Celebrex

Celebrex

celecoxib

Manufacturer:

Pfizer
Concise Prescribing Info
Contents
Celecoxib
Indications/Uses
Relief of signs & symptoms of OA, RA in adults, ankylosing spondylitis & the short-treatment of acute pain in adults following surgery or musculoskeletal injury.
Dosage/Direction for Use
The lowest dose should be sought for each patient. OA 200 mg once daily or 100 mg twice daily. RA 100 to 200 mg twice daily. Ankylosing spondylitis 200 mg once daily or 100 mg twice daily. Max total daily dose: 400 mg. Acute pain Initially 400 mg followed by an additional 200 mg, if needed on the 1st day. On subsequent days, 200 mg twice daily. Max: 7 days. Moderate hepatic impairment Reduce dose by 50%.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to celecoxib or sulfonamides. Patients who have experienced asthma, urticaria or allergic-type reactions after taking acetylsalicylic acid or other NSAIDs including other COX-2 specific inhibitors. Treatment of peri-op pain in the setting of CABG surgery.
Special Precautions
Increased risk of serious CV thrombotic events, MI & stroke; serious GI adverse events including bleeding, ulceration & perforation of the stomach or intestines. Patients w/ fluid retention or heart failure. Concurrent use w/ acetylsalicylic acid, non-aspirin NSAID, diuretics, ACE inhibitors. New onset of HTN or worsening of preexisting HTN. Closely monitor BP during initiation & throughout course of therapy. Fluid retention or heart failure; 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. Prior history of peptic ulcer disease &/or GI bleeding & who use NSAIDs. Dehydrated patients; rehydrate patients prior to start of therapy. Not to be given to patients w/ acetylsalicylic acid triad. Serious skin reactions eg, exfoliative dermatitis, Stevens-Johnson syndrome & toxic epidermal necrolysis. Discontinue at 1st appearance of skin rash or any other sign of hypersensitivity. Long-term administration of NSAIDs. Periodically check complete blood count & chemistry profile. Not a substitute for corticosteroids or to treat corticosteroid insufficiency. Check Hb or hematocrit if patient exhibit any signs or symptoms of anemia or blood loss. Pre-existing asthma. Unexplained wt gain or edema. Advanced renal disease. Evaluate patients w/ signs &/or symptoms suggesting liver dysfunction or in whom abnormal liver test occurred. Consider w/drawal of treatment in women who have difficulties conceiving or who are undergoing investigation of infertility. Avoid use at 30 wk of pregnancy onwards. Lactation. Ped patient <18 yr. Elderly or debilitated patient.
Adverse Reactions
Bronchitis, rhinitis, sinusitis, upper resp tract infection, UTI; insomnia; dizziness; HTN (including aggravated HTN); coughing; vomiting, abdominal pain, diarrhea, dyspepsia, flatulence; pruritus (includes pruritus generalized), rash; peripheral oedema. Ear infection, fungal infection; MI, angina pectoris; dyspnoea; nausea, GERD, diverticulum, dysphagia, irritable bowel syndrome; increased hepatic enzyme; muscle spasms; nephrolithiasis; vag haemorrhage, prostatitis, benign prostatic hyperplasia; increased blood creatinine, increased prostatic specific antigen, increased wt.
Drug Interactions
Increased plasma conc w/ CYP2C9 inhibitors & fluconazole. Decreased plasma conc w/ CYP2C9 inducers eg, rifampicin, carbamazepine & barbiturates. May diminish effect of antihypertensives including ACE inhibitors, angiotensin receptor blockers, diuretics & β-blockers. Possible deterioration of renal function w/ ACE inhibitors, AIIA or diuretics in patients who are elderly, vol-depleted or w/ compromised renal function. Increased risk of nephrotoxicity w/ cyclosporine. Reduce natriuretic effect of furosemide & thiazides. Increased rate of GI ulceration or other complications w/ acetylsalicylic acid. Not a substitute for acetylsalicylic acid for CV prophylaxis. Increased plasma conc of lithium, dextromethorphan & metoprolol. Increased risk of bleeding w/ oral anticoagulants.
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
10 × 10's;3 × 10's (Rp435,080/boks)
Form
Celebrex cap 200 mg
Packing/Price
10 × 10's;3 × 10's (Rp611,874/boks)
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