Acute & chronic treatment of signs & symptoms of OA & RA. Ankylosing spondylitis; acute gouty arthritis; primary dysmenorrhea; moderate to severe acute post-op pain associated w/ abdominal gynecological surgery. Relief of chronic musculoskeletal pain including chronic low back pain; acute pain including dental surgery.
RA, ankylosing spondylitis, post-op dental pain Recommended & max dose: 90 mg once daily. Chronic musculoskeletal pain including low back pain Recommended & max dose: 60 mg once daily. Acute pain Max: 120 mg daily for 8 days. Acute gouty arthritis & primary dysmenorrhea Recommended & max dose: 120 mg once daily. Post-op gynecological pain 90 mg once daily. Administer initial dose shortly before surgery. May be increased to max of 120 mg once daily. Mild hepatic insufficiency (Child-Pugh score 5-6) Max: 60 mg once daily. Moderate hepatic insufficiency (Child-Pugh score 7-9) Max: 60 mg every other day. May consider 30 mg once daily.
Hypersensitivity. CHF (NYHA class II-IV); active peptic ulceration or GI bleeding; inflammatory bowel disease; uncontrolled HTN (persistently >140/90 mmHg); ischemic heart disease, peripheral artery disease &/or cerebrovascular disease (including patient who have recently undergone CABG surgery or angioplasty). History of allergic reaction; asthma, acute rhinitis, nasal polyps, angioedema, urticaria following administration of aspirin or other NSAIDs. Severe hepatic dysfunction (Child-Pugh score >9). Severe renal impairment (CrCl <30 mL/min). Pregnancy & lactation. Childn <16 yr.
Discontinue use if worsening heart failure, edema or uncontrolled/severe HTN occur; at first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity; in persistent or worsening renal dysfunction. Not to be administered in patients w/ aspirin-sensitive asthma, severe bronchospasm. Not recommended in perioperative pain in CABG setting. Increased risk of serious CV thrombotic events including MI & stroke w/ long-term use or preexisting cardiac risk factors (eg, HTN, hyperlipidemia, diabetes, smoking); hyperkalemia particularly in diabetics & in concomitant use w/ other agents inducing hyperkalemia. May develop serious upper GI complications including perforations, ulcers & bleeding. Elevated transaminases (>3x ULN). Debilitated patients. Patients w/ other forms of asthma. Evaluate CV profiles prior to therapy. Monitor hepatic function in patients w/ previous abnormal hepatic function tests or sign & symptoms of hepatic function. Closely monitor K; renal function. Concomitant use w/ aspirin or other NSAIDs, anticoagulants &/or corticosteroids, alcohol. Not recommended in patients w/ advanced renal disease (CrCl <30 mL/min). Mild to moderate renal impairment. Severe hepatic insufficiency (Child-Pugh score >9). Avoid use during 3rd trimester of pregnancy. Risk of closure of fetal ductus arteriosus in utero & possibly persistent pulmonary HTN of newborn. Elderly.
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