Celecoxib 100 mg, 200 mg capsules. Therapeutic indications. Symptomatic relief in the treatment of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis. Posology and administration method. Osteoarthritis. 200 mg taken once a day or divided in two doses. For some patients with insufficient symptom relieve, an increased dose of 200 mg twice a day could increase the efficacy. Rheumatoid arthritis. The recommended initial daily dose is 200 mg in two divided doses. If necessary, the dose can be increased later to 200 mg twice a day. Ankylosing spondylitis. The recommended daily dose is 200 mg taken once a day or in two divided doses. In some patients with insufficient symptom relieve, an increased dose of 400 mg once a day or divided in two doses could increase the efficacy. The maximum daily dose recommended is 400 mg for every indication. Adults older than 65 years. Begin with 200 mg per day. If necessary, the dose can be increased later to 200 mg twice a day. The treatment must be initiated with half the recommended dose in patients with moderate hepatic insufficiency. Experience with celecoxib in patients with mild to moderate renal insufficiency is limited, so these patients must be treated with caution. Celecoxib is not indicated for use with children. Patients who are, or are suspected of being, poor metabolizers of the CYP2C9 based on the determination of the genotype or the history/previous experience with other CYP2C9 substrates, must be administered celecoxib with caution, since the risk of dose dependent adverse effects increases. Contraindications. Antecedents of hypersensitivity to the active substance or to some of the excipients. Known hypersensitivity to sulfonamides. Active peptic ulcer or gastrointestinal bleeding. Patients who have suffered asthma, acute rhinitis, nasal polyps, angioneurotic edema, hives, or other allergic reactions after taking acetylsalicylic acid or NSAIDs, including COX-2 inhibitors. Pregnancy in women of fertile age, unless using an effective birth control method. Breast-feeding. Severe liver dysfunction. Patients with renal insufficiency with an estimated creatinine clearance of < 30 ml/min. Intestinal inflammatory disease. Congestive cardiac insufficiency (NYHA II-IV). Established ischemic cardiopathy, peripheral artery disease and/or cerebrovascular disease. Warnings and precautions of use. Caution is recommended in the treatment of patients with an increased risk of developing a gastrointestinal complication with NSAIDs; elderly patients who use another NSAID or acetylsalicylic acid concomitantly, or patients with previous antecedents of gastrointestinal disease, like ulcers and GI hemorrhage. The concomitant use of celecoxib and NSAIDs without aspirin must be avoided. An increase in the number of severe cardiovascular events has been noted, mainly myocardial infarction, in a placebo controlled long term study in patients with sporadic adenomatous polyps treated with celecoxib, with a dose of 200 mg twice a day and 400 mg twice a day compared to placebo. Since the cardiovascular risk of celecoxib can increase with the dose and the duration of the exposure, it must be used the least amount of time possible, and with the lowest effective daily dose. Patients with important risk factors of cardiovascular events can only be treated with celecoxib after careful evaluation. Celecoxib must be used with caution in patients with a history of cardiac insufficiency, left ventricular dysfunction, or hypertension, and in patients with pre-existing edema for any other cause, since the inhibition of prostaglandins might deteriorate the renal function and cause liquid retention. It might lead to the apparition of a new hypertension or a worsening of the preexisting one, any of which might contribute to the increase of cardiovascular effect incidence. Might cause renal toxicity. With celecoxib some cases of severe hepatic reactions have been reported, including fulminant hepatitis, hepatic necrosis, and hepatic insufficiency. Severe cutaneous reactions, some of them mortal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been rarely reported in relation to the use of celecoxib. Celecoxib could mask fever and other signs of inflammation. Caution must be taken when combining celecoxib with warfarin and other oral anticoagulants. Celecoxib 100 mg and 200 mg capsules have lactose. There is no clinical data regarding pregnancies exposed to celecoxib. Studies with animals have demonstrated reproductive toxicity, including malformations. The potential risk for humans during pregnancy is unknown, but cannot be excluded. Celecoxib, like other active principles that inhibit the synthesis of prostaglandins, might cause uterine inertia and premature closure of the ductus arteriosus during the last trimester. Celecoxib is contraindicated during pregnancy and in women who might be pregnant. Women who take celecoxib cannot breastfeed. Adverse events. Sinusitis, upper respiratory tract infection, urinary tract infection. Allergy, insomnia, dizziness, hypertonia. Blurry vision. Hypertension. Myocardial infarction. Pharyngitis, rhinitis, cough, dyspnea. Abdominal pain, diarrhea, dyspepsia, flatulence, vomit, dysphagia. Cutaneous rash, pruritus. Peripheral edema, liquid retention, symptoms similar to the flu. CDS 04-2013. The availability of presentations can vary between countries. Celecoxib 200 mg available for: El Salvador and Costa Rica.