AMOXICILLIN/CLAVULANIC acid = CO-AMOXICLAV oral

Prescription under medical supervision


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:

Ratio 8:1

– 500 mg amoxicillin/62.5 mg clavulanic acid tablet
– 500 mg amoxicillin/62.5 mg clavulanic acid/5 ml powder for oral suspension

Ratio 7:1

– 875 mg amoxicillin/125 mg clavulanic acid tablet
– 400 mg amoxicillin/57 mg clavulanic acid/5 ml, powder for oral suspension
 200 mg amoxicillin/28.5 mg clavulanic acid dispersible tablet

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 to 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: below 25 °C -  -