Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
MESALAMINE (UNII: 4Q81I59GXC) (mesalamine - UNII:4Q81I59GXC)
State of Florida DOH Central Pharmacy
MESALAMINE
MESALAMINE 400 mg
ORAL
PRESCRIPTION DRUG
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. Abuse: None reported. Dependency: Drug dependence has not been reported with chronic administration of mesalamine.
Asacol tablets are available as red-brown, capsule-shaped tablets containing 400 mg mesalamine and imprinted “Asacol NE” in black. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at controlled room temperature 20°- 25°C (68°- 77°F) [See USP].
New Drug Application
ASACOL - MESALAMINE TABLET, DELAYED RELEASE STATE OF FLORIDA DOH CENTRAL PHARMACY ---------- 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, 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. T read_full_document