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Carefully consider the potential benefits and risks of Ketoprofen Capsules USP and other treatment options before deciding to use Ketoprofen Capsules, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Ketoprofen Capsules, USP is indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ketoprofen Capsules, USP is indicated for the management of pain. Ketoprofen Capsules, USP indicated for treatment of primary dysmenorrhea.

Ketoprofen Capsules, USP is contraindicated in patients who have shown hypersensitivity to ketoprofen. Ketoprofen Capsules, USP should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic reactions to ketoprofen have been reported in such patients (see WARNINGS, Anaphylacroid Reactions and PRECAUTIONS, Preexisting Asthma ). Ketoprofen Capsules, USP is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).

General Ketoprofen Capsules, USP cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids. If steroid dosage is reduced or eliminated during therapy, it should be reduced slowly and the patients observed closely for any evidence of adverse effects, including adrenal insufficiency and exacerbation of symptoms of arthritis. The pharmacological activity of Ketoprofen Capsules, USP in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions. Ketoprofen and other non-steroidal anti-inflammatory drugs cause nephritis in mice and rats associated with chronic administration. Rare cases of interstitial nephritis or nephrotic syndrome have been reported in humans with ketoprofen since it has been marketed. A second form of renal toxicity has been seen in patients with conditions leading to a reduction in renal blood flow or blood volume, where renal prostaglandins have a supportive role in the maintenance of renal blood flow. In these patients, administration of a non-steroidal anti-inflammatory drug results in a dose-dependent decrease in prostaglandin synthesis and, secondarily, in renal blood flow which may precipitate overt renal …

Pregnancy Risk Summary Use of NSAIDs, including Ketoprofen Capsules, USP, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of Ketoprofen Capsules, USP use between about 20 and 30 weeks of gestation, and avoid Ketoprofen Capsules, USP use at about 30 weeks of gestation and later in pregnancy [see WARNINGS ; Fetal Toxicity]. Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including Ketoprofen Capsules, USP, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus …