Clavulin (Amoxicillin-Clavulanate) Dosing Guidelines
For adults with respiratory infections, the standard dose is 875 mg/125 mg twice daily for 5–7 days, but patients with risk factors for resistant organisms require high-dose therapy: 2000 mg/125 mg twice daily. 1
Adult Dosing
Standard-Dose Regimen (Low-Risk Patients)
- 875 mg/125 mg twice daily for 5–7 days is appropriate for uncomplicated respiratory infections in adults without risk factors for resistant pathogens. 1, 2
- Alternative: 500 mg/125 mg three times daily for mild to moderate infections. 1, 2
- Duration: 5–7 days is as effective as 10 days for uncomplicated acute bacterial rhinosinusitis and reduces adverse effects. 1
High-Dose Regimen (High-Risk Patients)
2000 mg/125 mg twice daily is required when any of the following risk factors are present: 1, 3
- Antibiotic use within the past 4–6 weeks
- Age > 65 years
- Recent hospitalization or immunocompromised status
- Geographic area with > 10% penicillin-resistant S. pneumoniae
- Daycare exposure or household smoker
- Moderate-to-severe symptoms (fever ≥ 39°C, severe pain)
- Frontal or sphenoidal sinusitis
- Comorbidities (diabetes, chronic cardiac/hepatic/renal disease)
This high-dose regimen achieves 90–92% predicted clinical efficacy against resistant pathogens, compared to 83–88% for standard dosing. 1, 3
Renal Impairment Adjustments
- GFR 10–30 mL/min: 500 mg/125 mg every 12 hours (or 250 mg/125 mg every 12 hours for mild infections). 2
- GFR < 10 mL/min or hemodialysis: 500 mg/125 mg every 24 hours, with an additional dose during and after dialysis. 2
- Do not use 875 mg/125 mg formulation if GFR < 30 mL/min. 2
Pediatric Dosing
High-Dose Regimen (First-Line for Most Infections)
- 90 mg/kg/day of amoxicillin component + 6.4 mg/kg/day of clavulanate, divided into 2 doses (maximum 4000 mg/day amoxicillin). 1, 4
- This 14:1 ratio formulation is strongly recommended as first-line therapy for acute otitis media, acute bacterial rhinosinusitis, and community-acquired pneumonia in children. 1, 4
- Duration: 10–14 days for most pediatric infections. 4
Standard-Dose Regimen (Uncomplicated Cases Only)
- 45 mg/kg/day of amoxicillin component + 6.4 mg/kg/day of clavulanate, divided into 2 doses may be used only for uncomplicated infections without risk factors. 1, 4
Indications for High-Dose Therapy in Children
High-dose therapy is required when any of the following are present: 1, 4
- Age < 2 years
- Daycare attendance
- Recent antibiotic use (past 30 days)
- Incomplete Haemophilus influenzae type b vaccination
- Geographic area with > 10% penicillin-resistant S. pneumoniae
- Moderate-to-severe illness
- Concurrent purulent conjunctivitis or otitis media
- Treatment failure after 48–72 hours on amoxicillin alone
Age-Based Oral Suspension Dosing (Alternative to Weight-Based)
- < 1 year: 2.5 mL of 125/31 suspension three times daily. 4
- 1–6 years: 5 mL of 125/31 suspension three times daily. 4
- 7–12 years: 5 mL of 250/62 suspension three times daily. 4
- ≥ 40 kg or ≥ 12 years: Dose as adult (875 mg/125 mg twice daily or 500 mg/125 mg three times daily). 1, 2
Minimum Age for Use
- Clavulin may be initiated in children ≥ 3 months of age for acute otitis media, community-acquired pneumonia, or acute bacterial rhinosinusitis. 4
- For infants < 3 months with suspected serious bacterial infection, intravenous regimens (ampicillin + gentamicin or cefotaxime) are preferred over oral Clavulin. 4
Critical Dosing Considerations
Do NOT Substitute Formulations
- Two 250 mg/125 mg tablets are NOT equivalent to one 500 mg/125 mg tablet because both contain the same 125 mg of clavulanate. 2
- Substituting formulations will result in excessive clavulanate dosing and increased gastrointestinal adverse effects. 2
Administration
- Take at the start of a meal to enhance clavulanate absorption and minimize gastrointestinal intolerance. 2
- May be taken without regard to meals, but starting with food is preferred. 2
Clinical Reassessment
- Adults: If no improvement after 3–5 days, switch to high-dose amoxicillin-clavulanate or a respiratory fluoroquinolone. 1
- Children: If no improvement or worsening after 48–72 hours, escalate to high-dose amoxicillin-clavulanate or consider alternative diagnosis. 1, 4
- Urgent ENT referral is indicated for worsening symptoms, suspected complications (orbital cellulitis, meningitis, visual changes), or recurrent infections (≥ 3 episodes/year). 1
Common Pitfalls to Avoid
- Do not prescribe antibiotics for viral upper respiratory infections. 98–99.5% of acute rhinosinusitis cases lasting < 10 days are viral and do not benefit from antibiotics. 1
- Do not use macrolides or trimethoprim-sulfamethoxazole for respiratory infections due to high resistance rates (> 40% for macrolides, 50% for TMP-SMX against S. pneumoniae). 3
- Do not underdose. Subtherapeutic doses fail to achieve adequate tissue concentrations, promote antimicrobial resistance, and lead to treatment failure. 4
- Verify suspension concentration (125/31 vs. 250/62) before calculating volume to avoid dosing errors. 4
- The high-dose formulation (14:1 ratio) causes less diarrhea than other amoxicillin-clavulanate preparations while maintaining efficacy. 1, 4
Adjunctive Therapies
- Intranasal corticosteroids (mometasone, fluticasone, budesonide) twice daily reduce mucosal inflammation and speed symptom resolution in acute bacterial rhinosinusitis. 1
- Saline nasal irrigation 2–3 times daily provides symptomatic relief and enhances mucus clearance. 1
- Analgesics (acetaminophen or ibuprofen) for pain and fever control. 1