Label: MESALAMINE tablet, delayed release

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 25, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    Mesalamine Delayed-Release Tablets, USP - Rx only - These highlights do not include all the information needed to use MESALAMINE DELAYED-RELEASE TABLETS safely and effectively. See full ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Mesalamine delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis in adults. Limitations of Use: Safety and effectiveness of mesalamine ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Important Administration Instructions - Do not substitute one mesalamine delayed-release 800 mg tablet for two mesalamine delayed-release 400 mg oral products - [see Clinical ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Mesalamine delayed-release tablets, USP: 800 mg (reddish brown, film-coated, modified capsule-shaped tablets containing 800 mg mesalamine, USP and imprinted with “TV M80” in white ink on one side ...
  • 4 CONTRAINDICATIONS
    Mesalamine delayed-release tablets are contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of mesalamine ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Renal Impairment - Renal impairment, including minimal change disease, acute and chronic interstitial nephritis, and, rarely, renal failure, has been reported in patients taking products such ...
  • 6 ADVERSE REACTIONS
    The following serious or clinically significant adverse described elsewhere in labeling are: Renal Impairment - [see Warnings and Precautions ( 5.1)] Mesalamine-Induced Acute ...
  • 7 DRUG INTERACTIONS
    7.1 Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Drugs - The concurrent use of mesalamine with known nephrotoxic agents, including nonsteroidal anti-inflammatory drugs (NSAIDs ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Limited published data on mesalamine use in pregnant women are insufficient to inform a drug-associated risk. No fetal harm was observed in animal reproduction ...
  • 10 OVERDOSAGE
    Mesalamine delayed-release is an aminosalicylate, and symptoms of salicylate toxicity include nausea, vomiting and abdominal pain, tachypnea, hyperpnea, tinnitus, and neurologic symptoms ...
  • 11 DESCRIPTION
    Each mesalamine delayed-release tablet, USP for oral administration contains 800 mg of mesalamine, USP, an aminosalicylate. Mesalamine delayed-release tablets, USP have an outer protective coat ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The mechanism of action of mesalamine is not fully understood, but appears to be a topical anti-inflammatory effect on colonic epithelial cells. Mucosal production of ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Dietary mesalamine was not carcinogenic in rats at doses as high as 480 mg/kg/day, or in mice at 2,000 mg/kg/day. These doses are ...
  • 14 CLINICAL STUDIES
    The efficacy of mesalamine delayed-release at 4.8 grams per day was studied in a six-week, randomized, double-blind, active-controlled study in 772 patients with moderately active ulcerative ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Mesalamine delayed-release tablets, USP are available as reddish brown, film-coated, modified capsule-shaped tablets containing 800 mg mesalamine, USP and imprinted with “TV M80” in white ink on ...
  • 17 PATIENT COUNSELING INFORMATION
    Administration - [see Dosage and Administration ( 2.1)] Inform patients that if they are switching from a previous oral mesalamine therapy to mesalamine delayed-release tablets to ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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  • INGREDIENTS AND APPEARANCE
    Product Information