Product Dossier

APO-AMOXYCILLIN

Product Dossier for APO-AMOXYCILLIN (amoxicillin, Arrotex Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

APO-AMOXYCILLIN contains amoxicillin trihydrate and is available as an oral suspension powder in two strengths: 125 mg per 5 mL and 250 mg per 5 mL. When reconstituted with water, it forms a pale yellow to yellow coloured suspension with fruity aromatic odour.

Approved indications

— Skin and skin structure infections caused by susceptible strains of Staphylococcus (non-penicillinase producing), Streptococcus, or E. coli — Acute and chronic respiratory tract infections caused by susceptible strains of H. influenzae, Streptococcus, S. pneumoniae, Staphylococcus (non-penicillinase producing), 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 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

Children weighing more than 20 kg should be dosed according to adult recommendations. In renal impairment, the excretion of the antibiotic will be delayed and dosage reduction may be necessary; in patients receiving peritoneal dialysis, the maximum recommended dose is 500 mg/day. Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained.

Key safety warnings

Cases of gonorrhoea with a suspected lesion of syphilis should have darkfield examinations before receiving APO-AMOXYCILLIN and monthly serological tests for a minimum of four months.

PBS listing

APO-AMOXYCILLIN powder for oral suspension is listed on the PBS in two strengths: 125 mg per 5 mL and 250 mg per 5 mL, each available as 100 mL bottles with two PBS items per strength. The restriction type is unrestricted and the ex-manufacturer price is A$2.50 per item.

Regulatory history

APO-AMOXYCILLIN oral suspension formulations were first registered on the ARTG on 7 August 2007, with the 125 mg/5 mL strength (ARTG 137882) and 250 mg/5 mL strength (ARTG 137883). Capsule formulations in 250 mg (ARTG 208147) and 500 mg (ARTG 208144) strengths were subsequently registered on 6 August 2013.