📋 Indications & Clinical Dosage
*Susceptible infections due to Gram-positive and Gram-negative bacteria, Upper & lower respiratory tract infection:*
ORAL: Adult: 250 mg twice daily, dose may be doubled insevere lower respiratory-tract infections or if pneumonia is suspected.
Children 3 months-1 year: 10 mg/kg twice daily (max. per dose 125 mg); 2-11 years: 15 mg/kg twice daily (max. per dose 250 mg); Child 12-17 years: 250 mg twice daily, dose may be doubled in severe lower respiratory-tract infections or if pneumonia is suspected.
BY IV INF, ORIV INJ, OR IM INJ: Adult: 750 mg every 6-8 hours; increased if necessary up to 1.5 g every 6-8 hours, for severe infections and cystic fibrosis.
Children: 20 mg/kg every 8 hours (max. per dose 750 mg); increased to 50-60 mg/kg every 6-8 hours (max. perdose 1.5 g), for severe infection and cystic fibrosis.
*Septicaemia, Meningitis:*
BY IV INJ :Adults: 1.5 gm every 6 hr. Max: 3 gm every 8 hr. Children: 3 mth:100-200 mg/kg/day divided every 6-8 hr; Max: 4.5 gm/day.
*Lyme disease:*
ORAL: Adult: 500 mg twice daily for 14-21 days (for 28 days in Lyme arthritis)
*Lower urinary-tract infection:*
ORAL: Adult & Children above 12 years: 125 mg twice daily.
*Pyelonephritis, Pharyngitis, Tonsillitis:*
ORAL: Adult: 250 mg twice daily
Children 3 months-12 yrs: 125 mg every 12 hr for 10 days or 10 mg/kg every 12 hr for 10 days; Max: 500 mg/day.
*Sinusitis, Otitis Media:*
Children 3 mth-12 yr: 250 mg every 12 hr for 10days or 15 mg/kg every 12 hr for 10days; Max: 1 gm/day.
*Surgical prophylaxis:*
BY IV INJ: Adult: 1.5 g, to be administered up to 30 minutes before the procedure, then (by IV injection or by IM injection) 750 mg every 8 hours if required for up to 3 doses (in high risk procedures)
*Bone Infection, Open fractures, prophylaxis:*
BY IV INF, ORIV OR IM INJ: Adult: 1.5 g every 8 hours until soft tissue closure (max. duration 72 hours).
Children3 months: 50 mg/kg every 8 hr. Max: 4.5 gm/day.
💊 Mode of Administration
IM: Inject deep IM into large muscle mass. Inject direct IV over 3-5 min. Infuse intermittent infusion over 15-30 min. Restitute by adding 3 or 3.6 ml SWFI to each 750 mg vial to yield 220 mg/ml.
⚠️ Precautions & Warnings
Hypersensitivity, hepatic and renal impairment (CrCI-x20 ml/min). Suspension may contain aspartame; caution in phenylketonuria.
🔄 Drug Interactions
Loop diuretics, aminoglycosides. Probenecid, combined oral contraceptives.
⚠️ Adverse Reactions / Side Effects
Abdominal discomfort, agranulocytosis, allergic reactions, anaphylaxis, aplastic anaemia, blood disorders, confusion, disturbances in liver enzymes, dizziness, eosinophilia, haemolytic anaemia, hallucinations, headache, hypertonia, leucopenia, nervousness, pruritus, rashes, fever and arthralgia, sleep disturbances, urticaria, GI disturbances, Rare: Stevens-Johnson syndrome, thrombocytopenia, toxic epidermal necrolysis, transient cholestatic jaundice, transient hepatitis
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Caution advised
Lactation / Breastfeeding:
Caution advised, avoid
🧪 Compatibility & Storage Stability
Compatibility: Stable in D51/4NS, D51/2NS, D5NS, D5W, 010W, LR, NS.
Stability & Storage: Reconstituted solution is stable for 24 hours at room temperature, and 48 hours when refrigerated. For IV infusion in NS or D5W, solution is stable for 24 hours at room temperature, 1 week when refrigerated, or 26 weeks when frozen.
📚 Official Regulatory & Clinical References
- Drug Regulatory Authority of Pakistan (DRAP): Drug Registration, S.R.O. Price Gazettes & National Essential Medicines List (NEML).
- World Health Organization (WHO): Collaborating Centre for Drug Statistics Methodology (ATC/DDD Index).
- Formulary Standards: British National Formulary (BNF) & Pakistan National Formulary (PNF) guidelines.