Anfarm Hellas


Concise Prescribing Info
Parecoxib Na
Management of post-op pain in immediate post-op setting only.
Dosage/Direction for Use
Management of acute pain Initially 40 mg IV/IM, followed by 20 or 40 mg every 6-12 hr up to max: 80 mg daily. Elderly <50 kg Initially ½ usual dose. Max: 40 mg daily.
Hypersensitivity to parecoxib Na, valdecoxib, ASA, NSAIDs or other COX-2 inhibitors; sulfonamides. Patients undergoing CABG or other major vascular surgery; w/ unstable or significant established ischaemic heart disease, peripheral arterial disease &/or cerebrovascular disease. Severe hepatic impairment (Child-Pugh ≥10).
Special Precautions
Hypersensitivity to sulfonamides. Discontinue use at 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. History of GI disease eg, ulceration, bleeding, perforation; risk factors associated w/ PUD. Increased risk of CV & thrombotic adverse events in long-term use. Patients w/ compromised cardiac function, pre-existing oedema or other conditions predisposed to or worsened by fluid retention, or at risk of hypovolemia; significant risk factors for CV events eg, HTN, hyperlipidaemia, DM, smoking. May mask fever & other signs of inflammation. Closely monitor BP during therapy. Ensure adequate hydration. Avoid use w/ other non-ASA NSAIDs. Concomitant use w/ warfarin or other oral anticoagulants, glucocorticoids, SSRIs, other antiplatelets & NSAIDs, alcohol, ASA, fluconazole, corticosteroid therapy, diuretics. May affect ability to drive & use machines. Not recommended in severe hepatic impairment. Moderate hepatic (Child-Pugh 7-9) & severe renal (CrCl <30 mL/min) impairment. Not recommended in women of childbearing potential. Not to be given during pregnancy. Lactation. Childn <18 yr. Elderly or debilitated patients.
Adverse Reactions
Nausea. Abdominal pain, constipation, dyspepsia, vomiting; peripheral edema; alveolar osteitis; dizziness; insomnia; oliguria; increased sweating, pruritus; hypotension.
Drug Interactions
Increased risk of bleeding w/ warfarin or other oral anticoagulants. Increased risk of GI ulceration or other complications w/ low-dose ASA. Diminished effects of ACE inhibitors, AIIA, β-blockers, diuretics. Further deterioration of renal function w/ ACE inhibitors or AIIA. Increased nephrotoxic effect w/ cyclosporine, tacrolimus. Increased plasma exposure w/ fluconazole, ketoconazole. Increased metabolism w/ enzyme inducers eg, rifampicin, phenytoin, carbamazepine or dexamethasone. Increased plasma exposure of CYP2D6 substrate eg, dextromethorphan, flecainide, propafenone, metoprolol; CYP2C19 substrate eg, omeprazole, phenytoin, diazepam, imipramine. Increased MTX plasma levels. Decreased lithium serum & renal clearance. Not recommended for reconstitution w/ lactated ringer's, glucose in lactated ringer's, sterile water for inj.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AH04 - parecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Parecoxb powd for inj 40 mg
10 × 1's
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