TOLFEDINE 120 mg Tablet

Maa: Etelä-Afrikka

Kieli: englanti

Lähde: South African Health Products Regulatory Authority (SAHPRA)

Saatavilla:

Afrivet Business Management (Pty) Ltd

Lääkemuoto:

Tablet

Koostumus:

Each Tablet contains TOLFENAMIC ACID A 120.0 mg

Terapeuttinen alue:

C 0301. ANTI-INFLAMMATORY

Valtuutus päivämäärä:

2016-09-06

Valmisteyhteenveto

Afrivet Business Management (Pty) Ltd TOLFEDINE 20mg & 60 mg Tablets
Each tablet contains 20 mg or 60 mg of Tolfenamic acid
Page 1 of 5
PACKAGE INSERT
VETERINARY MEDICINE
SCHEDULING STATUS
S3
PROPRIETARY NAME (AND DOSAGE FORM)
TOLFEDINE
®
6 mg (tablet)
TOLFEDINE
®
20 mg (tablet)
TOLFEDINE
®
60 mg (tablet)
TOLFEDINE
®
120 mg (tablet)
COMPOSITION
Each tablet contains 6 mg, 20 mg, 60 mg or 120 mg tolfenamic acid
List or excipients: microcrystalline cellulose, magnesium stearate,
wheat starch,
calcium
hydrogen phosphate and docusate sodium.
PHARMACOLOGICAL CLASSIFICATION
C 3.1 Anti-rheumatics (Anti-inflammatory agents)
PHARMACOLOGICAL ACTION
Tolfenamic acid ((N-(2-methyl-3-chlorophenyl) anthranilic acid) is a
non- steroidal
anti-inflammatory drug (NSAID) belonging to the fenamate group.
Tolfenamic acid exerts
anti-inflammatory, analgesic and antipyretic activities. The
anti-inflammatory activity of
tolfenamic acid is mainly due to an inhibition of cyclo-oxygenase and
thus leads to a
reduction in the synthesis of prostaglandins and thromboxanes which
are important
inflammatory mediators.
PHARMACOKINETICS
Afrivet Business Management (Pty) Ltd TOLFEDINE 20mg & 60 mg Tablets
Each tablet contains 20 mg or 60 mg of Tolfenamic acid
Page 2 of 5
ABSORPTION:
Dogs
Tolfenamic acid is rapidly absorbed. After a single oral
administration of 4 mg/kg tolfenamic
acid, the mean maximal plasma concentration (C
max
) of about 4 μg/ml is reached in about
1 hour. When the same intake of tolfenamic acid is taken with food, C
max
is 2 ± 3 μg/ml.
These variations are due to a strong enterohepatic recycling of the
product.
Cats
The absorption is very fast. After a single oral administration of 4
mg/kg tolfenamic acid, the
mean maximal plasma concentration (C
max
) of about 5,6 μg/ml is reached in about 1 hour.
DISTRIBUTION, METABOLISM, EXCRETION:
Tolfenamic acid is distributed in all organs with a strong
concentration in plasma, digestive
tract, liver, lungs and kidneys. The concentration in the brain is
low.
Very little tolfenamic ac