WC 800
tablet , brown , oblong oblong
Black ink
Clinical Information
Gen. Code and Des.
53882 mesalamine ORAL TABLET DR 800 MG
GCN and Des.
21663 mesalamine ORAL TABLET DR 800 MG
Strength
800MG DR
Dose Form
TABLET, DELAYED RELEASE (ENTERIC COATED)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
56360000 ANTI-INFLAMMATORY AGENTS (GI DRUGS)
Active Ingredients
1600 mesalamine 89576
Inactive Ingredients
2432 lactose 64044515
2537 povidone 9003398
ASACOL- mesalamine tablet, delayed release
Procter Gamble Pharmaceuticals, Inc.
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 (methacrylic acid copolymer B, NF), which dissolves at pH 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
Inactive Ingredients: Each tablet contains colloidal silicon dioxide, dibutyl phthalate, edible black ink, iron oxide red, iron oxide yellow, lactose, magnesium stearate, methacrylic acid copolymer (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 to 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.
INDICATIONS AND USAGE
Asacol tablets are indicated for the treatment of mildly to moderately active ulcerative colitis and for the maintenance of remission of ulcerative colitis.
CONTRAINDICATIONS
Asacol tablets are contraindicated in patients with hypersensitivity to salicylates or to any of the components of the Asacol tablet.
PRECAUTIONS
General: Patients with pyloric stenosis may have prolonged gastric retention of Asacol tablets which could delay release of mesalamine in the colon
DOSAGE AND ADMINISTRATION
For the treatment of mildly to moderately active ulcerative colitis: The usual dosage in adults is two 400-mg tablets to be taken three times day for total daily dose of 2.4 grams for duration of weeks.
For the maintenance of remission of ulcerative colitis: The recommended dosage in adults is 1.6 grams daily, in divided doses. Treatment duration in the prospective, well-controlled trial was months.
Two Asacol 400 mg tablets have not been shown to be bioequivalent to one Asacol HD 800 mg tablet.
HOW SUPPLIED
Asacol tablets are available as red-brown, capsule-shaped tablets containing 400 mg mesalamine and imprinted ?Asacol NE? in black.
NDC 0149-0752-15 Bottle of 180
Store at controlled room temperature 20?- 25?C (68?- 77?F) [See USP].
