Celecoxib Farmoz

Celecoxib

Symptomatic relief of OA, RA & ankylosing spondylitis in adults.

OA 200 mg once daily or in 2 divided doses, may be increased to 200 mg bd. RA Initially 200 mg in 2 divided doses, may be increased to 200 mg bd if needed. Ankylosing spondylitis 200 mg once daily or in 2 divided doses, may be increased to 400 mg once daily or in 2 divided doses. Max daily dose for all indications: 400 mg. Elderly Initially 200 mg/day, may be increased to 200 mg bd if needed.

May be taken with or without food: Dose for OA/RA may be given w/ or w/o meals.

Hypersensitivity to celecoxib or to sulfonamides. Active peptic ulceration or GI bleeding. Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic type reactions after taking acetylsalicylic acid or other NSAIDs including COX-2 inhibitors. Inflammatory bowel disease. CHF (NYHA II-IV). Established ischaemic heart disease, peripheral arterial disease &/or cerebrovascular disease. Severe hepatic dysfunction (serum albumin <25 g/L or Child-Pugh score ≥10). Patients w/ estimated CrCl <30 mL/min. Women of childbearing potential unless using an effective method of contraception. Pregnancy & lactation.

Upper & lower GI complications; serious CV events, mainly MI; fluid retention & oedema; onset of new HTN or worsening of pre-existing HTN; renal toxicity; severe hepatic reactions including fulminant hepatitis, liver necrosis & hepatic failure. Shortest duration possible & lowest effective daily dose should be used. Discontinue use at the 1st appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. May mask fever & other signs of inflammation. Compromised renal or hepatic function & cardiac dysfunction are more likely in the elderly. Patients known to be poor CYP2C9 metabolisers. Concomitant use w/ CYP2D6 substrates; warfarin or other oral anticoagulants. Avoid concomitant use w/ non-aspirin NSAID. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Patients w/ hepatic or renal impairment. May delay or prevent rupture of ovarian follicles, which has been associated w/ reversible infertility in some women. Not indicated for use in childn.

HTN (including aggravated HTN). Sinusitis, upper resp tract infection, pharyngitis, UTI; hypersensitivity; insomnia; dizziness, hypertonia, headache; MI; rhinitis, cough, dyspnoea; nausea, abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting, dysphagia; rash, pruritus; arthralgia; flu-like illness, oedema peripheral; injury (accidental injury).

Increased risk of bleeding w/ warfarin or other anticoagulants. Reduced effect of anti-hypertensive eg, ACE inhibitors, angiotensin II receptor antagonists, diuretics & β-blockers. Increased risk of acute renal insufficiency w/ ACE inhibitors, angiotensin II receptor antagonists &/or diuretics in patients w/ compromised renal function. Increased nephrotoxic effect of ciclosporin or tacrolimus. Increased risk of GI ulceration or other GI complication w/ low-dose acetylsalicylic acid. Increased plasma conc of CYP2D6 substrates (eg, dextromethorphan & metoprolol). Adequately monitor for methotrexate-related toxicity when co-administered w/ celecoxib. Increased C_max & AUC of lithium. Increased exposure w/ CYP2C9 inhibitors (eg, fluconazole). Reduced plasma conc w/ CYP2C9 inducers (eg, rifampicin, carbamazepine, barbiturates). Potential for celecoxib to interact w/ CYP2C19 substrates (eg, diazepam, citalopram, imipramine).

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AH01 - celecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.

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