Label: CELECOXIB capsule

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

Drug Label Information

Updated July 25, 2019

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  • BOXED WARNING (What is this?)


    Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including ...

    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 the treatment and may increase with duration of use [see Warnings and Precautions (5.1) ].
    Celecoxib 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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  • INDICATIONS & USAGE
    Celecoxib capsules are indicated - 1.1 Osteoarthritis (OA) For the management of the signs and symptoms of OA [see Clinical Studies (14.1)] 1.2 Rheumatoid Arthritis (RA) For the management of the ...
  • DOSAGE & ADMINISTRATION
    2.1 General Dosing Instructions - Carefully consider the potential benefits and risks of celecoxib capsules and other treatment options before deciding to use celecoxib capsules. Use the lowest ...
  • DOSAGE FORMS & STRENGTHS
    Capsules: 50 mg, 100 mg and 200 mg
  • CONTRAINDICATIONS
    Celecoxib capsules are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib, any components of the drug product ...
  • WARNINGS AND PRECAUTIONS
    5.1 Cardiovascular Thrombotic Events - Clinical trials of several cyclooxygenase-2 (COX-2) selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious ...
  • ADVERSE REACTIONS
    The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1)] GI Bleeding, Ulceration ...
  • DRUG INTERACTIONS
    See Table 3 for clinically significant drug interactions with celecoxib. Table 3: Clinically Significant Drug Interactions with Celecoxib - Drugs That Interfere with Hemostasis - Clinical ...
  • USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Pregnancy Category C. Pregnancy category D from 30 weeks of gestation onward. Risk Summary - Use of NSAIDs, including celecoxib capsules, during the third trimester of pregnancy ...
  • 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 ...
  • DESCRIPTION
    Celecoxib capsules are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, and 200 mg celecoxib for oral administration. The chemical name is ...
  • CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Celecoxib has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of celecoxib is believed to be due to inhibition of prostaglandin synthesis ...
  • NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Celecoxib was not carcinogenic in Sprague-Dawley rats given oral doses up to 200 mg/kg for males and 10 mg/kg for ...
  • CLINICAL STUDIES
    14.1 Osteoarthritis - Celecoxib has demonstrated significant reduction in joint pain compared to placebo. Celecoxib was evaluated for treatment of the signs and the symptoms of OA of the knee and hip ...
  • HOW SUPPLIED
    Celecoxib capsules 50 mg are available for oral administration as hard gelatin capsules with a white opaque body and a white opaque cap. “APO C50” is imprinted on each capsule in red ink. They are ...
  • 88436-1 - Section Title Not Found In Database
    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
    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 ...
  • PRINCIPAL DISPLAY PANEL
    360-42
  • INGREDIENTS AND APPEARANCE
    Product Information