ASACOL mesalamine tablet delayed release

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

MESALAMINE (UNII: 4Q81I59GXC) (MESALAMINE - UNII:4Q81I59GXC)

Disponibbli minn:

Cardinal Health

INN (Isem Internazzjonali):

MESALAMINE

Kompożizzjoni:

MESALAMINE 400 mg

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Karatteristiċi tal-prodott

ASACOL- MESALAMINE TABLET, DELAYED RELEASE
CARDINAL HEALTH
----------
AS ACOL
(MES ALAMINE)
DELAYED-RELEASE TABLETS
DESCRIPTION:
Each ASACOL
delayed-release tablet for oral administration contains 400 mg of
mesalamine, an anti-
inflammatory drug. The ASACOL delayed-release tablets are coated with
acrylic based resin, Eudragit S
(methacrylic acid copolymer B, NF), which dissolves at pH 7 or
greater, releasing mesalamine in the
terminal ileum and beyond for topical anti-inflammatory action in the
colon. Mesalamine has the
chemical name 5-amino-2-hydroxybenzoic acid; its structural formula
is:
INACTIVE INGREDIENTS: Each tablet contains colloidal silicon dioxide,
dibutyl phthalate, edible black ink,
iron oxide red, iron oxide yellow, lactose monohydrate, magnesium
stearate, methacrylic acid
copolymer B (Eudragit S), polyethylene glycol, povidone, sodium starch
glycolate, and talc.
CLINICAL PHARMACOLOGY:
Mesalamine is thought to be the major therapeutically active part of
the sulfasalazine molecule in the
treatment of ulcerative colitis. Sulfasalazine is converted to
equimolar amounts of sulfapyridine and
mesalamine by bacterial action in the colon. The usual oral dose of
sulfasalazine for active ulcerative
colitis is 3 to 4 grams daily in divided doses, which provides 1.2 to
1.6 grams of mesalamine to the
colon.
The mechanism of action of mesalamine (and sulfasalazine) is unknown,
but appears to be topical rather
than systemic. Mucosal production of arachidonic acid (AA)
metabolites, both through the
cyclooxygenase pathways, i.e., prostanoids, and through the
lipoxygenase pathways, i.e., leukotrienes
(LTs) and hydroxyeicosatetraenoic acids (HETEs), is increased in
patients with chronic inflammatory
bowel disease, and it is possible that mesalamine diminishes
inflammation by blocking cyclooxygenase
and inhibiting prostaglandin (PG) production in the colon.
PHARMACOKINETICS :
ASACOL tablets are coated with an acrylic-based resin that delays
release of mesalamine until it reaches
the terminal ileum and beyond. This has