Label: MELOXICAM tablet

  • NDC Code(s): 16571-776-01, 16571-776-10, 16571-776-50, 16571-777-01, view more
  • Packager: Rising Pharma Holdings, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 23, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use MELOXICAM TABLETS safely and effectively. See full prescribing information for MELOXICAM TABLETS. MELOXICAM tablets, for oral ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS


    Cardiovascular Thrombotic Events

    • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions (5.1)].
    • Meloxicam is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) and Warnings and Precautions (5.1)].

    Gastrointestinal Bleeding, Ulceration, and Perforation

    •  NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see Warnings and Precautions (5.2)].

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  • 1 INDICATIONS AND USAGE
    1.1 Osteoarthritis (OA) Meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)]. 1.2 Rheumatoid Arthritis (RA) Meloxicam ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 General Dosing Instructions - Carefully consider the potential benefits and risks of meloxicam tablets and other treatment options before deciding to use meloxicam tablets. Use the lowest ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Meloxicam Tablets USP - 7.5 mg: pastel yellow, round, biconvex, uncoated tablet debossed with ‘C’ on one side and ‘79’ on the other side. 15 mg: pastel yellow, oblong, biconvex, uncoated tablet ...
  • 4 CONTRAINDICATIONS
    Meloxicam tablets are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Cardiovascular Thrombotic Events - Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Boxed Warning and Warnings and Precautions (5.1)] GI ...
  • 7 DRUG INTERACTIONS
    See Table 3 for clinically significant drug interactions with meloxicam. See also Warnings and Precautions (5.2, 5.6, 5.12) and Clinical Pharmacology (12.3).  Table 3 Clinically Significant ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Use of NSAIDs, including meloxicam, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some ...
  • 10 OVERDOSAGE
    Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care ...
  • 11 DESCRIPTION
    Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Each tablet contains 7.5 mg or 15 mg meloxicam USP for oral administration. Meloxicam is chemically designated as ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Meloxicam has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of meloxicam, like that of other NSAIDs, is not completely understood ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - There was no increase in tumor incidence in long-term carcinogenicity studies in rats (104 weeks) and mice (99 ...
  • 14 CLINICAL STUDIES
    14.1 Osteoarthritis and Rheumatoid Arthritis - The use of meloxicam for the treatment of the signs and symptoms of osteoarthritis of the knee and hip was evaluated in a 12-week, double-blind ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Meloxicam Tablets USP, 7.5 mg are pastel yellow, round, biconvex, uncoated tablet debossed with ‘C’ on one side and ‘79’ on the other side, and is supplied as follows:             Bottles of ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families or their caregivers of the following ...
  • Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
    What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: Increased risk ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 7.5 mg (100 Tablet Bottle)
    Rising® PHARMACEUTICALS - NDC 16571-776-01 - Meloxicam Tablets, USP - 7.5 mg - ATTENTION DISPENSER: Accompanying - Medication Guide must be dispensed with - this product. 100 ...
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 mg (100 Tablet Bottle)
    Rising® PHARMACEUTICALS - NDC 16571-777-01 - Meloxicam Tablets, USP - 15 mg - ATTENTION DISPENSER: Accompanying - Medication Guide must be dispensed with - this product. 100 ...
  • INGREDIENTS AND APPEARANCE
    Product Information