Celebrex

Celebrex

celecoxib

Manufacturer:

Pfizer

Distributor:

PF OFG
Concise Prescribing Info
Contents
Celecoxib
Indications/Uses
Symptomatic treatment of OA & RA. Relief of signs & symptoms of ankylosing spondylitis (AS). Management of acute pain. Primary dysmenorrhea. Acute & chronic low back pain.
Dosage/Direction for Use
Adult Symptomatic treatment of OA 200 mg as single dose or 100 mg bid. Symptomatic treatment of RA 100 or 200 mg bid. AS 200 mg as single dose or 100 mg bid. Total daily dose: 400 mg. Management of acute pain Initially 400 mg, followed by an additional 200 mg if needed on the 1st day; subsequently 200 mg bid or 400 mg once daily as needed. Primary dysmenorrhea Initially 400 mg, followed by an additional 200 mg if needed on the 1st day; subsequently 200 mg bid as needed. CYP2C9 poor metabolizers Start treatment at half the lowest recommended dose. Elderly <50 kg Initiate therapy at the lowest recommended dose. Arthritis or pain patients w/ moderate hepatic impairment & those receiving fluconazole Introduce at half the recommended dose.
Administration
May be taken with or without food: For patients w/ swallowing difficulties, open cap & empty contents in 1 tsp (5 mL) applesauce/rice gruel/yogurt/mashed banana. Swallow immediately w/ water.
Contraindications
Hypersensitivity to celecoxib & sulfonamides. Patients who experienced asthma, urticaria or allergic-type reactions after taking aspirin- or other NSAIDs, including other COX-2 specific inhibitors. Treatment of peri-operative pain in the setting of CABG surgery.
Special Precautions
Patients w/ ischemic heart disease & those w/ risk factors for heart disease; HTN; hyperlipidemia, diabetes, smoking & in patients w/ peripheral arterial disease. Increased risk of serious CV thrombotic events, MI, & stroke. Not a substitute for acetylsalicylic acid for prophylaxis of CV thromboembolic diseases. Onset of new HTN or worsening of preexisting HTN. Closely monitor BP during initiation & throughout the course of therapy; patients w/ preexisting CHF or HTN; renal function in patients w/ advanced renal disease. Patients w/ compromised cardiac function, preexisting edema or other conditions predisposing to, or worsened by, fluid retention including those taking diuretic treatment or otherwise at risk of hypovolemia. Risk of developing GI complications (upper & lower GI perforations, ulcers or bleeds) in elderly, patients w/ CV disease; concomitant use w/ glucocorticoids, antiplatelet drugs (eg, aspirin), or other NSAIDs; alcohol use; those w/ prior history of, or active GI disease (eg, ulceration, GI bleeding or inflammatory conditions). Dehydrated patients; rehydrate patients prior to start of therapy. Anaphylactoid reactions. Discontinue at the 1st appearance of skin rash, mucosal lesions, or any other signs of hypersensitivity. Patients who are known or suspected to be poor CYP2C9 metabolizers. Concomitant use w/ oral anticoagulants including warfarin/coumarin-type & novel oral anticoagulant (eg, apixaban, dabigatran & rivaroxaban). Avoid concomitant use w/ non-aspirin NSAID. May diminish utility of diagnostic signs in detecting infections eg, fever. Renal toxicity. Moderate hepatic impairment (Child-Pugh class B). Not recommended w/ severe hepatic impairment (Child-Pugh class C). Avoid use during 2nd & 3rd trimester of pregnancy. Lactation.
Adverse Reactions
Bronchitis, sinusitis, upper resp tract infection, UTI; insomnia; dizziness; HTN (including aggravated HTN); cough; vomiting, abdominal pain, diarrhea, dyspepsia, flatulence; pruritus (includes generalized pruritus), rash; peripheral edema.
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 including warfarin/coumarin-type & novel oral anticoagulants (eg, apixaban, dabigatran, & rivaroxaban). Increased lithium plasma levels. May diminish effects of antihypertensives including ACE inhibitors, angiotensin receptor blockers, diuretics & β-blockers. May increase risk of nephrotoxicity w/ cyclosporine. Increased plasma conc of dextromethorphan & metoprolol. Reduced natriuretic effect of furosemide & thiazides.
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 100 mg
Packing/Price
60's (P2,677/pack)
Form
Celebrex cap 200 mg
Packing/Price
60's (P3,785.39/pack)
Form
Celebrex cap 400 mg
Packing/Price
60's (P4,865.56/pack)
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