CILICAINE

What it is

CILICAINE VK contains phenoxymethylpenicillin (as potassium) in capsule form, available as 250 mg or 500 mg strengths. Phenoxymethylpenicillin is acid stable and hence better absorbed from the gastrointestinal tract than benzyl penicillin. It produces a bactericidal effect on penicillin sensitive organisms during the stage of active multiplication through inhibition of biosynthesis of cell wall mucopeptides.

Approved indications

— Treatment of mild to moderately severe infections due to penicillin sensitive staphylococci, pneumococci, gonococci and haemolytic streptococci infections. — Prophylactic use in recurrent streptococcal infections including the prevention of recurrence following rheumatic fever and/or Sydenham's chorea and to prevent 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

The dosage should be determined according to sensitivity of the organisms and severity of the infection.

Key safety warnings

Serious and occasionally fatal hypersensitivity (anaphylactoid) 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 history of sensitivity to multiple allergens. Serious anaphylactoid reactions require immediate emergency treatment with adrenaline. Oxygen, intravenous steroids, and airway management, including intubation, should also be administered as indicated. Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including phenoxymethylpenicillin. A toxin produced with Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. Drugs which delay peristalsis, e.g. opiates and diphenoxylate with atropine (Lomotil), may prolong and/or worsen the condition and should not be used. 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. Use of an alternative or additional method of contraception is strongly recommended if an estrogen containing contraceptive is taken concurrently.

Contraindications

Hypersensitivity to penicillins and/or cephalosporin.

PBS listing

CILICAINE VK 250 mg capsules are listed on the PBS with 4 items at an ex-manufacturer price of A$3.83, with both unrestricted and restricted access. The 500 mg capsules are listed with 2 items at an ex-manufacturer price of A$5.05 with unrestricted access.

Regulatory history

CILICAINE VK 250 mg and 500 mg capsule blister packs were first listed on the ARTG on 23 September 2020. The product was first approved on 23 September 2020.