Celecoxib

What is Celecoxib?

• Celecoxib (Celebrex) is a nonsteroidal anti-inflammatory drug used to treat the pain and inflammation in osteoarthritis, acute pain in adults, rheumatoid arthritis, ankylosing spondylitis, painful menstruation, and juvenile rheumatoid arthritis.

What are the uses of this medicine?

This medicine is used for: Osteoarthritis (OA)

• For the management of the signs and symptoms of OA.

Rheumatoid Arthritis (RA)

• For the management of the signs and symptoms of RA.

Juvenile Rheumatoid Arthritis (JRA)

• For the management of the signs and symptoms of JRA in patients 2 years and older.

Ankylosing Spondylitis (AS)

• For the management of the signs and symptoms of AS.

Acute Pain

• For the management of acute pain in adults.

Primary Dysmenorrhea

• For the management of primary dysmenorrhea.

How does this medicine work?

• Celecoxib (sel" e kox' ib) is a commonly used NSAID with relative Cox-2 specificity.
• Like other NSAIDs, celecoxib acts by inhibition of prostaglandin synthesis and thereby decreasing the mediators of inflammation, fever and pain.
• The specificity for Cox-2 is believed to make celecoxib less likely to cause gastrointestinal mucosal injury compared to standard NSAIDs that inhibit both Cox-1 and Cox-2 enzymes.
• Celecoxib is indicated for therapy of chronic arthritis due to osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis and ankylosing spondylitis.
• It is also approved for use in acute pain from musculoskeletal conditions and trauma and for primary dysmenorrheal.
• Because of the role of the Cox-2 enzyme system in the growth of adenomatous polyps, celecoxib has also been used to prevent adenomatous polyps formation.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib, any components of the drug product.
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs, have been reported in such patients.
• In the setting of CABG surgery.
• In patients who have demonstrated allergic-type reactions to sulfonamides.

What drug interactions can this medicine cause?

• The concomitant use of Celecoxib and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone.
• Concomitant use of Celebrex and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding.
• During concomitant use of Celebrex and ACE inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained.
• During concomitant use of Celebrex with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects.
• During concomitant use of Celebrex and digoxin, monitor serum digoxin levels.
• During concomitant use of Celebrex and lithium, monitor patients for signs of lithium toxicity.
• Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity.
• Concomitant use of Celebrex and cyclosporine may increase cyclosporine's nephrotoxicity.
• Concomitant use of Celecoxib with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy.
• Co-administration of celecoxib with drugs that are known to inhibit CYP2C9 (e.g., fluconazole) may enhance the exposure and toxicity of celecoxib whereas co-administration with CYP2C9 inducers (e.g., rifampin) may lead to compromised efficacy of celecoxib.
• A dosage adjustment may be warranted when celecoxib is administered with CYP2D6 substrates.
• Concomitant use of corticosteroids with Celebrex may increase the risk of GI ulceration or bleeding.

Is this medicine FDA approved?

• This medicine is approved in the year 2014.

How should this medicine be used?

Recommended Dosage: Osteoarthritis

• For OA, the dosage is 200 mg per day administered as a single dose or as 100 mg twice daily.

Rheumatoid Arthritis

• For RA, the dosage is 100 mg to 200 mg twice daily.

Juvenile Rheumatoid Arthritis

• For JRA, the dosage for pediatric patients (age 2 years and older) is based on weight. For patients ≥10 kg to ≤25 kg the recommended dose is 50 mg twice daily. For patients >25 kg the recommended dose is 100 mg twice daily.

Ankylosing Spondylitis

• For AS, the dosage of Celebrex is 200 mg daily in single (once per day) or divided (twice per day) doses.
• If no effect is observed after 6 weeks, a trial of 400 mg daily may be worthwhile.
• If no effect is observed after 6 weeks on 400 mg daily, a response is not likely and consideration should be given to alternate treatment options.

Management of Acute Pain and Treatment of Primary Dysmenorrhea

• For management of Acute Pain and Treatment of Primary Dysmenorrhea, the dosage is 400 mg initially, followed by an additional 200 mg dose if needed on the first day.
• On subsequent days, the recommended dose is 200 mg twice daily as needed.

Hepatic Impairment:

• Reduce daily dose by 50% in patients with moderate hepatic impairment (Child-Pugh Class B).

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As capsules: 50 mg, 100 mg, 200 mg, and 400 mg

This medicine is available in fallowing brand namesː

• Celebrex

What side effects can this medication cause?

The most common side effects of this medicine include:

• abdominal pain
• diarrhea
• dyspepsia
• flatulence
• peripheral edema
• accidental injury
• dizziness
• pharyngitis
• rhinitis
• sinusitis
• upper respiratory tract infection
• rash

What special precautions should I follow?

• Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.
• NSAIDs, including Celebrex, can lead to new onset of hypertension or worsening of preexisting hypertension. Monitor blood pressure (BP) during the initiation of NSAID treatment and throughout the course of therapy.
• Avoid the use of Celebrex in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If Celebrex is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.
• No information is available from controlled clinical studies regarding the use of Celebrex in patients with advanced renal disease. The renal effects of Celebrex may hasten the progression of renal dysfunction in patients with preexisting renal disease.
• Celecoxib has been associated with anaphylactic reactions in patients with and without known hypersensitivity to celecoxib and in patients with aspirin sensitive asthma. Seek emergency help if an anaphylactic reaction occurs.
• Celebrex is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity).
• Serious skin reactions have occurred following treatment with Celebrex. Discontinue Celebrex at first appearance of skin rash or other signs of hypersensitivity.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as Celebrex. If such signs or symptoms are present, discontinue Celebrex and evaluate the patient immediately.
• NSAIDs, including Celebrex, may increase the risk of bleeding events.
• The pharmacological activity of Celebrex in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.
• Limit use of NSAIDs, including Celebrex, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/fetal renal dysfunction and premature closure of the fetal ductus arteriosus.
• Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.

What to do in case of emergency/overdose?

• No overdoses of Celebrex were reported during clinical trials.

Management of overdosage:

• No information is available regarding the removal of celecoxib by hemodialysis, but based on its high degree of plasma protein binding (>97%) dialysis is unlikely to be useful in overdose.
• Manage patients with symptomatic and supportive care following an NSAID overdosage.
• There are no specific antidotes.
• Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

Can this medicine be used in pregnancy?

• Use of NSAIDs, including Celebrex, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.
• Because of these risks, limit dose and duration of Celebrex use between about 20 and 30 weeks of gestation and avoid Celebrex use at about 30 weeks of gestation and later in pregnancy.

Can this medicine be used in children?

• Celebrex is approved for relief of the signs and symptoms of Juvenile Rheumatoid Arthritis in patients 2 years and older.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• celecoxib

Inactive ingredients:

• croscarmellose sodium
• gelatin, unspecified
• lactose monohydrate
• magnesium stearate
• povidone, unspecified
• sodium lauryl sulfate

Who manufactures and distributes this medicine?

• Packager: Pfizer Laboratories Div Pfizer Inc

What should I know about storage and disposal of this medication?

• Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).

• Dailymed label info on Celecoxib
• FDA Celecoxib

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