Celebrex (celecoxib)
CELEBREX (celecoxib) – a nonsteroidal anti-inflammatory drug (NSAID) commonly used to treat various arthritic conditions and other types or pain. The mechanism of action of CELEBREX is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of cyclooxygenase-2 (COX-2), and at therapeutic concentrations in humans, CELEBREX does not inhibit the cyclooxygenase-1 (COX-1) isoenzyme.
FDA approved uses: Celebrex is indicated for the treatment of:
Osteoarthritis (OA)
Rheumatoid Arthritis (RA)
Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older
Ankylosing Spondylitis (AS)
Acute Pain (AP)
Primary Dysmenorrhea (PD)
Available dosage forms: Capsules: 25, 50, 75, 100, 150, 200, 225, and 300 mg.
Usual dosage: The manufacturer recommends the following doses for Celebrex – OA: 200 mg once daily or 100 mg twice daily[ RA: 100 to 200 mg twice daily; JRA: 50 mg twice daily in patients 10-25 kg. 100 mg twice daily in patients more than 25 kg; AS: 200 mg once daily single dose or 100 mg twice daily. If no effect is observed after 6 weeks, a trial of 400 mg (single or divided doses) may be of benefit ; AP and PD: 400 mg initially, followed by 200 mg dose if needed on first day. On subsequent days, 200 mg twice daily as needed.
Contraindications: Known hypersensitivity to celecoxib or sulfonamides. History of asthma, urticaria, or other allergic-type reactions while taking aspirin or other NSAIDS. Use during the perioperative period in the setting of coronary artery bypass graft (CABG) surgery.
Special warnings: Cardiovascular Risk – CELEBREX may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs may have a similar risk. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. CELEBREX is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Risk- NSAIDs, including CELEBREX, 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.
Adverse reactions (side effects) of these medications: The most common side effects of Celebrex include abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, rash. Other adverse reactions seen in clinical trials or post-marketing include: constipation, diverticulitis, dysphagia, esophagitis, gastroesophageal reflux disease, vomiting, hypertension, fatigue, leg cramps, palpitation, tachycardia, abnormal liver function tests, arthralgias, anorexia, anxiety, depression, nervousness, somnolence, and skin rashes .
Common drug interactions: Celecoxib is metabolized via the cytochrome P450 (CYP) 2C9 system in the liver. Caution should be used when administering with other drugs that inhibit CYP2C9. Anticoagulant activity should be monitored in the first few days after initiating or changing celecoxib therapy. Other drugs with confirmed or potential interactions with celecoxib include lithium, aspirin, ace inhibitors and angiotensin II antagonists, fluconazole, furosemide, mehotrexate, and other NSAIDs.
Special instructions for patients: Take Celebrex exactly as prescribed by physician. CELEBREX may cause anaphylactoid (severe allergic) reactions, like difficulty breathing and/or swelling of the face or throat. Tell your doctor if you have a prior history of asthma related to taking asthma or other NSAIDs. Consult official Medication Guide for details on all of the warnings and precautions for using this medication.
Full prescribing information may be found at the manufacturer‘s official website Celebrex.com or at the U.S. Food and Drug Administration’s website at Celebrex Info at Drugs@FDA
.accessdata.fda.gov/drugsatfda_docs/label/2011/020998s033,021156s003lbl.pdf
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