APO-AMOXY/CLAV

What it is

APO-AMOXY/CLAV is a combination product containing the semisynthetic antibiotic amoxicillin (as the trihydrate) and the β-lactamase inhibitor potassium clavulanate (as the potassium salt of clavulanic acid). The medicine is available in two strengths: 500 mg amoxicillin with 125 mg clavulanic acid, and 875 mg amoxicillin with 125 mg clavulanic acid.

Approved indications

APO-AMOXY/CLAV is 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 infection.

Dosing overview

For adults, the usual dose is one APO-AMOXY/CLAV 500/125 tablet every 12 hours. For more severe infections, the dose should be one APO-AMOXY/CLAV 875/125 tablet every 12 hours. The tablets should be taken immediately before or with the first mouthful of food, to minimise potential gastrointestinal intolerance and to optimise absorption. 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. Treatment should not exceed 14 days without review.

Key safety warnings

Serious and occasionally fatal hypersensitivity (anaphylactoid) 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. Drug induced enterocolitis syndrome (DIES) has been reported mainly in children receiving amoxicillin/clavulanate. DIES is an allergic reaction with the leading symptom of protracted vomiting (1–4 hours) after administration of amoxicillin/clavulanate) in the absence of allergic skin or respiratory symptoms. Further symptoms could comprise abdominal pain, diarrhoea, hypotension, or leucocytosis with neutrophilia. There have been severe cases including progression to shock. Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including amoxicillin. A toxin produced with Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use (this 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. Signs and symptoms may not become apparent until several weeks after treatment has ceased. In most cases resolution has occurred with time. However, in extremely rare circumstances, deaths have been reported. These have almost always been cases associated with serious underlying disease or concomitant medications. Hepatic events subsequent to APO-AMOXY/CLAV have occurred predominantly in males and elderly patients and may be associated with prolonged treatment.

Contraindications

A history of allergic reaction to β-lactams, for example penicillins or cephalosporins, is a contraindication. APO-AMOXY/CLAV is contraindicated in patients with a previous history of amoxicillin/clavulanic acid-associated jaundice or hepatic dysfunction.

Regulatory history

APO-AMOXY/CLAV was first registered on the Australian Register of Therapeutic Goods on 17 January 2017, with two variants listed: the 500/125 mg strength (ARTG 255075) and the 875/125 mg strength (ARTG 255080).