Celebrex

celecoxib

Celebrex

Pharmacologic class: Nonsteroidal cyclooxygenase-2 (COX-2) inhibitor, nonsteroidal anti-inflammatory drug (NSAID)

Therapeutic class: Antirheumatic

Pregnancy risk category C

FDA Box Warning

• Drug may increase risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke (which can be fatal). Risk may increase with duration of use, and may be greater in patients who have cardiovascular disease or risk factors for it.

• Drug is contraindicated for perioperative pain in setting of coronary artery bypass graft surgery.

• Drug increases risk of serious GI adverse events, including bleeding, ulcers, and stomach or intestinal perforation, which can be fatal. These events can occur at any time during therapy and without warning. Elderly patients are at greater risk.

Action

Exhibits anti-inflammatory, analgesic, and antipyretic action due to inhibition of COX-2 enzyme

Availability

Capsules: 50 mg, 100 mg, 200 mg, 400 mg

Indications and dosages

➣ Ankylosing spondylitis, osteoarthritis
Adults: 200 mg/day P.O. as a single dose or 100 mg P.O. b.i.d.

➣ Rheumatoid arthritis

Adults: 100 to 200 mg P.O. b.i.d.

➣ Adjunctive treatment in familial adenomatous polyposis to decrease the number of adenomatous colorectal polyps

Adults: 400 mg P.O. b.i.d.

➣ Acute pain or primary dysmenorrhea
Adults: 400 mg P.O. once, plus one additional 200 mg-dose as needed on first day; then 200 mg b.i.d. as needed

➣ Juvenile rheumatoid arthritis
Children age 2 and older weighing 10 to 25 kg (22 to 55 lb): 50 mg P.O. b.i.d.
Children age 2 and older weighing 25 kg or more: 100 mg P.O. b.i.d.

Dosage adjustment

• Hepatic impairment

• Patients weighing less than 50 kg (110 lb)

Contraindications

• Hypersensitivity to drug, sulfonamides, or other NSAIDs

• Advanced renal disease

• Severe hepatic impairment

• Sensitivity precipitated by aspirin

• Third trimester of pregnancy

• Breastfeeding

Precautions

Use cautiously in:

• renal insufficiency, hypertension

• history of asthma, urticaria, renal disease, hepatic dysfunction, heart failure

• patients on long-term NSAID therapy

• elderly patients

• pregnant patients in first or second trimester

• children younger than age 18 (safety not established).

Administration

• When administering doses higher than 200/mg daily, give with food or milk to improve drug absorption.

Adverse reactions

CNS: dizziness, drowsiness, headache, insomnia, fatigue, stroke

CV: angina, tachycardia, peripheral edema, myocardial infarction

EENT: ophthalmic effects, tinnitus, epistaxis, pharyngitis, rhinitis, sinusitis

GI: nausea, diarrhea, constipation, abdominal pain, dyspepsia, flatulence, dry mouth, GI bleeding

GU: menorrhagia, renal failure

Hematologic: eosinophilia, ecchymosis, neutropenia, leukopenia, pancytopenia, thrombocytopenia, agranulocytosis, granulocytopenia, aplastic anemia, bone marrow depression

Hepatic: hepatotoxicity

Metabolic: hyperchloremia, hypophosphatemia

Musculoskeletal: back pain, leg cramps

Respiratory: upper respiratory tract infection

Skin: rash

Other: anaphylaxis

Interactions

Drug-drug. Angiotensin-converting enzyme inhibitors, furosemide, thiazides: reduced celecoxib efficacy

Antacids containing aluminum and magnesium: decreased celecoxib blood level

Aspirin (regular doses): increased risk of GI bleeding and GI ulcers

Fluconazole, lithium: increased blood levels of these drugs

Warfarin: increased risk of bleeding

Drug-diagnostic tests. Alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen: increased levels

Hematocrit, hemoglobin: decreased values

Drug-herbs. Dong quai, feverfew, garlic, ginger, horse chestnut, red clover: increased risk of bleeding

White willow: increased risk of GI ulcers

Drug-behaviors. Long-term alcohol use, smoking: GI irritation and bleeding

Patient monitoring

• Monitor CBC, electrolyte levels, creatinine clearance, occult fecal blood test, and liver function test results every 6 to 12 months.

Patient teaching

Advise patient to immediately report bloody stools, vomiting of blood, or signs or symptoms of liver damage (nausea, fatigue, lethargy, pruritus, yellowing of eyes or skin, tenderness in upper right abdomen, or flulike symptoms).

• Instruct patient to take drug with food or milk.

• Tell patient to avoid aspirin and other NSAIDs (such as ibuprofen and naproxen) during therapy.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, herbs, and behaviors mentioned above.

celecoxib

(sel-e-kox-ib) celecoxib,

CeleBREX

(trade name)

Classification

Therapeutic: antirheumatics
Pharmacologic: cox 2 inhibitors
Pregnancy Category: C

Indications

Relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and juvenile rheumatoid arthritis.Management of acute pain including primary dysmenorrhea.

Action

Inhibits the enzyme COX-2. This enzyme is required for the synthesis of prostaglandins.Has analgesic, anti-inflammatory, and antipyretic properties.

Therapeutic effects

Decreased pain and inflammation caused by arthritis or spondylitis.Decreased pain.

Pharmacokinetics

Absorption: Bioavailability unknown.Distribution: 97% bound to plasma proteins; extensive tissue distribution.Metabolism and Excretion: Mostly metabolized by the hepatic CYP2C9 isoenzyme; genetic implication the CYP2C9 enzyme system exhibits genetic polymorphism; poor metabolizers may have significantly ↑ celecoxib concentrations and an ↑ risk of adverse effects; <3% excreted unchanged in urine and feces.Half-life: 11 hr.

Time/action profile (pain reduction)

ROUTE	ONSET	PEAK	DURATION
PO	24–48 hr	unknown	12–24 hr†

†After discontinuation.

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Cross-sensitivity may exist with other NSAIDs, including aspirin;History of allergic-type reactions to sulfonamides;History of asthma, urticaria, or allergic-type reactions to aspirin or other NSAIDs, including the aspirin triad (asthma, nasal polyps, and severe hypersensitivity reactions to aspirin);Advanced renal disease;Severe hepatic dysfunction;Peri-operative pain from coronary artery bypass graft (CABG) surgery; Obstetric: Should not be used in late pregnancy (may cause premature closure of the ductus arteriosus).Use Cautiously in: Cardiovascular disease or risk factors for cardiovascular disease (may ↑ risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, especially with prolonged use);Pre-existing renal disease, heart failure, liver dysfunction, concurrent diuretic, or ACE inhibitor therapy (↑ risk of renal impairment);Hypertension or fluid retention;Renal insufficiency (may precipitate acute renal failure);Serious dehydration (correct deficits before administering);genetic implication Patients who are known or suspected to be poor CYP2C9 metabolizers (↓ initial dose by 50%);Pre-existing asthma; Pediatric: Safety not established in children <2 yr or for longer than 6 mo; Geriatric: Concurrent therapy with corticosteroids or anticoagulants, long duration of NSAID therapy, history of smoking, alcoholism, geriatric patients, or poor general health status (↑ risk of GI bleeding); Lactation: Lactation.Exercise Extreme Caution in: History of ulcer disease or GI bleeding.

Adverse Reactions/Side Effects

Central nervous system

dizziness
headache
insomnia

Cardiovascular

myocardial infarction (life-threatening)
stroke (life-threatening)
thrombosis (life-threatening)
edema

Gastrointestinal

gi bleeding (life-threatening)
abdominal pain
diarrhea
dyspepsia
flatulence
nausea

Dermatologic

exfoliative dermatitis (life-threatening)
stevens-johnson syndrome (life-threatening)
toxic epidermal necrolysis (life-threatening)
rash

Interactions

Drug-Drug interaction

CYP2C9 inhibitors may ↑ levels.May ↓ effectiveness of ACE inhibitors, thiazide diuretics, and furosemide.Fluconazole ↑ levels (use lowest recommended dosage).May ↑ risk of bleeding with warfarin and aspirin.May ↑ serum lithium levels.Does not inhibit the cardioprotective effect of low-dose aspirin.

Route/Dosage

Oral (Adults) Osteoarthritis—200 mg once daily or 100 mg twice daily. Rheumatoid arthritis—100–200 mg twice daily. Ankylosing spondylitis—200 mg once daily or 100 mg twice daily; dose may be ↑ after 6 wk to 400 mg daily. Acute pain, including dysmenorrhea—400 mg initially, then a 200-mg dose if needed on the first day; then 200 mg twice daily as needed.

Hepatic Impairment

Oral (Adults) Moderate hepatic impairment (Child-Pugh Class B)—↓ dose by 50%.Oral (Children ≥2 yr, ≥10 kg–≤25 kg) Juvenile rheumatoid arthritis—50 mg twice daily.Oral (Children ≥2 yr, ≥25 kg) Juvenile rheumatoid arthritis—100 mg twice daily.

Availability

Capsules: 50 mg, 100 mg, 200 mg, 400 mg Cost: 100 mg $387.18 / 100, 200 mg $621.67 / 100, 400 mg $1,576.25 / 180

Nursing implications

Nursing assessment

Assess range of motion, degree of swelling, and pain in affected joints before and periodically throughout therapy.
Assess patient for allergy to sulfonamides, aspirin, or NSAIDs. Patients with these allergies should not receive celecoxib.
Assess patient for skin rash frequently during therapy. Discontinue at first sign of rash; may be life-threatening. Stevens-Johnson syndrome may develop. Treat symptomatically; may recur once treatment is stopped.
Lab Test Considerations: May cause ↑ AST and ALT levels.
- May cause hypophosphatemia and ↑ BUN.

Potential Nursing Diagnoses

Impaired physical mobility (Indications)
Acute pain (Indications)

Implementation

Do not confuse with Celexa (citalopram) or Cerebyx (fosphenytoin).
Oral: May be administered without regard to meals. Capsules may be opened and sprinkled on applesauce and ingested immediately with water. Mixture may be stored in the refrigerator for up to 6 hr.

Patient/Family Teaching

Instruct patient to take celecoxib exactly as directed. Do not take more than prescribed dose. Increasing doses does not appear to increase effectiveness. Use lowest effective dose for shortest period of time.
Advise patient to notify health care professional promptly if signs or symptoms of GI toxicity (abdominal pain, black stools), skin rash, unexplained weight gain, edema, or chest pain occurs. Patients should discontinue celecoxib and notify health care professional if signs and symptoms of hepatotoxicity (nausea, fatigue, lethargy, pruritus, jaundice, upper right quadrant tenderness, flu-like symptoms) occur.
Advise patient to notify health care professional if pregnancy is planned or suspected.

Evaluation/Desired Outcomes

Reduction in joint pain in patients with osteoarthritis.
Reduction in joint tenderness, pain, and joint swelling in patients with rheumatoid arthritis and juvenile rheumatoid arthritis.
Decreased pain with dysmenorrhea.

Celebrex

(sĕl′ə-brĕks′) A trademark for the drug celecoxib.

Celebrex^®

Celecoxib Pain management A COX-2 inhibitor NSAID approved for rheumatoid arthritis, osteoarthritis and other pain Pros Much lower incidence of GI bleeding Adverse effects Abdominal pain, diarrhea, dyspepsia. See Nonsteroidal anti-inflammatory drug. Cf Celexa^™, Cerebyx^®.

Celebrex

Celebrex

celecoxib

FDA Box Warning

Action

Availability

Indications and dosages

Dosage adjustment

Contraindications

Precautions

Administration

Adverse reactions

Interactions

Patient monitoring

Patient teaching

celecoxib

CeleBREX

Classification

Indications

Action

Therapeutic effects

Pharmacokinetics

Time/action profile (pain reduction)

Contraindications/Precautions

Adverse Reactions/Side Effects

Central nervous system

Cardiovascular

Gastrointestinal

Dermatologic

Interactions

Drug-Drug interaction

Route/Dosage

Hepatic Impairment

Availability

Nursing implications

Nursing assessment

Potential Nursing Diagnoses

Implementation

Patient/Family Teaching

Evaluation/Desired Outcomes

Celebrex

Celebrex®

Celebrex

Synonyms for Celebrex

noun a Cox-2 inhibitor (trade name Celebrex) that relieves pain and inflammation without harming the digestive tract

Synonyms

Related Words

Celebrex^®