ឪសថ AUGMENTIN

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:

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

Ratio 4:1 – 500 mg amoxicillin/125 mg clavulanic acid tablet

– 125 mg amoxicillin/31.25 mg clavulanic acid/5 ml, powder for oral suspension

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 times per day 

Note: the dose of clavulanic acid should not exceed 375 mg/day. 

– Acute uncomplicated cystitis in girls > 2 years

25 mg/kg/day in 2 divided doses (if using ratio 8:1 or 7:1 or 4:1) 

Note: the dose of clavulanic acid should not exceed 12.5 mg/kg/day or 375 mg/day. 

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

Use formulations with a ratio 8:1 or 7:1:

• Child < 40 kg: 80 to 100 mg/kg/day in 2 or 3 divided doses 

Note: the dose of clavulanic acid should not exceed 12.5 mg/kg/day or 375 mg/day.

• Child ≥ 40 kg and adult: 2500 to 3000 mg/day in 3 divided doses. 

Depending on the formulation available: 

Ratio 8:1: 3000 mg/day = 2 tablets of 500/62.5 mg 3 times per day 

Ratio 7:1: 2625 mg/day = 1 tablet of 875/125 mg 3 times per day 

Note: the dose of clavulanic acid should not exceed 375 mg/day.

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 to 14 days of treatment. 

Contra-indications, adverse effects, precautions 

– Do not administer to penicillin-allergic patients and patients with history of hepatic disorders duringa 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, without exceeding 1500 mg/day. 

– Take with meals. – Storage: below 25°C – –