Diclocil Powder for injection
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Summary of Product characteristics
(SPC)
28-04-2024
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Active ingredient:
Dicloxacillin sodium
Available from:
Bristol-Myers Squibb Australia Pty Ltd
Class:
Medicine Registered
Summary of Product characteristics
Diclocil Powder for Injection V3.0
PRODUCT INFORMATION
DICLOCIL
(DICLOXACILLIN SODIUM)
POWDER FOR INJECTION
NAME OF THE MEDICINE
Dicloxacillin sodium is sodium (6R)-6-[3-(2,6-dichlorophenyl)-5-methylisoxazole-4-
carboxamido]-penicillanate monohydrate; it is a penicillinase-resistant, acid-resistant,
semisynthetic penicillin with the following structure.
DESCRIPTION
Diclocil
powder for injection is a fine white crystalline powder,
containing only dicloxacillin
500mg or 1g as sodium dicloxacillin.
PHARMACOLOGY
_ _
_Pharmacokinetics: _
Dicloxacillin is 95% to 99% bound to serum proteins, mainly albumin. Dicloxacillin is
distributed into bone, bile, pleural fluid, and synovial fluid. Only minimal concentrations are
attained in cerebrospinal fluid.
The elimination half-life of Dicloxacillin is approximately 0.7 hours. Dicloxacillin is partially
metabolized to microbiologically active (5-hydroxymethyl derivative of dicloxacillin) and
inactive metabolites. Dicloxacillin and its metabolites are rapidly excreted in the urine by
glomerular filtration and tubular secretion. The drug is also partially excreted in the faeces via
biliary elimination.
Reduced plasma concentrations have been reported in patients with cystic fibrosis. This is
attributed to enhanced elimination of the drug in these patients.
Diclocil Powder for Injection V3.0
2
Dicloxacillin is not dialysable. Only minimal amounts are removed by haemodialysis or
peritoneal dialysis.
_Pharmacological Actions: _
Penicillinase-resistant penicillins exert a bactericidal action against penicillin-susceptible
microorganisms d
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