Celebrex

Celebrex

celecoxib

Manufacturer:

Viatris
Concise Prescribing Info
Contents
Celecoxib
Indications/Uses
Symptomatic treatment of OA & RA. Management of acute pain in adults & chronic low back pain. Primary dysmenorrhea. Relief of signs & symptoms of ankylosing spondylitis (AS).
Dosage/Direction for Use
Adult OA & AS 200 mg as a single dose or 100 mg bd. Max daily dose: 400 mg. RA 100 or 200 mg bd. Max daily dose: 400 mg. Acute pain & primary dysmenorrhoea Initially 400 mg followed by 200 mg if needed on the 1st day. Subsequently, 200 mg bd as needed. Chronic low back pain 200 or 400 mg daily, administered as a 200-mg single dose, or 100 or 200 mg bd. Total daily dose: 400 mg. Moderate hepatic impairment (serum albumin 25-35 g/L or Child-Pugh Class B), patient co-administered w/ fluconazole & CYP2C9 poor metabolizers Initiate treatment at ½ the recommended dose.
Administration
May be taken with or without food: Doses up to 200 mg bd can be taken w/ or w/ food. For patients w/ difficulty swallowing, the entire contents of the cap can be carefully emptied onto a level tsp of cool/room temp applesauce/rice gruel/yogurt/mashed banana & should be ingested immediately w/ water.
Contraindications
Hypersensitivity to celecoxib or sulfonamides. Active peptic ulceration or GI bleeding. Patients who have experienced asthma, urticaria or allergic-type reactions after taking acetylsalicylic acid or other NSAIDs including other cyclooxygenase-2 specific inhibitors. Treatment of peri-op pain in CABG surgery. CHF (NYHA II-IV). Established ischemic heart disease, peripheral arterial disease &/or cerebrovascular disease.
Special Precautions
Anaphylactoid reactions. Possibly greater risk of serious skin reactions in patients w/ history of sulphonamide allergy or any allergy; discontinue at the 1st appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. May increase risk of serious CV thrombotic events, MI & stroke. Closely monitor BP during initiation & throughout the course of therapy; patients w/ preexisting CHF or HTN. Patients w/ compromised cardiac function, preexisting edema or other conditions predisposing to or worsened by fluid retention including those taking diuretics or at risk of hypovolemia. Risk of developing GI complications in patients w/ CV disease; concomitantly using glucocorticoids, antiplatelet drugs (eg, aspirin), other NSAIDs, alcohol; prior history of, or active GI disease (eg, ulceration, GI bleeding or inflammatory conditions). Concomitant use w/ oral anticoagulants including warfarin/coumarin-type & novel oral anticoagulants (eg, apixaban, dabigatran & rivaroxaban). Contains lactose; not for patients w/ rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption. May diminish the utility of diagnostic signs (eg, fever) in detecting infections. Avoid concomitant use w/ non-aspirin NSAIDs. Concomitant use w/ drugs metabolized by CYP2D6. Patients w/ dehydration. Closely monitor renal function in patients w/ advanced renal disease. Not recommended in patients w/ severe renal & hepatic impairment. Moderate hepatic impairment. Carefully monitor patient w/ liver dysfunction symptoms &/or signs, or abnormal liver function test. Consider w/drawal of treatment in women who have difficulties conceiving or who are undergoing infertility investigation. Pregnancy (may cause fetal renal dysfunction if used during 2nd or 3rd trimester of pregnancy) & lactation. Childn <18 yr. Potential fatal GI events in elderly & debilitated patients.
Adverse Reactions
Bronchitis, sinusitis, upper resp tract infection, UTI; insomnia; dizziness; HTN (including aggravated HTN); cough; vomiting, abdominal pain, diarrhea, dyspepsia, flatulence; pruritus (including generalized pruritus), rash; peripheral edema. Ear & fungal infection; MI, angina pectoris; dyspnea; dysphagia, irritable bowel syndrome, GERD, nausea, diverticulum; increased hepatic enzyme (including ALT & AST); muscle spasms; nephrolithiasis, vag hemorrhage, prostatitis, benign prostatic hyperplasia; increased blood creatinine, prostatic specific antigen & wt.
Drug Interactions
Increased plasma conc w/ CYP2C9 inhibitors & fluconazole. Decreased plasma conc w/ CYP2C9 inducers (eg, rifampicin, carbamazepine & barbiturates). Increased risk of bleeding w/ oral anticoagulants. May diminish antihypertensive effects of ACE inhibitors, angiotensin receptor blockers, diuretics & β-blockers. Risk of nephrotoxicity may be increased w/ cyclosporine. Increased plasma conc of dextromethorphan & metoprolol. Reduced natriuretic effect of furosemide & thiazides. Increased lithium plasma levels.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AH01 - celecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Presentation/Packing
Form
Celebrex cap 200 mg
Packing/Price
100's;10's;30's
Form
Celebrex cap 400 mg
Packing/Price
10's
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