dose adjustment needed for mild-moderate renal impairment (e.g., GFR 10-80 mL/min); use with caution in severe renal impairment (GFR <10 mL/min).

Storage & Patient Advice

Stopping the Medicine

Complete the full prescribed course; no taper is required-stop after the last prescribed dose.

Overdose

Symptoms may include nausea, vomiting, diarrhea, and reversible hearing impairment; management is supportive (consider activated charcoal if early), monitor ECG for QT prolongation/arrhythmias, and seek urgent medical care/poison center advice.

Patient Counseling

Complete the prescribed course; take with or without food (with food if GI upset); separate aluminum/magnesium antacids by ~2 hours; seek care for severe/persistent diarrhea, rash/allergic symptoms, or signs of liver injury (jaundice/dark urine); inform clinicians about heart rhythm history or QT-prolonging medicines.

Pharmacology

Mechanism of Action

Binds to the 50S ribosomal subunit, inhibiting bacterial protein synthesis (translocation/translation), producing a primarily bacteriostatic effect.

Duration of Effect

Prolonged tissue persistence: therapeutic tissue concentrations can persist for several days after the last dose (often ~5-7 days).

Half-Life

Terminal elimination half-life is approximately 68 hours.

Bioavailability

Oral bioavailability is approximately 37%.

Metabolism

Limited hepatic metabolism (minor demethylation); azithromycin does not meaningfully inhibit/induce CYP450 at therapeutic doses (minimal CYP-mediated interactions compared with erythromycin/clarithromycin).

Excretion

Primarily excreted via bile into feces (mostly unchanged); a small fraction is excreted in urine (about 6-12% as unchanged drug).

Protein Binding

Concentration-dependent and variable: approximately 51% at low concentrations decreasing to about 7% at higher concentrations.

Product Information

Available Dosage Forms

Film-coated tablet, capsule, oral suspension, powder for injection (IV)

Composition per Dose

Each film-coated tablet: 500mg azithromycin (as azithromycin dihydrate)

Generic Availability

Yes

OTC Alternatives

No OTC alternative - prescription required for all antibiotic treatments

Spectrum

Broad-spectrum.

Antibiotic Class

Macrolide.

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