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Celedol

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Indications:

Relief of signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) in adults, and ankylosing spondylitis; management of acute pain in adults; treatment of primary dysmenorrhea; reduction of the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP), as an adjunct to usual care; relief of signs and symptoms of juvenile RA (JRA) in patients 2 yr of age and older. Unlabeled Uses Adjunctive therapy in the treatment of schizophrenia (inconclusive data); prevention of colorectal cancer; preterm labor.

Contraindications:

Hypersensitivity to celecoxib, aspirin, or other NSAIDs; allergy to sulfonamides; previous allergic reactions following aspirin or other NSAID use (eg, asthma, hives, rash); treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

Adverse reactions:

Cardiovascular Hypertension (13%); aggravated hypertension, angina pectoris, coronary artery disorder, MI, palpitations, tachycardia (less than 2%); deep venous thrombosis, vasculitis (postmarketing). CNS Headache (16%); dizziness, insomnia (2%); anorexia, anxiety, depression, fatigue, migraine, nervousness, paresthesia, somnolence, vertigo (less than 2%); ageusia, anosmia, aseptic meningitis, fatal intracranial hemorrhage (postmarketing). Dermatologic Rash (2%); alopecia, cellulitis, contact dermatitis, dermatitis, dry skin, erythematous rash, increased sweating, maculopapular rash, photosensitivity, pruritus, skin disorder, urticaria (less than 2%); erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, TEN (postmarketing). EENT Nasopharyngitis (6%); eye disorders, sinusitis (5%); rhinitis (2%); deafness, laryngitis, tinnitus (less than 2%). GI Diarrhea (11%); dyspepsia (9%); upper abdominal pain (8%); abdominal pain, nausea (7%); vomiting (6%); gastroesophageal reflux (5%); flatulence (2%); constipation, diverticulitis, dry mouth, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, hemorrhoids, hiatal hernia, increased appetite, melena, stomatitis, tenesmus (less than 2%). Genitourinary Albuminuria, cystitis, dysuria, hematuria, micturition frequency, renal calculus (less than 2%); interstitial nephritis (postmarketing). Hematologic Anemia, ecchymosis, epistaxis, thrombocythemia (less than 2%); agranulocytosis, aplastic anemia, leukopenia, pancytopenia (postmarketing). Hepatic Abnormal hepatic function, elevated AST and ALT (less than 2%); hepatitis, jaundice, liver failure (postmarketing). Metabolic Hypercholesterolemia; hyperglycemia; hypokalemia; increased alkaline phosphatase, BUN, CPK, creatinine, and nonprotein nitrogen; weight gain (less than 2%); hypoglycemia, hyponatremia (postmarketing). Musculoskeletal Arthralgia (7%); arthrosis, hypertonia, hypesthesia, leg cramps, myalgia, synovitis, tendonitis (less than 2%). Respiratory Upper respiratory tract infection (8%); cough (7%); dyspnea (3%); pharyngitis (2%); aggravated bronchospasm, bronchitis, bronchospasm, coughing, pneumonia (less than 2%). Miscellaneous Pyrexia (9%); injury and poisoning (6%); accidental injury, back pain (3%); peripheral edema (2%); aggravated allergy, allergic reaction, chest pain, cyst not otherwise specified, facial edema, flu-like symptoms, generalized edema, hot flushes, pain, peripheral pain (less than 2%); anaphylactoid reaction, angioedema (postmarketing).

Interactions:

ACE inhibitors, angiotensin II antagonists NSAIDs may diminish the antihypertensive effect of these drugs. Alcohol, corticosteroids, SSRIs (eg, fluoxetine) May increase risk of GI bleeding. Antacids (containing aluminum or magnesium) Coadministration may decrease celecoxib plasma levels. Aspirin Coadministration may result in an increased rate of GI ulceration or other complications. Clopidogrel Risk of hemorrhage may be increased. CYP2C9 and CYP2D6 inhibitors There is a potential for drug interaction when coadministered with celecoxib. Diuretics Patients taking thiazides or loop diuretics may have an impaired response to therapy. Risk of renal impairment may be increased. Fluconazole, voriconazole Increase in celecoxib plasma concentration may occur. Heparin, low molecular weight heparin (eg, enoxaparin) Risk of hemorrhagic adverse reactions may be increased. Monitor closely. Lithium Mean steady-state lithium plasma levels increased about 17% when coadministered. Nonaspirin NSAIDs Avoid concomitant use because of the potential for increased risk of adverse reactions. Warfarin Monitor anticoagulant activity, particularly in the first few days, after initiating or changing celecoxib therapy in patients receiving warfarin or similar agents.

Warnings:

Warnings CV risk May cause an increased risk of serious CV thrombotic events, MI, and stroke, which may be fatal. This risk may increase with duration of use. Patients with CV disease or risk factors for CV disease may be at higher risk. Celecoxib is contraindicated for the treatment of perioperative pain in the setting of CABG surgery. GI risk NSAIDs, including celecoxib, caused an increase in serious GI adverse reactions, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These reactions can occur at any time during use and without warning symptoms. Elderly patients are at higher risk for serious GI events. Monitor Monitor BP closely during initiation and throughout therapy. Monitor CBC and chemistry profile periodically during long-term use. Monitor for signs and symptoms of GI bleeding. Monitor renal function in patients with advanced renal disease. Monitor liver function in patients with signs and symptoms of liver dysfunction. Monitor for the development of abnormal coagulation tests in patients with JRA. Pregnancy Category C . Category D from 30 weeks’ gestation onward. Because celecoxib may cause premature closure of the patent ductus arteriosus, avoid use in late pregnancy. Lactation Excreted in breast milk. Children Safety and efficacy not established in children younger than 2 yr of age or less than 10 kg (22 lb) with JRA. For other indications, safety and efficacy not established in patients younger than 18 yr of age. Elderly There have been more spontaneous reports of fatal GI events and acute renal failure in elderly patients. Hypersensitivity Severe anaphylactoid reactions and angioedema have occurred. Renal Function Not recommended in patients with advanced renal disease. Hepatic Function Not recommended in patients with severe hepatic impairment. Anemia May occur. Aspirin triad Use not recommended. Asthma Use with caution in patients with preexisting asthma. CHF and edema Fluid retention and edema have been observed. Use with caution. Debilitated patients Use with caution. Most spontaneous reports of fatal GI events are in debilitated patients. Dermatologic Can cause serious skin reactions, which may be fatal (eg, Stevens-Johnson syndrome, TEN). FAP Celecoxib has not been shown to reduce the risk of GI cancer or the need for prophylactic colectomy or other FAP-related surgeries. Therefore, usual care of FAP patients should not be altered. GI effects Use with extreme caution in patients with history of ulcer disease or GI bleeding. Hepatic effects Elevated liver enzymes may occur. Rare cases of severe hepatic reactions (eg, jaundice, hepatic failure) have occurred. Discontinue use if liver disease develops or if systematic manifestations occur (eg, eosinophilia, rash). Hypertension Use with caution. Can lead to onset of new hypertension or worsening of preexisting hypertension. Renal effects Long-term use of NSAIDs has resulted in renal papillary necrosis and other renal injury. Those at greater risk are patients with impaired renal function, heart failure, or liver dysfunction; those taking diuretics, angiotensin II receptor antagonists, or ACE inhibitors; and elderly patients. Sulfa allergy Do not use in patients with a sulfa allergy. Systemic-onset JRA Use with caution because of risk of serious adverse reactions, including DIC.

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