The sprinkled capsule contents on mashed banana should not be stored under refrigerated conditions and should be ingested immediately.Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.Active peptic ulceration or gastrointestinal (GI) bleeding.Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2 inhibitors.In pregnancy and in women of childbearing potential unless using an effective method of contraception (see section 4.6).

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [These doses can be given without regard to timing of meals.For OA, the dosage is 200 mg per day administered as a single dose or as 100 mg twice daily.For RA, the dosage is 100 mg to 200 mg twice daily.For JRA, the dosage for pediatric patients (age 2 years and older) is based on weight. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.Anticoagulant activity should be monitored particularly in the first few days after initiating or changing the dose of celecoxib in patients receiving warfarin or other anticoagulants since these patients have an increased risk of bleeding complications.

• Adverse reactions reported in osteoarthritis patients and rheumatoid arthritis patients at incidence rates greater than 0.01 % and greater than those reported for placebo during 12 placebo- and/or active-controlled clinical trials of duration up to 12 weeks at celecoxib daily doses from 100 mg up to 800 mg. Celecoxib was evaluated for the treatment of the inflammation and pain of osteoarthritis of the knee and hip in approximately 4200 patients in placebo and active controlled trials of up to 12 weeks duration.

Patients at greatest risk for renal toxicity are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics, angiotensin converting enzyme

Patients who were taking low-dose aspirin were permitted to continue therapy, at baseline nearly half of the subjects were on aspirin. Use the lowest effective dosage for the shortest duration consistent with individual patient …

The significantly lower incidence of this event with celecoxib was maintained with or without acetylsalicylic acid use.In a prospective randomised 24 week safety study in patients who were aged ≥60 years or had a history of gastroduodenal ulcers (users of ASA excluded), the percentages of patients with decreases in haemoglobin (≥2 g/dL) and/or haematocrit (≥10 %) of defined or presumed GI origin were lower in patients treated with celecoxib 200 mg twice daily (N=2238) compared to patients treated with diclofenac SR 75 mg twice daily plus omeprazole 20 mg once daily (N=2246) (0.2 % vs. 1.1 % for defined GI origin, p = 0.004; 0.4 % vs. 2.4 % for presumed GI origin, p = 0.0001). If your dose is different, do not change it unless your doctor tells you to do so.

The FDA advised doctors to carefully weigh the potential benefits and risks of Celebrex and other treatment options before a decision is made to use Celebrex.

As with other medicinal products known to inhibit prostaglandin synthesis, fluid retention and oedema have been observed in patients taking celecoxib.

Dosing with food (high fat meal) delays absorption of celecoxib by about 1 hour resulting in a TIn healthy adult volunteers, the overall systemic exposure (AUC) of celecoxib was equivalent when celecoxib was administered as intact capsule or capsule contents sprinkled on applesauce. dehydrated patients, patients on diuretics, or elderly patients) when ACE-inhibitors, angiotensin II receptor antagonists, and/or diuretics are combined with NSAIDs, including celecoxib (see section 4.4).

The inter-subject variability in the exposure of celecoxib is about 10-fold.

For patients ≥10 kg to ≤25 kg the recommended dose is 50 mg twice daily. In the submitted studies, as with other NSAIDs, an increased risk of gastrointestinal ulceration or other gastrointestinal complications compared to use of celecoxib alone was shown for concomitant administration of low-dose acetylsalicylic acid (see section 5.1).Celecoxib is an inhibitor of CYP2D6.

All patients were prescribed open-label esomeprazole (20-40 mg) for gastro protection. No statistically significant inhibition of COX-1 (assessed as Cyclooxygenase is responsible for generation of prostaglandins. Taking Celebrex with a full glass of … The sprinkled capsule contents on applesauce are stable for up to 6 hours under refrigerated conditions (2°C to 8°C/35°F to 45°F).For AS, the dosage of CELEBREX is 200 mg daily in single (once per day) or divided (twice per day) doses.

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