Celecoxib 200 Mg (Page 3 of 9)

5.14 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, celecoxib should be discontinued.

In controlled clinical trials, elevated BUN occurred more frequently in patients receiving 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.

5.15 Inflammation

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

5.16 Concomitant NSAID Use

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

6. ADVERSE REACTIONS

Of the 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 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 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 reactioninformation 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.

6.1 Pre-marketing Controlled Arthritis Trials

Table 1 lists all adverse events, regardless of causality, occurring in >2% of patients receiving 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 Celecoxib Patients from Pre-marketing Controlled Arthritis Trials

CBX

N=4, 146

Placebo

N=1, 864

NAP

N=1, 366

DCF

N=387

IBU

N=345

Gastrointestinal

Abdominal Pain

Diarrhea

Dyspepsia

Flatulence

Nausea

4.1%

5.6%

8.8%

2.2%

3.5%

2.8%

3.8%

6.2%

1%

4.2%

7.7%

5.3%

12.2%

3.6%

6%

9%

9.3%

10.9%

4.1%

3.4%

9%

5.8%

12.8%

3.5%

6.7%

Body as a whole

Back Pain

Peripheral Edema

Injury-Accidental

2.8%

2.1%

2.9%

3.6%

1.1%

2.3%

2.2%

2.1%

3%

2.6%

1%

2.6%

0.9%

3.5%

3.2%

Central, Peripheral

Nervous system

Dizziness

Headache

2%

15.8%

1.7%

20.2%

2.6%

14.5%

1.3%

15.5%

2.3%

15.4%

Psychiatric

Insomnia

2.3% 2.3% 2.9% 1.3% 1.4%
Respiratory

Pharyngitis

Rhinitis

Sinusitis

Upper Respiratory Infection

2.3%

2%

5%

8.1%

1.1%

1.3%

4.3%

6.7%

1.7%

2.4%

4%

9.9%

1.6%

2.3%

5.4%

9.8%

2.6%

0.6%

5.8%

9.9%

Skin

Rash

2.2% 2.1% 2.1% 1.3% 1.2%

CBX = Celecoxib 100 to 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 celecoxib and 6.1% for patients receiving placebo. Among the most common reasons for discontinuation due to adverse events in the celecoxib treatmentgroups were dyspepsia and abdominal pain (cited as reasons for discontinuation in 0.8% and 0.7% of 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 to 1.9% of patients treated with celecoxib (100 to 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 nervous system: Leg cramps, hypertonia, hypoesthesia, 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, creatinineincreased, alkaline phosphatase increased, weight increased
Musculoskeletal: Arthralgia, arthrosis, myalgia, synovitis, tendinitis
Platelets (bleeding or clotting): Ecchymosis, epistaxis, thrombocythemia
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 alymphatic:

Thrombocytopenia, agranulocytosis,aplastic anemia, pancytopenia, leucopenia

Metabolic: Hypoglycemia, hyponatremia
Nervous:

Ataxia, suicide, aseptic meningitis, ageusia, anosmia, fatal intracranial hemorrhage [see Drug Interactions (7.1)]

Renal: Acute renal failure, interstitial nephritis
Skin:

Erythema multiforme, exfoliative dermatitis, StevensJohnson syndrome, toxic epidermal necrolysis

General: Sepsis, sudden death, anaphylactoid reaction, angioedema

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.