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, clover-shaped scored beige tablet containing enrofloxacin 50.0 mg. The tablet can be divided into four equal parts.

Uses

Dogs: Treatment of lower urinary tract infections (associated or not with prostatitis) and upper urinary tract infections caused by Escherichia Coli or Proteus mirabilis. Treatment of superficial and deep pyoderma.

Dosage and administration

Oral administration: 5 mg of enrofloxacin/kg/day as a single daily dosing, i.e. one tablet for 10 kg daily for: 10 days in lower urinary tract infections, 15 days in upper urinary tract infections and lower urinary tract infections associated with prostatitis. Up to 21 days in superficial pyoderma depending on clinical response. Up to 49 days in deep pyoderma depending on clinical response. The treatment should be reconsidered in case of lack of clinical improvement at half of the treatment duration.

The tablets are well accepted and may be administered directly in the mouth of the dog or simultaneously with food if necessary.

Contra-indications, warnings, etc

Do not use in: young or growing dogs (dogs aged less than 12 months (small breed) or less than 18 months (large breed)) as the product may cause epiphyseal cartilage alterations in growing puppies. Dogs having seizure disorders, since enrofloxacin may cause CNS stimulation. Dogs with known hypersensitivity to fluoroquinolones or to any of the excipients of the product. In case of resistance to quinolones, as there exists almost complete cross resistance to other quinolones and complete cross resistance to other fluoroquinolones. With tetracyclines, phenicols or macrolides because of potential antagonistic effects.

Use the product with caution in dogs with severe renal or hepatic impairment. Pyoderma is mostly secondary to an underlying disease. It is advisable to determine the underlying cause and to treat the animal accordingly.

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.

Possible joint cartilage alterations in growing puppies. In rare cases vomiting and anorexia are observed. 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 methods and symptomatic treatment. If necessary, administration of aluminium- or magnesium-containing antacids or activated carbon can be used to reduce absorption of enrofloxacin. According to literature, signs of overdosage with enrofloxacin in dogs such as inappetence and gastrointestinal disturbance were observed at approximately 10 times the recommended dose when administered for two weeks. No signs of intolerance were observed in dogs administered 5 times the recommended dose for a month.

Use during pregnancy: Laboratory 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. Use during lactation: 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 product does not require any special temperature storage conditions. Shelf-life of divisions of the tablets: 72 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 10 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.