Prosp Pharma
Concise Prescribing Info
Symptomatic treatment of OA & RA. Relief of signs & symptoms of ankylosing spondylitis. Management of acute & low back pain. Primary dysmenorrhea.
Dosage/Direction for Use
OA 200 mg as a single dose. May increase to 200 mg bid in patients w/ insufficient relief from symptoms. RA 200 mg bid. Ankylosing spondylitis (AS) 200 mg as a single dose. Total daily dose: 400 mg. Acute pain or primary dysmenorrhea Initially 400 mg, followed by 200 mg on day 1 as needed. On subsequent days, 200 mg bid or 400 mg once daily as needed. Low back pain 200 or 400 mg daily, administered as 200 mg single dose or as 100 or 200 mg bid. Total daily dose: 400 mg.
May be taken with or without food.
Hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs. History of asthma, urticaria or allergic-type reactions w/ aspirin or other NSAIDs. CABG surgery.
Special Precautions
Do not use in patients w/ hypersensitivity to celecoxib & sulfonamides; patients w/ coronary artery surgery on immediately post-op period; CV or cerebrovascular diseases; MI or CHF (NYHA II-IV); history of ischemic heart disease or paresis, paralysis due to CVA. Patients w/ risk factors for developing CHD eg, HTN, hyperlipidemia, diabetes, smoking, elderly. Discontinue if signs & symptoms of Stevens-Johnson syndrome, rash or common cold occur; w/ persistent or worsening abnormal renal function test. Prolonged use. May increase risk of serious & potentially fatal adverse CV thrombotic events eg, MI & stroke; serious GI inflammatory, ulceration, bleeding & perforation. History of PUD. Anemia; monitor Hb or hematocrit in patients on long-term treatment. Risk for renal toxicity in patients w/ impaired renal function, dehydration, hypovolemia, heart failure, liver dysfunction, taking diuretics, ACE inhibitors, angiotensin II receptor blockers. Rehydrate patient prior to therapy; closely monitor renal function. Decreased hepatic or renal function. Not recommended for patients w/ severe hepatic impairment & avoid use in advanced renal disease. Pregnancy (avoid starting at 30-wk gestation) & lactation. Elderly.
Adverse Reactions
Upper abdominal pain, GERD; nasopharyngitis; injury & poisoning. Aggravated HTN, CAD; fetal intracranial hemorrhage; cellulitis contact dermatitis, dermatitis, dry skin, rash erythematous/maculopapular, skin disorder/nodule; diverticulitis, dysphagia, hemorrhoids, abnormal hepatic function, hiatal hernia, tenesmus; increased alkaline phosphatase & creatine phosphokinase; hypercholesterolemia, increased non-protein nitrogen, hypoglycemia, hyponatremia; arthrosis, leg cramps, synovitis, tendinitis; aggravated bronchospasm, laryngitis; deafness; aggravated allergy, cyst NOS, hot flushes, peripheral pain.
Drug Interactions
May increase levels/effects of 5-aminosalicylic acid derivatives, ajmaline, aliskiren, aminoglycosides, aminolevulinic acid (systemic & topical), amodiaquine, anticoagulants, aripiprazole, bisphosphonate derivatives, cyclosporine (systemic), CYP2C8 substrates (high risk w/ inhibitors), deferasirox, desmopressin, dexibuprofen, digoxin, drospirenone, eplerenone, estrogen derivatives, haloperidol, lithium, mecamylamine, methotrexate, NSAIDs (COX-2 selective), omacetaxine, perhexiline, porfimer, K-sparing diuretics, pralatrexate, prilocaine, quinolones, selexipag, Na nitrate, tacrolimus (systemic), tenofovir products, tolperisone, triflusal, vancomycin, verteporfin, vit K antagonists. Levels/effects may be increased by acemetacin, alcohol (ethyl), angiotensin II receptor blockers, ACE inhibitors, aspirin; ceritinib, corticosteroids (systemic), cyclosporine (systemic), CYP2C9 inhibitors (moderate), CYP2C9 inhibitors (strong), dapsone (topical), dexketoprofen, felbinac, floctafenine, herbs (anticoagulant/antiplatelet properties), ketorolac (nasal), ketorolac (systemic), loop diuretics, lumacaftor, mifepristone, morniflumate, naftazone, nitric oxide, NSAIDs, pelubiprofen, phenylbutazone, probenecid, SSRIs, Na phosphates, talniflumate, tenoxicam, tetracaine (topical), thiazide & thiazide-like diuretics, tolperisone, TCAs (tertiary amine), triflusal, zaltoprofen. May decrease levels/effects of aliskiren, angiotensin II receptor blockers, ACE inhibitors, β-blockers, eplerenone, hydralazine, loop/K-sparing/thiazide & thiazide-like diuretics, macimorelin, mifamurtide, prostaglandins (ophthalmic), SSRIs. Levels/effects may be decreased by bile acid sequestrants, CYP2C9 inducers (moderate), dabrafenib, enzalutamide, lumacaftor, rifapentine. Delayed peak conc & increased AUC w/ high fat meal. Avoid concomitant use w/ acemetacin, aminolevulinic acid (systemic), amodiaquine, dexibuprofen, dexketoprofen, floctafenine, ketorolac (nasal, systemic), macimorelin, mecamylamine, mifamurtide, morniflumate, NSAIDs, NSAIDs (COX-2 selective), omacetaxine, pelubiprofen, phenylbutazone, talniflumate, tenoxicam, zaltoprofen.
ATC Classification
M01AH01 - celecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Painex Cap 400 mg
3 × 10's
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