SALOFALK (R) 5-ASA SUPPOSITORIES - 250MG SUPPOSITORY

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

MESALAZINE

Dostopno od:

AXCAN PHARMA INC

Koda artikla:

A07EC02

INN (mednarodno ime):

MESALAZINE

Odmerek:

250MG

Farmacevtska oblika:

SUPPOSITORY

Sestava:

MESALAZINE 250MG

Pot uporabe:

RECTAL

Enote v paketu:

30

Tip zastaranja:

Prescription

Terapevtsko območje:

ANTI-INFLAMMATORY AGENTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0116808003; AHFS:

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2006-09-12

Lastnosti izdelka

PRODUCT MONOGRAPH
Pr
SALOFALK7
Mesalamine (5-aminosalicylic acid)
Suppositories, 250, 500 and 1000 mg
LOWER GASTROINTESTINAL TRACT ANTI-INFLAMMATORY
AXCAN PHARMA
Date of Preparation:
597, Laurier Boulevard
July 15, 1994
Mont St. Hilaire (Québec)
CANADA J3H 4X8
Date of Revision:
September 10, 2004
Control #: 092435
1
NAME OF DRUG
Pr
SALOFALK
7
Mesalamine (5-aminosalicylic acid)
Suppositories, 250, 500 and 1000 mg
THERAPEUTIC CLASSIFICATION
Lower Gastrointestinal Tract Anti-Inflammatory
ACTIONS AND CLINICAL PHARMACOLOGY
SALOFALK7 suppositories contain mesalamine (5-aminosalicylic acid,
5-ASA), the
active principle of the prodrug sulfasalazine
(SAS)
1, 5, 6, 14
. Although its mode of action
is not clear, 5-ASA is thought to affect the inflammatory process
through its ability to
inhibit prostaglandin synthesis
37, 38
, interfere with leukotriene synthesis and
consequent leukocyte migration
16-18
as well as act as a potent scavenger of free
radicals
50
. Regardless of the mode of action, 5-ASA appears to be active only
topically. SALOFALK7 suppositories are inserted into the rectum thus
providing
topical application to the affected area.
Rectal administration, either as 250, 500 or 1000 mg suppositories or
as 4g/60g or
2g/60g rectal suspension of mesalamine (5-aminosalicylic acid) allows
for direct
targeting of free 5-ASA to the sites of inflammation along the mucosal
lumen of the
rectum, sigmoid and distal large bowel. Systemic absorption of
rectally administered
5-ASA is low as shown by urinary and rectal recoveries which range
from 5 to 35% of
the amount given
19,24,33
. Rectally administered 5-ASA with minimal systemic
absorption thus acts locally on the recto-sigmoidal colon. Plasma
concentrations are
low, peaking at about 10
µ
g/mL for daily rectal dosing of 4 grams
25
and are negligible
24 hours after administration
26
.
5-ASA and its major metabolite N-acetyl-5-aminosalicylic acid
(N-Ac-5-ASA) are short
2
lived in the serum with a half-life reported at between 5-10 hours
42
and 24 hours
29, 43,
47
. N-acetyl