AUGMENTIN

What it is

AUGMENTIN DUO and AUGMENTIN DUO FORTE are combination products containing the semisynthetic antibiotic amoxicillin (as the trihydrate) and the β-lactamase inhibitor potassium clavulanate (as the potassium salt of clavulanic acid). AUGMENTIN DUO FORTE contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. AUGMENTIN DUO contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt.

Approved indications

AUGMENTIN TABLETS are indicated for short term treatment of bacterial infections at the following sites when caused by sensitive organisms: — Urinary tract infections (uncomplicated and complicated) — Lower respiratory tract infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis — Upper respiratory tract infections, such as sinusitis, otitis media and recurrent tonsillitis — Skin and skin structure infections

Dosing overview

The usual adult dose is one AUGMENTIN DUO tablet every 12 hours, or for more severe infections, one AUGMENTIN DUO FORTE tablet every 12 hours. Treatment should usually be continued for 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained, and should not exceed 14 days without review. Children weighing 40 kg and more should be dosed according to the adult recommendations, whilst AUGMENTIN suspensions are recommended for children weighing less than 40 kg.

Key safety warnings

Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions) have been reported in patients on penicillin therapy. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction, with presenting symptoms that can include chest pain occurring in association with an allergic reaction to AUGMENTIN. Drug-induced enterocolitis syndrome (DIES) has been reported mainly in children receiving amoxicillin/clavulanate, presenting as an allergic reaction with protracted vomiting occurring 1–4 hours after administration in the absence of allergic skin or respiratory symptoms, and can include abdominal pain, diarrhoea, hypotension or leucocytosis with neutrophilia, with severe cases including progression to shock. Antibiotic-associated pseudomembranous colitis has been reported with many antibiotics including amoxicillin, with a toxin produced by Clostridium difficile appearing to be the primary cause, and the severity ranging from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use, which may occur up to several weeks after cessation of antibiotic therapy. Cholestatic hepatitis, which may be severe but is usually reversible, has been reported rarely, with signs and symptoms that may not become apparent until several weeks after treatment has ceased. In extremely rare circumstances, deaths have been reported, almost always in cases associated with serious underlying disease or concomitant medications.

Contraindications

History of allergic reaction to β-lactams such as penicillins or cephalosporins. Previous history of amoxicillin/clavulanic acid-associated jaundice or hepatic dysfunction.

Regulatory history

AUGMENTIN tablets were first listed on the ARTG in 1991. AUGMENTIN DUO FORTE tablets were first registered on the ARTG in 1998. AUGMENTIN DUO tablets were first registered on the ARTG in 2023.