Drug Catalog - Product Detail
MESALAMINE DR TB 800MG 180
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68382-0484-28 | ZYDUS PHARMACEUTICALS (USA) | 180 | 800MG | TABLET |
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Description
11 DESCRIPTION Each Mesalamine delayed-release tablet for oral administration contains 800 mg of mesalamine, an aminosalicylate. Mesalamine delayed-release tablets have an outer protective coat consisting of a combination of acrylic based resins, Eudragit S (methacrylic acid copolymer B, NF) and Eudragit L (methacrylic acid copolymer A, NF). The inner coat consists of an acrylic based resin, Eudragit S, which dissolves at pH 7 or greater, releasing mesalamine in the terminal ileum and beyond for topical anti- inflammatory action in the colon. Mesalamine (also referred to as 5-aminosalicylic acid or 5-ASA) 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, ferric oxide red, ferric oxide yellow, lactose monohydrate, magnesium stearate, methacrylic acid copolymer B (Eudragit S), methacrylic acid copolymer A (Eudragit L), polyethylene glycol, povidone, sodium starch glycolate, and talc. Mesalamine Tablets
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Mesalamine delayed-release tablets are available as red-brown, capsule-shaped tablets containing 800 mg mesalamine and imprinted with "WC 800" in black. NDC 68382-484-28 Bottle of 180 tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Tablets can be dispensed without desiccant for up to 6 weeks.
Indications & Usage
1 INDICATIONS AND USAGE Mesalamine delayed-release tablets is an aminosalicylate indicated for the treatment of moderately active ulcerative colitis in adults. ( 1 ) Limitation of Use : Safety and effectiveness of Mesalamine delayed-release tablets beyond 6 weeks have not been established ( 1 ) Mesalamine delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis in adults. Safety and effectiveness of Mesalamine delayed-release tablets beyond 6 weeks have not been established.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Recommended dosage is two 800 mg tablets three times daily (4.8 grams/day) with or without food for 6 weeks ( 2.1 ) Instruct patients to swallow tablets whole without cutting, breaking, or chewing ( 2.2 ) One Mesalamine delayed-release 800 mg tablet cannot be substituted for two Asacol® (mesalamine) delayed-release 400 mg tablets ( 2.2 ) Recommend that renal function be evaluated prior to initiation of Mesalamine delayed-release tablets ( 2.3 , 5.1 ) 2.1 Dosage Information For the treatment of moderately active ulcerative colitis, the recommended dosage of Mesalamine delayed-release tablets in adults is two 800 mg tablets to be taken three times daily with or without food, for a total daily dose of 4.8 grams, for a duration of 6 weeks. 2.2 Important Administration Instructions Swallow Mesalamine delayed-release tablets whole, do not cut, break or chew the tablets. One Mesalamine delayed-release 800 mg tablet has not been shown to be bioequivalent to two Asacol 400 mg tablets [see Clinical Pharmacology ( 12.3 )]. 2.3 Testing Prior to Mesalamine delayed-release tablets Administration It is recommended that all patients have an evaluation of renal function prior to initiation of Mesalamine delayed-release tablets [see Warnings and Precautions ( 5.1 )].