Celebrex

Celebrex

celecoxib

Manufacturer:

Viatris Pharmaceuticals

Distributor:

Viatris
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 a single dose or 100 mg bid. Symptomatic treatment of RA 100 or 200 mg bid. AS 200 mg as a single dose or 100 mg bid. Some patient may benefit from 400 mg total daily dose. Management of acute pain Initially 400 mg, followed by an additional 200 mg if needed on the 1st day. On subsequent days, 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. On subsequent days, 200 mg bid as needed. CYP2C9 poor metabolizer Consider starting treatment at ½ the lowest recommended dose. Elderly <50 kg Initiate therapy at the lowest recommended dose. Patient w/ moderate hepatic impairment (Child-Pugh class B) Arthritis or pain Introduce at ½ 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 or sulfonamides. Patients who experienced asthma, urticaria or allergic-type reactions after taking ASA (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 & patients w/ peripheral arterial disease; patients w/ compromised cardiac function, pre-existing edema or other conditions predisposing to, or worsened by, fluid retention including those taking diuretic treatment or otherwise at risk of hypovolemia; patients w/ dehydration; moderate hepatic impairment (Child-Pugh class B); patients who are known or suspected to be poor CYP2C9 metabolizers. Increased risk of serious CV thrombotic events, MI, & stroke. Not a substitute for ASA for prophylaxis of CV thromboembolic diseases. Can lead to onset of new HTN or worsening of pre-existing HTN. Closely monitor BP during initiation of therapy & throughout the course of therapy. Risk of fluid retention & edema. Risk of developing GI complications (upper & lower GI perforations, ulcers or bleeds). Risk of anaphylactoid reactions. Discontinue treatment at the 1st appearance of skin rash, mucosal lesions, or any other signs of hypersensitivity. Concomitant use w/ oral anticoagulants including warfarin/coumarin-type & novel oral anticoagulant (eg, apixaban, dabigatran & rivaroxaban); drugs that are metabolized by CYP2D6. Avoid concomitant use w/ non-aspirin NSAID. May diminish utility of diagnostic signs in detecting infections eg, fever. May cause renal toxicity; carefully monitor patients at greatest risk for renal toxicity eg, those w/ impaired renal function, heart failure, liver dysfunction, & elderly. Closely monitor renal function in patients w/ advanced renal disease. Not recommended w/ severe hepatic impairment (Child-Pugh class C). Carefully monitor patients w/ symptoms &/or signs of liver dysfunction, or in whom abnormal LFT has occurred, for evidence of development of a more severe hepatic reaction while on therapy. Avoid use during 3rd trimester of pregnancy. May cause fetal renal dysfunction if used during 2nd or 3rd trimester of pregnancy. Use during pregnancy only if potential benefit to the mother justifies potential risk to the fetus. Decision should be made whether to discontinue nursing during treatment or discontinue the drug. Consider w/drawal of treatment in women who have difficulties conceiving or who are undergoing investigation of infertility.
Adverse Reactions
Bronchitis, sinusitis, URTI, UTI; insomnia; dizziness; HTN (including aggravated HTN); cough; vomiting, abdominal pain, diarrhea, dyspepsia, flatulence; pruritus (includes 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 (eg, fluconazole). Decreased plasma conc w/ CYP2C9 inducers eg, rifampicin, carbamazepine, & barbiturates. Potential for an in vivo drug interaction w/ drugs that are metabolized by CYP2D6. Increased risk of bleeding w/ oral anticoagulants or similar agents. Increased lithium plasma levels. May diminish the effect of antihypertensives including ACE inhibitors &/or ARBs, diuretics & β-blockers. May result in deterioration of renal function, including possible acute renal failure, w/ ACE inhibitors, AIIA or diuretics in patients who are elderly, vol-depleted (including those on diuretic therapy), or w/ compromised renal function. May increase risk of nephrotoxicity w/ cyclosporine. Increased plasma conc of dextromethorphan & metoprolol. Can reduce 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 (P55.5/cap)
Form
Celebrex cap 200 mg
Packing/Price
60's (P71/cap)
Form
Celebrex cap 400 mg
Packing/Price
60's (P90.5/cap)