Dynastat

Dynastat

parecoxib

Manufacturer:

Pfizer

Distributor:

Zuellig
Concise Prescribing Info
Contents
Parecoxib Na
Indications/Uses
Short-term treatment of acute pain & post-op pain ie, oral surgery, abdominal hysterectomy, myomectomy, total knee replacement, total hip arthroplasty, laparoscopic cholecystectomy, inguinal hernia repair & other general surgery eg, diagnostic laparoscopy, gastrectomy, hernioplasty, appendectomy, hemithyroidectomy & splenectomy. Pre-op to prevent or reduce post-op pain & reduce opioid requirements when used concomitantly.
Dosage/Direction for Use
IV/IM Management of acute pain Initially 40 mg followed by 20 or 40 mg every 6-12 hr as required. Max: 80 mg/day. Prevention or reduction of post-op pain 40 mg 30-45 min prior to surgical incision, may be continued post-op as needed for adequate effect. Elderly <50 kg Reduce initial dose by 50%. Max: 40 mg/day. Moderate hepatic impairment (Child-Pugh class B), severe renal impairment (CrCl <30 mL/min) or predisposed to fluid retention, co-administration w/ fluconazole Lowest recommended dose.
Contraindications
Hypersensitivity to parecoxib or sulfonamides. History of previous serious allergic reaction of any type, especially cutaneous reactions eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme. Patients w/ history of CVA, MI, CABG, uncontrolled HTN, CHF (NYHA II-IV). Active peptic ulceration or GI bleeding. Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, bronchial asthma, angioneurotic edema, urticaria or other allergic-type reactions after taking aspirin or NSAIDs including other COX-2 inhibitors. Severe hepatic dysfunction (serum albumin <25 g/L or Child-Pugh Class C). Inflammatory bowel disease. Treatment of post-op pain immediately following CABG surgery. Established ischemic heart disease, peripheral arterial disease &/or cerebrovascular disease. Pregnancy (3rd trimester) & lactation.
Special Precautions
Administration other than IV or IM. 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. Most at risk of developing GI complications w/ NSAIDS are the elderly, patients w/ CV disease, concomitant use w/ aspirin, corticosteroids, SSRIs or other NSAIDs, or alcohol intake or w/ history or active GI disease eg, ulceration, bleeding or inflammatory conditions. W/ or w/o history of sulfonamide allergy. Discontinue use at the 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Severe hypotension may occur. Concomitant use w/ anticoagulants. Can lead to the onset of new HTN or worsening of preexisting HTN. Monitor BP closely during initiation of & throughout the course of therapy. Compromised cardiac function, preexisting edema, or other conditions predisposing to, or worsened by, fluid retention including those on diuretic therapy or at risk of hypovolemia. Monitor renal function closely in patients w/ advanced renal disease. Rehydrate patients prior to & at initiation of therapy. Moderate hepatic impairment (Child-Pugh Class B). May diminish the utility of diagnostic signs eg, fever in detecting infections; avoid concomitant use w/ other non-specific NSAIDs. Consider withdrawal in women who have difficulties conceiving or who are undergoing infertility investigation. Pregnant women on parecoxib should be closely monitored for amniotic fluid vol. Lactation. Childn <18 yr.
Adverse Reactions
Nausea. Abdominal pain, constipation, dyspepsia, vomiting; peripheral edema; alveolar osteitis; dizziness; insomnia; oliguria; increased sweating, pruritus; hypotension.
Drug Interactions
Increased AUC w/ CYP3A4 & 2C9 inhibitors. Increased risk of bleeding w/ oral anticoagulants including warfarin/coumarin-type & novel oral anticoagulants (eg, apixaban, dabigatran & rivaroxaban). Enhanced AUC w/ fluconazole & ketoconazole. May diminish effects of ACE inhibitors, angiotensin II antagonists, β-blockers & diuretics. May reduce natriuretic effect of furosemide & thiazides. Increased risk of nephrotoxicity w/ cyclosporine. May increase plasma levels of methotrexate. Decreased lithium serum & renal clearance.
ATC Classification
M01AH04 - parecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Presentation/Packing
Form
Dynastat powd for inj 40 mg/5 mL
Packing/Price
(+ amp (diluent) NaCl 9 mg/mL) 5 × 1's
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