Description:

Azithromycin for Oral Suspension USP 200mg/5ml is a paediatric macrolide antibiotic in powder form that, after reconstitution with water, yields a liquid suspension. It is used to treat a variety of bacterial infections in children, including acute otitis media, pharyngitis/tonsillitis, community-acquired pneumonia, sinusitis, skin/soft tissue infections, and certain atypical infections (e.g., Mycoplasma, Chlamydia). It works by inhibiting bacterial protein synthesis.

Prescription: Prescription-only (requires a doctor’s prescription in Ghana; dispensed by pharmacies with Rx; not OTC due to antibiotic resistance concerns, need for appropriate bacterial diagnosis, and paediatric dosing accuracy).

Therapeutic Category:

Macrolide Antibiotic (Oral antibacterial agent).

Active Ingredients/Composition: After reconstitution:

• Active ingredient: Azithromycin (as azithromycin dihydrate) – 200 mg per 5 ml of reconstituted suspension.
• The powder in the bottle is equivalent to 600 mg azithromycin total (reconstitutes to 15 ml of 200mg/5ml suspension). Other ingredients (in powder): Sucrose (sweetener), sodium phosphate, hydroxypropyl cellulose, xanthan gum, flavouring (typically cherry/banana or fruit), preservatives (e.g., sodium benzoate), and colorants. Reconstituted suspension is off-white to yellowish with pleasant fruit flavor.

Vitamins: None.

Minerals: None.

Variant:

• LUEX Azithromycin Oral Suspension 200mg/5ml powder for 15ml (standard paediatric strength and bottle size). Related variants: Azithromycin 100mg/5ml suspension (lower strength for younger/smaller children), Azithromycin 250mg/5ml (higher strength), azithromycin tablets (250mg or 500mg for adults/older children), or larger reconstituted volumes (e.g., 22.5ml, 30ml, 37.5ml, 45ml bottles). The 200mg/5ml 15ml bottle is the most common small paediatric formulation.

Consume Type:

Oral – Suspension (liquid after reconstitution; shake well before each dose; measured with provided spoon or syringe).

Directions/Usage: Reconstitute before first use: Add the required volume of boiled/cooled water (as marked on bottle) and shake vigorously until uniform.

• Children: Usual regimen is 10 mg/kg once daily for 3 days (most common short-course treatment).
  • Approximate weight-based dosing examples:
    • Weight 5–15 kg: 2.5–5 ml once daily
    • Weight 16–25 kg: 5–7.5 ml once daily
    • Weight 26–35 kg: 7.5–10 ml once daily
• Some infections (e.g., chlamydia): 20 mg/kg single dose or 10 mg/kg/day for 3 days.
• Take once daily, at the same time each day.
• Can be taken with or without food (food may reduce stomach upset).
• Duration: Usually 3 days (short course – complete all doses even if symptoms improve).
• Shake well before each dose; use provided measuring device.

Common Side Effects: Common (mild):

• Gastrointestinal: Diarrhoea, nausea, vomiting, abdominal pain.
• Headache.
• Altered taste (metallic/bitter).
• Rash. Rare/serious (seek help): Severe diarrhoea (Clostridium difficile-associated), allergic reactions (rash, swelling, breathing difficulty), liver enzyme elevation, hearing changes, or irregular heartbeat (QT prolongation – rare).

Package Type:

Amber plastic bottle of powder (for 15ml final volume after reconstitution; child-resistant cap; provided measuring spoon/syringe; labelled carton with reconstitution instructions, dosing chart, and warnings).

Storage Advice:

• Dry powder (unreconstituted): Store at room temperature (below 25–30°C), protected from light and moisture.
• Reconstituted suspension: Refrigerate (2–8°C) and use within 5–7 days (check label for exact discard date).
• Shake well before each dose. Discard unused portion after recommended period.

Safety Advice:

• Use only for proven or strongly suspected bacterial infections (risk of promoting antibiotic resistance).
• Contraindicated in hypersensitivity to azithromycin, other macrolides, or severe liver impairment.
• Caution in patients with QT prolongation risk (e.g., on other QT-prolonging drugs), myasthenia gravis (may worsen), or renal impairment.
• Monitor for superinfections (e.g., C. difficile diarrhoea).
• If severe diarrhoea, rash, jaundice, irregular heartbeat, or allergic symptoms occur, stop use and seek medical care.
• Keep out of reach of children (overdose risk).

Product Substitutes: Similar azithromycin oral suspensions in Ghana include:

• Azilex Suspension 200mg/5ml (Luex Healthcare – very similar product).
• Generic azithromycin 200mg/5ml oral suspension (various importers).
• Zithromax Suspension (original Pfizer brand if stocked).
• Other brands like Azithrom, Azomax, or local generics. Alternatives: Clarithromycin suspension, erythromycin suspension, amoxicillin suspension (if susceptible organism), or cefuroxime/cefpodoxime (for certain infections). Consult pharmacist/paediatrician in Accra for alternatives.

Manufacturer/Marketer:

Luex Healthcare

Country of Origin:

United Kingdom (UK)