Floxabactin 15 mg tablets: dogs and cats.

Floxabactin 50 mg and 150 mg tablets: dogs

Treatment of upper respiratory tract infections.

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.

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).

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).

Do not use in cats or dogs having seizure disorders, since enrofloxacin may cause CNS stimulation.

Do not use in cats or dogs with known hypersensitivity to fluoroquinolones or to any of the excipients of the product.

Do not use in case of resistance to quinolones, as there exists almost complete cross resistance to other quinolones and complete cross resistance to other fluoroquinolones.

Do not use with tetracyclines, phenicols or macrolides because of potential antagonistic effects.

Pregnant and lactating animals, please see Use during pregnancy and lactation.

Retinotoxic effects, including blindness, can occur in cats when the recommended dose is exceeded.

It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions that have responded poorly, or are expected to respond poorly, to other classes of antibiotics. Whenever possible, fluoroquinolones should only be used based on susceptibility testing. Official and local antimicrobial policies should be taken into account when the product is used. Use of the product deviating from the instructions given in this datasheet may increase the prevalence of bacteria resistant to fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential cross resistance.

Use the product with caution in cats or 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.

People with a known hypersensitivity to (fluoro)quinolones should avoid any contact with the product. 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 the eyes, rinse immediately with plenty of water.

- Hypersensitivity reactions

- Alterations in Central Nervous System

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

Possible joint cartilage alterations in growing puppies (see Contraindications).

In rare cases vomiting and anorexia are observed.

Use during pregnancy:

Studies in laboratory animals (rat, chinchilla) have not produced any evidence of a teratogenic, foetotoxic, maternotoxic 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.

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.

Do not administer simultaneously with tetracyclines, phenicols or macrolides because of potential antagonistic effects.

Do not administer simultaneously with non-steroidal anti-inflammatory drugs, convulsions can occur.

Oral use

5 mg of enrofloxacin/kg/day as a single daily dosing, i.e. one tablet for 3 kg (Floxabactin 5 mg) / 10 kg (Floxabactin 50 mg) / 30 kg (Floxabactin 150 mg) 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

5 mg of enrofloxacin/kg body weight once daily for 5-10 consecutive days.

- Either 1 tablet for 3 kg body weight as a single daily dosing

- Or ½ tablet for 1.5 kg body weight as a single daily dosing

The treatment should be considered in case of lack of clinical improvement at half of the treatment duration.

The tablets may be administered directly in the mouth of the dog or cat or simultaneously with food if necessary.

Do not exceed the recommended treatment dose.

After breaking a tablet, use the remaining tablet half for the next dose. Store the tablet half in the original blister pocket.

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.

In laboratory studies, ocular adverse effects in cats have been observed from 20 mg/kg.

The toxic effects on the retina caused by overdosing may be such that they lead to irreversible blindness in the cat.