Clamoxyl Palatable Tablets 40 Mg
Revised: June 2014
AN: 00245/2014
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE VETERINARY MEDICINAL PRODUCT
CLAMOXYL Palatable Tablets 40 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
The 40 mg tablet has the following composition:
Active ingredients
Amoxicillin as amoxicillin trihydrate - 40 mg/tablet
For the full list of all other excipients see section 6.1
PHARMACEUTICAL FORM
Tablet.
Speckled, off-white circular
tablets with a break line on one side, for oral
dosing.
CLINICAL PARTICULARS
Target species
Dogs and cats.
Indications for use, specifying the target species
Amoxicillinis a broad spectrum
semi-synthetic penicillin which is bactericidal against a wide
range of Gram-positive and Gram-negative bacteria found in dogs and
including the following:
Haemophilusspp., Pasteurellaspp., Proteus mirabilis,
Salmonellaspp.,
Staphylococci (penicillin-sensitive strains), Leptospiraspp., Streptococci
and Escherichia coli.
When susceptible organisms are present, the product may be effective in the following indications: localised infections, alimentary tract infections, respiratory infections, urogenital tract infections, secondary bacterial infections and generalised infections.
Contraindications
In common with all penicillins do not administer to
penicillin-sensitive animals.
Not to be used orallyor parenterally in rabbits, guinea pigs, hamsters or gerbils. Caution is advised in its use in any other very small herbivores.
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in
animals
Not to be used in cases of known
hypersensitivity.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Penicillinsand 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 reactions 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 breathing are more serious symptoms and require urgent medical attention. Wash hands after use.
Adverse reactions (frequency and seriousness)
See section 4.10 (Overdose).
Use during pregnancy, lactation or lay
May be used safely in pregnant or lactating animals.
Interaction with other medicinal products and other forms of interaction
Do not use concurrently with bacteriostatic antimicrobials.
Amounts to be administered and administration route
Dosage Rate:
An oral dose rate of 4 to 10 mg/kg twice
daily is recommended (1 to 2 tablets per 10 kg bodyweight twice
daily). In severe or acute conditions, these levels may be
increased and/or repeated at more frequent intervals.
Dosage
Guide:
Cats: ½ - 1 x 40 mg tablet twice daily
Dogs per 10 kg: 1 or 2 x 40 mg tablets, twice daily
The tablets are often accepted from the hand, even by sick animals. Alternatively, the tablets may be crushed and added to a little food.
Because of the high blood
levels rapidly achieved after oral dosing, parenteral antibiotic
treatment has generally been found to be unnecessary even in the
presence of systemic infection. However,
where parenteral treatment is required, the tablets may be useful
as follow-up therapy.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Amoxicillin is of a low order of toxicity to the target species and is well tolerated by the oral route. Apart from occasional instances of diarrhoea, which have been reported with the recommended dose, no adverse side effects are to be expected from accidental overdose.
Withdrawal period
Not applicable.
PHARMACOLOGICAL PROPERTIES
Bactericidalagainst a wide range of
Gram-negative and Gram-positive bacterial pathogens found in dogs
and cats including the following:
Haemophilusspp.
Pasteurellaspp.
Proteus
mirabilis
Salmonellaspp.
Staphylococci (penicillin-sensitive strains)
Leptospiraspp.
Streptococci
Escherichia
coli.
The following features are important:
Oral absorption is particularly good.
After absorption amoxicillin is widely distributed throughout the tissue with especially high levels in the kidney, urine, liver and bile.
Amoxicillin shares with other penicillins the virtual absence of toxicity problems even at very high dose levels.
ATCVet Code:QJ01CA04
PHARMACEUTICAL PARTICULARS
List of excipients
Magnesium Stearate
Silica Colloidal Anhydrous
Yeast
Methyl Cellulose
Microcrystalline Cellulose
Incompatibilities
None known.
Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Special precautions for storage
Store in a dry place.
Do not store above 25oC.
Nature and composition of immediate packaging
Aluminium foil blister packs containing 100 x 40 mg tablets.
Polypropylene securitainers containing 500 x 40 mg tablets.
Aluminium canister with screw-fit cap containing 500 x 40 mg tablets.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
MARKETING AUTHORISATION HOLDER
Zoetis UK Limited
5th Floor, 6 St. Andrew Street
London
EC4A 3AE
MARKETING AUTHORISATION NUMBER
Vm:42058/4015
DATE OF THE FIRST AUTHORISATION
Date:19 February 1990
DATE OF REVISION OF THE TEXT
Date:June 2014
26 June 2014
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