Dynastat

Short-term treatment of acute post-op pain.

IV/IM Acute pain management Recommended single or initial dose: 40 mg followed by 20 mg every 6-12 hr as required. Max daily dose: 60 mg. Moderate hepatic impairment (Child-Pugh class B) Max daily dose: 40 mg. Elderly weighing <50 kg May reduce initial dose by 50%. Max daily dose: 40 mg.

Hypersensitivity to parecoxib & sulphonamides. History of serious allergic drug reaction of any type especially cutaneous reaction (eg, SJS, TEN, erythema multiforme). Active peptic ulceration or GI bleeding. Patients who experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking ASA or NSAIDs including other COX-2 specific inhibitors. Inflammatory bowel disease. CHF (NYHA II-IV). Treatment of post-op pain following CABG surgery. Established ischemic 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.

Discontinue use at the 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Not to be administered other than IV/IM (eg, IA, intrathecal). Limited clinical experience w/ treatment >3 days. Discontinue use if there is deterioration in any organ system functions during treatment. Increased risk of CV & thrombotic adverse events when taken long-term; patients w/ known CV disease or risk factors may be at greater risk. Carefully consider patients w/ significant risk factors for CV events (eg, HTN, hyperlipidaemia, DM, smoking). CV revascularisation procedures other than CABG. Patients w/ active or history of GI disease (eg, ulceration, bleeding or inflammatory conditions); or concomitantly using aspirin. Possible increased GI complications when co-administered w/ corticosteroids, SSRIs, antiplatelets, NSAIDs or alcohol. Monitor for any serious skin reactions. Possible DRESS. Increased risk of generalised bullous fixed drug eruption. Possible severe hypotension. Increased risk of bleeding w/ oral anticoagulants. Monitor anticoagulant activity in patients receiving warfarin or similar agents particularly during 1st few days after initiating treatment. New onset or worsening of pre-existing HTN; closely monitor BP during initiation & throughout therapy. Patients w/ compromised cardiac function, pre-existing oedema or other predisposing conditions to or worsened by fluid retention including those taking diuretics or at risk of hypovolemia. Patients w/ dehydration; rehydrate patients prior to therapy. Use lowest recommended dose of Dynastat when co-administered w/ fluconazole. Closely monitor renal function in patients w/ advanced renal disease. Closely monitor kidney function & initiate Dynastat at lowest recommended dose in patients w/ severe renal impairment (CrCl <30 mL/min) or those who may be predisposed to fluid retention. Carefully monitor for evidence of the development of more severe hepatic reaction while on therapy. May diminish utility of diagnostic signs (eg, fever in detecting infections). Avoid concomitant use w/ other non-specific NSAIDs. Patients who experience dizziness, vertigo or somnolence after treatment should refrain from driving or operating machines. Not recommended in women attempting to conceive. Pregnancy (1st & 2nd trimesters). Not recommended in childn <18 yr. Elderly.

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.

May increase AUC of warfarin (or similar agents) & prothrombin time. Enhanced AUC w/ CYP3A4 (eg, ketoconazole) & CYP2C9 (eg, fluconazole) inhibitors. May diminish effects of ACE inhibitors, AIIA, β-blockers & diuretics. Possible renal function deterioration including acute renal failure when co-administered w/ ACE inhibitors &/or AIIA in elderly, patients who are vol-depleted or w/ compromised renal function. Reduced natriuretic effect of furosemide & thiazides. May increase plasma levels of MTX. Decreased lithium serum & renal clearance. Reduced daily requirement for PRN opioids when co-administered w/ parecoxib. Increased risk of GI ulceration or other GI complications in concomitant use w/ low-dose aspirin. Increased nephrotoxic effect of cyclosporine & tacrolimus. Increased plasma conc of dextromethorphan. Co-administration w/ medicinal products predominantly metabolised by CYP2D6 & which have narrow therapeutic margins (eg, flecainide, propafenone, metoprolol).

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AH04 - parecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.

POM