ASPECILLIN VK

What it is

ASPECILLIN VK is a tablet containing phenoxymethylpenicillin (as potassium) available in 250 mg or 500 mg strengths. The 250 mg tablets contain 28 mg of elemental potassium per tablet, while the 500 mg tablets contain 56 mg of elemental potassium per tablet.

Approved indications

— Treatment of mild to moderately severe infections caused by penicillin sensitive staphylococci, pneumococci, gonococci and haemolytic streptococci infections. — Prophylactic use in recurrent streptococcal infections including prevention of recurrence following rheumatic fever and/or Sydenham's chorea. — Prevention of bacterial endocarditis in patients with rheumatic fever and/or congenital heart disease who are about to undergo dental or upper respiratory surgery or instrumentation.

Dosing overview

For infants and small children, the dosage is 15 mg/kg to 50 mg/kg in three to six divided doses, or using a schedule based on age: up to 1 year 60 mg every six hours; 1 to 5 years 120 mg every six hours; 6 to 12 years 120 to 270 mg every six hours.

Key safety warnings

Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy, and although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. Before initiating therapy with any penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other allergens. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy instituted. Serious anaphylactoid reactions require immediate emergency treatment with adrenaline. Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including phenoxymethylpenicillin, with a toxin produced by Clostridium difficile appearing to be the primary cause, and the severity of 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, which may occur up to several weeks after cessation of antibiotic therapy. Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in patients taking beta-lactam antibiotics. When SCAR is suspected, phenoxymethylpenicillin should be discontinued immediately and an alternative treatment should be considered.

Contraindications

Known hypersensitivity to penicillin and/or cephalosporin is a contraindication to ASPECILLIN VK.

PBS listing

ASPECILLIN VK 500 mg tablets are listed on the PBS as 2 items with unrestricted access at an ex-manufacturer price of A$5.05. The 250 mg tablets are listed as 4 items with mixed restriction status at an ex-manufacturer price of A$3.83.

Regulatory history

ASPECILLIN VK phenoxymethylpenicillin 250 mg and 500 mg tablets were first registered on the Australian Register of Therapeutic Goods (ARTG) on 20 November 2012.