National Geographic : 2001 Oct
SE4RE 4Z CELEBREX® (celecoxib capsules) Pediatric Use: Safety and effectiveness in pediatric patients below the age of 18 years have not been evaluated. Geriatric Use: Of the total number of patients who received CELEBREX in clinical trials, more than 2,100 were 65-74 years of age, while approximately 800 addi tional patients were 75 years and over. While the incidence of adverse experi ences tended to be higher in elderly patients, no substantial differences in safety and effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in response be tween the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. 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. ADVERSE REACTIONS Adverse events occurring in 3 2% of Celebrex patients from controlled arthri tis trials, regardless of causality at recommended doses (N=4146): abdominal pain 4.1%, diarrhea 5.6%, dyspepsia 8.8%, flatulence 2.2%, nausea 3.5%, back pain 2.8%, peripheral edema 2.1%, injury-accidental 2.9%, dizziness 2.0%, headache 15.8%, insomnia 2.3%, pharyngitis 2.3%, rhinitis 2.0%, sinusitis 5.0%, upper respiratory tract infection 8.1%, rash 2.2%. In placebo- or active-controlled clinical trials, the discontinuation rate due to adverse events was 7.1% for patients receiving CELEBREX and 6.1% for patients receiving placebo. Among the most common reasons for discontinuation due to adverse events in the CELEBREX treatment groups were dyspepsia and abdominal pain (cited as reasons for discontinuation in 0.8% and 0.7% of CELEBREX patients, respec tively). Among patients receiving placebo, 0.6% discontinued due to dyspep sia and 0.6% withdrew due to abdominal pain. The following adverse events occurred in 0.1-1.9% of patients regardless of causality. Celebrex (100-200 mg BIDor 200 mg QD):GI: Constipation, diverticulitis, dys phagia, eructation, esophagitis, gastritis, gastroenteritis, gastroesophageal reflux, hemorrhoids, hiatal hernia, melena, dry mouth, stomatitis, tenesmus, tooth disorder, vomiting; Cardiovascular: Aggravated hypertension, angina pectoris, coronary artery disorder, myocardial infarction; General: Allergy aggravated, allergic reaction, asthenia, chest pain, cyst NOS, edema general ized, face edema, fatigue, fever, hot flushes, influenza-like symptoms, pain, peripheral pain; Resistance mechanism disorders: Herpes simplex, herpes zoster, infection bacterial, infection fungal, infection soft tissue, infection viral, moniliasis, moniliasis genital, otitis media; Central, peripheral nervous system: Leg cramps, hypertonia, hypoesthesia, migraine, neuralgia, neuropathy, pares thesia, vertigo; Female reproductive: Breast fibroadenosis, breast neoplasm, breast pain, dysmenorrhea, menstrual disorder, vaginal hemorrhage, vaginitis; Male reproductive: Prostatic disorder; Hearing and vestibular: Deafness, ear abnormality, earache, tinnitus; Heart rate and rhythm: Palpitation, tachy cardia; Liver and biliary system: Hepatic function abnormal, SGOT increased, SGPT increased; Metabolic and nutritional: BUN increased, CPK increased, diabetes mellitus, hypercholesterolemia, hyperglycemia, hypokalemia, NPN increase, creatinine increased, alkaline phosphatase increased, weight increase; Musculoskeletal: Arthralgia, arthrosis, bone disorder, fracture accidental, myalgia, neck stiffness, 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, nail disorder, photosensitivity reaction, pruritus, rash erythematous, rash mac ulopapular, skin disorder, skin dry, sweating increased, urticaria; Application site disorders: Cellulitis, dermatitis contact, injection site reaction, skin nodule; Special senses: Taste perversion; Urinary system: Albuminuria, cystitis, dysuria, hematuria, micturition frequency, renal calculus, urinary incontinence, urinary tract infection; Vision: Blurred vision, cataract, conjunctivitis, eye pain, glaucoma. Other serious adverse reactions which occur rarely (estimated < 0.1%), regard less of causality: The following serious adverse events have occurred rarely in patients taking CELEBREX. Cases reported only in the post-marketing experi ence are indicated in italics. Cardiovascular: Syncope, congestive heart failure, ventricular fibrillation, pulmonary embolism, cerebrovascular accident, periph eral gangrene, thrombophlebitis, vasculitis;GI:Intestinal obstruction, intestinal perforation, gastrointestinal bleeding, colitis with bleeding, esophageal perfo ration, pancreatitis, ileus; Liver and biliary system: Cholelithiasis, hepatitis, jaundice, liver failure; Hemic and lymphatic: Thrombocytopenia, agranulocy tosis, aplastic anemia, pancytopenia, leukopenia; Metabolic: Hypoglycemia; Nervous system: Ataxia, suicide; Renal: Acute renal failure, interstitialnephri tis; Skin: Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis; General: Sepsis, sudden death, ana phylactoid reaction, angioedema. OVERDOSAGE Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. GI bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylac toid 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 anti dotes. 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 fol lowing a large overdose. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. SSE f Mfd. by Searle Ltd. SE4RILE CaguasPR00725 Marketed by: G.D.Searle & Co. 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