FLOCTAFENINE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

FLOCTAFENINE

Tersedia dari:

AA PHARMA INC

Kode ATC:

N02BG04

INN (Nama Internasional):

FLOCTAFENINE

Dosis:

200MG

Bentuk farmasi:

TABLET

Komposisi:

FLOCTAFENINE 200MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

MISCELLANEOUS ANALGESICS AND ANTIPYRETICS

Ringkasan produk:

Active ingredient group (AIG) number: 0114463002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2001-11-13

Karakteristik produk

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