TOLCID 4% INJECTION

Maa: Malesia

Kieli: englanti

Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiivinen ainesosa:

TOLFENAMIC ACID

Saatavilla:

RANGE PHARMA SDN. BHD.

INN (Kansainvälinen yleisnimi):

TOLFENAMIC ACID

Kpl paketissa:

100.00 ml

Valmistaja:

RANGE PHARMA SDN. BHD.

Valmisteyhteenveto

TOLCID 4% INJECTION
DESCRIPTION AND COMPOSITION
TOLCID 4% INJECTION is an injectable solution. Each ml contains 40mg
of tolfenamic acid as its active ingredient and 10mg of benzyl alcohol
as
its preservative.
PHARMACODYNAMICS
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 to a reduction in the synthesis
of prostaglandins and thromboxanes, which are important inflammatory
mediators.
PHARMACOKINETICS
Pigs
In pigs, tolfenamic acid injected by IM route at a dose of 2mg/kg is
rapidly absorbed from the injection site with a mean maximum plasma
concentration of about 2.3µg/ml obtained at about 1 hour. The volume
of distribution is approximately 1.3 l/kg in pigs. It is extensively
bound to
plasma albumin (>97%).
Tolfenamic acid distribution involves extracellular fluids where
concentrations similar to plasma are achieved both in healthy and
inflamed
peripheral tissues.
Tolfenamic acid undergoes extensive enterohepatic recirculation and,
as a result, prolonged concentrations are found in plasma.
The elimination half life varies from 3 - 5 hours in pigs. In pigs,
tolfenamic acid is eliminated mainly unchanged in faeces (~30%) and
urine (~70%).
Cattle
Tolfenamic acid is distributed in all the organs with a high
concentration in the plasma, digestive tract, liver, lungs and
kidneys. However, the
concentration in the brain is low. Tolfenamic acid and its metabolites
do not cross the placental barrier to any great extent.
Tolfenamic acid distribution involves extracellular fluids where
concentrations similar to plasma are achieved both in healthy and
inflamed
peripheral tissues. It also appears in milk in the active form, mainly
associated with the curds.
Tolfenamic acid undergoes extensive enterohepatic recirculation and,
as a result, prolong