Celebrex (Celecoxib)
 Only available by prescription.
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Celebrex (Celecoxib)
Description:
CELEBREX (celecoxib) is indicated for relief of symptoms associated with:
Osteoarthritis, and
adult Rheumatoid Arthritis.
CELEBREX (celecoxib) is also indicated for the short-term (¡Ü7 days) management of moderate to severe acute pain in adults in conditions such as the following:
musculoskeletal and/or soft tissue trauma including sprains,
postoperative orthopaedic, and
pain following dental extraction.
Cardiovascular (CV) Effects¡ªRisk of serious cardiovascular events
As a group, selective COX-2 inhibitors, including CELEBREX, are associated with an increased risk of adverse cardiovascular events, a risk that is similar to those associated with most NSAIDs. As for all NSAIDs, CELEBREX should be prescribed at the lowest effective dose and for the shortest possible duration.
Some patients with pre-existing hypertension may develop worsening of blood pressure control when placed on an NSAID and regular monitoring of blood pressure should be performed under such circumstances. NSAIDs may exacerbate congestive heart failure.
Gastrointestinal System (GI)
CELEBREX (celecoxib) exhibited a low incidence of gastroduodenal ulceration and serious clinically significant GI events within clinical trials. However, serious GI toxicity (sometimes severe or fatal), such as peptic ulceration, perforation and bleeding, can occur at any time, with or without warning symptoms, in patients treated with nonsteroidal anti-inflammatory drugs (NSAIDs), including CELEBREX. Minor upper GI problems, such as dyspepsia, commonly occur at any time. Health care providers should remain alert for ulceration and bleeding in patients treated with NSAIDs, including CELEBREX, even in the absence of previous GI tract symptoms. Patients should be informed about the signs and/or symptoms of serious GI toxicity and instructed to discontinue using CELEBREX and seek emergency medical attention if they experience any such symptoms. The utility of periodic laboratory monitoring has not been demonstrated, nor has it been adequately assessed. Many patients who develop a serious upper GI adverse event on NSAID therapy have no symptoms. Upper GI ulcers, gross bleeding or perforation, caused by NSAIDs, appear to occur in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. These trends continue thus, increasing the likelihood of developing a serious GI event at some time during the course of therapy. Even short term therapy may be associated with risk for serious GI adverse events.
As for all NSAIDs, caution should be taken in prescribing CELEBREX to patients with a prior history of ulcer disease or gastrointestinal bleeding. Most spontaneous reports of fatal GI events are in elderly or debilitated patients. To minimize the potential risk for an adverse GI event, the lowest effective dose should be used for the shortest possible duration. (see Contraindications)
Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding and who use NSAIDs, have a greater than 10-fold higher risk for developing a GI bleed than patients with neither of these risk factors. Other risk factors for GI ulceration and bleeding include the following: H. pylori infection, increasing age, longer duration of NSAID therapy, excess alcohol intake, smoking, poor general health status or concomitant therapy with any of the following:
Anticoagulant (e.g. warfarin)
Antiplatelet agent (e.g. ASA, clopidogrel)
Oral corticosteroids (e.g. prednisone)
Selective Serotonin Reuptake Inhibitors (SSRIs) (e.g. citalopram, paroxetine)
There is no definitive evidence that the concomitant administration of histamine H2-receptor antagonists and/or antacids will either prevent the occurrence of gastrointestinal side effects or allow the continuation of CELEBREX when and if these adverse reactions appear.
Genitourinary
Some NSAIDs are known to cause persistent urinary symptoms (bladder pain, dysuria, urinary frequency), hematuria or cystitis. The onset of these symptoms may occur at any time after the initiation of therapy with an NSAID. Some cases have become severe on continued treatment. Should urinary symptoms occur, treatment with CELEBREX must be stopped immediately to obtain recovery. This should be done before any urological investigations or treatments are carried out.
Hematologic
Anemia is sometimes seen in patients receiving CELEBREX. In controlled clinical trials the incidence of anemia was 0.6% with CELEBREX and 0.4% with placebo. Patients on long-term treatment with CELEBREX should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia or blood loss. Serious potentially fatal bleeding events have been reported, predominantly in the elderly, in patients receiving CELEBREX concurrently with warfarin or similar agents. (See Drug Interactions and Adverse Reactions, Post-market Adverse Drug Reactions.)
CELEBREX does not generally affect platelet counts, prothrombin time (PT), or partial thromboplastin time (PTT), and does not appear to inhibit platelet aggregation at indicated dosages.
Blood dyscrasias (such as neutropenia, leukopenia, thrombocytopenia, aplastic anemia and agranulocytosis) associated with the use of nonsteroidal anti-inflammatory drugs are rare, but could occur with severe consequences.
Hepatic/Biliary/Pancreatic
Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs, and notable elevations of ALT or AST (approximately three 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. In controlled clinical trials of CELEBREX, the incidence of borderline elevations of liver tests was 6% for CELEBREX and 5% for placebo, and approximately 0.2% of patients taking CELEBREX 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. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), CELEBREX should be discontinued (see Contraindications).
Celebrex (Celecoxib) Manufacturer:
Pfizer
Celebrex (Celecoxib) Side Effects:
Adverse Drug Reaction Overview
Of the CELEBREX (celecoxib) treated patients in controlled trials, approximately 4250 were patients with OA, approximately 2100 were patients with RA, and approximately 1050 were patients with post-surgical pain. More than 8500 patients have received a total daily dose of CELEBREX of 200 mg (100 mg BID or 200 mg QD) or more, including more than 400 treated at 800 mg (400 mg BID). Approximately 3900 patients have received CELEBREX at these doses for 6 months or more; approximately 2300 of these have received it for 1 year or more and 124 of these have received it for 2 years or more.
CELEBREX has been extensively studied in elderly patients. Of the total number of patients who received CELEBREX in clinical trials, more than 3300 patients were 65-74 years of age, while approximately 1300 additional patients were 75 years and over. While the incidence of adverse experiences tended to be higher in elderly patients, no substantial differences in safety and effectiveness were observed between these subjects and younger patients. In GI endoscopy studies involving over 800 elderly patients, the rate of gastroduodenal ulceration was not different in elderly patients compared to the young. Other reported clinical experience has not identified differences in response between 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, urea and creatinine, and platelet function as measured by bleeding time and platelet aggregation, the results were not different between elderly and young volunteers.
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, respectively). Among patients receiving placebo, 0.6% discontinued due to dyspepsia and 0.6% withdrew due to abdominal pain.
The adverse event profile from the long-term outcomes trial (at 4- and 2-fold the recommended doses for OA and RA respectively) is similar to those reported in the arthritis-controlled trials. In the arthritis-controlled trials, the CELEBREX endoscopic gastroduodenal ulceration rate was consistently less than what was seen with the NSAID comparators. In the long-term outcome study however, there was no statistically significant difference for the incidence of complicated ulcers (perforation, obstruction, or bleeding) among the CELEBREX 400 mg BID and NSAID comparators. The major differences in study design and patient populations preclude direct comparison between the GI endpoint results in the arthritis controlled and the long-term outcome trials.
The incidences of withdrawals due to adverse events and the incidences of selected serious adverse events (i.e., those causing hospitalization or felt to be life-threatening or otherwise medically significant) observed in this trial are shown in Table 2. No significant differences were seen across treatment groups in the incidences of serious adverse events (see Table 2).
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| Product Code:1401 |
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