Description
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 > 2 years
– Postpartum upper genital tract infection
– Severe pneumonia: parenteral to oral switch therapy in patients treated with ceftriaxone + cloxacillin
Presentation
– The ratio of amoxicillin and clavulanic acid varies according to the manufacturer:
Also comes in formultions with a ratio amoxicillin/clavulanic acid of 16:1, 14:1, 6:1, 2:1.
Dosage
(expressed in amoxicillin)
Animal bites; second line treatment of acute otitis media and acute sinusitis
- Child < 40 kg: 45 to 50 mg/kg/day in 2 divided doses (if using ratio 8:1 or 7:1) or in 3 divided doses (if
using ratio 4:1)
Note: the dose of clavulanic acid should not exceed 12.5 mg/kg/day or 375 mg/day.
- Child ≥ 40 kg and adult: 1500 to 2000 mg/day depending on the formulation available:
Ratio 8:1: 2000 mg/day = 2 tablets of 500/62.5 mg 2 times per day
Ratio 7:1: 1750 mg/day = 1 tablet of 875/125 mg 2 times per day
Ratio 4:1: 1500 mg/day = 1 tablet of 500/125 mg 3 t
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 pneunonia: to complete a total of 10 to14 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).
Pregnancy: no contra-indication
Breast-feeding : no contra-indication
Remarks
– High doses of co-amoxiclav (80-100 mg/kg/day or 2.5-3 g/day) cannot be administered when using
formulations of amoxicillin/clavulanic acid in a ratio of 4:1 (the content in clavulanic acid is too high). The
maximum dose (expressed in amoxicillin) that can be given with these formulations is 50 mg/kg/day,
– Take with meals.
without exceeding 1500 mg/day.
Storage: below 25°C – –
Powder for oral suspension: between 15°C and 25°C
Once reconstituted, the oral suspension must be kept refrigerated (between 2°C and 8°C) and may be
used for up to 7 days.
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