AMILOXYN

What it is

AMILOXYN is available as capsules containing 250 mg and 500 mg amoxicillin as trihydrate. The 250 mg variant is a maroon/yellow size 1 hard gelatin capsule imprinted with A on the maroon cap and 85 on the yellow body, whilst the 500 mg variant is a maroon/yellow size OEL hard gelatin capsule imprinted with A on the maroon cap and 86 on the yellow body.

Approved indications

— Skin and skin structure infections caused by susceptible strains of non-penicillinase producing Staphylococcus, Streptococcus, or E. coli. — Acute and chronic respiratory tract infections caused by susceptible strains of H. influenzae, Streptococcus, S. pneumoniae, non-penicillinase producing Staphylococcus, or E. coli. — Complicated and uncomplicated acute and chronic genitourinary tract infections caused by susceptible strains of E. coli, P. mirabilis, or S. faecalis. — Gonorrhoea caused by susceptible strains of non-penicillinase producing N. gonorrhoeae. — Prophylaxis of bacterial endocarditis in individuals at particular risk, such as those with a prosthetic heart valve or those who have previously had endocarditis.

Dosing overview

For upper respiratory tract infections, genitourinary tract infections, and skin and soft tissue infections, adults are dosed at 250 mg every eight hours, whilst children under 20 kg are dosed at 20 mg/kg/day in equally divided doses every eight hours. In severe infections or those caused by less susceptible organisms, 500 mg every eight hours for adults and 40 mg/kg/day in equally divided doses every eight hours for children may be needed. For lower respiratory tract infections, adults are dosed at 500 mg every eight hours, whilst children under 20 kg are dosed at 40 mg/kg/day in equally divided doses every eight hours. For gonococcal urethritis, adults are given 3 g as a single dose. For acute uncomplicated lower urinary tract infections in non-pregnant adult females, adults are given 3 g as a single dose. In renal impairment, excretion of the antibiotic will be delayed and it may be necessary to reduce the total daily dosage. In patients receiving peritoneal dialysis, the maximum recommended dose is 500 mg/day.

Key safety warnings

AMILOXYN may contain traces of sulfites. Cases of gonorrhoea with a suspected lesion of syphilis should have darkfield examinations before receiving amoxicillin and monthly serological tests for a minimum of four months.

PBS listing

Both the 250 mg and 500 mg capsule strengths are listed on the PBS with streamlined unrestricted restrictions. Each strength has 3 PBS items with an ex-manufacturer price of A$2.50.

Regulatory history

AMILOXYN 250 mg capsules (ARTG 185793) and AMILOXYN 500 mg capsules (ARTG 185798) were both first listed on the ARTG on 1 March 2012.