Drug Notebook

FDA Alerts

    Cardiovascular Risk
  • Possible increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke). Risk may increase with duration of use. Individuals with cardiovascular disease or risk factors for cardiovascular disease may be at increased risk. (See Cardiovascular Effects under Cautions.)
  • Contraindicated for the treatment of pain in the setting of CABG surgery.

    GI Risk
  • Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine). Serious GI events can occur at any time and may not be preceded by warning signs and symptoms. Geriatric individuals are at greater risk for serious GI events. (See GI Effects under Cautions.)

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celecoxib
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(SEL e KOX ib)

Uses

Consider potential benefits and risks of celecoxib therapy as well as alternative therapies before initiating therapy with the drug. Use lowest effective dosage and shortest duration of therapy consistent with the patient's treatment goals.

Osteoarthritis

Symptomatic treatment of osteoarthritis. Effect comparable to that of prototypical NSAIAs (naproxen).

Lower incidence of endoscopically confirmed GI ulcer and serious adverse GI effects than prototypical NSAIAs.

Rheumatoid Arthritis in Adults

Symptomatic treatment of rheumatoid arthritis in adults. Effect comparable to that of prototypical NSAIAs (naproxen, diclofenac).

Lower incidence of endoscopically confirmed GI ulcer and serious adverse GI effects than prototypical NSAIAs.

Juvenile Arthritis

Symptomatic management of pauciarticular course, polyarticular course, or systemic onset juvenile rheumatoid arthritis in children ≥2 years of age. Effect comparable to that of naproxen.

Ankylosing Spondylitis

Management of the signs and symptoms of ankylosing spondylitis.

Colorectal Polyps

Reduction of the number of adenomatous colorectal polyps (colorectal adenomas) in adults with familial adenomatous polyposis (FAP); used as an adjunct to usual care. Not known whether celecoxib reduces the risk of colorectal, duodenal, or other FAP-related cancers.

Has been investigated for the prevention of colorectal adenomas in patients without a history of FAP†. Use of celecoxib reduces the risk of recurrent colorectal adenomas; not known whether celecoxib reduces the risk of colorectal cancer. Routine use not recommended because of the potential for serious cardiovascular events.

Pain

Management of acute pain, including postoperative (e.g., dental, orthopedic) pain, in adults.

Dysmenorrhea

Symptomatic management of primary dysmenorrhea in adults.

Cardiovascular Risk Reduction

Not a substitute for aspirin in the prevention of adverse cardiovascular events (MI). (See Cardiovascular Effects under Cautions.)

Dosage and Administration

General

  • Consider potential benefits and risks of celecoxib therapy as well as alternative therapies before initiating therapy with the drug.

Administration

Oral Administration

Administer orally once or twice daily for osteoarthritis or ankylosing spondylitis; administer twice daily for rheumatoid arthritis, juvenile arthritis, colorectal polyps, pain, or dysmenorrhea.

Administer dosages up to 200 mg twice daily without regard to meals; administer higher dosages (400 mg twice daily) with food.

For patients who have difficulty swallowing capsules, the capsule may be opened and the contents sprinkled onto a level teaspoonful of applesauce at room temperature or cooler, and the mixture swallowed immediately with water.

Dosage

To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient's treatment goals.

Attempt to titrate to the lowest effective dosage in adults with arthritis.

Pediatric Patients

Juvenile Arthritis

Oral

Children ≥2 years of age weighing 10–25 kg: 50 mg twice daily.

Children ≥2 years of age weighing >25 kg: 100 mg twice daily.

Adults

Osteoarthritis

Oral

200 mg daily as a single dose or in 2 equally divided doses.

No additional benefit from dosages >200 mg daily.

Rheumatoid Arthritis in Adults

Oral

100–200 mg twice daily.

No additional benefit from higher dosages (400 mg twice daily).

Ankylosing Spondylitis

Oral

Initially, 200 mg daily as a single dose or in 2 equally divided doses. If no response observed after 6 weeks, increase to 400 mg daily. If no response observed after 400 mg daily for 6 weeks, response is unlikely; consider alternative therapies.

Colorectal Polyps

Oral

400 mg twice daily.

Pain

Oral

400 mg initially as a single dose, followed by an additional dose of 200 mg, if necessary, on the first day. For continued relief, 200 mg twice daily as needed.

Dysmenorrhea

Oral

400 mg initially as a single dose, followed by an additional dose of 200 mg, if necessary, on the first day. For continued relief, 200 mg twice daily as needed.

Special Populations

Dosage in Hepatic Impairment

Reduce dosage by 50% in patients with moderate hepatic impairment; not recommended in patients with severe impairment.

Geriatric Patients

Dosage adjustment based solely on age is not necessary; initiate at lowest recommended dosage in geriatric patients weighing <50 kg.

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