SYNTOCLOR Hard capsule Ref.[28271] Active ingredients: Cefaclor

Source: Υπουργείο Υγείας (CY)  Revision Year: 2013  Publisher: Codal Synto Ltd, 33 Theklas Lysioti Street, 3030 Limassol, Cyprus

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Second-generation cephalosporins
ATC code: J01DC04

Cefaclor is active against the following organisms in vitro:

  • Alpha- and beta-haemolytic streptococci
  • Staphylococci; including coagulase-positive, coagulase-negative and penicillinase-producing strains
  • Streptococcus pneumoniae
  • Streptococcus pyogenes (group A beta-haemolytic streptococci)
  • Branhamella catarrhalis
  • Escherichia coli
  • Proteus mirabilis
  • Klebsiella species

Haemophilus influenzae, including ampicillin-resistant strains.

Cefaclor has no activity against Pseudomonas species or Acinetobacter species. Methicillin-resistant staphylococci and most strains of enterococci (eg, Str. faecalis) are resistant to cefaclor.

Cefaclor is not active against most strains of Enterobacter spp, Serratia spp, Morganella morganii, Proteus vulgaris and Providencia rettgeri.

5.2. Pharmacokinetic properties

Cefaclor is well absorbed following oral administration to fasting subjects.

Total absorption is the same whether the drug is given with or without food; however, when it is taken with food, the peak concentration achieved is 50-75% of that observed when the drug is administered to fasting subjects and generally appears from ¾ to one hour later. Following administration of 250mg, 500mg and 1g doses to fasting subjects, average peak serum levels of approximately 7, 13 and 23 mg/l, respectively, were obtained within 30-60 minutes.

Approximately 60-85% of the drug is excreted unchanged in the urine within eighthours, the greater portion being excreted within the first two hours. During the eight hour period, peak urine concentrations following the 250mg, 500mg and 1g doses were approximately 600, 900 and 1,900 mg/l, respectively. The serum half-life in normal subjects is 0.6-0.9 hours. In patients with reduced renal function, the serum halflife of cefaclor is slightly prolonged. In those with complete absence of renal function, the plasma half-life of the intact molecule is 2.3-2.8 hours. Excretion pathways in patients with markedly impaired renal function have not been determined. Haemodialysis shortens the halflife by 25-30%.

5.3. Preclinical safety data

No further relevant information.

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