Broad-spectrum penicillins / beta-lactamase inhibitors.

Amoxicillin [amoxycillin], clavulanic acid [co-amoxiclav]

Augmentin Tablets: 375mg and 625mg, white oval f-c tablets marked AUGMENTIN. Augmentin Dispersible:  Augmentin Dispersible: white tablets marked AUGMENTIN. Augmentin 250/62 SF: sucrose-free powder for suspension. Augmentin 125/31 SF: sucrose-free powder for suspension. Augmentin Intravenous: powder in vials. Augmentin DUO 400/57: sucrose- free powder for suspension.

Augmentin Tablets: Amoxicillin (as trihydrate) with clavulanic acid (as potassium salt) 375 mg (250 mg:125 mg); 625 mg (500 mg:125 mg). Augmentin Dispersible: Amoxicillin (as trihydrate) with clavulanic acid (as potassium salt) 375 mg (250 mg:125 mg). Augmentin 250/62 SF: Amoxicillin (as trihydrate) 250 mg , clavulanic acid (as potassium salt) 62 mg per 5 mL. Augmentin 125/31 SF: Amoxicillin (as trihydrate) 125 mg , clavulanic acid (as potassium salt) 31 mg per 5 mL. Augmentin Intravenous: Amoxicillin (as sodium salt) with clavulanic acid (as potassium salt) 600 mg (500 mg:100 mg); 1.2 g (1 g:200 mg). Augmentin DUO 400/57: Amoxicillin (as trihydrate) 400 mg , clavulanic acid (as potassium salt) 57 mg per 5 mL.

Tablets, Suspension and Injection: Short term treatment of bacterial infections at the following sites when amoxycillin- resistant beta-lactamase producing strains are suspected as the cause - Upper respiratory tract infections (in particular sinusitus, otitis media, recurrent tonsillitis), lower respiratory tract infections (in particular acute exacerbations of chronic bronchitis, bronchopneumonia), genito-urinary tract and abdominal infections (in particular cystitis, septic abortion, pelvic or puerperal sepsis and intra-abdominal sepsis), and skin and soft tissue infections (in particular cellulitis, animal bites and severe dental abscess with spreading cellulitis). Injection only: Prophylaxis of wound infection associated with surgical procedures in particular gastrointestinal, pelvic, major head and neck surgery and after limb amputation for infection.

Augmentin Tablets and Augmentin Dispersible: 375 mg three times daily before meals for up to 14 days, then review. Severe infections, 625 mg three times daily or 1 g twice daily. Dental infections, 375 mg three times daily for 5 days.

Augmentin Intravenous: Treatment of infection, 1.2 g by intravenous injection or intermittent infusion eight- hourly (or six-hourly in more serious infections). Treat up to 14 days then review. Surgical prophylaxis, usual dose is 1.2g intravenously at the induction of anaesthesia. risk of infection, eg, colorectal surgery, may require three or four 1.2g doses in 24 hours.

Augmentin Tablets and Augmentin Dispersible: Use suspension. Augmentin 250/62 SF: Under 15 kg, 25 mg/kg daily using the syringe measure; 6 - 12 years, 5 mL three times daily before meals for up to 14 days, then review. Augmentin 125/31 SF: Under 1 year, 25 mg/kg daily; 1 - 6 years, 5 mL three times daily before meals. All for up to 14 days, then review. Augmentin Intravenous: Up to 3 months, 30 mg/kg every twelve hours in premature and full term infants during the perinatal period, increasing to eight hours thereafter; 3 months - 12 years, 30 mg/kg eight or six hourly. All by intravenous injection or intermittent infusion for up to 14 days, then review. Augmentin DUO 400/57: Under 2 months, not recommended; 2 months - 2 years, 25/3.6 - 45/ 6.4 mg/kg daily in two divided doses; 2 - 6 years, 2.5 - 5 mL twice daily; 7 - 12 years, 5 - 10 mL twice daily. All before meals for up to 14 days, then review.

Hepatic dysfunction, renal impairment, infectious mononucleosis. Pregnancy.

Anticoagulants.

Hypersensitivity reactions. GI upset. Rarely hepatitis, cholestatic jaundice, interstitial nephritis, toxic epidermal necrolysis, blood dyscrasias.

GlaxoSmithKline(GSK)

(POM)

30 March 2009