Introduction

Pfizer

Company name: Pfizer Limited

Address: Ramsgate Road

Sandwich

Kent CT13 9NJ

Telephone: 0845 300 8034 (Out of hours: 01304 616161)

Fax: 01737 332521

Email: UKVetLine@pfizer.com

Website: www.only4vets.co.uk

Presentation

Synulox Palatable Tablets are presented as circular, pink tablets with a break line on one face and `SYNULOX' engraved on the other. Each tablet contains 100 mg clavulanic acid as potassium clavulanate and 400 mg amoxicillin as Amoxicillin trihydrate in a palatable base.

Uses

Synulox Palatable Tablets have a broad spectrum of activity against bacteria commonly found in dogs.

In vitro Synulox is active against a wide range of clinically important aerobic and anaerobic bacteria, including:

Gram-positive	Staphylococci (including beta-lactamase-producing strains), Clostridia Actinomyces, Peptostreptococcus spp., Streptococci Enterococci
Gram-negative	Bacteroides spp. (including β-lactamase-producing strains), Escherichia coli (including beta-lactamase-producing strains), Salmonellae (including β-lactamase-producing strains), Bordetella bronchiseptica, Campylobacter spp., Fusobacterium necrophorum, Klebsiellae, Pasteurellae, Proteus spp.

Clinically, Synulox has been shown to be effective in treating a wide range of diseases of dogs including: Skin disease (including deep and superficial pyoderma); urinary tract infection; respiratory disease involving upper and lower respiratory tract, enteritis, dental infections (e.g. gingivitis), soft tissue infections (e.g. abscesses and anal sacculitis).

Note: Synulox is not indicated for cases involving Pseudomonas spp.

Dosage and administration

Administration

By the oral route.

Dosage Guide

Recommended dose rate is 12.5 mg/kg, twice daily. The table below is intended as a guide only.

Bodyweight (kg)	Number of Tablets per dose Twice Daily
	500 mg
20 kg	½
40 kg	1
60 kg	1½
80 kg	2

For oral administration only. Synulox Palatable Tablets are often accepted from the hand, even by sick dogs. Alternatively, the tablets may be crushed and added to a small quantity of food. The majority of routine cases will respond between 5 and 7 days therapy. Because of the low toxicity profile of Synulox, the dose can be doubled if desired at the discretion of the veterinary surgeon for severe infection. In certain indications, for example canine pyoderma and chronic cystitis, bacterial infection may be secondary to other pathology. For such cases longer courses of antibacterial therapy may be required, in addition to diagnosis and treatment of the underlying condition. In such circumstances overall treatment length must be at the clinician's discretion, but should be long enough to ensure complete resolution of the bacterial disease.

Contra-indications, warnings, etc

In common with other penicillins, Synulox should not be administered orally to rabbits, guinea pigs hamsters or gerbils, and should be used with care in other small herbivores.

Synulox should not be administered concomitantly with bacteriostatic antibiotics, which are incompatible.

Operator warning

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 reaction to these substances may occasionally be serious.

Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.

Handle this product with great care to avoid exposure, taking all recommended precautions.

If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and may require urgent medical attention.

In the event of accidental ingestion, seek medical advice.

Wash hands after handling the tablets.

For animal use only.

Keep out of the reach of children.

Pharmaceutical precautions

Do not store above 25°C. Store in a dry place.

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

Legal category

POM-V

Packaging Quantities

Laminated aluminium foil packs with 2 tablets in each blister card. Packed in an outer carton box and marketed as a 100 tablet presentation.

Further information

Amoxicillin is a broad-spectrum antibiotic active against a wide range of Gram-positive and Gram-negative bacteria. However, many clinically important bacteria produce beta-lactamase enzymes which destroy this antibiotic. Clavulanic acid inactivates these enzymes, rendering the organisms susceptible to the amoxicillin.

Synulox Palatable Tablets can safely be used in pregnant and lactating animals