Phenylbutazone Tablets 200 mg

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Phenylbutazone

Available from:

Ayrton Saunders Limited

INN (International Name):

Phenylbutazone

Authorization status:

Expired

Summary of Product characteristics

Revised: November 2022
AN: 01984/2022
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Phenylbutazone 200mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE(S) MG/TABLET
Phenylbutazone......................……………………200
EXCIPIENTS
Titanium Dioxide (E171)………………………...0.85
For a full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Tablet
White, sugar coated.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Indicated in dogs of 20kg and over for the treatment of
osteoarthritis, acute
musculo-skeletal trauma, spondylitis, bursitis and inflammation of
ligament,
rheumatoid and other arthritic diseases.
4.2
CONTRA-INDICATIONS
Phenylbutazone 200mg should not be administered to dogs weighing less
than 20kg bodyweight.
Do not exceed the stated dose or duration of the treatment.
Use is contra-indicated in animals suffering from cardiac, hepatic or
renal
disease, where there is the possibility of gastrointestinal ulceration
or
bleeding, where there is evidence of blood dyscrasia or
hypersensitivity to the
product.
Do not administer other NSAID’s concurrently or within 24 hours of
each
other.
Not to be used in cats.
Revised: November 2022
AN: 01984/2022
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Some NSAID’s may be highly bound to plasma proteins and compete with
other highly bound drugs to produce an increase in non-bound
pharmacologically active concentrations, which can lead to toxic
effects.
Use in animals less than 6 weeks of age or in aged animals may involve
additional risk. If such use cannot be avoided animals may require a
reduced
dosage ad careful clinical management.
Avoid use in dehydrated, hypovolaemic or hypotensive animals as there
is a
potential risk of increase renal toxicity.
Concurrent administration of potentially nephrotoxic drugs should be
avoided.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
In suspected case of renal or hepa