Description:

Clarithromycin USP 125mg/5ml (Klabex by Opsonin Pharma) is a paediatric oral suspension of clarithromycin, a macrolide antibiotic. It is used to treat bacterial infections in children, including respiratory tract infections (tonsillitis, pharyngitis, sinusitis, acute otitis media, pneumonia), skin and soft tissue infections, and certain atypical infections (e.g., Mycoplasma, Chlamydia). It works by inhibiting bacterial protein synthesis. In Ghana (Accra), Klabex suspension is a common, affordable prescription antibiotic available in pharmacies for paediatric respiratory and skin infections when macrolides are indicated.

Prescription:

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

Therapeutic Category:

Macrolide Antibiotic (Oral antibacterial agent).

Active Ingredients/Composition: Per 5 ml of reconstituted suspension:

• Active ingredient: Clarithromycin – 125 mg. Other ingredients (typical in suspension): Sucrose (sweetener), xanthan gum (thickener), flavoring (e.g., fruit), preservatives (e.g., sodium benzoate), buffering agents, and purified water. The powder is off-white to pale yellow; reconstituted suspension is white to off-white with a pleasant fruit flavor.

Vitamins: None.

Minerals: None.

Variant:

• Klabex 125mg/5ml Oral Suspension (standard paediatric strength; common bottle size 60ml or 100ml after reconstitution). Related variants: Klabex 250mg/5ml suspension (higher strength), Klabex 250mg or 500mg tablets (for adults/older children), or clarithromycin extended-release tablets. The 125mg/5ml is the most common paediatric formulation.

Consume Type:

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

Directions/Usage: Shake bottle vigorously before each use.

• Children: Usual dose 7.5 mg/kg twice daily (maximum 500 mg twice daily).
  • Example (approximate):
    • Weight 8–11 kg: 2.5–5 ml twice daily
    • Weight 12–19 kg: 5 ml twice daily
    • Weight 20–29 kg: 7.5 ml twice daily
    • Weight 30–40 kg: 10 ml twice daily
• Duration: Typically 7–14 days depending on infection (e.g., 10 days for otitis media, 7–10 days for pharyngitis/tonsillitis).
• Take with or without food (food may reduce GI upset).
• Use the provided measuring device (spoon or syringe) for accurate dosing.
• Complete the full course even if symptoms improve.

Common Side Effects: Common (mild):

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

Package Type:

Amber plastic bottle of powder (usually 60ml or 100ml 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 14 days (check label).
• Shake well before each dose. Keep out of reach of children.

Safety Advice:

• Use only for proven or strongly suspected bacterial infections (risk of promoting antibiotic resistance).
• Contraindicated in hypersensitivity to clarithromycin, 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 (dose adjustment may be needed).
• Monitor for superinfections (e.g., C. difficile diarrhoea).
• If severe diarrhoea, rash, jaundice, irregular heartbeat, or allergic symptoms occur, stop use and seek urgent medical care.
• Keep out of reach of children (overdose risk).

Product Substitutes: Similar clarithromycin 125mg/5ml oral suspensions in Ghana include:

• Generic clarithromycin 125mg/5ml suspension (various importers).
• Klacid or Clarithromycin suspensions (other brands).
• Alternatives: Azithromycin suspension (Zithromax or generics – often preferred for shorter course), erythromycin suspension, amoxicillin suspension (if susceptible organism). Consult pharmacist/paediatrician in Accra (e.g., Scab Pharmacy) for best match.

Manufacturer/Marketer:

Opsonin Pharma Ltd. (Bangladesh-based; primary manufacturer of Klabex clarithromycin oral suspension). Marketed/distributed in Ghana by local importers/pharmacies (widely stocked as imported product).

Country of Origin:

Bangladesh (manufactured by Opsonin Pharma Ltd.; imported to Ghana and widely available in local pharmacies).