Composition: Each tablet contains: Cefalexin - 500mg, Excipient q.s.f 1 tablet
Indications:
For use in the treatment of infections of the respiratory tract, gastro-intestinal tract, urogenital tract, the skin and localized infections in soft
tissue caused by bacteria sensitive to Cefalexin.
Target Species: Dogs
Pharmacodynamic:
• Cefalexin is a semi-synthetic bactericidal antibiotic belonging to the cephalosporin group which acts by interference with bacterial cell
wall formation.
• Cefalexin is active against a wide range of Gram-positive and Gram-negative bacteria. The following micro-organisms have been shown
to be sensitive to cefalexin in vitro: Staphylococcus spp (including penicillin-resistant strains), Streptococcus spp, Corynebacterium spp,
Pasteurella multocida, Escherichia coli, Micrococcus spp, Moraxella spp.
• Cefalexin is resistant to the action of staphylococcal penicillinase and is therefore active against the strains of Staphylococcus aureus
that are insensitive to penicillin (or related antibiotics such as ampicillin or amoxycillin) because of production of penicillinase.
• Cefalexin is also active against the majority of ampicillin-resistant E.coli.
Pharmacokinetics:
• Following oral administration, cefalexin is rapidly and almost completely absorbed.
Peak plasma concentrations in the dog (Cmax= 17.49 μg/ml) are achieved within
approximately 1.5 hours (Tmax= 1.55). Cefalexin is excreted in the urine in high
concentrations and has an elimination half-life (T1/2) of approximately 2.5–3 hours.
• After oral administration, 60 to 80% of cefalexin is absorbed from the small intestine. The delay reported between administration and
beginning of absorption is approximately 20 minutes and differences in mean AUC, Cmax, and Tmax are not significantly affected by
food administration concomitant to treatment with cefalexin.
• Protein binding is low at 18%. Cefalexin is widely distributed into a variety of tissue fluids, including bile, synovial and pericardial fluid.
The passage into interstitial tissue, as demonstrated in wound fluid concentration, peritoneal fluid and skin blisters is generally good.
Cefalexin is minimally metabolized and primarily excreted via the renal route, around 70% of an oral dose is excreted into the urine in
24 hours in the dog. It is important to note that cefalexin concentrations obtained in urine are well above plasma concentrations, and
similarly concentrations in bile may be up to four times higher.
Dosage and route of administration
For oral administration only.
A dose of 15 mg/kg twice daily is recommended, to be doubled as appropriate.
Treatment for five days is recommended. Any increase in dose or duration of
use should be according to a risk/benefit assessment by the prescribing veterinarian.
Tablets may be added to food if necessary.
To avoid underdosing, the bodyweight should be accurately determined.
Contraindication
• Do not use in cases of known hypersensitivity to the active substance, to other cephalosporins, to other substances of the β-lactam
group or to any of the excipients.
• Do not use in rabbits, gerbils, guinea pigs and hamsters.
Withdrawal period: Not Applicable.
Side effects: Not Applicable.
Warnings:
• For use in dogs and cats only. Do not use in humans. Sensitized individuals handling such antimicrobials, including Cefalexin, should
avoid contact of the product with the skin and mucous membranes in order to minimize the risk of allergic reactions.
• In case of ingestion by humans, contact a physician immediately. Physicians may contact a poison control center for advice concerning
cases of ingestion by humans.
Precautions:
• Prescribing antibacterial drugs in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to treated
animals and may increase the risk of the development of drug-resistant animal pathogens.
Action on pregnancy and lactating animals:
• The safety of the product has not been demonstrated in studies in pregnant or lactating dogs. Use only in accordance with a risk/benefit
assessment by the responsible veterinarian.
Storage: Store at temperature below 25°C, protect from light. Keep out of reach of children.
Shelf-life: 36 months.
Presentation: 10 tablets per blister, box of 1 blister and box of 10 blisters.