Zuellig Pharma
Concise Prescribing Info
Short-term treatment of acute post-op pain.
Dosage/Direction for Use
Management of acute pain Initially 40 mg IV/IM followed by 20 mg every 6-12 hr as required. Max: 60 mg daily. Elderly <50 kg Max: 40 mg daily.
Hypersensitivity to parecoxib & sulphonamides. History of previous serious allergic drug reaction of any type, especially cutaneous reaction (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme). Active peptic ulceration or GI bleeding; patients who experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or other allergic-type reactions following aspirin or NSAIDs including other COX-2 specific inhibitors intake. Inflammatory bowel disease; CHF (NYHA II-IV). Treatment of post-op pain following CABG surgery; established ischaemic heart disease, peripheral arterial disease &/or cerebrovascular disease. Severe hepatic impairment (serum albumin <25 g/L or Child-Pugh class C). Pregnancy (3rd trimester) & lactation.
Special Precautions
Administration other than IV or IM (eg, intra-articular intrathecal). Limited clinical experience or treatment >3 days. Discontinue use if there is any organ system functions deterioration during treatment. Increased risk of CV & thrombotic adverse events associated w/ COX-2 inhibitors when taken long-term appears to be similar in those w/ or w/o known CV disease or CV risk factors. Patients w/ significant risk factors for CV events (eg, HTN, hyperlipidemia, DM, smoking). Not studied in CV revascularization procedures other than CABG. Patients w/ active or history of GI disease eg, ulceration, bleeding, or inflammatory conditions; or concomitantly using aspirin. Potential association w/ increased GI complications when co-administered w/ corticosteroids, SSRIs, other antiplatelet drugs, other NSAIDs or patients ingesting alcohol. Monitor for any serious skin reaction or severe hypotension during treatment. Discontinue use at the 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Increase risk of bleeding w/ oral anticoagulants (eg, apixaban, dabigatran & rivaroxaban). Monitor anticoagulant activity in patients on warfarin (or similar agent) therapy, particularly during the 1st few days after initiation of treatment. HTN; compromised cardiac function, preexisting edema or other conditions predisposing to, or worsened by fluid retention including those taking diuretic therapy or at risk of hypovolemia. Impaired renal function, advanced renal disease. Moderate hepatic impairment (Child-Pugh class B). Carefully monitor patients for evidence of the development of severe hepatic reaction while on therapy. Initiate treatment to dehydrated patients. Avoid concomitant use w/ other nonspecific NSAIDs. Not a replacement for aspirin in the prophylactic treatment of CV disease. May affect the ability to drive or operate machinery. Do not use during pregnancy (1st & 2nd trimesters). Not recommended in childn <18 yr. Elderly.
Adverse Reactions
Nausea. Pharyngitis, alveolar osteitis (dry socket); post-op anaemia; hypokalaemia; agitation, insomnia; hypoaesthesia, dizziness; HTN, hypotension; resp insufficiency; abdominal pain, vomiting, constipation, dyspepsia, flatulence; pruritus, hyperhidrosis; back pain; oliguria; peripheral oedema; increased blood creatinine.
Drug Interactions
Increased AUC w/ CYP3A4 (eg, ketoconazole) & CYP2C9 (eg, fluconazole) inhibitors. May diminish the effect of ACE inhibitors, angiotensin II antagonists, β-blockers & diuretics. Reduced the natriuretic effect of furosemide & thiazides. Increased plasma levels of methotrexate. Decreased lithium serum & renal clearance. Increased risk of GI ulceration or other GI complications in concomitant use w/ low-dose aspirin. Increased nephrotoxic effect of cyclosporine & tacrolimus. Increase plasma conc of dextromethorphan. Caution w/ drugs predominantly metabolized by CYP2D6 & which have narrow therapeutic margins (eg, flecainide, propafenone, metoprolol). Increased AUC of warfarin (or similar agents) & prothrombin time.
ATC Classification
M01AH04 - parecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Dynastat powd for inj 40 mg
(vial + 2-mL amp solvent of NaCl 9 mg/mL soln) 5 × 1's
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