Novugen Pharma


Novugen Pharma
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, sulfonamides, ASA or NSAIDs including COX-2 inhibitors. Active peptic ulceration or GI bleeding; 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 score ≥10). 3rd trimester of pregnancy. Lactation.
Special Precautions
Hypersensitivity to sulfonamides. Discontinue use at 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Serious skin reactions eg, erythema multiforme, SJS, TEN, DRESS syndrome. Increased risk of CV & thromboembolic adverse events; history of or active GI disease eg, ulceration, bleeding or inflammatory conditions; other risk factors associated w/ PUD; severe hypotension; HTN. Patients w/ compromised cardiac function, pre-existing edema or other conditions predisposed to or worsened by fluid retention, or at risk of hypovolemia. Ensure adequate hydration. Avoid use w/ non-specific NSAIDs. Concomitant use w/ fluconazole, aspirin, corticosteroids, SSRIs, other antiplatelets & NSAIDs, oral anticoagulants; alcohol. May affect ability to drive & use machines. Not recommended in severe hepatic impairment. Advanced renal disease; severe renal impairment (CrCl <30 mL/min). Moderate hepatic impairment (Child-Pugh class B). Not recommended in women of childbearing potential. Not to be given during 1st & 2nd trimesters of pregnancy. Lactation. Childn <18 yr. Elderly or debilitated patients.
Adverse Reactions
Nausea. Pharyngitis, alveolar osteitis; 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/ known CYP3A4 & 2C9 inhibitors. Increased risk of bleeding w/ oral anticoagulants eg, warfarin. Enhanced AUC w/ fluconazole, ketoconazole. Diminished effect of ACE inhibitors, AIIA, β-blockers, diuretics. Deteriorated renal function w/ ACE inhibitors &/or AIIA. Reduced natriuretic effect of furosemide, thiazides. Increased risk of nephrotoxicity w/ cyclosporine. Increased MTX plasma levels. Decreased lithium serum & renal clearance.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AH04 - parecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Dycox powd for inj 40 mg
10 × 1's
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