ASACOL- mesalamine tablet, delayed release

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

State of Florida DOH Central Pharmacy

INN (International Name):

MESALAMINE

Sammensetning:

MESALAMINE 400 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Asacol tablets are indicated for the treatment of mildly to moderately active ulcerative colitis and for the maintenance of remission of ulcerative colitis. Asacol tablets are contraindicated in patients with hypersensitivity to salicylates or to any of the components of the Asacol tablet. None reported. Drug dependence has not been reported with chronic administration of mesalamine.

Produkt oppsummering:

Asacol® (mesalamine) Delayed-Release Tablets are available as red-brown, capsule-shaped tablets containing 400 mg mesalamine and imprinted “0752 DR” in black. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Manufactured by: Warner Chilcott Deutschland GmbH D-64331 Weiterstadt Germany Marketed by: Warner Chilcott (US), LLC Rockaway, NJ 07866 1-800-521-8813 Under license from Medeva Pharma Suisse AG (registered trademark owner). U.S. Patent Nos. 5,541,170 and 5,541,171 To report SUSPECTED ADVERSE REACTIONS, contact Warner Chilcott at 1-800-521-8813 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

Autorisasjon status:

New Drug Application

Preparatomtale

ASACOL - MESALAMINE TABLET, DELAYED RELEASE
STATE OF FLORIDA DOH CENTRAL PHARMACY
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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 ileu