FLOCTAFENINE TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

FLOCTAFENINE

Saatavilla:

AA PHARMA INC

ATC-koodi:

N02BG04

INN (Kansainvälinen yleisnimi):

FLOCTAFENINE

Annos:

400MG

Lääkemuoto:

TABLET

Koostumus:

FLOCTAFENINE 400MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

MISCELLANEOUS ANALGESICS AND ANTIPYRETICS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0114463001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2001-11-13

Valmisteyhteenveto

0
PRODUCT MONOGRAPH
FLOCTAFENINE
FLOCTAFENINE TABLETS
200 MG AND 400 MG
ANTI-INFLAMMATORY, ANALGESIC
AA PHARMA INC.
DATE OF PREPARATION:
1165 CREDITSTONE ROAD UNIT # 1
JUNE 16, 2010
VAUGHN, ONTARIO
L4K 4N7
CONTROL NUMBER: 139384
1
PRODUCT MONOGRAPH
FLOCTAFENINE
Floctafenine Tablets
200 mg and 400 mg
THERAPEUTIC CLASSIFICATION
Anti-inflammatory, Analgesic
ACTIONS AND CLINICAL PHARMACOLOGY
Floctafenine, an anthranilic acid derivative, is a non-steroidal
anti-inflammatory agent with
analgesic and anti-inflammatory properties. The analgesic activity is
comparable to that of other
mild analgesics in the relief of acute pain. Floctafenine has been
shown to inhibit in vitro
biosynthesis of prostaglandins PGE
2
and PGF
2α
. Gastrointestinal bleeding determined by daily
fecal blood loss, was shown in one clinical trial to be approximately
1.2 mL after 1600 mg/day of
floctafenine compared to 10.4 mL after 2400 mg/day of acetylsalicylic
acid.
In normal volunteers, floctafenine was well absorbed after oral
administration and peak plasma
levels of floctafenic acid, the active metabolite, were attained 1-2
hours after administration and
declined in a biphasic manner, with an initial (α phase) half-life of
approximately 1 hour and a
later (β phase) half-life of approximately 8 hours. Floctafenine and
its metabolites do not
accumulate following oral administration of multiple doses.
After oral and intravenous administration of
14
C labelled floctafenine, urinary excretion accounted
for 40% and fecal and biliary excretion accounted for 60% of the
recovered radioactivity. The
main urinary metabolites are floctafenic acid and its conjugate with
minimal amounts of free
floctafenine.
2
Comparative Bioavailability
A comparative bioavailability study was performed on healthy human
volunteers. The rate and
extent of absorption of floctafenine was measured and compared
following oral administration of
2 x 400 mg of either FLOCTAFENINE 400 mg tablets or Idarac 400 mg
tablets. The results from
measured data are summarized as follows:
Su