Label: ETODOLAC capsule

  • NDC Code(s): 62559-250-01, 62559-251-01
  • Packager: ANI Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 2, 2024

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  • BOXED WARNING (What is this?)

    Cardiovascular Thrombotic Events

    Nonsteroidal anti-inflammatory drugs (NSAIDs1) 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).
    Etodolac capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS).

     

    Gastrointestinal Risk

    NSAIDs cause an increased risk of serious gastrointestinal 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 are at greater risk for serious gastrointestinal (GI) events. (See WARNINGS).
     

    1 Throughout this package insert, the term NSAID refers to a non-aspirin nonsteroidal anti-inflammatory drug.

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  • DESCRIPTION
    Etodolac is a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each capsule contains etodolac for oral administration. Etodolac is a racemic mixture of ...
  • CLINICAL PHARMACOLOGY
    Pharmacodynamics - Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of ...
  • CLINICAL TRIALS
    Analgesia - Controlled clinical trials in analgesia were single-dose, randomized, double-blind, parallel studies in three pain models, including dental extractions. The analgesic effective dose ...
  • INDICATIONS AND USAGE
    Carefully consider the potential benefits and risks of etodolac capsules and other treatment options before deciding to use etodolac capsules. Use the lowest effective dose for the shortest ...
  • CONTRAINDICATIONS
    Etodolac capsules are contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac capsules. Etodolac capsules should not be given to patients who have ...
  • WARNINGS
    Cardiovascular Effects 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 ...
  • PRECAUTIONS
    General - Etodolac capsules cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease ...
  • ADVERSE REACTIONS
    In patients taking etodolac or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1 to 10% of patients are: Gastrointestinal experiences including ...
  • OVERDOSAGE
    Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal ...
  • DOSAGE AND ADMINISTRATION
    Carefully consider the potential benefits and risks of etodolac capsules and other treatment options before deciding to use etodolac capsules. Use the lowest effective dose for the shortest ...
  • HOW SUPPLIED
    Etodolac Capsules USP, are available as follows: 200 mg: hard gelatin capsules with an opaque pale red body and an opaque dark red cap, imprinted with “ANI” on the cap and “250” on the body in ...
  • 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 Display Panel – 200 mg Capsule
    Etodolac Capsules USP, 200 mg - NDC 62559-250-01 - Rx only - 100 Capsules
  • Package/Label Display Panel - 300 mg Capsule
    Etodolac Capsules USP, 300 mg - NDC 62559-251-01 - Rx only - 100 Capsules
  • INGREDIENTS AND APPEARANCE
    Product Information