Can Augmentin Be Given to Children?
Yes, Augmentin (amoxicillin/clavulanate) can be given to children and is a first-line recommended antibiotic for specific bacterial respiratory tract infections, but only when a clear bacterial diagnosis is established using stringent clinical criteria. 1
When to Use Augmentin in Children
Approved Indications
Augmentin is FDA-approved and guideline-recommended for children in the following situations:
- Acute Bacterial Sinusitis: Amoxicillin-clavulanate is the preferred first-line empiric therapy for acute bacterial rhinosinusitis in children (strong recommendation) 1
- Acute Otitis Media: Particularly for severe cases, bilateral disease in young children, or when there is treatment failure with amoxicillin alone 1
- Community-Acquired Pneumonia: In children under 5 years who are inadequately vaccinated against H. influenzae type b, or when purulent acute otitis media coexists 1
- Lower Respiratory Tract Infections: For susceptible bacterial pathogens 2
Critical Diagnostic Requirements
Do not prescribe Augmentin unless you have established a bacterial infection using stringent clinical criteria. 1 The harms of antibiotic use outweigh benefits when diagnostic uncertainty exists. 1
For acute bacterial sinusitis, diagnosis requires either:
- Persistent symptoms (nasal discharge or daytime cough) for ≥10 days without improvement, OR
- Worsening symptoms (new fever, increased nasal discharge, headache) after initial improvement, OR
- Severe onset (high fever ≥39°C and purulent nasal discharge for ≥3 consecutive days) 1
Dosing in Children
Standard Dosing (Age ≥3 months, Weight <40 kg)
- Mild/Moderate Infections: 25 mg/kg/day (amoxicillin component) divided every 12 hours 2
- Severe Infections or Lower Respiratory Tract: 45 mg/kg/day divided every 12 hours 2
High-Dose Formulation
- For resistant pathogens or treatment failure: 90 mg/kg/day (Augmentin ES-600) in two divided doses 3
- This provides a 14:1 ratio of amoxicillin to clavulanate, maximizing efficacy against penicillin-resistant S. pneumoniae while minimizing gastrointestinal side effects 3
Infants <3 Months
- Maximum dose: 30 mg/kg/day divided every 12 hours due to immature renal function 2
Duration
Important Harms to Consider
Augmentin causes substantial adverse events in children, particularly compared to placebo. 1
Common Adverse Events
- Diarrhea and rash: Occur in approximately 5% more patients than placebo 1
- In recent trials using amoxicillin-clavulanate, adverse events (rash, diarrhea, vomiting, abdominal pain) occurred in 44% of treated children versus 14% receiving placebo 1
Serious Risks
- Stevens-Johnson syndrome 1
- Anaphylaxis 1
- C. difficile colitis (increasing incidence in hospitalized children) 1
- Long-term microbiome disruption potentially contributing to inflammatory bowel disease, obesity, eczema, and asthma 1
Medication-Related Emergency Visits
Antibiotics are responsible for over 150,000 unplanned medical visits annually for medication-related adverse events in children 1
Common Pitfalls to Avoid
Do not prescribe for viral upper respiratory infections or common colds - this provides no benefit and only exposes children to harm 1
Do not use for acute bronchiolitis - first-line antibiotic therapy has no value due to low risk of bacterial infection 1
Reassess at 72 hours - if symptoms worsen or fail to improve within 72 hours, consider alternative diagnosis or treatment failure 1
Avoid in children with severe penicillin allergy - hospitalization for parenteral therapy is preferable 1
Do not use the 875 mg dose in children with severe renal impairment (GFR <30 mL/min) 2