PHARMACLAV

What it is

PHARMACLAV contains amoxicillin trihydrate. It is available as an oral suspension in strengths of 125 mg per 5 mL and 250 mg per 5 mL when reconstituted. The medicine is supplied as a dry powder for oral suspension, which when constituted with water forms a pale yellow to yellow coloured suspension with fruity aromatic odour.

Approved indications

PHARMACLAV is indicated for the treatment of infections due to susceptible strains of sensitive organisms. The approved indications are: — 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. Experience in neonates is too limited to make any recommendations regarding dosage or the appropriateness of the oral route.

Regulatory history

PHARMACLAV 875 mg/125 mg amoxicillin and clavulanic acid tablets were first registered on the ARTG on 14 November 2013.