FELEXIN Powder for oral suspension Ref.[28224] Active ingredients: Cefalexin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2018  Publisher: Remedica Ltd, Aharnon Str., 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 pneumonia is usually cross-resistant to beta-lactam antibiotics. When tested in vitro methods, staphylococci exhibit cross-resistance between cefalexin and methicillin-type antibiotics.

5.2. Pharmacokinetic properties

Cefalexin is acid stable and may be given without regard to meals.

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 therapeutic maximum 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

The daily oral administration of cefalexin to rats in doses of 250 or 500 mg/Kg prior to and during pregnancy, or to rats and mice during the period of organogenesis only had no adverse effects on fertility, foetal viability, foetal weight or little size.

Cefalexin showed no enhanced toxicity in weanling and newborn rats as compared with adult animals.

Oral LD50 of cefalexin in rats is 5,000 mg/kg.

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