Concise Prescribing Info
Contents
Celecoxib
Indications/Uses
Management of acute pain in adults & treatment of primary dysmenorrhea. Relief of acute & chronic pain, RA & OA inflammation. Symptomatic relief of ankylosing spondylitis & management of low back pain.
Dosage/Direction for Use
Adult Symptomatic treatment of OA 200 mg as single dose. Symptomatic treatment of RA 200 mg bd. Ankylosing spondylitis 200 mg as single dose. Total dose: 400 mg daily. Management of acute pain & treatment of primary dysmenorrhea Initially 400 mg, followed by 200 mg if needed on 1st day. Subsequently, 200 mg bd as needed. Low back pain 200 mg once daily.
Administration
May be taken with or without food: Dose for OA/RA may be given w/ or w/o meals.
Contraindications
Hypersensitivity to celecoxib or sulfonamides. Patients who have experienced asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDs including other COX-2 inhibitors; established CV disease (ischemic heart disease & stroke); HTN; active peptic ulceration or GI bleeding; inflammatory bowel disease; CHF (NYHA II-IV); established peripheral arterial &/or cerebrovascular disease. Peri-op pain treatment in CABG surgery. Severe hepatic dysfunction (serum albumin <25 g/L or Child-Pugh score 10). Patients w/ estimated CrCl <30 mL/min.
Special Precautions
Discontinue use at 1st appearance of skin rash, mucosal lesions or other sign of hypersensitivity. Serious skin infections eg, exfoliative dermatitis, Stevens-Johnson syndrome & toxic epidermal necrolysis. Anaphylactoid reactions. Not a substitute for acetylsalicylic acid for prophylaxis of CV thromboembolic diseases. Increased risk of serious CV thrombotic events, MI & stroke. Risk of GI ulceration, bleeding & perforation. History of serious GI events & other risk factors associated w/ PUD eg, alcoholism, smoking, corticosteroid therapy. Patients w/ risk factors of heart disease, HTN, hyperlipidemia, diabetes, peripheral arterial disease; compromised cardiac function, history of CV disease; preexisting edema, other conditions predisposed to or worsened by fluid retention; hypovolaemia. Patients known or suspected to be CYP2C9 poor metabolizers. Ensure adequate hydration. Closely monitor BP during therapy. Avoid use w/ non-aspirin NSAID. Concomitant use w/ ACE inhibitors, thiazide or loop diuretics; aspirin, glucocorticoids or other NSAIDs; oral corticosteroids; anticoagulants eg, warfarin/coumarin-type & novel oral anticoagulants eg, apixaban, dabigatran, rivaroxaban; SSRIs; CYP2D6-metabolized drugs. Not recommended in severe hepatic impairment. Moderate hepatic impairment (Child-Pugh class B). Advanced renal disease; renal impairment. Avoid use during 3rd trimester of pregnancy. Lactation. Elderly or debilitated patients.
Adverse Reactions
Diarrhea. Bronchitis, sinusitis, upper resp tract, ear & fungal infection, UTI; insomnia; dizziness; MI, angina pectoris; HTN; cough, dyspnoea; vomiting, abdominal pain, dyspepsia, flatulence, dysphagia, irritable bowel syndrome, GERD, nausea, diverticulum; pruritus, rash; oedema, peripheral edema, increased blood creatinine, prostatic specific antigen & wt; muscle spasms; nephrolithiasis; vag haemorrhage, prostatitis, benign prostatic hyperplasia.
Drug Interactions
Increased plasma conc w/ CYP2C9 inhibitors. Decreased plasma conc w/ CYP2C9 inducers eg, rifampicin, carbamazepine, barbiturates. Potential in vivo interaction w/ CYP2D6-metabolized drugs. Increased lithium plasma levels. Diminished effect of antihypertensives eg, ACE inhibitors, ARBs, diuretics, β-blockers. Unresponsiveness to lisinopril. Increased risk of nephrotoxicity w/ cyclosporine. Increased Cmax & AUC w/ fluconazole. Increased plasma conc of dextromethorphan, metoprolol. Reduced natriuretic effect of furosemide, thiazides.
ATC Classification
M01AH01 - celecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Presentation/Packing
Form
Rabirox cap 200 mg
Packing/Price
10 × 10's
Form
Rabirox cap 400 mg
Packing/Price
10 × 10's
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