Introduction

Alstoe

Company name: Alstoe Ltd

Address: Sheriff Hutton Industrial Park

Sheriff Hutton

York

YO60 6RZ

Telephone: 01347 878606

Fax: 01347 878333

Email: info@alstoe.co.uk

Website: www.alstoe.co.uk

Presentation

Flavoured, oblong scored beige tablet containing enrofloxacin 15.0 mg. Each tablet can be divided into two equal parts.

Uses

Cats: The treatment of upper respiratory tract infections.

Dosage and administration

Oral administration 5 mg of enrofloxacin/kg body weight once daily for 5 to 10 consecutive days: either 1 tablet for 3 kg body weight as a single daily dosing, or half a tablet for 1.5 kg body weight as a single daily dose. The treatment should be reconsidered in case of lack of clinical improvement at half of the treatment duration. The tablets may be administered directly in the mouth or added to food if necessary.

Contra-indications, warnings, etc

Do not use in: young, growing cats, because of the possibility of the development of cartilage lesions. (cats aged less than 3 months or weighing less than 1kg). In the case that there is resistance to quinolones, as there exists almost complete cross resistance to other quinolones and complete cross resistance to other fluoquinolones. In cats having seizure disorders, since enrofloxacin may cause CNS stimulation. With tetracyclines, phenicols or macrolides because of potential antagonistic effects.

Retinotoxic effects including blindness can occur in cats when the recommended dose is exceeded. In laboratory studies, ocular adverse effects have been observed from 20 mg/kg.

Use the product with caution in cats with severe renal or hepatic impairment.

Vomiting or diarrhoea may appear during the treatment. These signs regress spontaneously and generally do not require treatment discontinuation.

Overdosing can cause vomiting and nervous signs (muscle tremor, incoordination and convulsions) which may require treatment discontinuation. In the absence of any known antidote, apply drug elimination and symptomatic treatment. If necessary, administration of aluminium or magnesium containing antacids or activated carbon can be used to reduce absorption of enrofloxacin.

Concurrent use of flunixin should be under careful veterinary monitoring, as the interactions between these drugs may lead to adverse events related to delayed elimination. Concomitant administration of theophylline requires careful monitoring as serum levels of theophylline may increase. Concurrent use of magnesium or aluminium containing substances (such as antacids or sucralfate) may reduce absorption of enrofloxacin. These drugs should be administered two hours apart.

Use during pregnancy: Studies in laboratory animals (rat, chinchilla) have not produced any evidence of a teratogenic, foetotoxic, maternototoxic effect. Use only according to the benefit/risk assessment by the responsible veterinarian. As enrofloxacin passes into the maternal milk, the use is not recommended during lactation.

Pharmaceutical precautions

Store in the original container. Protect from light. This medicinal product does not require any special temperature storage conditions.

Shelf-life of halves of the tablets: 24 hours

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulatory authority.

Keep out of the reach of children.

Legal category

POM-V

Packaging Quantities

Carton containing 10 blisters of 12 tablets

Further information

Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials. Wherever possible, fluoroquinolones should be used based on susceptibility testing. Use of the product deviating from instructions may increase the prevalence of bacteria resistant to fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.

Precautions to be taken by the person administering the product to animals: In case of accidental ingestion, seek medical advice immediately and show the package leaflet to the physician. Wash hands after handling the product. In case of contact with eyes, rinse immediately with plenty of water.