AMOXICILLIN MLPL

What it is

Amoxicillin trihydrate is available as a dry powder for oral suspension in two strengths: 125 mg/5 mL and 250 mg/5 mL. The powder is white to pale yellow and when reconstituted with water forms a pale yellow to yellow coloured suspension with fruity aromatic odour.

Approved indications —

Skin and skin structure infections caused by non-penicillinase producing Staphylococcus, Streptococcus, or E. coli. — Acute and chronic respiratory infections caused by H. influenzae, Streptococcus, S. pneumoniae, non-penicillinase producing Staphylococcus, or E. coli. — Complicated and uncomplicated acute and chronic genitourinary tract infections caused by 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

For upper respiratory tract infections, genitourinary tract infections, and skin and soft tissue infections, the standard adult dose is 250 mg every eight hours. Children under 20 kg receive 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 may be needed for adults, and 40 mg/kg/day in equally divided doses every eight hours for children. For lower respiratory tract infections, the adult dose is 500 mg every eight hours. Children under 20 kg receive 40 mg/kg/day in equally divided doses every eight hours. For gonococcal urethritis and acute uncomplicated lower urinary tract infections in non-pregnant adult females, the dose is 3 g as a single dose. Children weighing more than 20 kg should be dosed according to adult recommendations.

Key safety warnings

In renal impairment, the excretion of the antibiotic will be delayed, and depending on the degree of impairment, it may be necessary to reduce the total daily dosage. In patients receiving peritoneal dialysis, the maximum recommended dose is 500 mg/day. Amoxicillin may be removed from the circulation by haemodialysis. Experience in neonates is too limited to make any recommendations regarding dosage or the appropriateness of the oral route. In cases of gonorrhoea with a suspected lesion of syphilis, darkfield examinations should be performed before receiving Amoxicillin and monthly serological tests should be conducted for a minimum of four months.

Regulatory history

Amoxicillin was first registered on the ARTG on 8 April 2019, with four entries for the oral suspension formulations in 125 mg/5 mL and 250 mg/5 mL strengths.