Petalexin

Main information

  • Trade name:
  • Petalexin 75 mg Tablets for Dogs and Cats
  • Pharmaceutical form:
  • Tablet
  • Prescription type:
  • POM-V - Prescription Only Medicine – Veterinarian
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Petalexin 75 mg Tablets for Dogs and Cats
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Cats, Dogs
  • Therapeutic area:
  • Antimicrobial

Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Authorized
  • Authorization number:
  • 17902/4101
  • Authorization date:
  • 15-01-2018
  • Last update:
  • 19-01-2018

Summary of Product characteristics: dosage, interactions, side effects

Issued: January 2018

AN: 00484/2017

SUMMARY OF THE PRODUCT CHARACTERISTICS

1 - NAME OF THE VETERINARY MEDICINAL PRODUCT

PETALEXIN 75 mg tablets for dogs and cats

2 - QUALITATIVE AND QUANTITATIVE COMPOSITION

One tablet contains:

-Active substance

Cefalexin ……………………………………………?75 mg

(as Cefalexin Monohydrate)

For the full list of excipients see section 6.1.

3 - PHARMACEUTICAL FORM

Tablets.

Creamy oblong tablets with small brown spots with a score-line.

The tablets can be divided into halves.

4 - CLINICAL PARTICULARS

4.1 Target species

Dogs and cats.

4.2 Indications for use, specifying the target species

For the treatment of bacterial skin infections in dogs (including deep and superficial

pyodermas) caused by organisms susceptible to Cefalexin.

For the treatment of cutaneous and subcutaneous infections (wounds and

abscesses) in cats caused by organisms susceptible to Cefalexin.

For the treatment of urinary-tract infections in cats and dogs (including nephritis and

cystitis) caused by organisms susceptible to Cefalexin.

4.3 Contra-indications

Do not use in animals which are known to be hypersensitive to penicillins and

cephalosporins.

Do not use in rabbits, guinea pigs, hamsters and gerbils.

Do not use in known cases of hypersensitivity to the active substance, to other

cephalosporins, to other substances of the β-lactam group or to any of the excipients.

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4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals

As with other antibiotics which are excreted mainly by the kidneys, unnecessary

accumulation may occur in the body when renal function is impaired. In case of

known renal insufficiency, the dose should be reduced and antimicrobials known to

be nephrotoxic should not be administered concurrently.

This product should not be used to treat puppies of less than 1 kg of bodyweight or

kittens under 9 weeks of age.

Use of the product deviating from the instructions given in the SPC may increase the

prevalence of bacteria resistant to Cefalexin and may decrease the effectiveness of

treatment with other cephalosporins and penicillins, due to the potential for cross-

resistance.

Use of the product should be based on susceptibility testing of the bacteria isolated

from the animal. If this is not possible, therapy should be based on local

epidemiological information.

Official, national and regional antimicrobial policies should be taken into account

when the product is used.

As the tablets are palatable to animals there is a danger of excessive ingestion. The

tablets must therefore be stored out of the reach of animals.

Local treatment of cutaneous and subcutaneous infections in cats should be

considered as a complement of the antibiotic treatment.

Special precautions to be taken by the person administering the veterinary medicinal

product to animals

Penicillins and cephalosporins may cause hypersensitivity (allergy) following

injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillin may lead

to cross sensitivity to cephalosporin and vice versa. Allergic reactions to these

substances may occasionally be serious.

1- Do not handle this product if you know you are sensitised or if you have been

advised not to work with such preparations.

2- Handle this product with great care to avoid exposure, taking all recommended

precautions. Take care to avoid prolonged skin contact. Wash hands after use.

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3- If you develop symptoms following exposure such as skin rash, you should seek

medical advice and show the doctor this warning. Swelling of the face, lips or eyes or

difficulty with breathing are more-serious symptoms and require urgent medical

attention.

4.6 Adverse reactions (frequency and seriousness)

Very rare cases of soft faeces and vomiting may be observed in animals during

treatment.

Hypersensitivity to Cefalexin is rare, however, the product should not be

administered to animals which are known to be hypersensitive to Cefalexin or

penicillin. Refer also to section 4.3.

Allergic cross-reactivity with other β-lactams may occur.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy and lactation

The product can be used in pregnant and lactating animals.

4.8 Interaction with other medicinal products and other forms of interaction

The association of first-generation cephalosporins with aminoglycoside antibiotics

and some diuretics such as furosemide can enhance nephrotoxicity risks.

The bactericidal activity of cephalosporins is reduced by concomitant administration

of bacteriostatic acting compounds (tetracyclines, chloramphenicol, macrolides and

rifampicin).

4.9 Amounts to be administered and administration route

15 mg of Cefalexin per kg of bodyweight twice daily (equivalent to 30 mg per kg of

bodyweight per day) for a duration of:

- 5 days in case of cutaneous and subcutaneous infections (wounds and abscesses)

in cats;

- 14 days in case of urinary-tract infection in cats and dogs;

- at least 15 days in case of superficial infectious dermatitis in dogs;

- at least 28 days in case of deep infectious dermatitis in dogs.

To achieve this dosage, administer:

in cats and dogs:

Twice daily, one tablet per 5 kg of bodyweight or ½ tablet per 2.5 kg of

bodyweight.

To ensure correct dosage, bodyweight should be determined as accurately as

possible to avoid underdosing.

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Due to its palatable formulation, the product is well accepted by cats and dogs but

may be crushed or added to food if necessary.

In severe or acute conditions, the dose may be safely doubled.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Trials performed on animals with up to 5 times the recommended dose of 15 mg/kg

demonstrated that the product is well tolerated.

4.11 Withdrawal periods

Not applicable.

5 - PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic Group: Antibacterials for systemic use, first generation

cephalosporins.

ATCvet code: QJ01DB01.

5.1 Pharmacodynamic properties

The active ingredient of product is Cefalexin monohydrate.

Cefalexin is a bactericidal antibiotic of the cephalosporin family which acts by

inhibiting the nucleopeptide synthesis of the bacterial wall. It is obtained by hemi-

synthesis from the 7-amino cephalosporanic nucleus. Cephalosporins interfere with

transpepditation by acylating the enzyme making it unable to cross-link muramic

acid-containing peptidoglycan strands. The inhibition of the biosynthesis of the

material required to build the cell wall results in a defective cell wall which is

consequently osmotically unstable. The combined action results in cell lysis and

filament formation.

Cefalexin is active against a wide range of gram-positive and gram-negative aerobic

bacteria: Staphylococcus spp. (including penicillin-resistant strains), Streptococcus

spp., Escherichia coli, Klebsiella spp., Salmonella spp. and Pasteurella multocida.

Cefalexin is not inactivated by β-lactamases produced by gram-positive bacteria and

which usually affect penicillins.

Cefalexin had a time-dependent bactericidal activity on both tested bacteria species,

Staphylococcus felis (gram-positive) and Pasteurella multocida (gram-negative).

In vitro activity of Cefalexin towards European strains isolated in 2003-2006 in cats

exhibiting cutaneous or subcutaneous infections showed that the MIC90 was 2 µg/ml

for Staphylococcus spp. and Pasteurella spp. and 0.5 µg/ml for Streptococcus spp.

These susceptible genera were also the bacteria the most-frequently isolated from

wounds and abscesses in cats.

Resistance to Cefalexin may be due to one of the following mechanisms of

resistance. Firstly, the production of various beta-lactamases (cephalosporinase),

that inactivate the antibiotic, is the most prevalent mechanism among gram-negative

bacteria. Secondly, a decreased affinity of the PBPs (penicillin-binding proteins) for

β-lactam drugs is frequently involved for β-lactam resistant gram-positive bacteria.

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Lastly, efflux pumps, extruding the antibiotic from the bacterial cell, and structural

changes in porins, reducing passive diffusion of the drug through the cell wall, may

contribute to improve the resistant phenotype of a bacterium.

Well-known cross-resistance (involving the same resistance mechanism) exists

between antibiotics belonging to the β-lactam group due to structural similarities. It

occurs with β-lactamases enzymes, structural changes in porins or variations in efflux

pumps. Co-resistance (different resistance mechanisms involved) has been

described in Escherichia.coli due to a plasmid harbouring various resistance genes.

5.2 Pharmacokinetic particulars

Dogs:

After single oral administration of the recommended dosage of 15 mg of Cefalexin

per kg of bodyweight to Beagle dogs, plasma concentrations were observed within

30 minutes. The plasma peak was observed at 1.3 hour with a plasma concentration

of 18.2 µg/ml.

The bioavailability of the active was over 90 %. Cefalexin was detected until 24 hours

after the administration. The first urine specimen was collected within 2 to 12 hours

with peak concentrations of Cefalexin measured at 430 to 2758 µg/ml within 12

hours.

After repeated oral administration of the same dosage, twice a day for 7 days,

plasma peaks occurred 2 hours later with a concentration of 20 µg/ml. Over the

treatment period, concentrations were maintained above 1 µg/ml. The mean

elimination half-life is 2 hours. Skin levels were around 5.8 to 6.6 µg/g, 2 hours after

treatment.

Cats:

A single oral administration of 15 mg of Cefalexin per kg of bodyweight in cats led to

a bioavailability of 56 %. The plasma peak was observed at 1.55 hour following

administration with a plasma concentration above 15.1 µg/ml. The mean plasma half-

life was about 1 to 2 hours. The first urine specimen was collected between 4 and 24

hours with the highest concentrations ranging between 63.7 and 393 µg/ml, occurring

within 24 hours.

With the same dosage administered over 7 days, twice a day, the highest urine

concentration of Cefalexin reached between 518 and 1256 µg/ml.

6 - PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Crospovidone,

Mannitol

Starch pregelatinised

Croscarmellose sodium

Colloidal anhydrous silica

Colloidal hydrated silica

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Povidone K30

Microcrystalline cellulose type A

Poultry liver powder

Magnesium stearate

Microcrystalline cellulose type B

6.2 Major incompatibilities

Not applicable.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.

6.4 Special precaution for storage

Keep the blisters in the outer carton.

Divided tablets should be stored in blister packs.

6.5 Nature and composition of immediate packaging

Blister packs consisting of cold formed OPA/Al/PVC foil and aluminium foil.

Cardboard Box with 30 blisters of 7 tablets.

6.6 Special precautions for the disposal of unused veterinary medicinal

product or waste materials derived from the use of such products

Any unused veterinary medicinal products or waste materials derived from such

veterinary medicinal product should be disposed of in accordance with local

requirements.

7 - MARKETING AUTHORISATION HOLDER

Alfamed

13ème rue - L.I.D

Carros Cedex

06517

France

8 – MARKETING AUTHORISATION NUMBER

Vm 17902/4101

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9 - DATE OF FIRST AUTHORISATION

15 January 2018

10 - DATE OF REVISION OF THE TEXT

January 2018

Approved: 15/01/2018

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