Label: MESALAMINE tablet, delayed release
- NDC Code(s): 42291-489-18
- Packager: AvKARE
- This is a repackaged label.
- Source NDC Code(s): 0480-7750
- 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 INFORMATIONMesalamine 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 ...
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Table of ContentsTable of Contents
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1 INDICATIONS AND USAGEMesalamine delayed-release tablets are indicated for the treatment of moderately active ulcerative colitis in adults. Limitations of Use: Safety and effectiveness of mesalamine ...
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2 DOSAGE AND ADMINISTRATION2.1 Important Administration Instructions - Do not substitute one mesalamine delayed-release 800 mg tablet for two mesalamine delayed-release 400 mg oral products - [see Clinical ...
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3 DOSAGE FORMS AND STRENGTHSMesalamine 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 ...
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4 CONTRAINDICATIONSMesalamine delayed-release tablets are contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of mesalamine ...
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5 WARNINGS AND PRECAUTIONS5.1 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 ...
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6 ADVERSE REACTIONSThe following serious or clinically significant adverse described elsewhere in labeling are: Renal Impairment - [see Warnings and Precautions ( 5.1)] Mesalamine-Induced Acute ...
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7 DRUG INTERACTIONS7.1 Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Drugs - The concurrent use of mesalamine with known nephrotoxic agents, including nonsteroidal anti-inflammatory drugs (NSAIDs ...
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8 USE IN SPECIFIC POPULATIONS8.1 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 ...
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10 OVERDOSAGEMesalamine delayed-release is an aminosalicylate, and symptoms of salicylate toxicity include nausea, vomiting and abdominal pain, tachypnea, hyperpnea, tinnitus, and neurologic symptoms ...
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11 DESCRIPTIONEach 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 ...
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12 CLINICAL PHARMACOLOGY12.1 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 ...
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13 NONCLINICAL TOXICOLOGY13.1 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 ...
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14 CLINICAL STUDIESThe 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 ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGMesalamine 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 ...
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17 PATIENT COUNSELING INFORMATIONAdministration - [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 ...
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