Product Dossier
ALPHAMOX
Product Dossier for ALPHAMOX (amoxicillin, Alphapharm). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Alphapharm
- 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
ALPHAMOX contains amoxicillin as trihydrate and is available in capsule strengths of 250 mg or 500 mg of amoxicillin.
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 P. mirabilis, S. faecalis, or E. coli. — 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 8 hours, with children under 20 kg receiving 20 mg/kg/day in equally divided doses every 8 hours. In severe infections or those caused by less susceptible organisms, 500 mg every 8 hours for adults and 40 mg/kg/day for children may be needed. For lower respiratory tract infections, adults receive 500 mg every 8 hours and children under 20 kg receive 40 mg/kg/day in equally divided doses every 8 hours. For gonococcal urethritis and acute uncomplicated lower urinary tract infections in non-pregnant adult females, a single 3 gram dose is used. Children weighing more than 20 kg should be dosed according to adult recommendations.
Key safety warnings
In renal impairment, excretion of the antibiotic will be delayed and 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. At least 10 days of treatment is recommended for any infection caused by haemolytic streptococci to prevent the occurrence of acute rheumatic fever or glomerulonephritis.
Regulatory history
ALPHAMOX 250 and ALPHAMOX 500 were first registered on the ARTG on 20 September 1991.