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Dynastat

Dynastat

parecoxib

Manufacturer:

Pharmacia and Upjohn

Distributor:

Pfizer
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. Used 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 mg or 40 mg every 6-12 hr as required. Max daily dose: 80 mg. Prevention or reduction of post-op pain 40 mg administered 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 daily dose: 40 mg. Patient w/ 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, SJS, TEN, erythema multiforme. 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. CHF (NYHA II-IV). 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
Hypersensitivity reactions. Reports of serious skin reactions including erythema multiforme & SJS. 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 risk factors. Increased risk of upper GI perforations, ulcers, or bleeds in elderly; patients w/ CV disease, history of, or active GI disease eg, ulceration bleeding, or inflammatory conditions; concomitant use w/ aspirin. Severe hypotension. Increased risk of bleeding w/ oral anticoagulants including warfarin/coumarin-type & novel oral anticoagulants (eg, apixaban, dabigatran & rivaroxaban). HTN. Fluid retention & edema. May diminish utility of diagnostic signs in detecting infections eg, fever; avoid use w/ non-specific NSAIDs. Not recommended in patients w/ severe hepatic impairment. Consider w/drawal in patients who have difficulties conceiving or undergoing investigation of fertility. Used during pregnancy only if potential benefit justifies potential risk to the fetus. Decision should be made whether to discontinue nursing or treatment. Safety & efficacy have not been established in 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. Enhanced AUC w/ fluconazole & ketoconazole. May diminish effects of ACE inhibitors, angiotensin II antagonists, β-blockers & diuretics. Increased risk of bleeding w/ oral anticoagulants including warfarin/coumarin-type & novel oral anticoagulants (eg, apixaban, dabigatran & rivaroxaban). May reduce natriuretic effect of furosemide & thiazides. Increased risk of nephrotoxicity w/ cyclosporine. Increase plasma levels of MTX. 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.
Presentation/Packing
Form
Dynastat powd for inj 40 mg
Packing/Price
(+ amp (2-mL diluent) NaCl 9 mg/mL) 5 × 1's
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