Introduction
Company name: Bayer plc
Address: Animal Health Division
Bayer House, Strawberry Hill,
Newbury
Berkshire RG14 1JA
Telephone: 01635 563000
Fax: 01635 563622
Baytril Flavour Tablets
Introduction
Company name: Bayer plc
Address: Animal Health Division
Bayer House, Strawberry Hill,
Newbury
Berkshire RG14 1JA
Telephone: 01635 563000
Fax: 01635 563622
Presentation
Light brown to brown, slightly marbled, round coloured flavoured tablets containing 15 mg enrofloxacin for oral administration to dogs and cats, and 50 mg or 150 mgenrofloxacin for oral administration to dogs.
Uses
Enrofloxacin is a synthetic, broad spectrum antimicrobial substance, belonging to the fluoroquinolone group of antibiotics. It is bactericidal in action and effective against many gram positive and gram negative bacteria and mycoplasmas.
The product is for use in dogs and cats in the treatment of bacterial infections of the alimentary, respiratory and urogenital tracts, skin, secondary wound infections and otitis externa where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.
Dosage and administration
Dogs and cats
The dose rate of enrofloxacin is 5 mg/kg given orally once daily or as a divided dose twice daily for 3 to 10 days with or without food. Treatment may be initiated with Baytril 5% Solution for Injection or Baytril 2.5% Solution for Injection and maintained with the tablets.
The daily dose is achieved as follows:
Cats and small dogs: Baytril 15 mg – 1 tablet per 3 kg bodyweight
Medium dogs: Baytril 50 mg – 1 tablet per 10 kg bodyweight
Large dogs: Baytril 150 mg – 1 tablet per 30 kg bodyweight
Use during pregnancy and lactation
There is no restriction on the use of this product during pregnancy and lactation.
Contra-indications, warnings, etc
Do not exceed the recommended dose. In accidental overdosage vomiting, diarrhoea, and CNS/behavioural changes may occur. There is no antidote and treatment should be symptomatic.
In cats, retinotoxic effects including blindness can occur when the recommended dose is exceeded.
Not for use in dogs less than 1 year of age or in exceptionally large breeds of dog with a longer growth period under 18 months of age, as articular cartilage may be affected during the period of rapid growth.
Not recommended for use in cats less than 8 weeks of age.
The product should not be used for prophylaxis.
Pharmaceutical precautions
Do not store above 25°C.
Store in a dry place.
Unused product or waste material should be disposed of in accordance with current practice for pharmaceutical waste under national waste disposal regulations.
Further information
The pharmacokinetics of enrofloxacin are such that oral and parenteral administration lead to similar serum levels. Enrofloxacin possesses a high distribution volume. Tissue levels 2–3 times higher than that found in the serum have been demonstrated in laboratory animals and target species. Organs in which high levels can be expected are the lungs, liver, kidney, skin, bone, and lymphatic system.
Enrofloxacin also distributes into the C.S.F., the aqueous humour, and the foetus in pregnant animals.
In target animal studies, cats have been shown to suffer ocular damage after receiving doses of more than 15 mg/kg once daily for 21 consecutive days. Doses of 30 mg/kg given once daily for 21 consecutive days have been shown to cause irreversible ocular damage. At 50 mg/kg given once daily for 21 consecutive days, blindness can occur.
Legal category
POM-V
Packaging Quantities
Strips of 10 tablets in blister foil supplied in dispensing cartons containing 100 tablets.
Marketing authorisation numbers
Baytril® Flavour Tablets 15 mg tablets | Vm 00010/4081 |
Baytril® Flavour Tablets 50 mg tablets | Vm 00010/4082 |
Baytril® Flavour Tablets 150 mg tablets | Vm 00010/4083 |