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Date: Friday, September 25, 2020 17:24

Release 3.18
Synulox Palatable Drops, Powder for Oral Suspension
 
Species: Cats, Dogs
Therapeutic indication: Pharmaceuticals: Antimicrobials: Oral preparations: Others
Active ingredient: Amoxicillin Trihydrate, Clavulanic Acid
Product:Synulox® Palatable Drops
Product index: Synulox Palatable Drops
Presentation
Synulox Palatable Drops are presented in a bottle as an off-white powder, containing 150 mg potassium clavulanate equivalent to clavulanic acid and 600 mg Amoxicillin trihydrate equivalent to amoxicillin. Reconstitution of the powder with 15 ml of water provides a suspension containing 10 mg clavulanic acid and 40 mg amoxicillin per ml.
Uses
Synulox Palatable Drops have a notably broad spectrum of bactericidal activity against bacteria commonly found in dogs and cats.
In vitro Synulox is active against a wide range of clinically important aerobic and anaerobic bacteria including:
Gram-positive:
Staphylococci (including β-lactamase producing strains); Clostridia; Corynebacteria; Peptostreptococcus spp; Streptococci
Gram-negative:
Bacteroides spp. (including β-lactamase producing strains); Escherichia coli (including most β-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 cats and dogs including: Skin disease (including deep and superficial pyodermas); soft tissue infections (abscesses and anal sacculitis); dental infections (eg gingivitis); urinary tract infections; respiratory disease (involving upper and lower respiratory tract); enteritis.
Dosage and administration
Administration
By the oral route.
Reconstitution
Add 15 ml water. Shake the bottle before use.
Dosage rate
12.5 mg/kg bodyweight (i.e. 0.25 ml/kg). For the accurate dosing of particularly small patients it is valuable to note that one drop from the pipette provided contains 2.3 mg clavulanate-potentiated amoxicillin. Therefore 5–6 drops/kg twice daily are recommended as a guide.
Dosage frequency
Dogs and cats should be dosed at the rate of 0.25 ml of reconstituted product per kg bodyweight twice daily.
For the majority of infections, including those of the skin, urinary tract and gastrointestinal tract, the above dosing regime is effective.
Refractory cases, however, particularly those of the respiratory tract, have shown improved cure rates by doubling the dose to 25 mg/kg bodyweight twice daily (i.e. 0.5 ml of reconstituted product per kg bodyweight twice daily).
Duration of therapy
Routine cases involving all indications
The majority of these cases respond to between 5 and 7 days therapy.
Chronic or refractory cases
In these cases, where there is considerable tissue damage, a longer course of therapy may be required in that it allows sufficient time for damaged tissue to repair. Based on clinical trials, the following durations are suggested as guidelines:
Chronic skin disease
10–20 days
Chronic cystitis
10–28 days
Respiratory disease
8–10 days
Contra-indications, warnings, etc
Synulox Palatable Drops should not be given to rabbits, guinea pigs, hamsters or gerbils. Caution is advised in their use in any other very small herbivores.
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 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.
Wash hands after use.
Pharmaceutical precautions
Powder: Do not store above 25°C.
Reconstituted suspension: Store at 2-8°C. Any reconstituted suspension remaining 7 days after preparation should be discarded.
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
Synulox Palatable Drops are supplied in bottles containing 15ml of product following reconstitution (equivalent to 750 mg of clavulanate-potentiated amoxicillin). A dropper with graduations of 0.25 ml, up to 1 ml, is included in each pack to ensure accurate, convenient dosing.
Further information
Resistance to many antibiotics is caused by beta-lactamase enzymes which destroy the antibiotic before it can act on the bacteria themselves. The clavulanate in Synulox counteracts this defence mechanism by inactivating the beta-lactamases, thus rendering the organisms sensitive to amoxicillin's rapid bactericidal effect, at concentrations readily attainable in the body.
Synulox is effective against Klebsiella infections found in veterinary practice, but it is not indicated for cases involving Pseudomonas species.
Synulox Palatable Drops can be safely used in pregnant and lactating animals.
Synulox Palatable Tablets are available as an alternative presentation for treating sick dogs and cats.
Marketing Authorisation Number
Vm 42058/4144
Significant changes
GTIN
GTIN description:1 x 15 ml:
GTIN:05013457076967