AMOXICLAV JUNO

What it is

Amoxiclav Juno is a combination of amoxicillin sodium and potassium clavulanate. It is supplied as a powder for injection in sterile white to off-white form. Three strengths are available: 500/100 (500 mg amoxicillin and 100 mg clavulanic acid), 1000/200 (1000 mg amoxicillin and 200 mg clavulanic acid), and 2000/200 (2000 mg amoxicillin and 200 mg clavulanic acid).

Approved indications

Amoxiclav Juno is indicated for the short term treatment of serious bacterial infections including upper respiratory tract infections such as mastoiditis, tonsillitis, otitis media, epiglottitis and sinusitis when accompanied by severe signs and symptoms. — Lower respiratory tract infections, for example acute exacerbations of chronic bronchitis, lobar and broncho-pneumonia, and community acquired pneumonia. — Genito-urinary tract infections such as cystitis, urethritis, pyelonephritis and female genital infections. — Gastrointestinal infections including intra-abdominal sepsis and peritonitis. — Skin and skin structure infections, in particular cellulitis, animal bites, diabetic foot infections, vascular surgery infection/ischaemic soft tissue infection, and severe dental abscess. — Other infections such as septic abortion, puerperal sepsis and post-surgical infections. — Prophylaxis against infection in major surgical procedures that may be associated with higher risk of infectious complications, for example gastrointestinal surgery.

Dosing overview

Amoxiclav Juno powder for injection is for administration by intravenous (IV) or intravenous infusion (IVI) route after reconstitution. It is not for intramuscular administration. For adults and children weighing 40 kg and over, the usual dose is 1.2 g eight hourly; in more serious infections this may be increased to six-hourly intervals. If higher doses are required, dosage can be increased to 2.2 g eight hourly, with more serious infections requiring six-hourly administration. Children aged 3 months to 12 years usually receive 30 mg/kg eight hourly, with six-hourly dosing for more serious infections. Children aged 0–3 months receive 30 mg/kg every 12 hours if under 4 kg and every 8 hours if over 4 kg. For surgical prophylaxis in adults, the recommended dose is 1.2 g or 2.2 g given at induction of anaesthesia with a further 1.2 g or 2.2 g given after 2 hours if necessary. Treatment should not be extended beyond 14 days without review. The duration of therapy should be determined by the response of the patient.

Key safety warnings

Serious and occasionally fatal hypersensitivity reactions including anaphylaxis have been reported in patients receiving beta-lactam antibiotics such as penicillins. These can progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction. Before commencing therapy, careful enquiries should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If a hypersensitivity reaction occurs, amoxicillin/clavulanic acid therapy should be discontinued and appropriate therapy instituted. Serious anaphylactic reactions require emergency treatment with adrenaline, oxygen, intravenous steroids and airway management including intubation as indicated. Drug-induced enterocolitis syndrome has been reported mainly in children receiving amoxicillin/clavulanate. It is an allergic reaction with protracted vomiting (1–4 hours after drug administration) in the absence of allergic skin or respiratory symptoms, and may progress to shock with abdominal pain, diarrhoea, hypotension or leucocytosis with neutrophilia. Antibiotic-associated pseudomembranous colitis has been reported with amoxicillin. A toxin produced by Clostridium difficile appears to be the primary cause, with 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 therapy. Abnormal prolongation of prothrombin time has been reported rarely in patients receiving amoxicillin/clavulanate and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently, and adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.

Contraindications

Amoxiclav Juno is contraindicated in patients with a history of hypersensitivity to beta-lactams such as penicillins and cephalosporins. It is also contraindicated in patients with a previous history of amoxicillin/clavulanic acid-associated jaundice or hepatic dysfunction.

Regulatory history

Amoxiclav Juno received initial ARTG registration on 18 January 2017 across three strengths: 500/100 mg, 1000/200 mg and 2000/200 mg powder for injection vials.