Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland
Pharmacotherapeutic group: antibacterial agents for systemic use, beta-lactam resistant penicillins
ATC code: J01CF01
Dicloxacillin is a penicillinase stable, acid-stable semisynthetic penicillin. It inhibits bacterial cell wall synthesis and has bactericidal effect on penicillin susceptible bacteria in the growth phase.
Dicloxacillin is effective against most gram positive cocci including beta-haemolytic streptococci, pneumococci and staphylococci also penicillinase producing strains.
Resistant staphylococcus strains may occur, but they are rare.
The prevalence of acquired resistance may vary geographically and with time for selected species, and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Absorption from the gastrointestinal tract is rapid but incomplete. In fasting healthy adults maximum serum concentration is reached during 30 minutes-2 hours and 35-76% of the oral dose is absorbed. Food in the gastrointestinal tract reduces the absorption of dicloxacillin. Serum concentrations after oral administration are directly proportional to dose. Single oral doses of 500 mg dicloxacillin produced maximum serum concentrations of approx. 15 μg per ml.
Protein-binding of dicloxacillin is 95%. It is distributed into bone, bile, pleural fluid, and synovial fluid, but only minimal concentrations are attained in cerebrospinal fluid.
The elimination half-life is approximately 45 minutes. Dicloxacillin is partially metabolized to active and inactive metabolites and is excreted in urine by glomerular filtration and tubular secretion. It is also partially excreted in faeces.
Reduced plasma concentrations have been reported in patients with cystic fibrosis.
In cases where high serum concentrations are required rapidly dicloxacillin may be administered parenterally.
Only minimal amounts are removed by haemodialysis or peritoneal dialysis.
No data from longterm animal studies with dicloxacillin are available.
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