Composition: Celecoxib 100mg and 200mg.
Presentation: Hard capsules; 100mg, white with two blue bands; 200mg, white with two gold bands.
Storage and stability: Do not store above 30C.
Action: Selective cyclo-oxygenase-2 inhibitor.
Indications: Symptomatic relief in the treatment of osteoarthritis or rheumatoid arthritis.
Contraindications: Pregnancy and women of childbearing potential, unless using an effective method of contraception; breast feeding; hypersensitivity to the active substance or any of the excipients; known sulphon-amide hypersensitivity; patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or NSAIDs; active peptic ulceration or gastrointestinal bleeding; inflammatory bowel disease; severe congestive heart failure; severe hepatic disease (serum albumin <25g/L or Child-Pugh greater than or equal to 10); patients with estimated creatinine clearance < 30ml/min.
Dosage and administration: Osteoarthritis, usual recommended dose 200mg once daily or in two divided doses. 200mg twice daily may be used if needed. Rheumatoid arthritis, recommended daily dose 200-400mg in two divided doses.
The maximum daily dose is 400mg. Celecoxib may be taken with or without food.
Elderly (over 65 years), 200mg per day initially which may, if needed, later be increased to 400mg per day.
Established moderate hepatic impairment, initiate treatment at half the recommended dose in patients with a serum albumin of 25-35g/L. Experience in such patients is limited to cirrhotic patients.
Mild or moderate renal impairment, experience limited. Such patients should be treated with caution.
Children, not indicated.
Overdosage: No clinical experience of overdose. In the event of suspected overdose, appropriate supportive medical care should be provided, eg, by eliminating the gastric contents, clinical supervision and, if necessary, the institution of symptomatic treatment. Dialysis is unlikely to be an efficient method of drug removal due to high protein binding.
Precautions: Caution should be taken in patients with: a history of or special risk of gastrointestinal disease, such as ulceration and inflammatory conditions; history of cardiac failure, left ventricular dysfunction or hypertension, and patients with pre-existing oedema for any other reason; patients taking diuretics or otherwise at risk of hypovolaemia. Compromised renal or hepatic function and cardiac dysfunction more likely in the elderly in whom the the lowest effective dose should be used. Celecoxib may mask fever.
Drug interactions: Caution should be exercised when combining celecoxib with warfarin and anticoagulant activity should be monitored. The risk of acute renal insufficiency may be increased with ACE inhibitors. Monitor renal function when co-administering celecoxib with NSAIDs, ciclosporin or tacrolimus. The dose of individually dose-titrated CYP2D6 substrates may need to be reduced when treatment with celecoxib is initiated, or increased if treatment is terminated (see SPC). Patients on lithium should be closely monitored when celecoxib is introduced or withdrawn. Concomitant use of inducers of CYP2C9, such as rifampicin, carbamazepine and barbiturates, may reduce plasma concentrations of celecoxib. An interaction with the oral contraceptive pill cannot be excluded and women should be advised to use alternative methods of contraception.
Side effects: In trials, common undesirable effects (incidence of 1 per cent or higher) included: peripheral oedema/fluid retention, abdominal pain, diarrhoea, dyspepsia, flatulence, dizziness, insomnia, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, rash. See SPC for uncommon and rare undesirable effects and reports from postmarketing experience.
Net price: 100mg 60 £18.34, 200mg 30 £18.34.
Supplier: Searle, PO Box 53, Lane End Road, High Wycombe, Buckinghamshire HP12 4HL (tel 01494 521124, fax 01494 447872) and Pfizer Ltd, Ramsgate Road, Sandwich, Kent CT13 9NJ (tel 01304 616161, fax 01304 656221).
Legal class: POM.