Product Dossier
AMOXICILLIN/CLAVULANIC ACID-WGR
Product Dossier for AMOXICILLIN/CLAVULANIC ACID-WGR (amoxicillin trihydrate, potassium clavulanate, GM Pharma). ARTG record, PBS listing, PBAC outcomes —…
- Sponsor: GM Pharma
- Active ingredient: amoxicillin trihydrate, potassium clavulanate
- Therapeutic area: Infectious Disease
- Related brand: AMILOXYN
- Related brand: ALPHACLAV DUO
- Related brand: AMOXYCLAV GENERICHEALTH
- Same area: RETROVIR
- Same area: Savacol Antiseptic Mouth & Throat Rinse
What it is
AMOXICILLIN/CLAVULANIC ACID-WGR is available as tablets containing amoxicillin 500 mg and clavulanic acid 125 mg, or amoxicillin 875 mg and clavulanic acid 125 mg.
Approved indications —
Skin and skin structure infections due to non-penicillinase-producing Staphylococcus, Streptococcus, or E. coli — Acute and chronic respiratory tract infections due to H. influenzae, Streptococcus, S. pneumoniae, non-penicillinase-producing Staphylococcus, or E. coli — Complicated and uncomplicated genitourinary tract infections (acute and chronic) due to E. coli, P. mirabilis, or S. faecalis — Gonorrhoea due to 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 given 250 mg every eight hours, or 500 mg every eight hours in severe infections or those caused by less susceptible organisms. Children under 20 kg receive 20 mg/kg/day in equally divided doses every eight hours, or 40 mg/kg/day in equally divided doses every eight hours for severe infections. 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 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. Cases of gonorrhoea with a suspected lesion of syphilis should have darkfield examinations before receiving AMOXICILLIN/CLAVULANIC ACID-WGR and monthly serological tests for a minimum of four months.
Regulatory history
AMOXICILLIN/CLAVULANIC ACID-WGR was first registered on the ARTG on 8 May 2024, with two variants: the 500/125 mg tablet (ARTG 440370) and the 875/125 mg tablet (ARTG 440371).