Product Dossier
AMOXICILLIN-WGR
Product Dossier for AMOXICILLIN-WGR (amoxicillin, GM Pharma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: GM Pharma
- Active ingredient: amoxicillin
- Therapeutic area: Infectious Disease
- Related brand: AMOXIL
- Related brand: MAXAMOX
- Related brand: APO-AMOXYCILLIN
- Same area: RETROVIR
- Same area: Savacol Antiseptic Mouth & Throat Rinse
What it is
AMOXICILLIN-WGR contains amoxicillin trihydrate and is available as an oral suspension in two strengths: 125 mg/5 mL and 250 mg/5 mL. It is supplied as a dry powder for oral suspension. The powder is white to pale yellow and when reconstituted with water forms a pale yellow to yellow coloured suspension with a fruity aromatic odour.
Approved indications
— Skin and skin structure infections caused by non-penicillinase-producing Staphylococcus, Streptococcus, or E. coli. — Acute and chronic respiratory tract 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
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.
Regulatory history
AMOXICILLIN-WGR was first listed on the ARTG on 29 May 2024 with registrations for 125 mg/5 mL powder for suspension, 250 mg/5 mL powder for suspension, 250 mg capsules, and 500 mg capsules.