Product Dossier

MAXAMOX

Product Dossier for MAXAMOX (amoxicillin, Sandoz). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

MAXAMOX contains amoxicillin trihydrate. It is available as an oral suspension in strengths of 125 mg per 5 mL and 250 mg per 5 mL as a dry powder for reconstitution.

Approved indications —

Skin and skin structure infections caused by susceptible non-penicillinase-producing Staphylococcus, Streptococcus, or E. coli. — Acute and chronic respiratory tract infections caused by susceptible H. influenzae, Streptococcus, S. pneumoniae, non-penicillinase-producing Staphylococcus, or E. coli. — Complicated and uncomplicated acute and chronic genitourinary tract infections caused by susceptible E. coli, P. mirabilis, or S. faecalis. — Gonorrhoea caused by susceptible 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 usual 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 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 receive 500 mg every eight hours, and children under 20 kg receive 40 mg/kg/day in equally divided doses every eight hours. For urethritis caused by gonorrhoea and for acute uncomplicated lower urinary tract infections in non-pregnant adult females, the dose is 3 g as a single dose.

Key safety warnings

In patients with renal impairment, the excretion of amoxicillin is 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. Cases of gonorrhoea with a suspected lesion of syphilis should have darkfield examinations before receiving MAXAMOX and monthly serological tests for a minimum of four months.

PBS listing

MAXAMOX tablets 1 g are listed on the PBS with 2 items under streamlined and restricted access. The ex-manufacturer price is A$3.50. The powder for oral suspension at 500 mg per 5 mL in 100 mL bottles is listed with 2 items under unrestricted access. The ex-manufacturer price is A$2.77.

Regulatory history

MAXAMOX 1000 mg tablets were first listed on the ARTG on 22 November 2001. MAXAMOX powder for oral suspension 500 mg per 5 mL was first listed on the ARTG on 22 July 2003.