FELEXIN Hard capsule Ref.[28223] Active ingredients: Cefalexin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antibacterials for systemic use; Other beta-lactam antibacterials
ATC code: J01DB01

In vitro tests demonstrate that cephalosporins are bactericidal because of their inhibition of cell wall synthesis.

Cefalexin is active against the following micro-organisms in vitro:

  • Beta-haemolytic streptococci.
  • Staphylococci, including coagulase-positive, coagulase-negative and penicillinase-producing strains.
  • Streptococcus pneumoniae.
  • Escherichia coli.
  • Klebsiella species.
  • Proteus mirabilis.
  • Haemophilus influenzae.
  • Branhamella catarrhalis.

Most strains of enterococci (Streptococcus faecalis) and a few strains of staphylococci are resistant to cefalexin. It is not active against most strains of Enterobacter species, Morganella morganii, and Pr. vulgaris. It has no activity against Pseudomonas or Herellea species or Acinetobacter calcoaceticus. Penicillin-resistant Streptococcus pneumoniae is usually cross-resistant to beta-lactam antibiotics. When tested by in vitro methods, staphylococci exhibit cross-resistance between cefalexin and methicillin-type antibiotics.

5.2. Pharmacokinetic properties

Cefalexin is acid stable. Cefalexin is almost completely absorbed from the gastro-intestinal tract, and 75-100% is rapidly excreted in active form in the urine. Absorption is slightly reduced if the drug is administered with food. The half-life is approximately 60 minutes in patients with normal renal function. Haemodialysis and peritoneal dialysis will remove cefalexin from the blood.

Peak blood levels are achieved one hour after administration, and therapeutic levels are maintained for 6-8 hours. Approximately 80% of the active drug is excreted in the urine within 6 hours. No accumulation is seen with dosages above the therapeutic maximum of 4 g/day.

The half-life may be increased in neonates due to their renal immaturity, but there is no accumulation when given at up to 50 mg/kg/day.

5.3. Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.

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