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| Presentation
White tablets containing 6 mg, 20mg or 60mg Tolfenamic Acid PhEur respectively.
Uses
Tolfenamic acid is a nonsteroidal, anti-inflammatory drug (NSAID) with analgesic and antipyretic properties.
In dogs, Tolfedine Tablets are for use in the alleviation of inflammation and pain, and chronic locomotor disease. In small dogs: in pathologies of osteoarticular and musculoskeletal systems. In cats, Tolfedine 6mg Tablets are used in the treatment of febrile syndromes.
Dosage and administration
The recommended dosage is 4 mg tolfenamic acid per kg bodyweight once daily by oral administration with food for 3 days. Each 6 mg tablet treats 1.5 kg bodyweight, once daily, each 20mg tablet treats 5kg bodyweight, once daily and each 60mg tablet treats 15kg bodyweight, once daily.
In dogs, subject to clinical response, the administration may be repeated every 7 days, i.e. 3 days of medication followed by 4 days without medication.
Contra-indications, warnings, etc
Do not exceed the stated dose or the duration of treatment.
Long-term treatment of over 3 month duration should be under regular veterinary supervision. In particular, dogs with hepatic insufficiency should be closely monitored.
Do not administer to animals suffering from cardiac, hepatic or renal disease, where there is a possibility of gastro-intestinal ulceration or bleeding, where there is evidence of a blood dyscrasia or hypersensitivity to the product.
Do not administer NSAIDs concurrently or within 24 hours of each other. Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs, which can lead to toxic effects.
Do not administer in conjunction with glucocorticosteroids.
NSAIDS can cause inhibition of phagocytosis and hence in the treatment of inflammatory conditions associated with bacterial infections appropriate concurrent antimicrobial therapy should be instigated.
Use in animals less than 6 weeks of age, or in aged animals may involve additional risk. If such a use cannot be avoided, animals may require a reduced dosage and careful clinical management.
Avoid use in any dehydrated, hypovolaemic or hypotensive animals as there is a potential risk of increased renal toxicity.
Concurrent administration of potential nephrotoxic drugs should be avoided.
It is preferable that Tolfedine Tablets are not administered to animals undergoing general anaesthesia until fully recovered.
If side effects such as anorexia, vomiting, diarrhoea or blood in the faeces are seen during treatment, veterinary advice should be sought. Moreover, a temporary increase of thirst and/or diuresis may occur. In most of the cases, these signs cease spontaneously after the treatment.
If an overdose is administered, symptomatic treatment should be instituted. No antidote is currently available.
Although studies in laboratory animals did not show any effect on reproduction, it is not advisable to administer the product during gestation.
Withdrawal period
Not applicable
Operator warning
None
Pharmaceutical precautions
Do not store above 25°C. Store in a dry place.
For animal treatment only
Keep out of reach of children
Legal category
POM-V (previously POM)
Packaging Quantities
6mg tablets - blister packs containing 100 tablets.
20mg tablets - blister packs containing 96 tablets.
60mg tablets - blister packs containing 96 tablets.
Further information
Tolfenamic acid (N-(2-methyl-3-chlorophenyl) anthranilic acid) is a non-steroidal anti-inflammatory drug belonging to the fenamate group. Tolfenamic acid possesses anti-inflammatory, analgesic and antipyretic properties.
The anti-inflammatory activity of tolfenamic acid is due to inhibition of cyclooxygenase leading to a reduction in prostaglandin and thromboxane synthesis, major inflammatory mediators.
Tolfenamic acid is rapidly absorbed. After a single oral administration of 4mg/kg tolfenamic acid, the mean maximal plasma concentration (Cmax) of about 4µg/ml is reached in about 1 hour. When the same intake of tolfenamic acid is taken with food, Cmax is 2 ± 3µg/ml. These variations are due to a strong enterohepatic recycling of the product.
Tolfenamic acid and its metabolites do not cross the placenta barrier to any great extent.
Tolfenamic acid is excreted mainly unchanged.
In dogs with renal insufficiency, the elimination of tolfenamic acid is unchanged.
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