سلکوکسیب
Celecoxib (Celebrex)
سلکوکسیب

نام ژنریک

Celecoxib

شکل دارویی

اشكال دارويي:


Capsule: 100, 200mg

موارد مصرف

موارد و مقدار مصرف


الف) استئوآرتريت.


بزرگسالان : 200 ميلي گرم خوراکي، روزانه به صورت تک دوز يا در دو دوز منقسم.


ب) آرتريت روماتوييد.


بزرگسالان : 100 تا 200 ميلي گرم خوراکي دو بار در روز.


پ) اسپونديليت آنکيلوزان.


بزرگسالان : 200 ميلي گرم خوراکي يک بار در روز يا در دو دوز منقسم. در صورت عدم وجود پاسخ پس از 6 هفته، دوز را مي‌توان تا 400 ميلي گرم در روز افزايش داد. چنانچه پس از 6 هفته ديگر پاسخي از مصرف دارو مشاهده نشود، درمان ديگري را در نظر بگيريد.


ت) درمان تکميلي براي پوليپ آدنوماتوز فاميليال براي کم کردن تعداد پوليپهاي آدنوماتوز کولورکتال:


بزرگسالان: 400 ميلي گرم خوراکي دو بار در روز با غذا.


ث) درد حاد و ديسمنوره اوليه:


بزرگسالان: شروع با 400 ميلي گرم خوراکي، در صورت نياز 200 ميلي گرم دوز اضافه در روز اول. در روزهاي بعد 200 ميلي گرم خوراکي دو بار در روز در صورت نياز.


مقدار مصرف در نارسايي کبدي


براي بيماران با وزن کمتر از 50 کيلوگرم با دوز‌هاي کمتر شروع شود. براي بيماران با آسيب متوسط کبدي (child-paugh class II) با 50% دوز نرمال شروع شود.

موارد منع مصرف

تداخل دارويي


ممکن است اثر پائين آوردن فشار خون ACEIs را کم کند. فشار خون بيمار را مونيتور کنيد.


ممکن است ريسک زخمهاي گوارشي ناشي از آسپيرين را افزايش دهد. آسپيرين با دوز کم مي‌تواند بدون خطر در پيشگيري از حوادث قلبي- عروقي استفاده شود. بيمار را از نظر خونريزيهاي گوارشي بررسي کنيد.


فلوکونازول ممکن است سطح سلکوکسيب را افزايش دهد. بهتر است سطح سلکوکسيب به حداقل مقدار مؤثر کاهش داده شود.


ضد التهابهاي غير استروئيدي مي‌توانند دفع سديم ناشي از ديورتيکها مانند فوروزمايد را کاهش داده و منجر به احتباس سديم شوند. بيمار را از نظر ايجاد ادم و افزايش فشار خون بررسي کنيد.


سلکوکسيب ممکن است سطح ليتيوم را افزايش دهد. سطح اين دارو به صورت مرتب کنترل شود.


ممکن است باعث طولاني شدن PT شود. در بيماران تحت درمان با وارفارين PT، INR و علائم و نشانه‌هاي خونريزي به صورت مرتب کنترل شود.


استفاده طولاني مدت از الکل ممکن است ريسک تحريک گوارشي يا خونريزي را افزايش دهد. بهتر است مصرف الکل کنار گذاشته شده و بيمار از نظر علائم خونريزي بررسي شود.

عوارض جانبی دارو

ملاحظات اختصاصي


1- ضد التهابهاي غير استروئيدي ممکن است خطر اتفاقات ترومبوتيک، سکته‌هاي قلبي يا مغزي را افزايش دهند. اين خطر ممکن است با طولاني شدن دوره مصرف و در بيماران با خطر بيماريهاي قلبي- عروقي افزايش پيدا کند. قبل از شروع درمان بيمار از نظر ريسک فاکتورهاي قلبي- عروقي بررسي شود.


2- چنانچه بيماران به سولفوناميدها، آسپيرين يا ديگر ضد التهابهاي غير استروئيدي حساسيت داشته باشند، ممکن است به سلکوکسيب نيز حساس باشند.


3- بيماران با سابقه زخم يا خونريزي گوارشي، از نظر ايجاد خونريزي با سلکوکسيب در ريسک بالاتري قرار دارند.


4- بيماران از نظر علائم و نشانه‌هاي سميت کبدي و کليوي بررسي شوند، بويژه اگر دهيدره باشند.


5- در بيماران با آسيب شديد کليوي، عملکرد کليه بررسي شود.

موارد قابل توجه

-

تداخل دارویی

عوارض جانبي


اعصاب مرکزي: گيجي، سردرد، بي خوابي.


قلبي - عروقي: ادم محيطي.


گوش، حلق، بيني، چشم: فارنژيت، رينيت، سينوزيت.


دستگاه گوارش: درد شکمي، اسهال، سوء هاضمه، تهوع.


متابوليک: هايپرکلرمي، هايپوفسفاتمي.


عضلاني - اسکلتي: کمر درد (درد پشت).


تنفسي: عفونت دستگاه تنفسي فوقاني.


پوست: راش، TEN، سندرم استيونس جانسون، اريتم مولتي فرم، درماتيت اکسفولياتيو.


ساير عوارض: آسيبهاي تصادفي.

مکانیزم اثر

عوارض جانبي


اعصاب مرکزي: گيجي، سردرد، بي خوابي.


قلبي - عروقي: ادم محيطي.


گوش، حلق، بيني، چشم: فارنژيت، رينيت، سينوزيت.


دستگاه گوارش: درد شکمي، اسهال، سوء هاضمه، تهوع.


متابوليک: هايپرکلرمي، هايپوفسفاتمي.


عضلاني - اسکلتي: کمر درد (درد پشت).


تنفسي: عفونت دستگاه تنفسي فوقاني.


پوست: راش، TEN، سندرم استيونس جانسون، اريتم مولتي فرم، درماتيت اکسفولياتيو.


ساير عوارض: آسيبهاي تصادفي.

فارماكوكینتیك

موارد منع مصرف و احتياط


مصرف آن در سه ماهه سوم بارداري، در بيماران با آسيب شديد کبدي و بيماران حساس به سلکوکسيب، سولفوناميدها، آسپيرين يا ضد التهابهاي غير استروئيدي ديگر ممنوع مي‌باشد.


جهت درمان دردهاي قبل از جراحي به دنبال CABG ممنوع مي‌باشد.


در بيماران با سابقه زخم يا خونريزي گوارشي، بيماري کليوي پيشرفته، آنمي، علائم بيماري کبدي، هايپرتنشن، ادم، نارسايي قلبي يا آسم با احتياط مصرف شود. همچنين در بيماراني که سيگار مي‌کشند يا الکل مصرف مي‌کنند، در آنهايي که ضد انعقاد يا کورتيکواستروئيدهاي خوراکي مصرف مي‌کنند و در بيماران ضعيف با احتياط مصرف شود.

سایر اطلاعات

طبقه‌بندي فارماكولوژيك: مهار کننده سيکلواکسيژناز 2.


طبقه‌بندي درماني: ضد التهاب.


طبقه‌‌بندي مصرف در بارداري: رده C


نام‌هاي تجاري: Celebrex, Cobix


نکات قابل توصيه به بيمار


1- برطرف شدن درد به صورت کامل، نياز به زمان دارد.


2- علائمي مانند ورم، افزايش خستگي، زردي پوست، علائم سرماخوردگي، علائم خونريزي يا سختي تنفس را اطلاع دهيد.


3- در صورت ايجاد راش پوستي، دارو سريعا قطع شود.


4- در صورت ايجاد ناراحتي گوارشي، دارو با غذا مصرف شود.


مصرف در سالمندان: چنانچه بيمار وزن کمتر از 50 کيلوگرم نداشته باشد، نيازي به تنظيم دوزاژ نمي‌باشد. اما در حالت کلي افراد مسن عوارض جانبي دارو مانند عوارض گوارشي و اختلال عملکرد کليه حاد را بيشتر نشان مي‌دهند. در اين بيماران دارو با احتياط مصرف شود.


مصرف در كودكان: استفاده از اين دارو در گروه سني زير 18 سال بررسي نشده است.


مصرف در شيردهي: ترشح شدن اين دارو در شير نامشخص مي‌باشد. در مورد تجويز اين دارو در خانمهاي شيرده، منافع و مضرات اين دارو سنجيده شود.


اثر بر آزمايشهاي تشخيصي


اين دارو مي‌تواند مقدار ALT، AST، BUN و کلرايد را افزايش و سطح فسفات را کاهش دهد.


مسموميت و درمان


تظاهرات باليني: خستگي، خواب آلودگي، تهوع، استفراغ، درد بالاي شکم و خونريزي گوارشي. علائم ديگر شامل هايپرتنشن، ARF، دپرسيون تنفسي و کوما مي‌باشد.


درمان: شامل اقدامات حمايتي و درمان علامتي مي‌باشد. چنانچه تنها 4 ساعت از مصرف دارو گذشته باشد، تحريک به استفراغ، استفاده از ذغال فعال، استفاده از مسهل اسموتيک يا مخلوطي از آنها مي‌تواند استفاده شود. به علت اتصال پروتئيني بالا، دياليز براي برداشت اين دارو مؤثر نمي‌باشد.

Celecoxib (Celebrex)

CELEBREX ®
(celecoxib) Capsules

WARNING

CARDIOVASCULAR AND GASTROINTESTINAL RISKS

Cardiovascular Risk

  • CELEBREX (celecoxib) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. All nonsteroidal anti-inflammatory drugs (NSAIDs) may have a similar risk. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
  • CELEBREX (celecoxib) is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk

  • NSAIDs, including CELEBREX (celecoxib) , cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.

DRUG DESCRIPTION

CELEBREX (celecoxib) is chemically designated as 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chemical structure is as follows:

CELEBREX® (celecoxib) Structural Formula Illustration

CELEBREX (celecoxib) oral capsules contain either 50 mg, 100 mg, 200 mg or 400 mg of celecoxib, together with inactive ingredients including: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.

What are the possible side effects of celecoxib (Celebrex)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using celecoxib and call your doctor at once if you have a serious side effect such as:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • swelling or rapid weight gain;
  • urinating less than usual or not at all;
  • nausea, upper stomach pain,...

Read All Potential Side Effects and See Pictures of Celebrex »

What are the precautions when taking celecoxib (Celebrex)?

Before taking celecoxib, tell your doctor or pharmacist if you are allergic to it; or to aspirin, other NSAIDs (e.g., ibuprofen), other COX-2 inhibitors; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), recent heart bypass surgery (CABG).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood flow problem in the brain (e.g.,...

Read All Potential Precautions of Celebrex »

Last reviewed on RxList: 4/4/2011
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Carefully consider the potential benefits and risks of CELEBREX (celecoxib) and other treatment options before deciding to use CELEBREX (celecoxib) . Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS]

Osteoarthritis (OA)

CELEBREX (celecoxib) is indicated for relief of the signs and symptoms of OA [see Clinical Studies]

Rheumatoid Arthritis (RA)

CELEBREX (celecoxib) is indicated for relief of the signs and symptoms of RA [see Clinical Studies]

Juvenile Rheumatoid Arthritis (JRA)

CELEBREX (celecoxib) is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [see Clinical Studies]

Ankylosing Spondylitis (AS)

CELEBREX (celecoxib) is indicated for the relief of signs and symptoms of AS [see Clinical Studies]

Acute Pain (AP)

CELEBREX (celecoxib) is indicated for the management of AP in adults [see Clinical Studies]

Primary Dysmenorrhea (PD)

CELEBREX (celecoxib) is indicated for the treatment of PD [see Clinical Studies]

DOSAGE AND ADMINISTRATION

Use lowest effective dose for the shortest duration consistent with treatment goals for the individual patient.

These doses can be given without regard to timing of meals.

Osteoarthritis

For relief of the signs and symptoms of OA the recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice daily.

Rheumatoid Arthritis

For relief of the signs and symptoms of RA the recommended oral dose is 100 to 200 mg twice daily.

Juvenile Rheumatoid Arthritis

For the relief of the signs and symptoms of JRA the recommended oral dose for pediatric patients (age 2 years and older) is based on weight. For patients > 10 kg to < 25 kg the recommended dose is 50 mg twice daily.

For patients > 25 kg the recommended dose is 100 mg twice daily. For patients who have difficulty swallowing capsules, the contents of a CELEBREX (celecoxib) capsule can be added to applesauce. The entire capsule contents are carefully emptied onto a level teaspoon of cool or room temperature applesauce and ingested immediately with water. The sprinkled capsule contents on applesauce are stable for up to 6 hours under refrigerated conditions (2-8° C/ 35-45° F).

Ankylosing Spondylitis

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

Management of Acute Pain and Treatment of Primary Dysmenorrhea

The recommended dose of CELEBREX (celecoxib) is 400 mg initially, followed by an additional 200 mg dose if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily as needed.

Special Populations

Hepatic insufficiency

The daily recommended dose of CELEBREX (celecoxib) capsules in patients with moderate hepatic impairment (Child-Pugh Class B) should be reduced by 50%. The use of CELEBREX (celecoxib) in patients with severe hepatic impairment is not recommended [see WARNINGS AND PRECAUTIONS, Use In Specific Populations and CLINICAL PHARMACOLOGY].

Poor Metabolizers of CYP2C9 Substrates

Patients who are known or suspected to be poor CYP2C9 metabolizers based on genotype or previous history/experience with other CYP2C9 substrates (such as warfarin, phenytoin) should be administered celecoxib with caution. Consider starting treatment at half the lowest recommended dose in poor metabolizers (i.e. CYP2C9*3/*3). Consider using alternative management in JRA patients who are poor metabolizers. [see Use In Specific Populations, and CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

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

Storage And Handling

CELEBREX (celecoxib) 50 mg capsules are white, with reverse printed white on red band of body and cap with markings of 7767 on the cap and 50 on the body, supplied as:

NDC Number Size
0025-1515-01 bottle of 60

CELEBREX (celecoxib) 100 mg capsules are white, with reverse printed white on blue band of body and cap with markings of 7767 on the cap and 100 on the body, supplied as:

NDC Number Size
0025-1520-31 bottle of 100
0025-1520-51 bottle of 500
0025-1520-34 carton of 100 unit dose

CELEBREX (celecoxib) 200 mg capsules are white, with reverse printed white on gold band with markings of 7767 on the cap and 200 on the body, supplied as

NDC Number Size
0025-1525-31 bottle of 100
0025-1525-51 bottle of 500
0025-1525-34 carton of 100 unit dose

CELEBREX (celecoxib) 400 mg capsules are white, with reverse printed white on green band with markings of 7767 on the cap and 400 on the body, supplied as:

NDC Number Size
0025-1530-02 bottle of 60
0025-1530-01 carton of 100 unit dose

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]

Distributed by: G.D. Searle LLC, Division of Pfizer Inc, NY, NY 10017. January 2011

Last reviewed on RxList: 4/4/2011
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Of the CELEBREX (celecoxib) -treated patients in the pre-marketing controlled clinical trials, approximately 4,250 were patients with OA, approximately 2,100 were patients with RA, and approximately 1,050 were patients with post-surgical pain. More than 8,500 patients received a total daily dose of CELEBREX (celecoxib) of 200 mg (100 mg twice daily or 200 mg once daily) or more, including more than 400 treated at 800 mg (400 mg twice daily). Approximately 3,900 patients received CELEBREX (celecoxib) at these doses for 6 months or more; approximately 2,300 of these have received it for 1 year or more and 124 of these have received it for 2 years or more.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Pre-marketing Controlled Arthritis Trials

Table 1 lists all adverse events, regardless of causality, occurring in ≥ 2% of patients receiving CELEBREX (celecoxib) from 12 controlled studies conducted in patients with OA or RA that included a placebo and/or a positive control group. Since these 12 trials were of different durations, and patients in the trials may not have been exposed for the same duration of time, these percentages do not capture cumulative rates of occurrence.

Table 1: Adverse Events Occurring in > 2% of CELEBREX (celecoxib) Patients from Pre-marketing Controlled Arthritis Trials

  CBX
N=4146
Placebo
N=1864
NAP
N=1366
DCF
N=387
IBU
N=345
Gastrointestinal
Abdominal Pain 4.1% 2.8% 7.7% 9.0% 9.0%
Diarrhea 5.6% 3.8% 5.3% 9.3% 5.8%
Dyspepsia 8.8% 6.2% 12.2% 10.9% 12.8%
Flatulence 2.2% 1.0% 3.6% 4.1% 3.5%
Nausea 3.5% 4.2% 6.0% 3.4% 6.7%
Body as a whole
Back Pain 2.8% 3.6% 2.2% 2.6% 0.9%
Peripheral Edema 2.1% 1.1% 2.1% 1.0% 3.5%
Injury-Accidental 2.9% 2.3% 3.0% 2.6% 3.2%
Central, Peripheral Nervous system
Dizziness 2.0% 1.7% 2.6% 1.3% 2.3%
Headache 15.8% 20.2% 14.5% 15.5% 15.4%
Psychiatric          
Insomnia 2.3% 2.3% 2.9% 1.3% 1.4%
Respiratory
Pharyngitis
Rhinitis 2.3% 1.1% 1.7% 1.6% 2.6%
Sinusitis 2.0% 1.3% 2.4% 2.3% 0.6%
Upper Respiratory 5.0% 4.3% 4.0% 5.4% 5.8%
Infection 8.1% 6.7% 9.9% 9.8% 9.9%
Skin
Rash 2.2% 2.1% 2.1% 1.3% 1.2%
CBX = CELEBREX (celecoxib) 100 – 200 mg twice daily or 200 mg once daily;
NAP = Naproxen 500 mg twice daily;
DCF = Diclofenac 75 mg twice daily;
IBU = Ibuprofen 800 mg three times daily.

In placebo- or active-controlled clinical trials, the discontinuation rate due to adverse events was 7.1% for patients receiving CELEBREX (celecoxib) and 6.1% for patients receiving placebo. Among the most common reasons for discontinuation due to adverse events in the CELEBREX (celecoxib) treatment groups were dyspepsia and abdominal pain (cited as reasons for discontinuation in 0.8% and 0.7% of CELEBREX (celecoxib) patients, respectively). Among patients receiving placebo, 0.6% discontinued due to dyspepsia and 0.6% withdrew due to abdominal pain.

The following adverse reactions occurred in 0.1 - 1.9% of patients treated with CELEBREX (celecoxib) (100 - 200 mg twice daily or 200 mg once daily):

Gastrointestinal: Constipation, diverticulitis, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, gastroesophageal reflux, hemorrhoids, hiatal hernia, melena, dry mouth, stomatitis, tenesmus, vomiting

Cardiovascular: Aggravated hypertension, angina pectoris, coronary artery disorder, myocardial infarction

General: Allergy aggravated, allergic reaction, chest pain, cyst NOS, edema generalized, face edema, fatigue, fever, hot flushes, influenza-like symptoms, pain, peripheral pain

Central, peripheral Leg cramps, hypertonia, hypoesthesia, nervous system: migraine, paresthesia, vertigo

Hearing and vestibular: Deafness, tinnitus

Heart rate and rhythm: Palpitation, tachycardia

Liver and biliary: Hepatic function abnormal, SGOT increased, SGPT increased

Metabolic and nutritional: BUN increased, CPK increased, hypercholesterolemia, hyperglycemia, hypokalemia, NPN increased, creatinine increased, alkaline phosphatase increased, weight increased

Musculoskeletal: Arthralgia, arthrosis, myalgia, synovitis, tendinitis

Platelets (bleeding clotting): Ecchymosis, epistaxis, thrombocythemia, or

Psychiatric: Anorexia, anxiety, appetite increased, depression, nervousness, somnolence

Hemic: Anemia

Respiratory: Bronchitis, bronchospasm, bronchospasm aggravated, coughing, dyspnea, laryngitis, pneumonia

Skin and appendages : Alopecia, dermatitis, photosensitivity reaction, pruritus, rash erythematous, rash maculopapular, skin disorder, skin dry, sweating increased, urticaria

Application site disorders: Cellulitis, dermatitis contact

Urinary: Albuminuria, cystitis, dysuria, hematuria, micturition frequency, renal calculus

The following serious adverse events (causality not evaluated) occurred in < 0.1% of patients (cases reported only in post-marketing experience are indicated in italics):

Cardiovascular: Syncope, congestive heart failure, ventricular fibrillation, pulmonary embolism, cerebrovascular accident, peripheral gangrene, thrombophlebitis, vasculitis, deep venous thrombosis

Gastrointestinal: Intestinal obstruction, intestinal perforation, gastrointestinal bleeding, colitis with bleeding, esophageal perforation, pancreatitis, ileus

Liver and biliary: Cholelithiasis, hepatitis, jaundice, liver failure

Hemic and lymphatic: Thrombocytopenia, agranulocytosis,aplastic anemia, pancytopenia, leucopenia

Metabolic: Hypoglycemia, hyponatremia

Nervous: Ataxia, suicide, aseptic meningitis, ageusia, anosmia, fatal intracranial hemorrhage [see DRUG INTERACTIONS]

Renal: Acute renal failure, interstitial nephritis

Skin: Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis

General: Sepsis, sudden death, anaphylactoid reaction, angioedema

The Celecoxib Long-Term Arthritis Safety Study

[see Special Studies]

Hematological Events

The incidence of clinically significant decreases in hemoglobin ( > 2 g/dL) was lower in patients on CELEBREX (celecoxib) 400 mg twice daily (0.5%) compared to patients on either diclofenac 75 mg twice daily (1.3%) or ibuprofen 800 mg three times daily 1.9%. The lower incidence of events with CELEBREX (celecoxib) was maintained with or without ASA use [see CLINICAL PHARMACOLOGY].

Withdrawals/Serious Adverse Events

Kaplan-Meier cumulative rates at 9 months for withdrawals due to adverse events for CELEBREX (celecoxib) , diclofenac and ibuprofen were 24%, 29%, and 26%, respectively. Rates for serious adverse events (i.e., causing hospitalization or felt to be life-threatening or otherwise medically significant), regardless of causality, were not different across treatment groups (8%, 7%, and 8%, respectively).

Juvenile Rheumatoid Arthritis Study

In a 12-week, double-blind, active-controlled study, 242 JRA patients 2 years to 17 years of age were treated with celecoxib or naproxen; 77 JRA patients were treated with celecoxib 3 mg/kg BID, 82 patients were treated with celecoxib 6 mg/kg BID, and 83 patients were treated with naproxen 7.5 mg/kg BID. The most commonly occurring ( ≥ 5%) adverse events in celecoxib treated patients were headache, fever (pyrexia), upper abdominal pain, cough, nasopharyngitis, abdominal pain, nausea, arthralgia, diarrhea and vomiting. The most commonly occurring ( ≥ 5%) adverse experiences for naproxen-treated patients were headache, nausea, vomiting, fever, upper abdominal pain, diarrhea, cough, abdominal pain, and dizziness (Table 2). Compared with naproxen, celecoxib at doses of 3 and 6 mg/kg BID had no observable deleterious effect on growth and development during the course of the 12-week double-blind study. There was no substantial difference in the number of clinical exacerbations of uveitis or systemic features of JRA among treatment groups.

In a 12-week, open-label extension of the double-blind study described above, 202 JRA patients were treated with celecoxib 6 mg/kg BID. The incidence of adverse events was similar to that observed during the double-blind study; no unexpected adverse events of clinical importance emerged.

Table 2: Adverse Events Occurring in ≥ 5% of JRA Patients in Any Treatment Group, by System Organ Class (% of patients with events)

System Organ Class Preferred Term All Doses Twice Daily
Celecoxib 3 mg/kg
N=77
Celecoxib 6 mg/kg
N=82
Naproxen 7.5 mg/kg
N=83
Any Event 64 70 72
Eye Disorders 5 5 5
Gastrointestinal 26 24 36
Abdominal pain NOS 4 7 7
Abdominal pain upper 8 6 10
Vomiting NOS 3 6 11
Diarrhea NOS 5 4 8
Nausea 7 4 11
General 13 11 18
Pyrexia 8 9 11
Infections 25 20 27
Nasopharyngitis 5 6 5
Injury and Poisoning 4 6 5
Investigations* 3 11 7
Musculoskeletal 8 10 17
Arthralgia 3 7 4
Nervous System 17 11 21
Headache NOS 13 10 16
Dizziness (excl vertigo) 1 1 7
Respiratory 8 15 15
Cough 7 7 8
Skin & Subcutaneous 10 7 18
* Abnormal laboratory tests, which include: Prolonged activated partial thromboplastin time, Bacteriuria NOS present, Blood creatine phosphokinase increased, Blood culture positive, Blood glucose increased, Blood pressure increased, Blood uric acid increased, Hematocrit decreased, Hematuria present, Hemoglobin decreased, Liver function tests NOS abnormal, Proteinuria present, Transaminase NOS increased, Urine analysis abnormal NOS

Other Pre-Approval Studies

Adverse Events from Ankylosing Spondylitis Studies

A total of 378 patients were treated with CELEBREX (celecoxib) in placebo- and active-controlled AS studies. Doses up to 400 mg once daily were studied. The types of adverse events reported in the AS studies were similar to those reported in the OA/RAstudies.

Adverse Events from Analgesia and Dysmenorrhea Studies

Approximately 1,700 patients were treated with CELEBREX (celecoxib) in analgesia and dysmenorrhea studies. All patients in post-oral surgery pain studies received a single dose of study medication. Doses up to 600 mg/day of CELEBREX (celecoxib) were studied in primary dysmenorrhea and post-orthopedic surgery pain studies. The types of adverse events in the analgesia and dysmenorrhea studies were similar to those reported in arthritis studies. The only additional adverse event reported was post-dental extraction alveolar osteitis (dry socket) in the post-oral surgery pain studies.

The APC and PreSAP Trials

Adverse reactions from long-term, placebo-controlled polyp prevention studies

Exposure to CELEBREX (celecoxib) in the APC and PreSAP trials was 400 to 800 mg daily for up to 3 years [see Special Studies Adenomatous Polyp Prevention Studies].

Some adverse reactions occurred in higher percentages of patients than in the arthritis pre-marketing trials (treatment durations up to 12 weeks; see Adverse events from CELEBREX (celecoxib) pre-marketing controlled arthritis trials, above). The adverse reactions for which these differences in patients treated with CELEBREX (celecoxib) were greater as compared to the arthritis pre-marketing trials were as follows:

  CELEBREX (400 to 800 mg daily)
N = 2285
Placebo
N=1303
Diarrhea 10.5% 7.0%
Gastroesophageal reflux disease 4.7% 3.1%
Nausea 6.8% 5.3%
Vomiting 3.2% 2.1%
Dyspnea 2.8% 1.6%
Hypertension 12.5% 9.8%

The following additional adverse reactions occurred in ≥ 0.1% and < 1% of patients taking CELEBREX (celecoxib) , at an incidence greater than placebo in the long-term polyp prevention studies, and were either not reported during the controlled arthritis pre-marketing trials or occurred with greater frequency in the long-term, placebo-controlled polyp prevention studies:

Nervous system disorders: Cerebral infarction

Eye disorders: Vitreous floaters, conjunctival hemorrhage

Ear and labyrinth: Labyrinthitis

Cardiac disorders: Angina unstable, aortic valve incompetence, coronary artery atherosclerosis, sinus bradycardia, ventricular hypertrophy

Vascular disorders: Deep vein thrombosis

Reproductive system and breast disorders: Ovarian cyst

Investigations: Blood potassium increased, blood sodium increased, blood testosterone decreased

Injury, poisoning and procedural complications: Epicondylitis, tendon rupture

Read the Celebrex (celecoxib) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

General: Celecoxib metabolism is predominantly mediated via cytochrome P450 (CYP) 2C9 in the liver. Co-administration of celecoxib with drugs that are known to inhibit CYP2C9 should be done with caution. Significant interactions may occur when celecoxib is administered together with drugs that inhibit CYP2C9.

In vitro studies indicate that celecoxib, although not a substrate, is an inhibitor of CYP2D6. Therefore, there is a potential for an in vivo drug interaction with drugs that are metabolized by CYP2D6.

Warfarin

Anticoagulant activity should be monitored, particularly in the first few days, after initiating or changing CELEBREX (celecoxib) therapy in patients receiving warfarin or similar agents, since these patients are at an increased risk of bleeding complications. The effect of celecoxib on the anticoagulant effect of warfarin was studied in a group of healthy subjects receiving daily 2-5 mg doses of warfarin. In these subjects, celecoxib did not alter the anticoagulant effect of warfarin as determined by prothrombin time. However, in post-marketing experience, serious bleeding events, some of which were fatal, have been reported, predominantly in the elderly, in association with increases in prothrombin time in patients receiving CELEBREX (celecoxib) concurrently with warfarin.

Lithium

In a study conducted in healthy subjects, mean steady-state lithium plasma levels increased approximately 17% in subjects receiving lithium 450 mg twice daily with CELEBREX (celecoxib) 200 mg twice daily as compared to subjects receiving lithium alone. Patients on lithium treatment should be closely monitored when CELEBREX (celecoxib) is introduced or withdrawn.

Aspirin

CELEBREX (celecoxib) can be used with low-dose aspirin. However, concomitant administration of aspirin with CELEBREX (celecoxib) increases the rate of GI ulceration or other complications, compared to use of CELEBREX alone [see WARNINGS AND PRECAUTIONS and Clinical Studies].

Because of its lack of platelet effects, CELEBREX (celecoxib) is not a substitute for aspirin for cardiovascular prophylaxis [see CLINICAL PHARMACOLOGY].

ACE-inhibitors and Angiotensin II Antagonists

Reports suggest that NSAIDs may diminish the antihypertensive effect of Angiotensin Converting Enzyme (ACE) inhibitors and angiotensin II antagonists. This interaction should be given consideration in patients taking CELEBREX (celecoxib) concomitantly with ACE-inhibitors and angiotensin II antagonists [see CLINICAL PHARMACOLOGY].

Fluconazole

Concomitant administration of fluconazole at 200 mg once daily resulted in a two-fold increase in celecoxib plasma concentration. This increase is due to the inhibition of celecoxib metabolism via P450 2C9 by fluconazole [see CLINICAL PHARMACOLOGY]. CELEBREX (celecoxib) should be introduced at the lowest recommended dose in patients receiving fluconazole.

Furosemide

Clinical studies, as well as post-marketing observations, have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis.

Methotrexate

In an interaction study of rheumatoid arthritis patients taking methotrexate, CELEBREX (celecoxib) did not have an effect on the pharmacokinetics of methotrexate [see CLINICAL PHARMACOLOGY].

Concomitant NSAID Use

The concomitant use of CELEBREX (celecoxib) with any dose of a non-aspirin NSAID should be avoided due to the potential for increased risk of adverse reactions.

Last reviewed on RxList: 4/4/2011
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Cardiovascular Thrombotic Events

Chronic use of CELEBREX (celecoxib) may cause an increased risk of serious adverse cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. In the APC (Adenoma Prevention with Celecoxib) trial, the hazard ratio for the composite endpoint of cardiovascular death, MI, or stroke was 3.4 (95% CI 1.4 – 8.5) for CELEBREX (celecoxib) 400 mg twice daily and 2.8 (95% CI 1.1 – 7.2) with CELEBREX (celecoxib) 200 mg twice daily compared to placebo. Cumulative rates for this composite endpoint over 3 years were 3.0% (20/671 subjects) and 2.5% (17/685 subjects), respectively, compared to 0.9% (6/679 subjects) with placebo treatment. The increases in both celecoxib dose groups versus placebo-treated patients were mainly due to an increased incidence of myocardial infarction [see Clinical Studies].

All NSAIDs, both COX-2 selective and non-selective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with CELEBREX (celecoxib) , the lowest effective dose should be used for the shortest duration consistent with individual patient treatment goals. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV toxicity and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and CELEBREX (celecoxib) does increase the risk of serious GI events.

Two large, controlled, clinical trials of a different COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke [see CONTRAINDICATIONS].

Hypertension

As with all NSAIDs, CELEBREX (celecoxib) can lead to the onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including CELEBREX (celecoxib) , should be used with caution in patients with hypertension. Blood pressure should be monitored closely during the initiation of therapy with CELEBREX (celecoxib) and throughout the course of therapy. The rates of hypertension from the CLASS trial in the CELEBREX (celecoxib) , ibuprofen and diclofenac-treated patients were 2.4%, 4.2% and 2.5%, respectively [see Clinical Studies].

Congestive Heart Failure and Edema

Fluid retention and edema have been observed in some patients taking NSAIDs, including CELEBREX [see ADVERSE REACTIONS]. In the CLASS study [see Clinical Studies], the Kaplan-Meier cumulative rates at 9 months of peripheral edema in patients on CELEBREX (celecoxib) 400 mg twice daily (4-fold and 2-fold the recommended OA and RA doses, respectively), ibuprofen 800 mg three times daily and diclofenac 75 mg twice daily were 4.5%, 6.9% and 4.7%, respectively. CELEBREX (celecoxib) should be used with caution in patients with fluid retention or heart failure.

Gastrointestinal (GI) Effects Risk of GI Ulceration, Bleeding, and Perforation

NSAIDs, including CELEBREX (celecoxib) , can cause serious gastrointestinal events including bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Complicated and symptomatic ulcer rates were 0.78% at nine months for all patients in the CLASS trial, and 2.19% for the subgroup on low-dose ASA. Patients 65 years of age and older had an incidence of 1.40% at nine months, 3.06% when also taking ASA [see Clinical Studies]. With longer duration of use of NSAIDs, there is a trend for increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.

NSAIDs should be prescribed with extreme caution in patients with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk of GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore special care should be taken in treating this population.

To minimize the potential risk for an adverse GI event, the lowest effective dose should be used for the shortest duration consistent with individual patient treatment goals. Physicians and patients should remain alert for signs and symptoms of GI ulceration and bleeding during CELEBREX (celecoxib) therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. For high-risk patients, alternate therapies that do not involve NSAIDs should be considered.

Hepatic Effects

Borderline elevations of one or more liver-associated enzymes may occur in up to 15% of patients taking NSAIDs, and notable elevations of ALT or AST (approximately 3 or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with NSAIDs. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. Rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure (some with fatal outcome) have been reported with NSAIDs, including CELEBREX [see ADVERSE REACTIONS]. In controlled clinical trials of CELEBREX (celecoxib) , the incidence of borderline elevations (greater than or equal to 1.2 times and less than 3 times the upper limit of normal) of liver associated enzymes was 6% for CELEBREX (celecoxib) and 5% for placebo, and approximately 0.2% of patients taking CELEBREX (celecoxib) and 0.3% of patients taking placebo had notable elevations of ALT and AST.

A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be monitored carefully for evidence of the development of a more severe hepatic reaction while on therapy with CELEBREX (celecoxib) . If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), CELEBREX (celecoxib) should be discontinued.

Renal Effects

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics, ACE-inhibitors, angiotensin II receptor antagonists, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state. Clinical trials with CELEBREX (celecoxib) have shown renal effects similar to those observed with comparator NSAIDs.

No information is available from controlled clinical studies regarding the use of CELEBREX (celecoxib) in patients with advanced renal disease. Therefore, treatment with CELEBREX (celecoxib) is not recommended in these patients with advanced renal disease. If CELEBREX (celecoxib) therapy must be initiated, close monitoring of the patient's renal function is advisable.

Anaphylactoid Reactions

As with NSAIDs in general, anaphylactoid reactions have occurred in patients without known prior exposure to CELEBREX (celecoxib) . In post-marketing experience, rare cases of anaphylactic reactions and angioedema have been reported in patients receiving CELEBREX (celecoxib) . CELEBREX (celecoxib) should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs [see CONTRAINDICATIONS]. Emergency help should be sought in cases where an anaphylactoid reaction occurs.

Skin Reactions

CELEBREX (celecoxib) is a sulfonamide and can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events can occur without warning and in patients without prior known sulfa allergy. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Pregnancy

In late pregnancy, starting at 30 weeks gestation, CELEBREX (celecoxib) should be avoided because it may cause premature closure of the ductus arteriosus [see Use in Specific Populations].

Corticosteroid Treatment

CELEBREX (celecoxib) cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to exacerbation of corticosteroid-responsive illness. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.

Hematological Effects

Anemia is sometimes seen in patients receiving CELEBREX (celecoxib) . In controlled clinical trials the incidence of anemia was 0.6% with CELEBREX (celecoxib) and 0.4% with placebo. Patients on long-term treatment with CELEBREX (celecoxib) should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia or blood loss. CELEBREX (celecoxib) does not generally affect platelet counts, prothrombin time (PT), or partial thromboplastin time (PTT), and does not inhibit platelet aggregation at indicated dosages [see CLINICAL PHARMACOLOGY].

Disseminated Intravascular Coagulation (DIC)

CELEBREX (celecoxib) should be used only with caution in pediatric patients with systemic onset JRA due to the risk of disseminated intravascular coagulation.

Preexisting Asthma

Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm, which can be fatal. Since cross reactivity, including bronchospasm, between aspirin and other nonsteroidal anti-inflammatory drugs has been reported in such aspirin-sensitive patients, CELEBREX (celecoxib) should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma.

Laboratory Tests

Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of GI bleeding. Patients on long-term treatment with NSAIDs should have a CBC and a chemistry profile checked periodically. If abnormal liver tests or renal tests persist or worsen, CELEBREX (celecoxib) should be discontinued.

In controlled clinical trials, elevated BUN occurred more frequently in patients receiving CELEBREX (celecoxib) compared with patients on placebo. This laboratory abnormality was also seen in patients who received comparator NSAIDs in these studies. The clinical significance of this abnormality has not been established.

Inflammation

The pharmacological activity of CELEBREX (celecoxib) in reducing inflammation, and possibly fever, may diminish the utility of these diagnostic signs in detecting infectious complications of presumed noninfectious, painful conditions.

Concomitant NSAID Use

The concomitant use of CELEBREX (celecoxib) with any dose of a non-aspirin NSAID should be avoided due to the potential for increased risk of adverse reactions.

Patient Counseling Information

Patients should be informed of the following information before initiating therapy with CELEBREX (celecoxib) and periodically during the course of ongoing therapy.

Medication Guide

Patients should be informed of the availability of a Medication Guide for NSAIDs that accompanies each prescription dispensed, and should be instructed to read the Medication Guide prior to using CELEBREX (celecoxib) .

Cardiovascular Effects

Patients should be informed that CELEBREX (celecoxib) may cause serious CV side effects such as MI or stroke, which may result in hospitalization and even death. Patients should be informed of the the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and to seek immediate medical advice if they observe any of these signs or symptoms. [see WARNINGS AND PRECAUTIONS].

Patients should be informed that CELEBREX (celecoxib) can lead to the onset of new hypertension or worsening of preexisting hypertension, and that CELEBREX (celecoxib) may impair the response of some antihypertensive agents. Patients should be instructed on the proper follow up for monitoring of blood pressure. [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].

Gastrointestinal Effects

Patients should be informed that CELEBREX (celecoxib) can cause gastrointestinal discomfort and more serious side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Patients should be informed of the signs and symptoms of ulcerations and bleeding, and to seek immediate medical advice if they observe any signs or symptoms that are indicative of these disorders, including epigastric pain, dyspepsia, melena, and hematemesis. [see WARNINGS AND PRECAUTIONS].

Hepatic Effects

Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). Patients should be instructed that they should stop therapy and seek immediate medical therapy if these signs and symptoms occur [see WARNINGS AND PRECAUTIONS, Use In Specific Populations].

Adverse Skin Reactions

Patients should be informed that CELEBREX (celecoxib) is a sulfonamide and can cause serious skin side effects such as exfoliative dermatitis, SJS, and TEN, which may result in hospitalizations and even death. Although serious skin reactions may occur without warning, patients should be informed of the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and seek immediate medical advice when observing any indicative signs or symptoms.

Patients should be advised to stop CELEBREX (celecoxib) immediately if they develop any type of rash and contact their physician as soon as possible.

Patients with prior history of sulfa allergy should not take CELEBREX (celecoxib) [see WARNINGS AND PRECAUTIONS].

Weight Gain and Edema

Long-term administration of NSAIDs including CELEBREX (celecoxib) has resulted in renal injury. Patients at greatest risk are those taking diuretics, ACE-inhibitors, angiotensin II antagonists, or with renal or liver dysfunction, heart failure, and the elderly [see WARNINGS AND PRECAUTIONS, Use In Specific Populations].

Patients should be instructed to promptly report to their physicians signs or symptoms of unexplained weight gain or edema following treatment with CELEBREX (celecoxib) [see WARNINGS AND PRECAUTIONS].

Anaphylactoid Reactions

Patients should be informed of the signs and symptoms of an anaphylactoid reaction (e.g., difficulty breathing, swelling of the face or throat). Patients should be instructed to seek immediate emergency assistance if they develop any of these signs and symptoms [see WARNINGS AND PRECAUTIONS].

Effects During Pregnancy

Patients should be informed that in late pregnancy CELEBREX (celecoxib) should be avoided because it may cause premature closure of the ductus arteriosus [see WARNINGS AND PRECAUTIONS, Use In Specific Populations].

Preexisting Asthma

Patients should be instructed to tell their physicians if they have a history of asthma or aspirin-sensitive asthma because the use of NSAIDs in patients with aspirin-sensitive asthma has been associated with severe bronchospasm, which can be fatal. Patients with this form of aspirin sensitivity should be instructed not to take Celebrex (celecoxib) . Patients with preexisting asthma should be instructed to seek immediate medical attention if their asthma worsens after taking Celebrex (celecoxib) [see WARNINGS AND PRECAUTIONS].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Celecoxib was not carcinogenic in rats given oral doses up to 200 mg/kg for males and 10 mg/kg for females (approximately 2-to 4-fold the human exposure as measured by the AUC0-24 at 200 mg twice daily) or in mice given oral doses up to 25 mg/kg for males and 50 mg/kg for females (approximately equal to human exposure as measured by the AUC0-24 at 200 mg twice daily) for two years.

Celecoxib was not mutagenic in an Ames test and a mutation assay in Chinese hamster ovary (CHO) cells, nor clastogenic in a chromosome aberration assay in CHO cells and an in vivo micronucleus test in rat bone marrow.

Celecoxib did not impair male and female fertility in rats at oral doses up to 600 mg/kg/day (approximately 11-fold human exposure at 200 mg twice daily based on the AUC0-24).

Use In Specific Populations

Pregnancy

Pregnancy Category C. Pregnancy category D from 30 weeks of gestation onward.

Teratogenic effects

Celecoxib at oral doses ≥ 150 mg/kg/day (approximately 2-fold human exposure at 200 mg twice daily as measured by AUC0-24), caused an increased incidence of ventricular septal defects, a rare event, and fetal alterations, such as ribs fused, sternebrae fused and sternebrae misshapen when rabbits were treated throughout organogenesis. A dose-dependent increase in diaphragmatic hernias was observed when rats were given celecoxib at oral doses ≥ 30 mg/kg/day (approximately 6-fold human exposure based on the AUC0-24 at 200 mg twice daily) throughout organogenesis. There are no studies in pregnant women. CELEBREX (celecoxib) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic effects

Celecoxib produced pre implantation and post-implantation losses and reduced embryo/fetal survival in rats at oral dosages ≥ 50 mg/kg/day (approximately 6-fold human exposure based on the AUC0-24 at 200 mg twice daily). These changes are expected with inhibition of prostaglandin synthesis and are not the result of permanent alteration of female reproductive function, nor are they expected at clinical exposures. No studies have been conducted to evaluate the effect of celecoxib on the closure of the ductus arteriosus in humans. Therefore, use of CELEBREX (celecoxib) during the third trimester of pregnancy should be avoided.

Labor and Delivery

Celecoxib produced no evidence of delayed labor or parturition at oral doses up to 100 mg/kg in rats (approximately 7-fold human exposure as measured by the AUC0-24 at 200 mg BID). The effects of CELEBREX (celecoxib) on labor and delivery in pregnant women are unknown.

Nursing Mothers

Limited data from 3 published reports that included a total of 12 breastfeeding women showed low levels of CELEBREX (celecoxib) in breast milk. The calculated average daily infant dose was 10-40 mcg/kg/day, less than 1% of the weight-based therapeutic dose for a two-year old-child. A report of two breastfed infants 17 and 22 months of age did not show any adverse events. Caution should be exercised when CELEBREX (celecoxib) is administered to a nursing woman.

Pediatric Use

CELEBREX (celecoxib) is approved for relief of the signs and symptoms of Juvenile Rheumatoid Arthritis in patients 2 years and older. Safety and efficacy have not been studied beyond six months in children. The long-term cardiovascular toxicity in children exposed to CELEBREX (celecoxib) has not been evaluated and it is unknown if long-term risks may be similar to that seen in adults exposed to CELEBREX (celecoxib) or other COX-2 selective and non-selective NSAIDs [(see BOXED WARNING and Clinical Studies].

The use of celecoxib in patients 2 years to 17 years of age with pauciarticular, polyarticular course JRA or in patients with systemic onset JRA was studied in a 12-week, double-blind, active controlled, pharmacokinetic, safety and efficacy study, with a 12-week open-label extension. Celecoxib has not been studied in patients under the age of 2 years, in patients with body weight less than 10 kg (22 lbs), and in patients with active systemic features. Patients with systemic onset JRA (without active systemic features) appear to be at risk for the development of abnormal coagulation laboratory tests. In some patients with systemic onset JRA, both celecoxib and naproxen were associated with mild prolongation of activated partial thromboplastin time (APTT) but not prothrombin time (PT). NSAIDs including celecoxib should be used only with caution in patients with systemic onset JRA, due to the risk of disseminated intravascular coagulation. Patients with systemic onset JRA should be monitored for the development of abnormal coagulation tests [see DOSAGE AND ADMINISTRATION, Animal Toxicology and Clinical Studies].

Alternative therapies for treatment of JRA should be considered in pediatric patients identified to be CYP2C9 poor metabolizers [see Poor Metabolizers of CYP2C9 substrates].

Geriatric Use

Of the total number of patients who received CELEBREX (celecoxib) in pre-approval clinical trials, more than 3,300 were 65-74 years of age, while approximately 1,300 additional patients were 75 years and over. No substantial differences in effectiveness were observed between these subjects and younger subjects. In clinical studies comparing renal function as measured by the GFR, BUN and creatinine, and platelet function as measured by bleeding time and platelet aggregation, the results were not different between elderly and young volunteers. However, as with other NSAIDs, including those that selectively inhibit COX-2, there have been more spontaneous post-marketing reports of fatal GI events and acute renal failure in the elderly than in younger patients.

Hepatic Insufficiency

The daily recommended dose of CELEBREX (celecoxib) capsules in patients with moderate hepatic impairment (Child-Pugh Class B) should be reduced by 50%. The use of CELEBREX (celecoxib) in patients with severe hepatic impairment is not recommended [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY].

Renal Insufficiency

CELEBREX (celecoxib) is not recommended in patients with severe renal insufficiency [see CLINICAL PHARMACOLOGY].

Poor Metabolizers of CYP2C9 Substrates

Patients who are known or suspected to be poor CYP2C9 metabolizers based on genotype or previous history/experience with other CYP2C9 substrates (such as warfarin, phenytoin) should be administered celecoxib with caution. Consider starting treatment at half the lowest recommended dose in poor metabolizers (i.e., CYP2C9*3/*3). Alternative management should be considered in JRA patients identified to be CYP2C9 poor metabolizers. [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY].

Last reviewed on RxList: 4/4/2011
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No overdoses of CELEBREX (celecoxib) were reported during clinical trials. Doses up to 2400 mg/day for up to 10 days in 12 patients did not result in serious toxicity. Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.

Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. No information is available regarding the removal of celecoxib by hemodialysis, but based on its high degree of plasma protein binding ( > 97%) dialysis is unlikely to be useful in overdose. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.

CONTRAINDICATIONS

CELEBREX (celecoxib) is contraindicated:

  • In patients with known hypersensitivity to celecoxib, aspirin, or other NSAIDs.
  • In patients who have demonstrated allergic-type reactions to sulfonamides.
  • In patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe anaphylactoid reactions to NSAIDs, some of them fatal, have been reported in such patients [see WARNINGS AND PRECAUTIONS].
  • For the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see WARNINGS AND PRECAUTIONS].

Last reviewed on RxList: 4/4/2011
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Of the CELEBREX (celecoxib) -treated patients in the pre-marketing controlled clinical trials, approximately 4,250 were patients with OA, approximately 2,100 were patients with RA, and approximately 1,050 were patients with post-surgical pain. More than 8,500 patients received a total daily dose of CELEBREX (celecoxib) of 200 mg (100 mg twice daily or 200 mg once daily) or more, including more than 400 treated at 800 mg (400 mg twice daily). Approximately 3,900 patients received CELEBREX (celecoxib) at these doses for 6 months or more; approximately 2,300 of these have received it for 1 year or more and 124 of these have received it for 2 years or more.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Pre-marketing Controlled Arthritis Trials

Table 1 lists all adverse events, regardless of causality, occurring in ≥ 2% of patients receiving CELEBREX (celecoxib) from 12 controlled studies conducted in patients with OA or RA that included a placebo and/or a positive control group. Since these 12 trials were of different durations, and patients in the trials may not have been exposed for the same duration of time, these percentages do not capture cumulative rates of occurrence.

Table 1: Adverse Events Occurring in > 2% of CELEBREX (celecoxib) Patients from Pre-marketing Controlled Arthritis Trials

  CBX
N=4146
Placebo
N=1864
NAP
N=1366
DCF
N=387
IBU
N=345
Gastrointestinal
Abdominal Pain 4.1% 2.8% 7.7% 9.0% 9.0%
Diarrhea 5.6% 3.8% 5.3% 9.3% 5.8%
Dyspepsia 8.8% 6.2% 12.2% 10.9% 12.8%
Flatulence 2.2% 1.0% 3.6% 4.1% 3.5%
Nausea 3.5% 4.2% 6.0% 3.4% 6.7%
Body as a whole
Back Pain 2.8% 3.6% 2.2% 2.6% 0.9%
Peripheral Edema 2.1% 1.1% 2.1% 1.0% 3.5%
Injury-Accidental 2.9% 2.3% 3.0% 2.6% 3.2%
Central, Peripheral Nervous system
Dizziness 2.0% 1.7% 2.6% 1.3% 2.3%
Headache 15.8% 20.2% 14.5% 15.5% 15.4%
Psychiatric
Insomnia 2.3% 2.3% 2.9% 1.3% 1.4%
Respiratory
Pharyngitis          
Rhinitis 2.3% 1.1% 1.7% 1.6% 2.6%
Sinusitis 2.0% 1.3% 2.4% 2.3% 0.6%
Upper Respiratory 5.0% 4.3% 4.0% 5.4% 5.8%
Infection 8.1% 6.7% 9.9% 9.8% 9.9%
Skin
Rash 2.2% 2.1% 2.1% 1.3% 1.2%
CBX = CELEBREX (celecoxib) 100 – 200 mg twice daily or 200 mg once daily;
NAP = Naproxen 500 mg twice daily;
DCF = Diclofenac 75 mg twice daily;
IBU = Ibuprofen 800 mg three times daily.

In placebo- or active-controlled clinical trials, the discontinuation rate due to adverse events was 7.1% for patients receiving CELEBREX (celecoxib) and 6.1% for patients receiving placebo. Among the most common reasons for discontinuation due to adverse events in the CELEBREX (celecoxib) treatment groups were dyspepsia and abdominal pain (cited as reasons for discontinuation in 0.8% and 0.7% of CELEBREX (celecoxib) patients, respectively). Among patients receiving placebo, 0.6% discontinued due to dyspepsia and 0.6% withdrew due to abdominal pain.

The following adverse reactions occurred in 0.1 - 1.9% of patients treated with CELEBREX (celecoxib) (100 - 200 mg twice daily or 200 mg once daily):

Gastrointestinal: Constipation, diverticulitis, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, gastroesophageal reflux, hemorrhoids, hiatal hernia, melena, dry mouth, stomatitis, tenesmus, vomiting

Cardiovascular: Aggravated hypertension, angina pectoris, coronary artery disorder, myocardial infarction

General: Allergy aggravated, allergic reaction, chest pain, cyst NOS, edema generalized, face edema, fatigue, fever, hot flushes, influenza-like symptoms, pain, peripheral pain

Central, peripheral Leg cramps, hypertonia, hypoesthesia, nervous system: migraine, paresthesia, vertigo

Hearing and vestibular: Deafness, tinnitus

Heart rate and rhythm: Palpitation, tachycardia

Liver and biliary: Hepatic function abnormal, SGOT increased, SGPT increased

Metabolic and nutritional: BUN increased, CPK increased, hypercholesterolemia, hyperglycemia, hypokalemia, NPN increased, creatinine increased, alkaline phosphatase increased, weight increased

Musculoskeletal: Arthralgia, arthrosis, myalgia, synovitis, tendinitis

Platelets (bleeding clotting): Ecchymosis, epistaxis, thrombocythemia, or

Psychiatric: Anorexia, anxiety, appetite increased, depression, nervousness, somnolence

Hemic: Anemia

Respiratory: Bronchitis, bronchospasm, bronchospasm aggravated, coughing, dyspnea, laryngitis, pneumonia

Skin and appendages : Alopecia, dermatitis, photosensitivity reaction, pruritus, rash erythematous, rash maculopapular, skin disorder, skin dry, sweating increased, urticaria

Application site disorders: Cellulitis, dermatitis contact

Urinary: Albuminuria, cystitis, dysuria, hematuria, micturition frequency, renal calculus

The following serious adverse events (causality not evaluated) occurred in < 0.1% of patients (cases reported only in post-marketing experience are indicated in italics):

Cardiovascular: Syncope, congestive heart failure, ventricular fibrillation, pulmonary embolism, cerebrovascular accident, peripheral gangrene, thrombophlebitis, vasculitis, deep venous thrombosis

Gastrointestinal: Intestinal obstruction, intestinal perforation, gastrointestinal bleeding, colitis with bleeding, esophageal perforation, pancreatitis, ileus

Liver and biliary: Cholelithiasis, hepatitis, jaundice, liver failure

Hemic and lymphatic: Thrombocytopenia, agranulocytosis,aplastic anemia, pancytopenia, leucopenia

Metabolic: Hypoglycemia, hyponatremia

Nervous: Ataxia, suicide, aseptic meningitis, ageusia, anosmia, fatal intracranial hemorrhage [see DRUG INTERACTIONS]

Renal: Acute renal failure, interstitial nephritis

Skin: Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis

General: Sepsis, sudden death, anaphylactoid reaction, angioedema

The Celecoxib Long-Term Arthritis Safety Study

[see Special Studies]

Hematological Events

The incidence of clinically significant decreases in hemoglobin ( > 2 g/dL) was lower in patients on CELEBREX (celecoxib) 400 mg twice daily (0.5%) compared to patients on either diclofenac 75 mg twice daily (1.3%) or ibuprofen 800 mg three times daily 1.9%. The lower incidence of events with CELEBREX (celecoxib) was maintained with or without ASA use [see CLINICAL PHARMACOLOGY].

Withdrawals/Serious Adverse Events

Kaplan-Meier cumulative rates at 9 months for withdrawals due to adverse events for CELEBREX (celecoxib) , diclofenac and ibuprofen were 24%, 29%, and 26%, respectively. Rates for serious adverse events (i.e., causing hospitalization or felt to be life-threatening or otherwise medically significant), regardless of causality, were not different across treatment groups (8%, 7%, and 8%, respectively).

Juvenile Rheumatoid Arthritis Study

In a 12-week, double-blind, active-controlled study, 242 JRA patients 2 years to 17 years of age were treated with celecoxib or naproxen; 77 JRA patients were treated with celecoxib 3 mg/kg BID, 82 patients were treated with celecoxib 6 mg/kg BID, and 83 patients were treated with naproxen 7.5 mg/kg BID. The most commonly occurring ( ≥ 5%) adverse events in celecoxib treated patients were headache, fever (pyrexia), upper abdominal pain, cough, nasopharyngitis, abdominal pain, nausea, arthralgia, diarrhea and vomiting. The most commonly occurring ( ≥ 5%) adverse experiences for naproxen-treated patients were headache, nausea, vomiting, fever, upper abdominal pain, diarrhea, cough, abdominal pain, and dizziness (Table 2). Compared with naproxen, celecoxib at doses of 3 and 6 mg/kg BID had no observable deleterious effect on growth and development during the course of the 12-week double-blind study. There was no substantial difference in the number of clinical exacerbations of uveitis or systemic features of JRA among treatment groups.

In a 12-week, open-label extension of the double-blind study described above, 202 JRA patients were treated with celecoxib 6 mg/kg BID. The incidence of adverse events was similar to that observed during the double-blind study; no unexpected adverse events of clinical importance emerged.

Table 2: Adverse Events Occurring in ≥ 5% of JRA Patients in Any Treatment Group, by System Organ Class (% of patients with events)

System Organ Class Preferred Term All Doses Twice Daily
Celecoxib 3 mg/kg
N=77
Celecoxib 6 mg/kg
N=82
Naproxen 7.5 mg/kg
N=83
Any Event 64 70 72
Eye Disorders 5 5 5
Gastrointestinal 26 24 36
Abdominal pain NOS 4 7 7
Abdominal pain upper 8 6 10
Vomiting NOS 3 6 11
Diarrhea NOS 5 4 8
Nausea 7 4 11
General 13 11 18
Pyrexia 8 9 11
Infections 25 20 27
Nasopharyngitis 5 6 5
Injury and Poisoning 4 6 5
Investigations* 3 11 7
Musculoskeletal 8 10 17
Arthralgia 3 7 4
Nervous System 17 11 21
Headache NOS 13 10 16
Dizziness (excl vertigo) 1 1 7
Respiratory 8 15 15
Cough 7 7 8
Skin & Subcutaneous 10 7 18
* Abnormal laboratory tests, which include: Prolonged activated partial thromboplastin time, Bacteriuria NOS present, Blood creatine phosphokinase increased, Blood culture positive, Blood glucose increased, Blood pressure increased, Blood uric acid increased, Hematocrit decreased, Hematuria present, Hemoglobin decreased, Liver function tests NOS abnormal, Proteinuria present, Transaminase NOS increased, Urine analysis abnormal NOS

Other Pre-Approval Studies

Adverse Events from Ankylosing Spondylitis Studies

A total of 378 patients were treated with CELEBREX (celecoxib) in placebo- and active-controlled AS studies. Doses up to 400 mg once daily were studied. The types of adverse events reported in the AS studies were similar to those reported in the OA/RAstudies.

Adverse Events from Analgesia and Dysmenorrhea Studies

Approximately 1,700 patients were treated with CELEBREX (celecoxib) in analgesia and dysmenorrhea studies. All patients in post-oral surgery pain studies received a single dose of study medication. Doses up to 600 mg/day of CELEBREX (celecoxib) were studied in primary dysmenorrhea and post-orthopedic surgery pain studies. The types of adverse events in the analgesia and dysmenorrhea studies were similar to those reported in arthritis studies. The only additional adverse event reported was post-dental extraction alveolar osteitis (dry socket) in the post-oral surgery pain studies.

The APC and PreSAP Trials

Adverse reactions from long-term, placebo-controlled polyp prevention studies

Exposure to CELEBREX (celecoxib) in the APC and PreSAP trials was 400 to 800 mg daily for up to 3 years [see Special Studies Adenomatous Polyp Prevention Studies].

Some adverse reactions occurred in higher percentages of patients than in the arthritis pre-marketing trials (treatment durations up to 12 weeks; see Adverse events from CELEBREX (celecoxib) pre-marketing controlled arthritis trials, above). The adverse reactions for which these differences in patients treated with CELEBREX (celecoxib) were greater as compared to the arthritis pre-marketing trials were as follows:

  CELEBREX (400 to 800 mg daily)
N = 2285
Placebo
N=1303
Diarrhea 10.5% 7.0%
Gastroesophageal reflux disease 4.7% 3.1%
Nausea 6.8% 5.3%
Vomiting 3.2% 2.1%
Dyspnea 2.8% 1.6%
Hypertension 12.5% 9.8%

The following additional adverse reactions occurred in ≥ 0.1% and < 1% of patients taking CELEBREX (celecoxib) , at an incidence greater than placebo in the long-term polyp prevention studies, and were either not reported during the controlled arthritis pre-marketing trials or occurred with greater frequency in the long-term, placebo-controlled polyp prevention studies:

Nervous system disorders: Cerebral infarction

Eye disorders: Vitreous floaters, conjunctival hemorrhage

Ear and labyrinth: Labyrinthitis

Cardiac disorders: Angina unstable, aortic valve incompetence, coronary artery atherosclerosis, sinus bradycardia, ventricular hypertrophy

Vascular disorders: Deep vein thrombosis

Reproductive system and breast disorders: Ovarian cyst

Investigations: Blood potassium increased, blood sodium increased, blood testosterone decreased

Injury, poisoning and procedural complications: Epicondylitis, tendon rupture

Read the Celebrex (celecoxib) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

General: Celecoxib metabolism is predominantly mediated via cytochrome P450 (CYP) 2C9 in the liver. Co-administration of celecoxib with drugs that are known to inhibit CYP2C9 should be done with caution. Significant interactions may occur when celecoxib is administered together with drugs that inhibit CYP2C9.

In vitro studies indicate that celecoxib, although not a substrate, is an inhibitor of CYP2D6. Therefore, there is a potential for an in vivo drug interaction with drugs that are metabolized by CYP2D6.

Warfarin

Anticoagulant activity should be monitored, particularly in the first few days, after initiating or changing CELEBREX (celecoxib) therapy in patients receiving warfarin or similar agents, since these patients are at an increased risk of bleeding complications. The effect of celecoxib on the anticoagulant effect of warfarin was studied in a group of healthy subjects receiving daily 2-5 mg doses of warfarin. In these subjects, celecoxib did not alter the anticoagulant effect of warfarin as determined by prothrombin time. However, in post-marketing experience, serious bleeding events, some of which were fatal, have been reported, predominantly in the elderly, in association with increases in prothrombin time in patients receiving CELEBREX (celecoxib) concurrently with warfarin.

Lithium

In a study conducted in healthy subjects, mean steady-state lithium plasma levels increased approximately 17% in subjects receiving lithium 450 mg twice daily with CELEBREX (celecoxib) 200 mg twice daily as compared to subjects receiving lithium alone. Patients on lithium treatment should be closely monitored when CELEBREX (celecoxib) is introduced or withdrawn.

Aspirin

CELEBREX (celecoxib) can be used with low-dose aspirin. However, concomitant administration of aspirin with CELEBREX (celecoxib) increases the rate of GI ulceration or other complications, compared to use of CELEBREX alone [see WARNINGS AND PRECAUTIONS and Clinical Studies].

Because of its lack of platelet effects, CELEBREX (celecoxib) is not a substitute for aspirin for cardiovascular prophylaxis [see CLINICAL PHARMACOLOGY].

ACE-inhibitors and Angiotensin II Antagonists

Reports suggest that NSAIDs may diminish the antihypertensive effect of Angiotensin Converting Enzyme (ACE) inhibitors and angiotensin II antagonists. This interaction should be given consideration in patients taking CELEBREX (celecoxib) concomitantly with ACE-inhibitors and angiotensin II antagonists [see CLINICAL PHARMACOLOGY].

Fluconazole

Concomitant administration of fluconazole at 200 mg once daily resulted in a two-fold increase in celecoxib plasma concentration. This increase is due to the inhibition of celecoxib metabolism via P450 2C9 by fluconazole [see CLINICAL PHARMACOLOGY]. CELEBREX (celecoxib) should be introduced at the lowest recommended dose in patients receiving fluconazole.

Furosemide

Clinical studies, as well as post-marketing observations, have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis.

Methotrexate

In an interaction study of rheumatoid arthritis patients taking methotrexate, CELEBREX (celecoxib) did not have an effect on the pharmacokinetics of methotrexate [see CLINICAL PHARMACOLOGY].

Concomitant NSAID Use

The concomitant use of CELEBREX (celecoxib) with any dose of a non-aspirin NSAID should be avoided due to the potential for increased risk of adverse reactions.

Last reviewed on RxList: 4/4/2011
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

(See the end of this Medication Guide for a list of prescription NSAID medicines.)

What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.

This chance increases:

  • with longer use of NSAID medicines
  • in people who have heart disease

NSAID medicines should never be used right before or after a heart surgery called a "coronary artery bypass graft (CABG)."

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

  • can happen without warning symptoms
  • may cause death

The chance of a person getting an ulcer or bleeding increases with:

  • taking medicines called "corticosteroids" and "anticoagulants"
  • longer use
  • smoking
  • drinking alcohol
  • older age
  • having poor health

NSAID medicines should only be used:

  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed

What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

  • different types of arthritis
  • menstrual cramps and other types of short-term pain

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

  • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
  • for pain right before or after heart bypass surgery

Tell your healthcare provider:

  • about all of your medical conditions.
  • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
  • if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.
  • if you are breastfeeding. Talk to your doctor.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

Serious side effects include: Other side effects include:
  • heart attack
  • stroke
  • high blood pressure
  • heart failure from body swelling (fluid retention)
  • kidney problems including kidney failure
  • bleeding and ulcers in the stomach and intestine
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions
  • liver problems including liver failure
  • asthma attacks in people who have asthma
  • stomach pain
  • constipation
  • diarrhea
  • gas
  • heartburn
  • nausea
  • vomiting
  • dizziness

Get emergency help right away if you have any of the following symptoms:

  • shortness of breath or trouble breathing
  • chest pain
  • weakness in one part or side of your body
  • slurred speech
  • swelling of the face or throat

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

  • nausea
  • more tired or weaker than usual
  • itching
  • your skin or eyes look yellow
  • stomach pain
  • flu-like symptoms
  • vomit blood
  • there is blood in your bowel movement or it is black and sticky like tar
  • skin rash or blisters with fever
  • unusual weight gain
  • swelling of the arms and legs, hands and feet

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

  • Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
  • Some of these NSAID medicines are sold in lower doses without a prescription (over -the -counter). Talk to your healthcare provider before using over -the -counter NSAIDs for more than 10 days.

NSAID medicines that need a prescription

Generic Name Tradename
Celecoxib Celebrex
Diclofenac Cataflam, Voltaren, Arthrotec (combined with misoprostol)
Diflunisal Dolobid
Etodolac Lodine, Lodine XL
Fenoprofen Nalfon, Nalfon 200
Flurbiprofen Ansaid
Ibuprofen Motrin, Tab-Profen, Vicoprofen* (combined with hydrocodone), Combunox (combined with oxycodone)
Indomethacin Indocin, Indocin SR, Indo-Lemmon, Indomethagan
Ketoprofen Oruvail
Ketorolac Toradol
Mefenamic Acid Ponstel
Meloxicam Mobic
Nabumetone Relafen
Naproxen Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan, Naprapac (copackaged with lansoprazole)
Oxaprozin Daypro
Piroxicam Feldene
Sulindac Clinoril
Tolmetin Tolectin, Tolectin DS, Tolectin 600

* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 4/14/2011
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

(See the end of this Medication Guide for a list of prescription NSAID medicines.)

What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.

This chance increases:

  • with longer use of NSAID medicines
  • in people who have heart disease

NSAID medicines should never be used right before or after a heart surgery called a "coronary artery bypass graft (CABG)."

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

  • can happen without warning symptoms
  • may cause death

The chance of a person getting an ulcer or bleeding increases with:

  • taking medicines called "corticosteroids" and "anticoagulants"
  • longer use
  • smoking
  • drinking alcohol
  • older age
  • having poor health

NSAID medicines should only be used:

  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed

What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

  • different types of arthritis
  • menstrual cramps and other types of short-term pain

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

  • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
  • for pain right before or after heart bypass surgery

Tell your healthcare provider:

  • about all of your medical conditions.
  • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
  • if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.
  • if you are breastfeeding. Talk to your doctor.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

Serious side effects include: Other side effects include:
  • heart attack
  • stroke
  • high blood pressure
  • heart failure from body swelling (fluid retention)
  • kidney problems including kidney failure
  • bleeding and ulcers in the stomach and intestine
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions
  • liver problems including liver failure
  • asthma attacks in people who have asthma
  • stomach pain
  • constipation
  • diarrhea
  • gas
  • heartburn
  • nausea
  • vomiting
  • dizziness

Get emergency help right away if you have any of the following symptoms:

  • shortness of breath or trouble breathing
  • chest pain
  • weakness in one part or side of your body
  • slurred speech
  • swelling of the face or throat

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

  • nausea
  • more tired or weaker than usual
  • itching
  • your skin or eyes look yellow
  • stomach pain
  • flu-like symptoms
  • vomit blood
  • there is blood in your bowel movement or it is black and sticky like tar
  • skin rash or blisters with fever
  • unusual weight gain
  • swelling of the arms and legs, hands and feet

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

  • Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
  • Some of these NSAID medicines are sold in lower doses without a prescription (over -the -counter). Talk to your healthcare provider before using over -the -counter NSAIDs for more than 10 days.

NSAID medicines that need a prescription

Generic Name Tradename
Celecoxib Celebrex
Diclofenac Cataflam, Voltaren, Arthrotec (combined with misoprostol)
Diflunisal Dolobid
Etodolac Lodine, Lodine XL
Fenoprofen Nalfon, Nalfon 200
Flurbiprofen Ansaid
Ibuprofen Motrin, Tab-Profen, Vicoprofen* (combined with hydrocodone), Combunox (combined with oxycodone)
Indomethacin Indocin, Indocin SR, Indo-Lemmon, Indomethagan
Ketoprofen Oruvail
Ketorolac Toradol
Mefenamic Acid Ponstel
Meloxicam Mobic
Nabumetone Relafen
Naproxen Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan, Naprapac (copackaged with lansoprazole)
Oxaprozin Daypro
Piroxicam Feldene
Sulindac Clinoril
Tolmetin Tolectin, Tolectin DS, Tolectin 600

* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 4/14/2011
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Celebrex Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

CELECOXIB - ORAL

(sell-eh-COX-ib)

COMMON BRAND NAME(S): Celebrex

WARNING: Rarely, this medication can cause serious (very rarely fatal) stomach/intestinal bleeding. Also, this medication and related drugs have rarely caused blood clots to form, resulting in possibly fatal heart attacks and strokes. The risk may be greater if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes), or with longer use. This drug should not be taken right before or after heart bypass surgery (CABG).

If you notice any of these rare but very serious side effects, stop taking celecoxib and seek immediate medical attention: coffee-ground vomit, black stools, persistent stomach/abdominal pain, chest pain, weakness on one side of the body, slurred speech, sudden vision changes.

USES: This medication is a nonsteroidal anti-inflammatory drug (NSAID), specifically a COX-2 inhibitor, which relieves pain and swelling (inflammation). It is used to treat arthritis, acute pain, and menstrual pain and discomfort. The pain and swelling relief provided by this medication helps you perform more of your normal daily activities.

If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

This drug works by blocking the enzyme in your body that makes prostaglandins. Decreasing prostaglandins helps to reduce pain and swelling.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using celecoxib and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

Take by mouth, usually once or twice daily, or as directed by your doctor. To decrease the chance of stomach upset, this drug is best taken with food. Dosage is based on your medical condition and response to therapy. The lowest effective dosage should always be used, and only for the prescribed length of time (see also Warning section).

Take this medication with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for 10 minutes after taking this medication.

In certain conditions (e.g., arthritis), it may take up to two weeks, taken regularly, before significant benefits of this drug take effect.

If you are taking this drug on an "as needed" basis (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has significantly worsened, the medicine may not work as well.

Disclaimer

Celebrex Consumer (continued)

SIDE EFFECTS: See also Warning section.

Stomach upset or gas may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: severe headache, unexplained weight gain, swelling of the hands or feet, pain/swelling/warmth in the groin/calf, change in amount of urine, difficult/painful swallowing, unusual tiredness.

This drug may rarely cause serious liver disease. If you notice any of the following highly unlikely but very serious side effects, stop taking celecoxib and consult your doctor or pharmacist immediately: yellowing eyes or skin, dark urine, persistent stomach/abdominal pain.

In the unlikely event you have a serious allergic reaction to this drug, seek immediate medical attention. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Celebrex (celecoxib) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking celecoxib, tell your doctor or pharmacist if you are allergic to it; or to aspirin, other NSAIDs (e.g., ibuprofen), other COX-2 inhibitors; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), recent heart bypass surgery (CABG).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood flow problem in the brain (e.g., stroke, cerebrovascular disease), kidney problems, liver problems, heart disease (e.g., angina, heart attack, congestive heart failure), high blood pressure, alcohol use, swelling (e.g., edema), blood disorders (e.g., anemia), serious infections, stomach/intestine/esophagus problems (e.g., bleeding, ulcers, recurring heartburn), bleeding/clotting problems, asthma, growths in the nose (nasal polyps), dehydration, poorly controlled diabetes.

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and smoking. Consult your doctor or pharmacist for more information.

Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of this medication, especially stomach bleeding and kidney effects.

Caution is advised when using this drug in children with a certain type of arthritis (systemic onset juvenile rheumatoid arthritis) because they may be at increased risk for a very serious bleeding/clotting problem (disseminated intravascular coagulation). Seek immediate medical attention if your child develops sudden bleeding/bruising or bluish skin in the fingers/toes.

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery.

This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

Disclaimer

Celebrex Consumer (continued)

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medication because very serious interactions may occur: cidofovir.

If you are currently using the medication listed above, tell your doctor or pharmacist before starting celecoxib.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: aliskiren, ACE Inhibitors (such as lisinopril), angiotensin II receptor blockers (such as valsartan, losartan), anti-platelet drugs (e.g., cilostazol, clopidogrel), oral bisphosphonates (e.g., alendronate), "blood thinners" (e.g., enoxaparin, heparin, warfarin), corticosteroids (e.g., prednisone), desmopressin, fluconazole, lithium, pemetrexed.

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as naproxen or ibuprofen). These drugs are similar to celecoxib and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include severe stomach pain, coffee ground-like vomit, change in amount of urine, slow or shallow breathing, severe headache or loss of consciousness.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., complete blood count, liver and kidney function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Non-drug treatment for arthritis that is approved by your doctor (e.g., weight loss if needed, strengthening and conditioning exercises) may help improve your flexibility, range of motion, and joint function. Consult your doctor for specific instructions.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised March 2012. Copyright(c) 2012 First Databank, Inc.

Celebrex Patient Information Including Side Effects

Brand Names: Celebrex

Generic Name: celecoxib (oral) (Pronunciation: SEL e KOX ib)

What is celecoxib (Celebrex)?

Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID). Celecoxib works by reducing hormones that cause inflammation and pain in the body.

Celecoxib is used to treat pain or inflammation caused by many conditions such as arthritis, ankylosing spondylitis, and menstrual pain. Celecoxib is also used in the treatment of hereditary polyps in the colon

Celecoxib may also be used for purposes not listed in this medication guide.

Celebrex 100 mg

white, imprinted with 7767, 100

Celebrex 200 mg

white, imprinted with 7767, 200

Celebrex 400 mg

green/white, imprinted with 7767, 400

What are the possible side effects of celecoxib (Celebrex)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using celecoxib and call your doctor at once if you have a serious side effect such as:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • swelling or rapid weight gain;
  • urinating less than usual or not at all;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • upset stomach, diarrhea, bloating, gas;
  • dizziness, nervousness, headache;
  • runny or stuffy nose, sore throat; or
  • mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Celebrex (celecoxib) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about celecoxib (Celebrex)?

This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use celecoxib just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking celecoxib, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Ask a doctor or pharmacist before using any other cold, allergy, or pain medicine. Medicines similar to celecoxib are contained in many combination medicines. Check the label to see if a medicine contains an NSAID (non-steroidal anti-inflammatory drug) such as aspirin, ibuprofen, ketoprofen, or naproxen.

Side Effects Centers

Celebrex Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking celecoxib (Celebrex)?

Do not use celecoxib just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking celecoxib, especially in older adults.

You should not use this medication if you are allergic to celecoxib, or if you have a history of allergic reaction to aspirin, sulfa drugs, or other NSAIDs.

To make sure you can safely take celecoxib, tell your doctor if you have any of these other conditions:

  • a history of heart attack, stroke, or blood clot;
  • heart disease, congestive heart failure, high blood pressure;
  • a history of stomach ulcers or bleeding;
  • liver or kidney disease,
  • a seizure disorder such as epilepsy;
  • asthma;
  • polyps in your nose; or
  • a bleeding or blood clotting disorder.

FDA pregnancy category D. Taking celecoxib during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using celecoxib.

Celecoxib passes into breast milk and may affect a nursing baby. Do not take celecoxib without first talking to your doctor if you are breast-feeding a baby.

Do not give this medicine to a child younger than 2 years old without the advice of a doctor.

How should I take celecoxib (Celebrex)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take celecoxib with food or milk to lessen stomach upset.

You may open the celecoxib capsule and sprinkle the medicine into a spoonful of applesauce to make swallowing easier. Swallow right away without chewing. Discard the empty capsule. If you do not take the mixture right away, keep it in the refrigerator and take it within 6 hours.

If you use this medication long-term, your blood will need to be tested often. Visit your doctor regularly.

Store at room temperature away from moisture and heat.

Side Effects Centers

Celebrex Patient Information including If I Miss a Dose

What happens if I miss a dose (Celebrex)?

Since celecoxib is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Celebrex)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.

What should I avoid while taking celecoxib (Celebrex)?

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking celecoxib together with other NSAIDs such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn, Naprelan, Treximet), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), or piroxicam (Feldene).

Ask a doctor or pharmacist before using any other cold, allergy, or pain medicine. Medicines similar to celecoxib are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain type of drug Check the label to see if a medicine contains an NSAID (non-steroidal anti-inflammatory drug) such as aspirin, ibuprofen, ketoprofen, or naproxen.

Avoid exposure to sunlight or tanning beds. Celecoxib can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What other drugs will affect celecoxib (Celebrex)?

Ask your doctor before using an antidepressant such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft). Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Tell your doctor about all other medicines you use, especially:

  • a blood thinner such as warfarin (Coumadin, Jantoven);
  • a diuretic (water pill) such as furosemide (Lasix);
  • fluconazole (Diflucan);
  • lithium (Eskalith, Lithobid);
  • a heart or blood pressure medication such as candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro, Avalide), losartan (Cozaar, Hyzaar), valsartan (Diovan), telmisartan (Micardis), or olmesartan (Benicar); or
  • an ACE inhibitor such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others.

This list is not complete and other drugs may interact with celecoxib. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about celecoxib.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 13.01. Revision date: 4/25/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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