Celecoxib (Lexi-Drugs)

ALERT: US Boxed Warning
  Serious cardiovascular risk:
  Serious gastrointestinal risk:
Pronunciation

(se le KOKS ib)

Brand Names: US

CeleBREX

Brand Names: Canada

ACCEL-Celecoxib [DSC]; ACT Celecoxib; AG-Celecoxib; APO-Celecoxib; Auro-Celecoxib; BIO-Celecoxib; CeleBREX; GD-Celecoxib; JAMP-Celecoxib; Mar-Celecoxib; MINT-Celecoxib; MYLAN-Celecoxib [DSC]; PMS-Celecoxib; Priva-Celecoxib; RAN-Celecoxib; RIVA-Celecox; SANDOZ Celecoxib; SDZ Celecoxib; TEVA-Celecoxib [DSC]

Dosing: Adult

Note: Use the lowest effective dose for the shortest duration of time, consistent with individual patient treatment goals. Due to an increased risk of cardiovascular events, use should generally be avoided in patients with established cardiovascular disease or risk factors for cardiovascular disease. Use should also be avoided in those with heart failure (Chan 2018; Schmidt 2016).

Acute pain or primary dysmenorrhea: Oral: Initial dose: 400 mg, followed by an additional 200 mg if needed on day 1; maintenance dose: 200 mg twice daily as needed

Ankylosing spondylitis: Oral: 200 mg once daily or 100 mg twice daily; if no effect after 6 weeks, may increase to 400 mg/day. If no response following 6 weeks of treatment with 400 mg/day, consider discontinuation and alternative treatment.

Gout, acute flare (alternative agent) (off-label use): Oral: 200 mg twice daily; initiate within 24 to 48 hours of flare onset preferably; discontinue 2 to 3 days after resolution of clinical signs; usual duration: 5 to 7 days (ACR [Khanna 2012]; Becker 2018)

Osteoarthritis: Oral: 200 mg once daily or 100 mg twice daily

Rheumatoid arthritis: Oral: 100 to 200 mg twice daily

Dosing adjustment in poor CYP2C9 metabolizers (ie, CYP2C9*3/*3): Reduce initial dose by 50%; consider alternative treatment in patients with JIA who are poor CYP2C9 metabolizers.

Dosing: Geriatric

Initiate at the lowest recommended dose. The AUC in elderly patients (especially females and patients weighing <50 kg) may be increased by 50% compared with younger subjects.

Dosing: Renal Impairment: Adult

Mild or moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling; however, since <1% of the drug is excreted in the urine, dosage adjustment is not necessary (Davies 2000). Based on unpublished data, AUC was ~40% lower in patients with chronic renal insufficiency (GFR 35 to 60 mL/minute) compared with subjects with normal renal function due to a higher apparent clearance.

Severe impairment: Use is not recommended.

Advanced renal disease: Use is not recommended; however, if celecoxib treatment cannot be avoided, monitor renal function closely.

Abnormal renal function tests (persistent or worsening): Discontinue use.

Dosing: Hepatic Impairment: Adult

Mild impairment (Child-Pugh class A): No dosage adjustment necessary; AUC increased ~40% in mild hepatic impairment compared with healthy subjects.

Moderate impairment (Child-Pugh class B): Reduce dose by 50%.

Severe impairment (Child-Pugh class C): Use is not recommended.

Abnormal liver function tests (persistent or worsening): Discontinue use.

Dosing: Pediatric

Juvenile idiopathic arthritis (JIA): Note: Use the lowest effective dose for the shortest duration of time, consistent with individual patient goals.

Children ≥2 years and Adolescents:

≥10 kg to ≤25 kg: Oral: 50 mg twice daily

>25 kg: Oral: 100 mg twice daily

Dosing adjustment in poor metabolizers of CYP2C9 substrates: Use with caution in patients who are known or suspected poor metabolizers of cytochrome P450 isoenzyme 2C9 substrates.

Children ≥2 years and Adolescents: Consider alternate therapy in JIA patients who are poor metabolizers; experience in adult patients suggests dosing adjustment.

Dosing: Renal Impairment: Pediatric

Children ≥2 years and Adolescents:

Baseline:

Mild or moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling; however, since <1% of the drug is excreted in the urine, dosage adjustment is not necessary (Davies 2000). Based on unpublished data, AUC was ~40% lower in adult patients with chronic renal insufficiency (GFR 35 to 60 mL/minute) compared with subjects with normal renal function due to a higher apparent clearance.

Severe impairment: Use is not recommended.

Advanced renal disease: Use is not recommended; however, if celecoxib treatment cannot be avoided, monitor renal function closely.

During therapy: Abnormal renal function tests (persistent or worsening): Discontinue use.

Dosing: Hepatic Impairment: Pediatric

Children ≥2 years and Adolescents:

Moderate hepatic impatient (Child-Pugh Class B): Reduce dose by 50%; monitor closely

Severe hepatic impairment (Child-Pugh Class C): Use is not recommended; has not been studied

Use: Labeled Indications

Acute pain: Management of acute pain.

Ankylosing spondylitis: Relief of the signs/symptoms of ankylosing spondylitis.

Juvenile idiopathic arthritis: Relief of the signs/symptoms of juvenile idiopathic arthritis (JIA) in patients 2 years and older.

Osteoarthritis: Relief of the signs/symptoms of osteoarthritis.

Primary dysmenorrhea: Treatment of primary dysmenorrhea.

Rheumatoid arthritis: Relief of the signs/symptoms of rheumatoid arthritis.

Use: Off-Label: Adult

  Gout, acute flaresLevel of Evidence [B, G]

Data from a multinational, randomized, double-blind, controlled trial demonstrate efficacy of celecoxib for the treatment of acute gout flares Ref. Clinical experience also supports the utility of celecoxib for this condition Ref.

Based on the American College of Rheumatology guidelines for the management of acute gout flares, celecoxib is an effective and recommended treatment option for patients with GI contraindications or intolerance to nonselective NSAIDs.

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Ankylosing Spondylitis:

ACR/SAA/SPARTAN, “Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis,” 2016

Gout:

3e Initiative, Guidelines for the Management of Gout, 2014

American College of Rheumatology (ACR), Guideline for the Management of Acute Gout, 2012

BSR/BHPR, Guideline for the Management of Gout, 2007

Heart Failure:

ACCF/AHA, “2013 ACCF/AHA Guideline for the Management of Heart Failure,” June 2013

Juvenile Idiopathic Arthritis:

American College of Rheumatology, “2013 Update of the 2011 American College of Rheumatology Recommendations for the Treatment of Juvenile Idiopathic Arthritis,” 2013

Osteoarthritis:

American College of Rheumatology, “Recommendations for the Use of Nonpharmacologic and Pharmacologic Therapies in Osteoarthritis of the Hand, Hip, and Knee,” 2012

Other:

“The Use of Antiplatelet Therapy in the Outpatient Setting: Canadian Cardiovascular Society Guidelines,” 2011

Administration: Oral

May be administered without regard to meals. Capsules may be swallowed whole or the entire contents emptied onto a teaspoon of cool or room temperature applesauce and administered immediately with water. The contents of the capsules sprinkled onto applesauce may be stored under refrigeration for up to 6 hours.

Administration: Pediatric

Lower doses (up to 200 mg twice daily) may be administered without regard to meals (may administer with food to reduce GI upset); larger doses should be administered with food to improve absorption. Capsules may be swallowed whole or the entire contents emptied onto a teaspoon of cool or room temperature applesauce and ingested immediately with water. The sprinkled contents of the capsule on applesauce may be stored under refrigeration for up to 6 hours.

Storage/Stability

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

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience abdominal pain, heartburn, nausea, vomiting, constipation, diarrhea, flatulence, cough, pharyngitis, or rhinitis. Have patient report immediately to prescriber signs of abdominal ulcers (severe abdominal or back pain; black, tarry, or bloody stools; vomiting blood or vomit that looks like coffee grounds; or weight gain or abnormal swelling), signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of high potassium (abnormal heartbeat, confusion, dizziness, passing out, weakness, shortness of breath, numbness or tingling feeling), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes), severe headache, vision changes, severe dizziness, passing out, shortness of breath, excessive weight gain, swelling of arms or legs, angina, severe loss of strength and energy, or hearing loss (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

NSAIDs: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020998s050lbl.pdf#page=21

Contraindications

Hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs, or any component of the formulation; patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs; use in the setting of CABG surgery.

Note: Although the FDA approved product labeling states this medication is contraindicated with other sulfonamide-containing drug classes, the scientific basis of this statement has been challenged. See “Warnings/Precautions” for more detail.

Canadian labeling: Additional contraindications (not in US labeling): Pregnancy (third trimester); women who are breast-feeding; severe, uncontrolled heart failure; active gastrointestinal ulcer (gastric, duodenal, peptic); active gastrointestinal bleeding; inflammatory bowel disease; cerebrovascular bleeding; severe liver impairment or active hepatic disease; severe renal impairment (CrCl <30 mL/minute) or deteriorating renal disease; known hyperkalemia; use in patients <18 years of age

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid reactions: Even in patients without prior exposure, anaphylactic reactions and angioedema may occur; patients with “aspirin triad” (bronchial asthma, aspirin intolerance, rhinitis) may be at increased risk. Contraindicated in patients who have experienced an anaphylactic reaction with NSAID or aspirin therapy.

• Cardiovascular events: [US Boxed Warning]: NSAIDs cause an increased risk of serious (and potentially fatal) adverse cardiovascular thrombotic events, including MI and stroke. Risk may occur early during treatment and may increase with duration of use. Relative risk appears to be similar in those with and without known cardiovascular disease or risk factors for cardiovascular disease; however, absolute incidence of cardiovascular events (which may occur early during treatment) was higher in patients with known cardiovascular disease or risk factors. New onset hypertension or exacerbation of hypertension may occur (NSAIDs may also impair response to ACE inhibitors, thiazide diuretics, or loop diuretics); may contribute to cardiovascular events; monitor blood pressure; use with caution in patients with hypertension. May cause sodium and fluid retention, use with caution in patients with edema. Avoid use in patients with heart failure (ACCF/AHA [Yancy 2013]). Avoid use in patients with recent MI unless benefits outweigh risk of cardiovascular thrombotic events. Long-term cardiovascular risk in children has not been evaluated. Use the lowest effective dose for the shortest duration of time, consistent with individual patient goals, to reduce risk of cardiovascular events; alternate therapies should be considered for patients at high risk.

• Gastrointestinal events: [US Boxed Warning]: NSAIDs cause an increased risk of serious gastrointestinal inflammation, ulceration, bleeding, and perforation (may be fatal); elderly patients and patients with history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. These events may occur at any time during therapy and without warning. Avoid use in patients with active GI bleeding. Use caution with a history of GI ulcers, concurrent therapy known to increase the risk of GI bleeding (eg, aspirin, anticoagulants and/or corticosteroids, selective serotonin reuptake inhibitors), smoking, use of alcohol, or in elderly or debilitated patients. Use the lowest effective dose for the shortest duration of time, consistent with individual patient goals, to reduce risk of GI adverse events; alternate therapies should be considered for patients at high risk. When used concomitantly with aspirin, a substantial increase in the risk of gastrointestinal complications (eg, ulcer) occurs; concomitant gastroprotective therapy (eg, proton pump inhibitors) is recommended (Bhatt 2008).

• Hematologic effects: Anemia may occur; monitor hemoglobin or hematocrit in patients on long-term treatment. Celecoxib does not usually affect PT, PTT or platelet counts; does not inhibit platelet aggregation at approved doses.

• Skin reactions: NSAIDs may cause serious skin adverse events including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN); may occur without warning and in patients without prior known sulfa allergy; discontinue use at first sign of rash (or any other hypersensitivity).

• Sulfonamide (“sulfa”) allergy: The FDA-approved product labeling for many medications containing a sulfonamide chemical group includes a broad contraindication in patients with a prior allergic reaction to sulfonamides. There is a potential for cross-reactivity between members of a specific class (eg, two antibiotic sulfonamides). However, concerns for cross-reactivity have previously extended to all compounds containing the sulfonamide structure (SO2NH2). An expanded understanding of allergic mechanisms indicates cross-reactivity between antibiotic sulfonamides and nonantibiotic sulfonamides may not occur or at the very least this potential is extremely low (Brackett 2004; Johnson 2005; Slatore 2004; Tornero 2004). In particular, mechanisms of cross-reaction due to antibody production (anaphylaxis) are unlikely to occur with nonantibiotic sulfonamides. T-cell-mediated (type IV) reactions (eg, maculopapular rash) are less well understood and it is not possible to completely exclude this potential based on current insights. In cases where prior reactions were severe (Stevens-Johnson syndrome/TEN), some clinicians choose to avoid exposure to these classes.

Disease-related concerns:

• Asthma: The manufacturer’s labeling states to not administer to patients with aspirin-sensitive asthma due to severe and potentially fatal bronchospasm that has been reported in such patients having received aspirin and the potential for cross reactivity with other NSAIDs. The manufacturer also states to use with caution in patients with other forms of asthma. However, in patients with known aspirin-exacerbated respiratory disease (AERD), the use of celecoxib initiated at a low dose with gradual titration in patients with stable, mild to moderate persistent asthma has been used without incident (Morales 2013).

• Coronary artery bypass graft surgery: [US Boxed Warning]: Celecoxib is contraindicated in the setting of coronary artery bypass graft surgery (CABG). Risk of MI and stroke may be increased with use following CABG surgery.

• Cytochrome P450 isoenzyme 2C9 deficiency: Use with caution in patients with known or suspected deficiency of cytochrome P450 isoenzyme 2C9; poor metabolizers may have higher plasma levels due to reduced metabolism; consider reduced initial doses. Alternate therapies should be considered in patients with JIA who are poor metabolizers of CYP2C9.

• Hepatic impairment: Use with caution in patients with moderate hepatic impairment; dosage adjustment recommended. Not recommended for patients with severe hepatic impairment. Transaminase elevations have been reported with use; closely monitor patients with any abnormal LFT. Rare (sometimes fatal), severe hepatic reactions (eg, fulminant hepatitis, hepatic necrosis, hepatic failure) have occurred with NSAID use; discontinue if signs or symptoms of liver disease develop, if systemic manifestations occur, or with persistent or worsening abnormal hepatic function tests.

• Renal impairment: NSAID use may compromise existing renal function. Dose-dependent decreases in prostaglandin synthesis may result from NSAID use, causing a reduction in renal blood flow which may cause renal decompensation (usually reversible). Patients with impaired renal function, dehydration, hypovolemia, heart failure, liver dysfunction, those taking diuretics, ACE inhibitors, angiotensin II receptor blockers, and the elderly are at greater risk for renal toxicity. Rehydrate patient before starting therapy; monitor renal function closely. Avoid use in patients with advanced renal disease; discontinue use with persistent or worsening abnormal renal function tests. Long-term NSAID use may result in renal papillary necrosis.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Pediatric: Use with caution in pediatric patients with systemic-onset juvenile idiopathic arthritis (JIA); serious adverse reactions, including disseminated intravascular coagulation, may occur.

Geriatric Considerations

The elderly are at increased risk for adverse effects from NSAIDs. As many as 60% of elderly can develop peptic ulceration and/or hemorrhage asymptomatically; however, elderly patients may demonstrate these adverse effects at lower doses than younger adults. The elderly are also at increased risk of renal toxicity. Although celecoxib is associated with a decreased incidence of GI side effects, use the lowest recommended dose in patients weighing <50 kg.

Warnings: Additional Pediatric Considerations

Consider alternate therapy in JIA patients who are identified to be CYP2C9 poor metabolizers. In a small pediatric study (n=4), the AUC of celecoxib was ~10 times higher in a child who was homozygous for CYP2C9*3, compared to children who were homozygous for the *1 allele (n=2) or who had the CYP2C9*1/*2 genotype; further studies are needed to determine if carriers of the CYP2C9*3 allele are at increased risk for cardiovascular toxicity or dose related adverse effects of celecoxib, especially with long-term, high-dose use of the drug (Stempak 2005). Long-term (>6 months) cardiovascular toxicity in children and adolescents has not been studied.

Pregnancy Risk Factor

C (prior to 30 weeks gestation)/D (≥30 weeks gestation)

Pregnancy Considerations

Birth defects have been observed following in utero NSAID exposure in some studies, however data is conflicting (Bloor 2013). Nonteratogenic effects, including prenatal constriction of the ductus arteriosus, persistent pulmonary hypertension of the newborn, oligohydramnios, necrotizing enterocolitis, renal dysfunction or failure, and intracranial hemorrhage have been observed in the fetus/neonate following in utero NSAID exposure. In addition, non-closure of the ductus arteriosus postnatally may occur and be resistant to medical management (Bermas 2014; Bloor 2013). Because NSAIDs may cause premature closure of the ductus arteriosus, product labeling for celecoxib specifically states use should be avoided starting at 30 weeks’ gestation.

Use of NSAIDs can be considered for the treatment of mild rheumatoid arthritis flares in pregnant women, however use should be minimized or avoided early and late in pregnancy (Bermas 2014; Saavedra Salinas 2015). Some guidelines recommend avoiding use of selective Cox-2 inhibitors completely during pregnancy due to limited data (Flint 2016).

The chronic use of NSAIDs in women of reproductive age may be associated with infertility that is reversible upon discontinuation of the medication. Consider discontinuing use in women having difficulty conceiving or those undergoing investigation of fertility. The use of NSAIDs close to conception may be associated with an increased risk of miscarriage (Bermas 2014; Bloor 2013).

Breast-Feeding Considerations

Celecoxib is present in breast milk.

The relative infant dose (RID) of celecoxib is 1.7% when calculated using the highest breast milk concentration located and compared to a weight-adjusted maternal dose of 200 mg/day.

In general, breastfeeding is considered acceptable when the RID of a medication is <10% (Anderson 2016; Ito 2000).

The RID of celecoxib was calculated using a milk concentration of 330 ng/mL, providing an estimated daily infant dose via breast milk of 0.05 mg/kg/day. This milk concentration was obtained following maternal administration of celecoxib 200 mg as a single oral dose to six postpartum women (Gardiner 2006). In one study, the half-life of celecoxib in breast milk was calculated to be 4 to 6.5 hours (Knoppert 2003). Peak concentrations occurred between 2 and 4 hours in breast milk (Gardner 2006; Hale 2004).

Adverse events were not observed in two breastfeeding infants, 17 and 22 months of age. In general, NSAIDs may be used in postpartum women who wish to breastfeed (Montgomery 2012); however, use should be avoided in women breastfeeding infants with platelet dysfunction or thrombocytopenia (Bloor 2013; Sammaritano 2014). Although other agents are preferred, celecoxib is considered acceptable for short-term use (Montgomery 2012). According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Lexicomp Pregnancy & Lactation, In-Depth
Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

≥2%:

Cardiovascular: Peripheral edema (2%)

Gastrointestinal: Diarrhea (6%), dyspepsia (9%), abdominal pain (4%), flatulence (2%), gastroesophageal reflux disease, vomiting

Hepatic: Increased liver enzymes (<3x ULN: ≤6%)

Renal: Nephrolithiasis (3%)

Respiratory: Upper respiratory tract infection (8%), sinusitis (5%), pharyngitis (2%), rhinitis (2%), dyspnea

Miscellaneous: Accidental injury (3%)

Frequency not defined:

Dermatologic: Acute generalized exanthematous pustulosis, exfoliative dermatitis

Gastrointestinal: Gastrointestinal perforation, gastrointestinaI ulcer, GI inflammation, intestinal perforation

Hypersensitivity: Anaphylaxis

Immunologic: DRESS syndrome

Respiratory: Local alveolar osteitis (post oral surgery patients)

<2%, postmarketing, and/or case reports: Acute renal failure, ageusia, agranulocytosis, albuminuria, alopecia, anaphylactoid reaction, anemia, angina pectoris, angioedema, anorexia, anosmia, anxiety, aplastic anemia, arthralgia, aseptic meningitis, ataxia, bronchitis, bronchospasm, bronchospasm (aggravated), cellulitis, cerebrovascular accident, chest pain, cholelithiasis, colitis (with bleeding), constipation, contact dermatitis, coronary artery disease, cough, cyst, cyst (NOS), cystitis, deafness, decreased hemoglobin, deep vein thrombosis, depression, dermatitis, diaphoresis, diverticulitis, drowsiness, dysphagia, dysuria, ecchymoses, edema, epistaxis, eructation, erythema multiforme, erythematous rash, esophageal perforation, esophagitis, exacerbation of hypertension, facial edema, fatigue, fever, flu-like symptoms, gangrene of skin or other tissue, gastritis, gastroenteritis, gastroesophageal reflux disease, gastrointestinal hemorrhage, hematuria, hemorrhoids, hepatic failure, hepatic necrosis, hepatitis, hiatal hernia, hot flash, hypercholesterolemia, hyperglycemia, hypersensitivity exacerbation, hypersensitivity reaction, hypertonia, hypoesthesia, hypoglycemia, hypokalemia, hyponatremia, increased appetite, increased blood urea nitrogen, increased creatine phosphokinase, increased nonprotein nitrogen, increased serum alkaline phosphatase, interstitial nephritis, intestinal obstruction, intracranial hemorrhage, jaundice, laryngitis, leg cramps, leukopenia, maculopapular rash, melena, migraine, myalgia, myocardial infarction, nervousness, osteoarthritis, pain, palpitations, pancreatitis, pancytopenia, paresthesia, peripheral pain, pneumonia, pruritus, pulmonary embolism, skin changes, skin photosensitivity, Stevens-Johnson syndrome, stomatitis, syncope, synovitis, tachycardia, tendonitis, tenesmus, thrombocythemia, thrombocytopenia, thrombophlebitis, tinnitus, toxic epidermal necrolysis, urinary frequency, urticaria, vasculitis, ventricular fibrillation, vertigo, weight gain, xeroderma, xerostomia

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

Substrate of CYP2C9 (major), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits CYP2D6 (weak)

Drug Interactions 

5-Aminosalicylic Acid Derivatives: Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of 5-Aminosalicylic Acid Derivatives. Risk C: Monitor therapy

Acemetacin: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Ajmaline: Sulfonamides may enhance the adverse/toxic effect of Ajmaline. Specifically, the risk for cholestasis may be increased. Risk C: Monitor therapy

Alcohol (Ethyl): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the risk of GI bleeding may be increased with this combination. Risk C: Monitor therapy

Aliskiren: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Aliskiren. Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of Aliskiren. Management: Monitor renal function periodically in patients receiving aliskiren and any nonsteroidal anti-inflammatory agent. Patients at elevated risk of renal dysfunction include those who are elderly, are volume depleted, or have pre-existing renal dysfunction. Risk C: Monitor therapy

Aminoglycosides: Nonsteroidal Anti-Inflammatory Agents may decrease the excretion of Aminoglycosides. Data only in premature infants. Risk C: Monitor therapy

Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination

Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy

Angiotensin II Receptor Blockers: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the combination may result in a significant decrease in renal function. Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Angiotensin II Receptor Blockers. The combination of these two agents may also significantly decrease glomerular filtration and renal function. Risk C: Monitor therapy

Angiotensin-Converting Enzyme Inhibitors: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the combination may result in a significant decrease in renal function. Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Angiotensin-Converting Enzyme Inhibitors. Risk C: Monitor therapy

Anticoagulants: Nonsteroidal Anti-Inflammatory Agents may enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

ARIPiprazole: CYP2D6 Inhibitors (Weak) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy and/or indication. Consult full interaction monograph for specific recommendations. Risk C: Monitor therapy

Aspirin: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective). Management: Concurrent use of aspirin at doses beyond cardioprotective levels is not recommended. While concurrent use of low-dose aspirin with a COX-2 inhibitor is permissable, patients should be monitored closely for signs/symptoms of GI ulceration/bleeding. Risk D: Consider therapy modification

Beta-Blockers: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Beta-Blockers. Exceptions: Levobunolol; Metipranolol. Risk C: Monitor therapy

Bile Acid Sequestrants: May decrease the absorption of Nonsteroidal Anti-Inflammatory Agents. Risk D: Consider therapy modification

Bisphosphonate Derivatives: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Bisphosphonate Derivatives. Both an increased risk of gastrointestinal ulceration and an increased risk of nephrotoxicity are of concern. Risk C: Monitor therapy

Corticosteroids (Systemic): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective). Risk C: Monitor therapy

CycloSPORINE (Systemic): Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of CycloSPORINE (Systemic). CycloSPORINE (Systemic) may increase the serum concentration of Nonsteroidal Anti-Inflammatory Agents. Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of CycloSPORINE (Systemic). Management: Consider alternatives to nonsteroidal anti-inflammatory agents (NSAIDs). Monitor for evidence of nephrotoxicity, as well as increased serum cyclosporine concentrations and systemic effects (eg, hypertension) during concomitant therapy with NSAIDs. Risk D: Consider therapy modification

CYP2C9 Inducers (Moderate): May decrease the serum concentration of CYP2C9 Substrates (High risk with Inducers). Risk C: Monitor therapy

CYP2C9 Inhibitors (Moderate): May decrease the metabolism of CYP2C9 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Dabrafenib: May decrease the serum concentration of CYP2C9 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP2C9 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Risk D: Consider therapy modification

Dapsone (Topical): May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Risk C: Monitor therapy

Deferasirox: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Risk C: Monitor therapy

Desmopressin: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Desmopressin. Risk C: Monitor therapy

Dexibuprofen: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Dexibuprofen. Risk X: Avoid combination

Dexketoprofen: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Digoxin: Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Digoxin. Risk C: Monitor therapy

Drospirenone: Nonsteroidal Anti-Inflammatory Agents may enhance the hyperkalemic effect of Drospirenone. Risk C: Monitor therapy

Enzalutamide: May decrease the serum concentration of CYP2C9 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP2C9 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP2C9 substrate should be performed with caution and close monitoring. Risk D: Consider therapy modification

Eplerenone: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Eplerenone. Nonsteroidal Anti-Inflammatory Agents may enhance the hyperkalemic effect of Eplerenone. Risk C: Monitor therapy

Estrogen Derivatives: Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective) may enhance the thrombogenic effect of Estrogen Derivatives. Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective) may increase the serum concentration of Estrogen Derivatives. Risk C: Monitor therapy

Felbinac: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk C: Monitor therapy

Floctafenine: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Haloperidol: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Haloperidol. Specifically including drowsiness and confusion. Risk C: Monitor therapy

Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Bleeding may occur. Management: Concomitant treatment with these agents should generally be avoided. If used concomitantly, increased diligence in monitoring for adverse effects (eg, bleeding, bruising, altered mental status due to CNS bleeds) must be employed. Risk D: Consider therapy modification

HydrALAZINE: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of HydrALAZINE. Risk C: Monitor therapy

Ketorolac (Nasal): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Ketorolac (Systemic): May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Lithium: Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Lithium. Risk D: Consider therapy modification

Local Anesthetics: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased.Risk C: Monitor therapy

Loop Diuretics: Nonsteroidal Anti-Inflammatory Agents may diminish the diuretic effect of Loop Diuretics. Loop Diuretics may enhance the nephrotoxic effect of Nonsteroidal Anti-Inflammatory Agents. Management: Monitor for evidence of kidney injury or decreased therapeutic effects of loop diuretics with concurrent use of an NSAID. Consider avoiding concurrent use in CHF or cirrhosis. Concomitant use of bumetanide with indomethacin is not recommended. Risk D: Consider therapy modification

Lumacaftor: May decrease the serum concentration of CYP2C9 Substrates (High Risk with Inhibitors or Inducers). Lumacaftor may increase the serum concentration of CYP2C9 Substrates (High Risk with Inhibitors or Inducers). Risk C: Monitor therapy

Macimorelin: Nonsteroidal Anti-Inflammatory Agents may diminish the diagnostic effect of Macimorelin. Risk X: Avoid combination

Mecamylamine: Sulfonamides may enhance the adverse/toxic effect of Mecamylamine. Risk X: Avoid combination

Methotrexate: Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Methotrexate. Management: Alternative anti-inflammatory therapy should be considered whenever possible, especially if the patient is receiving higher, antineoplastic doses of methotrexate. Risk D: Consider therapy modification

Mifamurtide: Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Mifamurtide. Risk X: Avoid combination

MiFEPRIStone: May increase the serum concentration of CYP2C9 Substrates (High risk with Inhibitors). Management: Use CYP2C9 substrates at the lowest recommended dose, and monitor closely for adverse effects, during and in the 2 weeks following mifepristone treatment. Risk D: Consider therapy modification

Morniflumate: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Naftazone: May enhance the antiplatelet effect of Nonsteroidal Anti-Inflammatory Agents. Risk C: Monitor therapy

Nitric Oxide: May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when nitric oxide is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine. Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective). Risk X: Avoid combination

Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective): Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective). Risk X: Avoid combination

Omacetaxine: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Omacetaxine. Specifically, the risk for bleeding-related events may be increased. Management: Avoid concurrent use of nonsteroidal antiinflammatory drugs (NSAIDs) with omacetaxine in patients with a platelet count of less than 50,000/uL. Risk X: Avoid combination

Pelubiprofen: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Perhexiline: CYP2D6 Inhibitors (Weak) may increase the serum concentration of Perhexiline. Risk C: Monitor therapy

Phenylbutazone: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy

Potassium-Sparing Diuretics: Nonsteroidal Anti-Inflammatory Agents may diminish the antihypertensive effect of Potassium-Sparing Diuretics. Nonsteroidal Anti-Inflammatory Agents may enhance the hyperkalemic effect of Potassium-Sparing Diuretics. Risk C: Monitor therapy

PRALAtrexate: Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of PRALAtrexate. More specifically, NSAIDS may decrease the renal excretion of pralatrexate. Management: Closely monitor for increased pralatrexate serum levels and/or toxicity if used concomitantly with an NSAID. Monitor for decreased pralatrexate serum levels with NSAID discontinuation. Risk C: Monitor therapy

Prilocaine: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine in infants receiving such agents. Risk C: Monitor therapy

Probenecid: May increase the serum concentration of Nonsteroidal Anti-Inflammatory Agents. Risk C: Monitor therapy

Prostaglandins (Ophthalmic): Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents may also enhance the therapeutic effects of Prostaglandins (Ophthalmic). Risk C: Monitor therapy

Quinolones: Nonsteroidal Anti-Inflammatory Agents may enhance the neuroexcitatory and/or seizure-potentiating effect of Quinolones. Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Quinolones. Risk C: Monitor therapy

Rifapentine: May decrease the serum concentration of CYP2C9 Substrates (High risk with Inducers). Risk C: Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the antiplatelet effect of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective). Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective) may diminish the therapeutic effect of Selective Serotonin Reuptake Inhibitors. Risk C: Monitor therapy

Sincalide: Drugs that Affect Gallbladder Function may diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Risk D: Consider therapy modification

Sodium Nitrite: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy

Sodium Phosphates: May enhance the nephrotoxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the risk of acute phosphate nephropathy may be enhanced. Management: Consider avoiding this combination by temporarily suspending treatment with NSAIDs, or seeking alternatives to oral sodium phosphate bowel preparation. If the combination cannot be avoided, maintain adequate hydration and monitor renal function closely. Risk D: Consider therapy modification

Tacrolimus (Systemic): Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of Tacrolimus (Systemic). Risk C: Monitor therapy

Talniflumate: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Tenofovir Products: Nonsteroidal Anti-Inflammatory Agents may enhance the nephrotoxic effect of Tenofovir Products. Management: Seek alternatives to these combinations whenever possible. Avoid use of tenofovir with multiple NSAIDs or any NSAID given at a high dose. Risk D: Consider therapy modification

Tenoxicam: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Thiazide and Thiazide-Like Diuretics: May enhance the nephrotoxic effect of Nonsteroidal Anti-Inflammatory Agents. Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Tolperisone: Nonsteroidal Anti-Inflammatory Agents may enhance the adverse/toxic effect of Tolperisone. Specifically, the risk of hypersensitivity reactions may be increased. Tolperisone may enhance the therapeutic effect of Nonsteroidal Anti-Inflammatory Agents. Risk C: Monitor therapy

Tricyclic Antidepressants (Tertiary Amine): May enhance the antiplatelet effect of Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective). Risk C: Monitor therapy

Triflusal: Nonsteroidal Anti-Inflammatory Agents may decrease the protein binding of Triflusal. Specifically, NSAIDs may decrease protein binding of the active Triflusal metabolite. Triflusal may decrease the protein binding of Nonsteroidal Anti-Inflammatory Agents. Risk C: Monitor therapy

Vancomycin: Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Vancomycin. Risk C: Monitor therapy

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy

Vitamin K Antagonists (eg, warfarin): Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective) may enhance the anticoagulant effect of Vitamin K Antagonists. Nonsteroidal Anti-Inflammatory Agents (COX-2 Selective) may increase the serum concentration of Vitamin K Antagonists. Risk C: Monitor therapy

Zaltoprofen: May enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Risk X: Avoid combination

Food Interactions

Peak concentrations are delayed and AUC is increased by 10% to 20% when taken with a high-fat meal. Management: Administer without regard to meals.

Monitoring Parameters

CBC; hemoglobin/hematocrit (anemic patients); basic metabolic panel; occult blood loss and periodic liver function tests; monitor renal function (urine output, serum BUN and creatinine); monitor response (pain, range of motion, grip strength, mobility, ADL function), inflammation; blood pressure (baseline and during treatment); observe for weight gain, edema; observe for bleeding, bruising; evaluate gastrointestinal effects (abdominal pain, bleeding, dyspepsia)

JIA: Monitor for development of abnormal coagulation tests with systemic onset JIA

Advanced Practitioners Physical Assessment/Monitoring

Evaluate cardiac risk and potential for GI bleeding (older adults and those with history of) prior to prescribing this medication. Assess allergy history (aspirin, NSAIDs, salicylates). Monitor blood pressure at the beginning of therapy and periodically during use in patients with underlying hypertension. Use lowest possible dose and shortest duration for treatment. In moderate hepatic impairment dosage should be reduced.

Nursing Physical Assessment/Monitoring

Assess allergy history (aspirin, NSAIDs, salicylates). Monitor blood pressure in those with underlying hypertension; symptoms of GI irritation. Monitor effectiveness of therapy (pain, range of motion, mobility, ADL function, inflammation). Educate patients about calling healthcare provider for significant GI symptoms.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

CeleBREX: 50 mg, 100 mg, 200 mg, 400 mg

Generic: 50 mg, 100 mg, 200 mg, 400 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

CeleBREX: 100 mg, 200 mg

Generic: 100 mg, 200 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • L01XX33
  • M01AH01
Generic Available (US)

Yes

Pricing: US

Capsules (CeleBREX Oral)

50 mg (per each): $4.33

100 mg (per each): $9.26

200 mg (per each): $15.19

400 mg (per each): $22.79

Capsules (Celecoxib Oral)

50 mg (per each): $0.33 – $2.16

100 mg (per each): $0.38 – $4.62

200 mg (per each): $0.63 – $7.58

400 mg (per each): $1.46 – $11.37

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

 Inhibits prostaglandin synthesis by decreasing the activity of the enzyme, cyclooxygenase-2 (COX-2), which results in decreased formation of prostaglandin precursors; has antipyretic, analgesic, and anti-inflammatory properties. Celecoxib does not inhibit cyclooxygenase-1 (COX-1) at therapeutic concentrations.

Pharmacodynamics/Kinetics

Absorption: Prolonged due to low solubility

Distribution: Vd (apparent): Children and Adolescents ~7-16 years (steady-state): 8.3 ± 5.8 L/kg (Stempak 2002); Adults: ~400 L

Protein binding: ~97% primarily to albumin; binds to alpha1-acid glycoprotein to a lesser extent

Metabolism: Hepatic via CYP2C9; forms inactive metabolites (a primary alcohol, corresponding carboxylic acid, and its glucuronide conjugate)

Bioavailability: Absolute: Unknown

Half-life elimination: Children and Adolescents ~7-16 years (steady-state): 6 ± 2.7 hours (range: 3-10 hours) (Stempak 2002); Adults: ~11 hours (fasted)

Time to peak: Children: Median: 3 hours (range: 1-5.8 hours) (Stempak 2002); Adults: ~3 hours

Excretion: Feces (~57% as metabolites, <3% as unchanged drug); urine (27% as metabolites, <3% as unchanged drug); primary metabolites in feces and urine: Carboxylic acid metabolite (73% of dose); low amounts of glucuronide metabolite appear in urine

Pharmacodynamics/Kinetics: Additional Considerations

Renal function impairment: AUC is approximately 40% lower in patients with a CrCl of 35 to 60 mL/minute.

Hepatic function impairment: AUC is increased approximately 40% in patients with mild impairment and 180% in patients with moderate impairment.

Pediatric: The AUC and Cmax following administration of a capsule contents sprinkled on applesauce were reported to be similar as administration of an intact capsule (Krishnaswami 2012).

Geriatric: Cmax is 40% higher and AUC is 50% higher.

Race: AUC is approximately 40% higher in black compared with white patients.

Dental Use

Management of acute dental pain

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Dental Health Professional Considerations

The product labeling for all prescription nonsteroidal anti-inflammatory agents (NSAIDs) now include boxed warnings regarding an increased risk of cardiovascular (CV) events and gastrointestinal (GI) bleeding associated with their use and a contraindication for use in patients who have recently undergone coronary artery bypass graft (CABG) surgery. Medication guides are also now required for these products. Manufacturers of over-the-counter products are to include warnings about potential skin reactions, which are already included in prescription labeling.

The FDA encourages physicians to consider this information in risk-to-benefit evaluations while considering the use of the COX-2 selective celecoxib (CeleBREX®) in patients. Similar COX-2 selective drugs, including rofecoxib (Vioxx®) and valdecoxib (Bextra®), were pulled from the market due to increased risks of adverse CV events associated with their use. In addition, the FDA advises an evaluation of alternative therapy. If physicians determine that continued use is appropriate for individual patients, the lowest effective dose of celecoxib should be prescribed.

The association between selective COX-2 inhibitors and increased cardiovascular risk has been noted previously and prompted by publication of a meta-analysis entitled “Risk of Cardiovascular Events Associated With Selective COX-2 Inhibitors” in the August 22, 2001, edition of the Journal of the American Medical Association (JAMA). The researchers re-evaluated four previously published trials, assessing cardiovascular events in patients receiving either celecoxib or rofecoxib. They found an association between the use of COX-2 inhibitors and cardiovascular events (including MI and ischemic stroke). The annualized MI rate was found to be significantly higher in patients receiving celecoxib or rofecoxib than in the control (placebo) group from a recent meta-analysis of primary prevention trials. Although cause and effect cannot be established (these trials were originally designed to assess GI effects, not cardiovascular ones), the authors believe the available data raise a cautionary flag concerning the risk of cardiovascular events with the use of COX-2 inhibitors.

Cross-reactivity, including bronchospasm, is a concern with aspirin and other NSAIDs, in aspirin-sensitive patients. The manufacturer suggests that celecoxib should not be administered to patients with this type of aspirin sensitivity and should be used with caution in patients with preexisting asthma.

The manufacturer studied the effect of celecoxib on the anticoagulant effect of warfarin and found no alteration of anticoagulant effect, as determined by prothrombin time, in patients taking 2-5 mg daily. However, the manufacturer has issued a caution when using celecoxib with warfarin since those patients are at increased risk of bleeding complications.

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Stomatitis, abnormal taste, and xerostomia (normal salivary flow resumes upon discontinuation).

Effects on Bleeding

No effects on bleeding or platelet function have been reported. See Dental Health Professional Considerations.

Dental Usual Dosing

Acute dental pain: Adults: Oral: 400 mg, followed by an additional 200 mg if needed on day 1; maintenance dose: 200 mg twice daily as needed

FDA Approval Date
December 31, 1998
References

Anderson PO, Sauberan JB. Modeling drug passage into human milk. Clin Pharmacol Ther. 2016;100(1):42-52.[PubMed 27060684]

Becker MA. Treatment of gout flares. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed November 8, 2018.

Bermas BL. Non-steroidal anti inflammatory drugs, glucocorticoids and disease modifying anti-rheumatic drugs for the management of rheumatoid arthritis before and during pregnancy. Curr Opin Rheumatol. 2014;26(3):334-340.[PubMed 24663106]

Bhatt DL, Scheiman J, Abraham NS, et al, “ACCF/ACG/AHA 2008 Expert Consensus Document on Reducing the Gastrointestinal Risk of Antiplatelet Therapy and NSAID Use. A Report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents,” J Am Coll Cardiol, 2008, 52(18):1502-17.[PubMed 19017521]

Bloor M, Paech M. Nonsteroidal anti-inflammatory drugs during pregnancy and the initiation of lactation. Anesth Analg. 2013;116(5):1063-1075.[PubMed 23558845]

Brackett CC, Singh H, Block JH. Likelihood and mechanisms of cross-allergenicity between sulfonamide antibiotics and other drugs containing a sulfonamide functional group. Pharmacotherapy. 2004;24(7):856-870.[PubMed 15303450]

Celebrex (celecoxib) [prescribing information]. New York, NY: Pfizer Inc; June 2018.

Celebrex (celecoxib) [product monograph]. Kirkland, Quebec, Canada: Pfizer Canada Inc; July 2016.

Chan CW, Yap YN. Pharmacotherapeutic management of gout in patients with cardiac disease [published online October 20, 2018]. Expert Opin Pharmacother. doi: 10.1080/14656566.2018.1536747.[PubMed 30345832]

Davies NM, McLachlan AJ, Day RO, et al. Clinical pharmacokinetics and pharmacodynamics of celecoxib: a selective cyclo-oxygenase-2 inhibitor. Clin Pharmacokinet. 2000;38(3):225-242.[PubMed 10749518]

Doyle G, Jayawardena S, Ashraf E, et al, “Efficacy and Tolerability of Nonprescription Ibuprofen Versus Celecoxib for Dental Pain,” J Clin Pharmacol, 2002, 42(8):912-9.[PubMed 12162474 ]

Flint J, Panchal S, Hurrell A, et al. BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding-Part II: analgesics and other drugs used in rheumatology practice. Rheumatology (Oxford). 2016;55(9):1698-1702.[PubMed 26750125]

Gardiner SJ, Doogue MP, Zhang M, et al, “Quantification of Infant Exposure to Celecoxib Through Breast Milk,” Br J Clin Pharmacol, 2006, 61(1):101-4.[PubMed 16390357]

Geis GS, et al, “Efficacy and Safety of Celecoxib, A Specific COX-2 Inhibitor, in Patients With Rheumatoid Arthritis,” Arthritis Rheum, 1998, 41(9 Suppl):316:1699.

Hale TW, McDonald R, and Boger J, “Transfer of Celecoxib Into Human Milk,” J Hum Lact, 2004, 20(4):397-403.[PubMed 15479658]

Hochberg MC, Altman RD, April KT, et al, “American College of Rheumatology 2012 Recommendations for the Use of Nonpharmacologic and Pharmacologic Therapies in Osteoarthritis of the Hand, Hip, and Knee,” Arthritis Care Res (Hoboken), 2012, 64(4):465-74.[PubMed 22563589]

Ito S. Drug therapy for breast-feeding women. N Engl J Med. 2000;343(2):118-126.[PubMed 10891521]

Johnson KK, Green DL, Rife JP, Limon L. Sulfonamide cross-reactivity: fact or fiction? [published correction appears in Ann Pharmacother. 2005;39(7-8):1373]. Ann Pharmacother. 2005;39(2):290-301.[PubMed 15644481]

Karim A, et al, “Celecoxib, a Specific COX-2 Inhibitor, Lacks Significant Drug-Drug Interactions With Methotrexate or Warfarin,” Arthritis Rheum, 1998, 41(9 Suppl):315:1698.[PubMed 9485090]

Khanna D, Khanna PP, Fitzgerald JD, et al; American College of Rheumatology. 2012 American College of Rheumatology guidelines for management of gout. Part 2: therapy and antiinflammatory prophylaxis of acute gouty arthritis. Arthritis Care Res (Hoboken). 2012;64(10):1447-1461. doi: 10.1002/acr.21773.[PubMed 23024029]

Knoppert DC, Stempak D, Baruchel S, et al, “Celecoxib in Human Milk: A Case Report,” Pharmacotherapy, 2003, 23(1):97-100.[PubMed 12523466]

Krishnaswami S, Hutmacher MM, Robbins JL, et al. Dosing celecoxib in pediatric patients with juvenile rheumatoid arthritis. J Clin Pharmacol. 2012;52(8):1134-1149. doi: 10.1177/0091270011412184.[PubMed 21878579]

Lane NE, “Pain Management in Osteoarthritis: The Role of COX-2 Inhibitors,” J Rheumatol, 1997, 24(Suppl 49):20-4.[PubMed 9002006]

Lipsky PE and Isakson PC, “Outcome of Specific COX-2 Inhibition in Rheumatoid Arthritis,” J Rheumatol, 1997, 24(Suppl 49):9-14.[PubMed 9002004]

Mengle-Gaw L, et al, “A Study of the Platelet Effects of SC-58635, A Novel COX-2 Selective Inhibitor,” Arthritis Rheum, 1998, 41(9 Suppl):93-374.

Montgomery A, Hale TW; Academy Of Breastfeeding Medicine. ABM clinical protocol #15: analgesia and anesthesia for the breastfeeding mother, revised 2012. Breastfeed Med. 2012;7(6):547-553.[PubMed 23215911]

Moore PA and Hersh EV, “Celecoxib and Rofecoxib. The Role of COX-2 Inhibitors in Dental Practice,” J Am Dent Assoc, 2001, 132(4):451-6.[PubMed 11315375 ]

Morales DR, Lipworth BJ, Guthrie B, Jackson C, Donnan PT, Santiago VH. Safety risks for patients with aspirin-exacerbated respiratory disease after acute exposure to selective nonsteroidal anti-inflammatory drugs and COX-2 inhibitors: Meta-analysis of controlled clinical trials [published online ahead of print December 30, 2013]. J Allergy Clin Immunol.[PubMed 24388008]

Needleman P and Isakson PC, “The Discovery and Function of COX-2,” J Rheumatol, 1997, 24(Suppl 49):6-8.[PubMed 9002003]

Nussmeier NA, Whelton AA, Brown MT, et al, “Complications of the COX-2 Inhibitors Parecoxib and Valdecoxib After Cardiac Surgery,” N Engl J Med, 2005, 352(11):1081-91.[PubMed 15713945]

Saavedra Salinas MÁ, Barrera Cruz A, Cabral Castañeda AR, et al. Clinical practice guidelines for the management of pregnancy in women with autoimmune rheumatic diseases of the Mexican College of Rheumatology. Part II. Reumatol Clin. 2015;11(5):305-315.[PubMed 25683368]

Sammaritano LR, Bermas BL. Rheumatoid arthritis medications and lactation. Curr Opin Rheumatol. 2014;26(3):354-360.[PubMed 24614280]

Schmidt M, Lamberts M, Olsen AM, et al. Cardiovascular safety of non-aspirin non-steroidal anti-inflammatory drugs: review and position paper by the working group for Cardiovascular Pharmacotherapy of the European Society of Cardiology. Eur Heart J. 2016;37(13):1015-1023. doi: 10.1093/eurheartj/ehv505.[PubMed 26984863]

Schumacher HR, Berger MF, Li-Yu J, Perez-Ruiz F, Burgos-Vargas R, Li C. Efficacy and tolerability of celecoxib in the treatment of acute gouty arthritis: a randomized controlled trial. J Rheumatol. 2012;39(9):1859-1866. doi: 10.3899/jrheum.110916.[PubMed 22859357]

Simon LS, et al, “Preliminary Study of the Safety and Efficacy of SC-58635, a Novel Cyclo-oxygenase 2 Inhibitor: Efficacy and Safety in Two Placebo-Controlled Trials in Osteoarthritis and Rheumatoid Arthritis, and Studies of Gastrointestinal and Platelet Effects,” Arthritis Rheum, 1998, 41:1591-602.[PubMed 9751091]

Sivera F, Andres M, Carmona L, et al. Multinational evidence-based recommendations for the diagnosis and management of gout: integrating systematic literature review and expert opinion of a broad panel of rheumatologists in the 3e initiative. Ann Rheum Dis. 2014;73(2):328-335.[PubMed 23868909]

Slatore CG, Tilles SA. Sulfonamide hypersensitivity. Immunol Allergy Clin North Am. 2004;24(3):477-490.[PubMed 15242722]

Solomon SD, McMurray JJ, Pfeffer MA, et al, “Cardiovascular Risk Associated With Celecoxib in a Clinical Trial for Colorectal Adenoma Prevention,” N Engl J Med, 2005, 352(11):1071-80.[PubMed 15713944]

Stempak D, Gammon J, Klein J, et al, “Single-Dose and Steady-State Pharmacokinetics of Celecoxib in Children,” Clin Pharmacol Ther, 2002, 72(5):490-7.[PubMed 12426512]

Tornero P, De Barrio M, Baeza ML, Herrero T. Cross-reactivity among p-amino group compounds in sulfonamide fixed drug eruption: diagnostic value of patch testing. Contact Dermatitis. 2004;51(2):57-62.[PubMed 15373844]

Yancy CW, Jessup M, Bozkurt B, et al; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013;128(16):e240-e327.[PubMed 23741058]

Zhang W, Doherty M, Bardin T, et al; EULAR Standing Committee for International Clinical Studies Including Therapeutics. EULAR evidence based recommendations for gout. Part II: Management. Report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis. 2006;65(10):1312-1324.[PubMed 16707532]

Brand Names: International

Acicox (BD); Aclexa (CZ, EE, HR, MT); Algoxib (BG); Artilog (ES); Artose (VN); Arythrex (EG); Aubrex (PH); Brexen (PH); Caditar (PE); Cecox (LK); Celbexx (PK); Celbric (KR); Celcox (IL, KR); Celcoxx (PH, VN); Cele V (KR); Celebex (KR); Celebone (KR); Celebra (BR, CL, CR, DK, DO, FI, GT, HN, IS, NI, NO, PA, SE, SV, UY); Celebrex (AE, AR, AT, AU, BB, BD, BE, BF, BG, BH, BJ, CH, CI, CN, CO, CY, CZ, DE, DK, EE, EG, ES, FR, GB, GH, GM, GN, GR, HK, HR, ID, IE, IQ, IR, IT, JO, JP, KE, KR, KW, LB, LR, LT, LU, LV, LY, MA, ML, MR, MT, MU, MW, MX, MY, NE, NG, NL, NO, NZ, OM, PE, PH, PK, PL, PT, QA, RO, RU, SA, SC, SD, SG, SK, SL, SN, SY, TH, TN, TR, TW, TZ, UA, UG, VE, YE, ZM, ZW); Celecox (AE, BH, CY, IQ, IR, JO, JP, KR, KW, LY, OM, QA, SA, SY, YE); Celecsil (KR); Celenta (BD); Celexib (PH); Celexil (AU); Celib (IN, ZW); Celofen (ZW); Celoxib (EG); Celxib (TH); Celzib (LK); Cerebrex (KR); Colcibid (LK); Colcibra (LK, ZW); Cox-2 (PH); Coxib (BD); Coxileb (VN); Coxoral (PH); Coxzan (PH); Eliflam (PY); Eurocox (EG); Ezy (BD); Favocox (HK); Flamar (PH); Flamex (JO); Flaxel (PE); Flogoxib (UA); Geocoxib (PH); Icox (PH); Keltrex (HK); Letabex (CZ); Lexfin (CO); Mecelxib (VN); Mibecerex (VN); Miodar (CO); Nacoxib (PH); Normocoxib (LB); Onsenal (AT, DE, DK, FR, TR); Painex (TH); Rancelex (TH); Ranselex (UA); Relexa (SK); Revcox (LB); Roxib (CR, DO, GT, HN, NI, PA, SV); Selexa (PT); Stadloric (VN); Stadloric 200 (HK); Swelcid (PH); Unicelib (ZW); Valdyne (CR, DO, GT, HN, NI, PA, SV); Zecroxil (PH); Zobrex (TH); Zycel (IN)

Celecoxib (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(se le KOKS ib)

Brand Names: US

CeleBREX

Brand Names: Canada

Celebrex

Warning
  • This drug may raise the chance of heart and blood vessel side effects like heart attack and stroke. If these happen, they can be deadly. The risk of these side effects may be greater if you have heart disease or risks for heart disease. However, the risk may also be raised in people who do not have heart disease or risks for heart disease. The risk of these health problems can happen as soon as the first weeks of using this drug and may be greater with higher doses or with long-term use. Do not use this drug right before or after bypass heart surgery.
  • This drug may raise the chance of very bad and sometimes deadly stomach or bowel side effects like ulcers or bleeding. The risk is greater in older people. The risk is also greater in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs. Talk with the doctor.
What is this drug used for?
  • It is used to ease pain and swelling.
  • It is used to treat arthritis.
  • It is used to ease painful period (menstrual) cycles.
  • It is used to treat ankylosing spondylitis.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to celecoxib or any other part of this drug.
  • If you have an allergy to aspirin or NSAIDs.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have gotten nasal polyps or had swelling of the mouth, face, lips, tongue, or throat; unusual hoarseness; or trouble breathing with aspirin or NSAID use.
  • If you have a sulfa (sulfonamide) allergy, talk with your doctor.
  • If you have any of these health problems: Kidney disease or liver disease.
  • If you have GI (gastrointestinal) bleeding.
  • If you are having trouble getting pregnant or you are having your fertility checked.
  • If you are pregnant or may be pregnant. Do not take this drug if you are in the third trimester of pregnancy. You may also need to avoid this drug at other times during pregnancy. Talk with your doctor to see when you need to avoid taking this drug during pregnancy.
  • If you are taking any other NSAID.
  • If you are taking a salicylate drug like aspirin.
  • If you are taking pemetrexed.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Have your blood work checked if you are on this drug for a long time. Talk with your doctor.
  • High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
  • Talk with your doctor before you drink alcohol.
  • If you smoke, talk with your doctor.
  • If you have asthma, talk with your doctor. You may be more sensitive to this drug.
  • Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
  • Do not take this drug for longer than you were told by your doctor.
  • You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
  • The chance of heart failure is raised with the use of drugs like this one. In people who already have heart failure, the chance of heart attack, having to go to the hospital for heart failure, and death is raised. Talk with the doctor.
  • The chance of heart attack and heart-related death is raised in people taking drugs like this one after a recent heart attack. People taking drugs like this one after a first heart attack were also more likely to die in the year after the heart attack compared with people not taking drugs like this one. Talk with the doctor.
  • If you are taking aspirin to help prevent a heart attack, talk with your doctor.
  • This drug may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this drug with your other drugs.
  • Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • Use with care in children. Talk with the doctor.
  • NSAIDs like this drug may affect egg release (ovulation) in women. This may cause you to not be able to get pregnant. This goes back to normal when this drug is stopped. Talk with your doctor.
  • This drug may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this drug, call your doctor right away.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Chest pain or pressure.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Feeling very tired or weak.
  • Hearing loss.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Headache.
  • Belly pain or heartburn.
  • Upset stomach or throwing up.
  • Constipation.
  • Diarrhea.
  • Gas.
  • Dizziness.
  • Nose and throat irritation.
  • Cough.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • Take with or without food. Take with food if it causes an upset stomach.
  • Take with a full glass of water.
  • You may sprinkle contents of capsule on applesauce. Do not chew.
  • If mixing on applesauce, the applesauce should not be warm. Do not sprinkle on other liquids or foods.
  • Use right away after mixing or you may store in a refrigerator for up to 6 hours.
What do I do if I miss a dose?
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Celecoxib (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(se le KOKS ib)

Brand Names: US

CeleBREX

Brand Names: Canada

Celebrex

Warning
  • This drug may raise the chance of heart and blood vessel side effects like heart attack and stroke. If these happen, they can be deadly. The risk of these side effects may be greater if your child has heart disease or risks for heart disease. However, the risk may also be raised in people who do not have heart disease or risks for heart disease. The risk of these health problems can happen as soon as the first weeks of using this drug and may be greater with higher doses or with long-term use. Do not give this drug to your child right before or after bypass heart surgery.
  • This drug may raise the chance of very bad and sometimes deadly stomach or bowel side effects like ulcers or bleeding. The risk is greater in older people. The risk is also greater in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs. Talk with the doctor.
What is this drug used for?
  • It is used to treat juvenile arthritis.
  • It may be given to your child for other reasons. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child has an allergy to aspirin or NSAIDs.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has gotten nasal polyps or had swelling of the mouth, face, lips, tongue, or throat; unusual hoarseness; or trouble breathing with aspirin or NSAID use.
  • If your child has a sulfa (sulfonamide) allergy, talk with the doctor.
  • If your child has any of these health problems: Kidney disease or liver disease.
  • If your child has GI (gastrointestinal) bleeding.
  • If your child is having her fertility checked.
  • If your child is taking any other NSAID.
  • If your child is taking a salicylate drug like aspirin.
  • If your child is taking pemetrexed.
  • If your child is pregnant:
  • Do not give this drug to your child if she is in the third trimester of pregnancy. You may also need to avoid giving this drug to your child at other times during pregnancy. Talk with your child’s doctor to see when you need to avoid giving this drug to your child during pregnancy.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • High blood pressure has happened with drugs like this one. Have your child’s blood pressure checked as you have been told by the doctor.
  • Have your child’s blood work checked if he/she is on this drug for a long time. Talk with your child’s doctor.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • If your child smokes, talk with the doctor.
  • If your child has asthma, talk with the doctor. He/she may be more sensitive to this drug.
  • Do not give your child more of this drug than what the doctor told you to give. Giving more of this drug than you are told may raise the chance of very bad side effects.
  • Do not have your child use longer than you have been told by your child’s doctor.
  • Your child may bleed more easily. Make sure your child is careful and avoids injury. Be sure your child has a soft toothbrush.
  • The chance of heart failure is raised with the use of drugs like this one. In people who already have heart failure, the chance of heart attack, having to go to the hospital for heart failure, and death is raised. Talk with the doctor.
  • The chance of heart attack and heart-related death is raised in people taking drugs like this one after a recent heart attack. People taking drugs like this one after a first heart attack were also more likely to die in the year after the heart attack compared with people not taking drugs like this one. Talk with the doctor.
  • If your child is taking aspirin to help prevent a heart attack, talk with the doctor.
  • This drug may affect how much of some other drugs are in the body. If your child is taking other drugs, talk with the doctor. Your child may need to have blood work checked more closely while taking this drug with other drugs.
  • Use with care in children. Talk with the doctor.
  • If your child is or may be sexually active:
  • NSAIDs like this drug may affect egg release (ovulation) in females. This may affect being able to get pregnant. This goes back to normal when this drug is stopped. Talk with the doctor.
  • If your child is pregnant or breast-feeding a baby:
  • This drug may cause harm to the unborn baby if your child takes it during pregnancy. If your child is pregnant or gets pregnant while taking this drug, call the doctor right away.
  • Tell the doctor if your child is breast-feeding a baby. You will need to talk about any risks to the baby.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Chest pain or pressure.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Feeling very tired or weak.
  • Hearing loss.
  • Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call the doctor right away if your child has signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Headache.
  • Belly pain or heartburn.
  • Upset stomach or throwing up.
  • Constipation.
  • Diarrhea.
  • Gas.
  • Dizziness.
  • Nose and throat irritation.
  • Cough.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • Give this drug with or without food. Give with food if it causes an upset stomach.
  • Give this drug with a full glass of water.
  • You may sprinkle contents of capsule on applesauce. Have your child swallow without chewing.
  • If mixing on applesauce, the applesauce should not be warm. Do not sprinkle on other liquids or foods.
  • Use right away after mixing or you may store in a refrigerator for up to 6 hours.
What do I do if my child misses a dose?
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.