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Olicoxib

Olicoxib

parecoxib

Manufacturer:

OLIC

Distributor:

DKSH

Marketer:

OLIC
Concise Prescribing Info
Contents
Parecoxib
Indications/Uses
Management of acute pain & short-term treatment of post-op pain in patients w/ need for parenteral therapy & for whom similar benefit could not be obtained from alternative oral therapy.
Dosage/Direction for Use
IM/IV Administer IM inj slowly & deeply into muscle or as IV bolus inj directly into vein or existing IV line. Max treatment duration: 3 days. Management of acute pain & treatment of post-op pain 40 mg as single or initial dose, followed by 20 or 40 mg every 6-12 hr, up to max of 80 mg daily. Elderly weighing <50 kg Reduce initial dose by 50%. Max daily dose: 40 mg.
Contraindications
Hypersensitivity. Serious allergic-type reactions, especially cutaneous reactions eg, SJS, TEN, erythema multiforme or known hypersensitivity to sulfonamides. Active peptic ulceration or GI bleeding. Asthma, urticaria, or 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 immediately following CABG surgery. Established ischemic heart, peripheral arterial &/or cerebrovascular disease. Severe hepatic dysfunction (serum albumin <25 g/L or Child-Pugh score ≥10). Pregnancy (3rd trimester) & lactation.
Special Precautions
Not to be administered via IA or intrathecal. Discontinue treatment at 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity; if clinical signs & symptoms consistent w/ hepatic disease develop, or if systemic manifestations occur (eg, eosinophilia, rash). Not to be used in acute traumatic pain patients w/ unstable hemodynamic condition. Not to be given in patients w/ aspirin triad; aspirin-sensitive patients. Serious skin reactions (eg, erythema multiforme, SJS, exfoliative dermatitis, TEN, generalised bullous fixed drug eruption, DRESS syndrome); anaphylactic reactions & angioedema. May mask fever. Increased risk of CV & thrombotic events when taken long term. Other CV surgical procedures. Serious GI toxicity (eg, bleeding, ulceration, perforation of stomach, small or large intestine). Jaundice, hepatomegaly & hepatic failure. Renal toxicity; renal papillary necrosis & other renal injury in long-term use; acute renal failure. Onset of new or worsening of pre-existing HTN. Severe hypotension. May experience dizziness, vertigo, or somnolence after treatment. Patients w/ significant & multiple risk factors for CV events (eg, HTN, hyperlipidaemia, DM, smoking); CV disease; history of, or active, GI disease (eg, ulceration, bleeding or inflammatory conditions); longer duration of NSAID therapy, alcoholism, poor general health status; history of peripheral vascular or cerebrovascular disease or poor post-surgical renal function; considerable dehydration; pre-existing or severe renal disease; heart failure, liver dysfunction; compromised cardiac function, pre-existing oedema, or other conditions predisposing to, or worsened by, fluid retention; pre-existing asthma. Asthmatic patients experiencing rhinitis w/ or w/o nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. Monitor incision for signs of infection. Rehydrate patients first before starting treatment. Closely monitor renal function; serum creatinine; BP during initiation & throughout course of therapy. Perform appropriate post-op lab monitoring during therapy. Avoid concomitant use w/ other non-specific NSAIDs. Concomitant use w/ aspirin, corticosteroids, SSRIs, alcohol or anticoagulants including warfarin/coumarin-type & novel oral anticoagulants (eg, apixaban, dabigatran, & rivaroxaban); ACE inhibitors or AIIA, anti-inflammatory drugs (NSAID or COX-2 inhibitor) & thiazide diuretics. Not recommended in severe hepatic impairment (Child-Pugh class C). Consider w/drawal of therapy in women who have difficulties conceiving or undergoing investigation of infertility. Not recommended during pregnancy. Avoid use during 3rd trimester of pregnancy. Closely monitor pregnant women for amniotic fluid vol. Discontinue breastfeeding during treatment. Childn <18 yr. Elderly (<65 yr) or debilitated patients.
Adverse Reactions
Nausea. Abdominal pain, constipation, dyspepsia, vomiting; peripheral edema; alveolar osteitis (dry socket); dizziness; insomnia; oliguria; increased sweating, pruritis; hypotension. Erythema multiforme, SJS, TEN.
Drug Interactions
Increased plasma levels of MTX. Diminished antihypertensive effects of ACE inhibitors, AIIA, β-blockers & diuretics. Increased risk of nephrotoxicity w/ cyclosporin. Increased AUC & Cmax w/ fluconazole & ketoconazole. Decreased serum & renal clearance of lithium. Slightly increased plasma conc of R-warfarin.
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
Olicoxib powd for inj 40 mg
Packing/Price
(+ 5 amps solvent) 5 × 1's
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