Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Aurogen South Africa (Pty) Ltd, 53 Phillip Engelbrecht Avenue, Woodhill Office Park, Building 1, Meyersdal, Extension 12, 1448, Johannesburg, South Africa
A 20.1.1 Broad and medium spectrum antibiotics
Cefprozil belongs to a sub-group of beta-lactam antibiotics, cephalosporins. It is bactericidal and acts by inhibiting synthesis of bacterial cell wall.
Cefprozil has in vitro activity against the following organisms. The bactericidal action of cefprozil results from inhibition of cell-wall synthesis.
Aerobes, gram-positive:
NOTE: Cefprozil is inactive against methicillin-resistant staphylococci and E. faecium.
Aerobes, gram-negative:
NOTE: Cefprozil is inactive against most strains of Acinetobacter, Enterobacter, Morganella morganii, Proteus vulgaris, Providencia, Pseudomonas and Serratia.
Anaerobes:
Most strains of the Bacteroides fragilis group are resistant to cefprozil. Other resistant organisms include: Clostridium difficile; C. perfringens; Fusobacterium spp.; Peptostreptococcus spp.; Prevotella melaninogenica (formerly known as Bacteroides melaninogenicus) Propionibacterium acnes.
In vitro sensitivity does not necessarily imply clinical efficacy.
Cefprozil is an orally administered agent more active than first-generation cephalosporins against penicillin-sensitive streptococci, E. coli, P. mirabilis, Klebsiella spp., and Citrobacter spp. It has a serum half-life of 1,2 to 1,4 hours.
Cefprozil is approximately 96% absorbed following oral administration in both fasting and non-fasting subjects.
Plasma protein binding is approximately 36% and is independent of concentration in the range of 2 μg/ml to 20 μg/ml.
In individuals with normal renal function, cefprozil does not accumulate in the plasma.
The plasma half-life prolongation is related to the degree of renal dysfunction in patients with reduced renal dysfunction. In patients with complete absence of renal function, the plasma half-life of cefprozil has been shown to be as long as 5,9 hours.
The half-life is shortened during hemodialysis to 2,1 hours. Excretion pathways in patients with markedly impaired renal function have not been determined. (See "WARNINGS AND SPECIAL PRECAUTIONS" and "DOSAGE AND DIRECTIONS FOR USE").
The average AUC observed in elderly subjects (65 years of age) is approximately 35-60% higher than that of young adults and the average AUC in females is approximately 15-20% higher than in males. The magnitude of these age and gender-related variations in the pharmacokinetics of cefprozil are not sufficient to necessitate dosage adjustments.
In patients with impaired hepatic function, no significant differences in pharmacokinetic parameters are observed, when compared to normal control subjects.
Adequate data on CSF levels of cefprozil are not available.
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