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Date: Sunday, May 29, 2022 12:02

Release 4.55
Synulox Palatable Tablets 500 mg
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Antimicrobials: Oral preparations: Tablets
Active ingredient: Amoxicillin Trihydrate, Clavulanic Acid
Product:Synulox® Palatable Tablets 500 mg
Product index: Synulox Palatable Tablets 500 mg
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
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.
Chloramphenicol, macrolides, sulfonamides and tetracyclines may inhibit the antibacterial effect of penicillin because of the rapid onset of bacteriostatic action.
The potential for allergic cross-reactivity with other penicillins should be considered.
Penicillins may increase the effects of aminoglycoside.
Very rarely hypersensitivity reactions (allergic skin reactions, anaphylaxis) may occasionally occur. If allergic reactions occur, the product should be discontinued immediately. Appropriate symptomatic treatment should be initiated.
In very rare cases the use of the product may result in instances of gastro-intestinal disorders (vomiting, diarrhoea, anorexia).
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Operator warning
Inappropriate use of the product may increase the prevalence of bacteria resistant to amoxicillin/clavulanic acid.
In animals with hepatic and renal failure, the dosing regimen should be carefully evaluated.
Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies. Narrow spectrum antibacterial therapy should be used for first line treatment where susceptibility testing suggests likely efficacy of this approach.
Special precautions to be taken by the person administering the veterinary medicinal product to animals.
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.
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.
Keep out of the sight and reach of children.
For animal treatment only.
Legal category
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
Marketing Authorisation Number
Vm 42058/4146
Significant changes
GTIN
GTIN description:100 x 500 mg:
GTIN:05013457077827