AZI-ONCE 200/MG/5/ML 15/ML SUSP

Indications

Approved Uses

Labeled indications vary by country/brand; commonly approved uses for oral azithromycin include community-acquired pneumonia, acute bacterial sinusitis, acute exacerbation of chronic bronchitis/COPD, pharyngitis/tonsillitis, uncomplicated skin/skin-structure infections, acute otitis media, and uncomplicated urethritis/cervicitis due to Chlamydia trachomatis (and some labels include chancroid).

Dosage & Administration

Dosing by Condition

Adults (common regimens): CAP 500 mg day 1 then 250 mg daily days 2-5; sinusitis or AECB/COPD exacerbation 500 mg daily for 3 days (or 500 mg day 1 then 250 mg days 2-5 depending on label). Pediatrics: acute otitis media 30 mg/kg single dose OR 10 mg/kg daily for 3 days OR 10 mg/kg day 1 then 5 mg/kg days 2-5; pharyngitis/tonsillitis 12 mg/kg daily for 5 days (max 500 mg/day). STI: chlamydial urethritis/cervicitis 1 g single dose (gonorrhea requires combination therapy per current guidelines).

Initial Dose

500mg on Day 1 (adults) for most respiratory indications; 10mg/kg on Day 1 (children)

Maintenance Dose

250mg once daily on Days 2-5 (adults); 5mg/kg once daily on Days 2-5 (children)

Maximum Dose

Depends on indication: common adult regimens are 500 mg/day (often then 250 mg/day) with typical maximum 500 mg/day for many infections; however, a 2 g single dose is used for certain indications in some guidelines/labels (e.g., some STI regimens).

Children's Dosage

Otitis media: 30mg/kg single dose or 10mg/kg/day for 3 days or 10mg/kg Day 1 then 5mg/kg Days 2-5. Pharyngitis: 12mg/kg/day for 5 days (max 500mg/day). Community-acquired pneumonia: 10mg/kg on Day 1 then 5mg/kg on Days 2-5. Approved for children ≥6 months for otitis media and community-acquired pneumonia; ≥2 years for pharyngitis

How to Take

Reconstitute the powder with the specified amount of water per the product label, then shake well before each dose; measure doses with an oral syringe/medicine spoon; give once daily as prescribed; may be taken with or without food (food may improve GI tolerability).

How to Prepare

Tap/loosen powder, then add the exact volume of water specified on the bottle/leaflet (often in two portions), shaking well after each addition until uniformly suspended; final reconstituted volume is 15 mL.

Side Effects

Common Side Effects

Diarrhea, nausea, abdominal pain, vomiting, and headache (GI effects are most common).

Side Effect Frequency

Very common/common: diarrhea, nausea, abdominal pain; vomiting is common. Other common: headache. Rash and dizziness occur but are less frequent. Rare/serious: QT prolongation/arrhythmia, hepatotoxicity, severe hypersensitivity (including SJS/TEN), and C. difficile-associated diarrhea.

Safety & Warnings

Contraindications

Contraindicated in patients with hypersensitivity to azithromycin, erythromycin, or any macrolide/ketolide; and in those with a history of cholestatic jaundice/hepatic dysfunction associated with prior azithromycin use.

Warnings & Precautions

Precautions: QT prolongation risk (especially with existing QT issues, electrolyte abnormalities, bradycardia, or QT-prolonging drugs), severe hypersensitivity/SCARs, hepatotoxicity (stop if hepatic dysfunction), C. difficile-associated diarrhea, potential myasthenia gravis exacerbation, and superinfection with prolonged use.

Age Restriction

Generally approved for pediatric use ≥6 months for labeled indications (e.g., acute otitis media, community-acquired pneumonia); safety/efficacy not established in infants <6 months for most indications.

Drug Interactions

Drug Interactions

Key interactions: aluminum/magnesium antacids (separate dosing), warfarin (monitor INR), digoxin (monitor levels/toxicity), ergot derivatives (avoid), cyclosporine (monitor levels), nelfinavir (↑ azithromycin exposure), and other QT-prolonging drugs (additive risk).

Food Interaction

May be taken with or without food; taking with food can lessen gastrointestinal upset.

Alcohol Interaction

Safe

Special Populations

Pregnancy

Category B (no evidence of risk in animal studies; inadequate human data)

Children

Otitis media: 30mg/kg single dose or 10mg/kg/day for 3 days or 10mg/kg Day 1 then 5mg/kg Days 2-5. Pharyngitis: 12mg/kg/day for 5 days (max 500mg/day). Community-acquired pneumonia: 10mg/kg on Day 1 then 5mg/kg on Days 2-5. Approved for children ≥6 months for otitis media and community-acquired pneumonia; ≥2 years for pharyngitis

Liver Impairment

No established dose adjustment for mild-moderate hepatic impairment; use with caution and discontinue if signs of hepatitis/liver dysfunction occur; avoid/use only if benefits outweigh risks in severe hepatic disease.

Storage & Patient Advice

Preparation Instructions

Tap/loosen powder, then add the exact volume of water specified on the bottle/leaflet (often in two portions), shaking well after each addition until uniformly suspended; final reconstituted volume is 15 mL.

Patient Counseling

Complete the prescribed course. Shake well before each dose and measure with an oral syringe/spoon. May be taken with or without food; take with food if stomach upset occurs. Avoid aluminum- or magnesium-containing antacids within 2 hours of the dose. Seek urgent care for signs of severe allergy (rash/face swelling/breathing difficulty), severe or persistent diarrhea (possible C. difficile), jaundice/dark urine (liver injury), or palpitations/syncope (QT prolongation). This treats bacterial infections only (not colds/flu). Store as directed below 30°C and keep out of reach of children; discard any remaining reconstituted suspension after the labeled in-use period.

Monitoring Requirements

No routine labs for short courses in low-risk patients; monitor for clinical response and adverse effects; check LFTs if hepatic symptoms or prolonged therapy, and consider ECG/QT risk assessment in patients with risk factors or on QT-prolonging drugs.

Pharmacology

Mechanism of Action

Binds to the 50S ribosomal subunit (23S rRNA) of susceptible bacteria, inhibiting translocation/protein synthesis (primarily bacteriostatic).

Onset of Action

Peak plasma concentrations occur about 2-3 hours after an oral dose; clinical improvement in susceptible infections is typically seen within 24-72 hours.

Half-Life

Terminal elimination half-life: approximately 68 hours.

Metabolism

Limited hepatic metabolism (minor); largely eliminated unchanged in bile and does not meaningfully inhibit CYP450 at therapeutic doses.

Product Information

Available Dosage Forms

For azithromycin generally: tablets/capsules, powder for oral suspension (including this product), and IV powder for infusion; ophthalmic solution is a separate ophthalmic product and not a standard systemic dosage form listing for azithromycin.

Composition per Dose

Each 5ml of reconstituted suspension: 200mg azithromycin (as azithromycin dihydrate)

Generic Availability

Yes

OTC Alternatives

No OTC alternative - prescription required for antibiotic therapy

Spectrum

Broad-spectrum

Antibiotic Class

Macrolide

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