Generic Medicine Info
May be taken with or without food. Dose for OA/RA may be given w/ or w/o meals, but doses for FAP must be given w/ meals.
Hypersensitivity (including urticaria, asthma, angioneurotic edema) to celecoxib and other NSAIDs, aspirin or sulfonamides. Active peptic ulceration or gastrointestinal bleeding, inflammatory bowel disease, CHF (NYHA II-IV), established ischaemic heart disease, cerebrovascular disease or peripheral arterial disease. Treatment of postoperative pain in the setting of CABG surgery. Severe renal (CrCl <30 mL/min) and hepatic (Child-Pugh class C or ≥10 score) impairment. Pregnancy (3rd trimester) and lactation.
Special Precautions
Patient with history of gastrointestinal complications (e.g. ulceration and bleeding), hypertension, diabetes mellitus, hyperlipidaemia, recent MI, and other CV disease risk factors (e.g. smoking, alcoholism); pre-existing asthma (without known aspirin sensitivity), pre-existing oedema, hypovolaemia. Dehydrated patient. May mask underlying fever and other signs of inflammation. CYP2C9 poor metabolisers. Moderate hepatic impairment. Children and elderly. Pregnancy (1st-2nd trimester). Patient Counselling This drug may cause dizziness, vertigo or somnolence, if affected, do not drive or operate machinery. Monitoring Parameters Monitor blood pressure during initial treatment and throughout therapy, CBC and chemistry profile periodically (prolonged use), liver and renal functions. Monitor for signs and symptoms of abnormal bleeding or clotting in children with juvenile idiopathic arthritis. Correct volume depletion in dehydrated or hypovolaemic patients prior to treatment.
Adverse Reactions
Significant: Fluid retention, oedema, hypertension, renal papillary necrosis (prolonged use). Blood and lymphatic system disorders: Anaemia. Cardiac disorders: Angina pectoris. Gastrointestinal disorders: Nausea, abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting, dysphagia, GERD, irritable bowel syndrome. General disorders and administration site conditions: Influenza-like symptoms. Injury, poisoning and procedural complications: Accidental injury. Investigations: Increased blood creatinine, weight increased, elevated ALT or AST. Musculoskeletal and connective tissue disorders: Arthralgia. Nervous system disorders: Headache, hypertonia. Psychiatric disorders: Insomnia. Renal and urinary disorders: Nephrolithiasis, UTI. Reproductive system and breast disorders: Benign prostatic hyperplasia. Respiratory, thoracic and mediastinal disorders: Sinusitis, upper respiratory tract infection, pharyngitis, dyspnea, rhinitis, cough. Skin and subcutaneous tissue disorders: Rash, pruritus.
Potentially Fatal: Gastrointestinal perforation, ulceration, or bleeding; CV thrombotic events including MI and stroke, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalised exanthematous pustulosis, anaphylaxis, severe hepatic reactions (e.g. fulminant hepatitis, hepatic necrosis, hepatic failure).
ROUTE(S) : PO: C prior to 30 weeks gestation
ROUTE(S) : PO: D starting at 30 weeks gestation
Drug Interactions
Increased risk of gastrointestinal ulceration or bleeding with anticoagulants (e.g. warfarin, apixaban), antiplatelet agents (e.g. aspirin), SSRIs, corticosteroids (e.g. glucocorticoids), other NSAIDs. May reduce the antihypertensive effect of ACE inhibitors, angiotensin II receptor antagonists, diuretics, β-blockers and other antihypertensive agents. May increase the nephrotoxic effect of ciclosporin and tacrolimus. Increases the serum concentration of lithium, digoxin and methotrexate. Increased plasma concentration with CYP2C9 inhibitors (e.g. fluconazole). Decreased plasma concentrations with CYP2C9 inducers (e.g. rifampicin, carbamazepine, barbiturates). May increase serum concentration and toxicity of CYP2D6 substrates (e.g. aripiprazole, perhexiline, atomoxetine).
CIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AH01 - celecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
L01XX33 - celecoxib ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.
Disclaimer: This information is independently developed by CIMS based on celecoxib from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 CIMS. All rights reserved. Powered by CIMSAsia.com
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