Adult: Short-term treatment in acute cases: 40 mg via rapid IV bolus inj or into an existing IV line, or via slow IM inj; may be followed by 20 mg or 40 mg 6-12 hourly as required. Max: 80 mg daily. Use the lowest effective dose for the shortest possible duration. Elderly: <50 kg: Initiate with half of the recommended dose. Max: 40 mg daily.
Special Patient Group
Patient with a predisposition to fluid retention: Initiate at the lowest recommended dose (20 mg); closely monitor kidney function.
Co-administration with fluconazole: Use the lowest recommended dose of parecoxib.
Initiate at the lowest recommended dose (20 mg); closely monitor kidney function.
Moderate (Child-Pugh score 7-9): Reduce dose to half of the recommended dose. Max: 40 mg daily. Severe (serum albumin >25 g/L or Child-Pugh score ≥10): Contraindicated.
Reconstitute a 40 mg vial with 2 mL of the provided diluent (0.9% NaCl solution for inj) or other acceptable solvents (e.g. bacteriostatic 0.9% NaCl inj, 5% dextrose in water, 5% dextrose with 0.45% NaCl solution for inj) to make a final concentration of 20 mg/mL. Gently swirl to completely dissolve the powder.
Incompatible with opioids in the same syringe. May precipitate with Lactated Ringer's Solution or 5% dextrose in Lactated Ringer's solution. Not recommended for reconstitution with sterile water for inj.
Hypersensitivity to parecoxib, aspirin, other NSAIDs, or sulfonamides. History of serious allergic drug reaction (any type), particularly cutaneous reactions (e.g. Stevens-Johnson syndrome, DRESS, toxic epidermal necrolysis, erythema multiforme); history of asthma, bronchospasm, rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking aspirin or NSAIDs, including other cyclooxygenase-2 (COX-2) inhibitors; active peptic ulceration, active gastrointestinal bleeding, inflammatory bowel disease; previous MI or stroke, CHF (NYHA class II-IV), established ischaemic heart disease, peripheral arterial disease, and/or established cerebrovascular disease; treatment of post-operative pain after CABG surgery, or major vascular surgery. Severe hepatic (serum albumin <25 g/L or Child-Pugh score ≥10) impairment. Pregnancy (3rd trimester) and lactation.
Patient with known CV disease, significant risk factors for CV disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), dehydrated states, preexisting oedema, predisposition to fluid retention; history of gastrointestinal disease (e.g. bleeding, ulceration, inflammatory conditions). Not to be considered as a treatment or replacement for corticosteroid-dependent diseases. Co-administration with fluconazole. Severe renal (CrCl >30 mL/min) and moderate hepatic (Child-Pugh score 7-9) impairment. Elderly. Pregnancy (1st-2nd trimester).
Significant: Anaphylactic reactions, angioedema, increased risk of CV and thrombotic events (e.g. MI, stroke), particularly with prolonged use or following CABG surgery, new-onset or exacerbated hypertension, severe hypotension, fluid retention, oedema, acute renal failure, CNS effects (e.g. dizziness, somnolence), elevated LFTs; may mask fever and other signs of inflammation and infection. Rarely, jaundice, hepatomegaly, and hepatic failure. Blood and lymphatic system disorders: Postoperative anaemia. Gastrointestinal disorders: Nausea, vomiting, abdominal pain, constipation, dyspepsia, flatulence. General disorders and administration site conditions: Peripheral oedema. Infections and infestations: Alveolar osteitis. Investigations: Increased serum creatinine. Metabolism and nutrition disorders: Hypokalaemia. Musculoskeletal and connective tissue disorders: Back pain. Nervous system disorders: Hypoaesthesia. Psychiatric disorders: Insomnia, agitation. Renal and urinary disorders: Oliguria. Respiratory, thoracic and mediastinal disorders: Respiratory insufficiency, pharyngitis. Skin and subcutaneous tissue disorders: Pruritus, hyperhidrosis. Potentially Fatal: Serious skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, drug reaction with eosinophilia and systemic symptoms [DRESS]); gastrointestinal bleeding, ulceration and perforation.
IM/IV/Parenteral: Z (NSAIDs caused foetal ductus arteriosus premature closure, foetal renal impairment and persistent pulmonary hypertension. Avoid near term, else use lowest dose for shortest time.)
Patient Counseling Information
This drug may cause somnolence, dizziness, or vertigo; if affected, do not drive or operate machinery.
Monitor blood pressure at the start of therapy and periodically during use; CBC, LFTs, renal function. Asses for weight gain, oedema, bleeding, bruising, serious skin or hypersensitivity reactions, and signs of gastrointestinal effects.
Increased plasma exposure to valdecoxib when given with fluconazole (CYP2C9 inhibitor) and ketoconazole (CYP3A4 inhibitor). Increased risk of bleeding with warfarin and other anticoagulants (e.g. apixaban, dabigatran). May reduce the therapeutic effects of ACE-inhibitors, angiotensin II antagonists, β-blockers and diuretics. May increase the plasma levels and risk of toxicity of methotrexate and lithium. Increased risk of renal toxicity with ACE inhibitors, angiotensin II antagonists, ciclosporin and tacrolimus. Valdecoxib (active metabolite of parecoxib) may increase the plasma concentrations of dextromethorphan and omeprazole. Potentially Fatal: Increased risk of gastrointestinal adverse effects with aspirin.
Increased risk of gastrointestinal bleeding with alcohol.
Description: Mechanism of Action: Parecoxib, a prodrug of valdecoxib, is a selective COX-2 inhibitor that exhibits anti-inflammatory, analgesic and antipyretic properties. It decreases the activity of COX-2 which leads to reduced formation of prostaglandin precursors, thereby inhibiting prostaglandin synthesis. Onset: Analgesic effect: 7-13 minutes (IV/IM). Duration: Analgesic effect: 6->12 hours. Pharmacokinetics: Absorption: Time to peak plasma concentration: Approx 30 minutes (IV); approx 1 hour (IM). Distribution: Enters breastmilk. Volume of distribution: 55 L (IV). Plasma protein binding: Approx 98%. Metabolism: Rapidly and almost completely converted in the liver via hydrolysis into valdecoxib (active metabolite), which is then extensively metabolised in the liver by the CYP3A4 and CYP2C9 isoenzymes and via glucuronidation. Excretion: Mainly via urine (parecoxib: approx 70% as inactive metabolites; valdecoxib: <5%); faeces (trace amounts as unchanged drug). Elimination half-life: 22 minutes (parecoxib); approx 8 hours (valdecoxib).
Intact vial: Store below 30°C. Reconstituted solutions are stable for up to 24 hours at 25°C; do not refrigerate or freeze. Storage and stability recommendations may vary between countries (refer to detailed local product guideline).
M01AH04 - parecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
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