Revcox® (celecoxib) 200 mg, 100 capsules. Therapeutic indications. Symptomatic relief in the treatment of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, juvenile rheumatoid arthritis, acute pain and primary dysmenorrhea. Dosage and method of administration. Osteoarthritis. 200 mg taken once a day or divided into two doses per day. In some patients, with insufficient relief of symptoms, an increased dose of 200 mg twice daily may increase efficacy. Rheumatoid arthritis. The recommended daily starting dose is 200 mg taken in two divided doses. If necessary, the dose can then be increased to 200 mg twice daily. Ankylosing spondylitis. The recommended daily dose is 200 mg taken once a day or in two divided doses. In some patients, with insufficient relief of symptoms, an increased dose of 400 mg once daily or divided into two doses may increase efficacy. Juvenile rheumatoid arthritis. The dose for pediatric patients (two years of age and older) is based on weight. For patients ≥10kg to ≤25kg the recommended dose is 50 mg twice a day. For patients> 25kg the recommended dose is 100 mg twice a day. Management of acute pain and treatment of primary dysmenorrhea. The initial dose is 400 mg, followed by an additional dose of 200 mg, if necessary on the first day. In subsequent days, the recommended dose is 200 mg twice daily, as needed. The maximum recommended daily dose is 400 mg for all indications.
Adults over 65 years. Initially use 200 mg per day. If necessary, the dose can then be increased to 200 mg twice daily. Treatment should be started with half the recommended dose in patients with moderate hepatic impairment. The experience with Revcox® in patients with mild or moderate renal impairment is limited, therefore, these patients should be treated with caution. Revcox® is not indicated for use in children. Patients who are known or suspected to be slow metabolizers of CYP2C9 based on genotype determination or previous history/experience with other CYP2C9 substrates should be given Revcox® with caution because the risk of adverse effects depending on the dose increases. Revcox® should be taken with or without meals. Contraindications history of hypersensitivity to the active substance or any of the excipients. Known hypersensitivity to sulfonamides. Active peptic ulceration or gastrointestinal bleeding (GI). Patients who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic edema, hives or other allergic reactions after taking acetylsalicylic acid or NSAIDs including COX-2 inhibitors. Pregnancy and women of childbearing age unless they use an effective method of contraception. Lactation. Severe liver dysfunction Patients with renal insufficiency with estimated creatinine clearance <30 mL/min. Inflammatory bowel disease. Congestive heart failure (NYHA II-IV). Established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease. Warnings and precautions for use. Caution is recommended in the treatment of patients at high risk of developing a gastrointestinal complication with NSAIDs; older adults, patients who use any other NSAID or acetylsalicylic acid concomitantly, or patients with a previous history of gastrointestinal disease, such as ulcer and GI hemorrhage. The concomitant use of Revcox® and NSAIDs without aspirin should be avoided. An increase in the number of serious cardiovascular events, mainly myocardial infarction, has been found in a long-term placebo-controlled study in patients with sporadic adenomatous polyps treated with Revcox® at a dose of 200 mg twice daily and 400 mg twice daily. day compared to placebo. Since the cardiovascular risk of Revcox® can be increased with the dose and duration of exposure, the shortest possible time and the lowest effective daily dose should be used. Patients with significant risk factors for cardiovascular events should only be treated with Revcox® after careful evaluation. Revcox® should be used with caution in patients with a history of heart failure, left ventricular dysfunction or hypertension, and in patients with preexisting edema due to any other cause since the inhibition of prostaglandins can lead to impaired renal function and fluid retention. It can lead to the onset of new hypertension or worsening of preexisting hypertension, any of which may contribute to the increased incidence of cardiovascular events. May cause renal toxicity. Some cases of severe liver reactions, including fulminant hepatitis, liver necrosis, and liver failure, have been reported with Revcox®. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of Revcox®. Revcox® can mask fever and other signs of inflammation. Caution should be used when combining Revcox® with warfarin and other oral anticoagulants. An increase in prothrombin time (INR) has been reported with concomitant therapy. Concomitant use of anticoagulants with NSAIDs may increase the risk of bleeding. Revcox® 200 mg capsules contain lactose. There are no clinical data on pregnancies exposed to Revcox®. Animal studies have shown reproductive toxicity, including malformations. The potential risk in humans during pregnancy is unknown, but cannot be excluded. Revcox®, like other active ingredients that inhibit the synthesis of prostaglandins, can cause uterine inertia and premature closure of the ductus arteriosus during the last trimester. Revcox® is contraindicated in pregnancy and in women who may become pregnant. Women who take Revcox® should not breastfeed. Adverse events. Sinusitis, upper respiratory tract infection, urinary tract infection. Allergy, insomnia, dizziness, hypertonia, headache. Blurry vision. Hypertension. Myocardial infarction Pharyngitis, rhinitis, cough, dyspnea. Nausea, abdominal pain, diarrhea, dyspepsia, flatulence, vomiting, dysphagia. Rash, itching Peripheral edema, fluid retention, flu-like symptoms. CDS 04-2018.