Negara: Afrika Selatan
Bahasa: Inggris
Sumber: South African Health Products Regulatory Authority (SAHPRA)
Afrivet Business Management (Pty) Ltd
Tablet
Each Tablet contains TOLFENAMIC ACID A 120.0 mg
C 0301. ANTI-INFLAMMATORY
2016-09-06
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 Baca dokumen lengkapnya