AMOXICILLIN/CLAVULANIC acid = CO-AMOXICLAV oral

Therapeutic action

• Combination of two antibacterials. The addition of clavulanic acid to amoxicillin extends its spectrum of activity to cover beta-lactamase producing Gram-positive and Gram-negative organisms, including some Gram-negative anaerobes.

Indications

• Animal bites, if antibiotic therapy or antibiotic prophylaxis is clearly indicated
• Second line treatment of acute otitis media and acute bacterial sinusitis, when amoxicillin alone given at high dose failed
• Acute uncomplicated cystitis (no systemic signs) in girls over 2 years
• Postpartum upper genital tract infection
• Parenteral to oral switch therapy in severe infections (e.g. severe pneumonia)

Forms and strengths

• The ratio of amoxicillin and clavulanic acid varies according to the manufacturer:

Dosage

(expressed in amoxicillin)

Animal bites; second line treatment of acute otitis media and acute sinusitis

• Child < 40 kg: 25 mg/kg 2 times daily
• Child ≥ 40 kg and adult:
  • Ratio 8:1: 2000 mg daily = 2 tablets of 500/62.5 mg 2 times daily
  • Ratio 7:1: 1750 mg daily = 1 tablet of 875/125 mg 2 times daily

Acute uncomplicated cystitis in girls > 2 years

• 12.5 mg/kg 2 times daily

Postpartum upper genital tract infection; parenteral to oral switch therapy in severe infections

• Child < 40 kg: 50 mg/kg 2 times daily
• Child ≥ 40 kg and adult:
  • Ratio 8:1: 3000 mg daily = 2 tablets of 500/62.5 mg 3 times daily
  • Ratio 7:1: 2625 mg daily = 1 tablet of 875/125 mg 3 times daily

Duration

• Animal bites: 5 to 7 days
• Otitis media: 5 days
• Sinusitis: 7 to 10 days
• Cystitis: 3 days
• Upper genital tract infection: 7 days
• Parenteral to oral switch therapy in severe pneumonia: to complete a total of 10 to 14 days of treatment.

Contra-indications, adverse effects, precautions

• Do not administer to penicillin-allergic patients and patients with history of hepatic disorders during a previous treatment with co-amoxiclav.
• Administer with caution to patients allergic to cephalosporins (cross-sensitivity may occur).
• Administer with caution to patients with hepatic impairment; reduce dosage and give every 12 or 24 hours in patients with severe renal impairment.
• May cause: gastrointestinal disturbances (mainly diarrhoea); allergic reactions sometimes severe (stop treatment immediately); jaundice and cholestatic hepatitis in the event of prolonged treatment (> 10 to 15 days).
• The dose of clavulanic acid should not exceed 12.5 mg/kg daily or 375 mg daily.
• Pregnancy: no contra-indication
• Breast-feeding: no contra-indication

Remarks

• Take with meals.
• Also comes in formulations with a ratio of amoxicillin/clavulanic acid of 4:1: 125 mg amoxicillin/31.25 mg clavulanic acid/5 ml powder for oral suspension and 500 mg amoxicillin/125 mg clavulanic acid tablet. The maximum dose (expressed in amoxicillin) that can be given with these formulations is 50 mg/kg daily, without exceeding 1500 mg daily.

Storage