Cefaseptin Tablets for Dogs

Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication.

Introduction

Company name: Vétoquinol UK Ltd
Address: Vétoquinol House
Great Slade
Buckingham Industrial Park
Buckingham
MK18 1PA
Telephone: 01280 814500
Fax: 01280 825460
Email: office@vetoquinol.co.uk
Website: www.vetoquinol.co.uk

Presentation

Film coated tablets available in two strengths.
Cefaseptin 120mg Tablets contain Cefalexin 120 mg (as Cefalexin Monohydrate) and Titanium Dioxide (E171) 1.246mg per tablet as colouring agent.
Cefaseptin 600mg Tablets contain Cefalexin 600 mg (as Cefalexin Monohydrate) and Titanium Dioxide (E171) 6.23mg per tablet as colouring agent.

Uses

Canine pyoderma caused by Staphylococcus intermedius

Dosage and administration

25 mg/kg body weight orally, twice daily for up to 3 weeks. The treatment should be re-assessed if no improvement is seen after 14 days.

Contra-indications, warnings, etc

Do not use in animals with known hypersensitivity to cefalexin or penicillin
Special precautions for use in animals
Where renal insufficiency exists, the dose rate should be reduced. Where serious disturbances of the gastrointestinal tract occur, treatment should be discontinued.
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 (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Adverse reactions (frequency and seriousness)
Mild diarrhoea, salivation and vomiting may occur in rare cases.
Renal insufficiency requires a reduced dose rate as this condition influences plasma levels and overall distribution
Cefalexin may cause sensitisation (allergy)
Use during pregnancy and lactation
No evidence of adverse effects (teratogenic or otherwise) have been seen in pregnant bitches or queens. The product should only be used where the clinical benefits outweigh the potential risks.
Interaction with other medicinal products and other forms of interaction
Cross sensitisation and cross-resistance may exist between penicillins and cephalosporins.
Overdose
There is no specific information relating to overdosage. The recommended posology should be followed.
Withdrawal period
Not applicable.
Operator warnings
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross reactions to cephalosporins 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.
3.If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the doctor this warning.
Swellings of the face, lips or eyes or difficulty breathing are more serious symptoms and require urgent medical attention.
4.Wash hands after use.

Pharmaceutical precautions

Do not store above 25°C.
Store in a dry place.
Protect from light.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with national requirements.

Legal category

POM-V

Packaging Quantities

Cefaseptin 120mg Tablets: 15 blisters of 10 tablets
Cefaseptin 600mg Tablets: 20 blisters of 10 tablets

Further information

ATCVet code QJ01DB01
The products contain cefalexin, a first generation cephalosporin for oral administration. Cefalexin is a broad spectrum antibiotic with bactericidal activity against most gram-positive cocci, and some gram-negative bacteria (e.g., E. coli, Proteus mirabilis, Klebsiella and Pasteurella multocida). As for other beta-lactams the specific target sites of cephalosporins are the penicillin binding proteins (PBPs). Binding to PBPs causes an inhibiting effect on mucopeptide synthesis in the cell wall resulting in a bactericidal effect. The cephalosporins are usually penicillinase resistant.
The products are indicated for the treatment of canine pyoderma caused by Staphylococcus intermedius. Product specific pharmacokinetic data demonstrate that the proposed dosage of 25 mg/kg produces a clinically effective drug concentration in the skin. This level remains above the MIC (Minimum Inhibitory Concentration) of the aetiologic agent of canine pyoderma (i.e. Staphylococcus intermedius) for 12 hours, indicating a sufficient dose interval.
Cefalexin is absorbed rapidly after oral administration. Peak plasma levels of Cefalexin are reached 1-2 hours after oral administration and Cmax is about 30 µg/ml in plasma. Cefalexin is widely distributed through the organism (e.g. bone, muscle). Cefalexin is excreted renally in the active, non-metabolized form.

Marketing authorisation number

Cefaseptin 120mg Tablets Vm 08007/4098.
Cefaseptin 600mg Tablets Vm 08007/4099.