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Consensi is a combination of amlodipine besylate, a calcium channel blocker, and celecoxib, a nonsteroidal anti-inflammatory drug (NSAID), indicated for patients for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriate. Lowering blood pressure reduces the risk of fatal and nonfatal CV events, primarily strokes and myocardial infarctions. Consensi is only available in a celecoxib strength of 200 mg and is only to be taken once daily.
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use. Consensi is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
Consensi is contraindicated in patients with a known hypersensitivity to amlodipine, celecoxib or any of its inactive ingredients. Consensi is contraindicated in patients with a known history of asthma, urticaria or other allergic-type reactions after taking aspirin or other NSAIDs and in the setting of CABG surgery. Consensi is contraindicated in patients with known demonstrated allergic-type reactions to sulfonamides.
Patients should be warned about the potential signs and symptoms of hepatotoxicity and hepatic failure. Physicians should discontinue Consensi if abnormal liver tests persist or worsen, or if clinical signs and symptoms of liver disease develop. Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Physicians should carefully monitor blood pressure.
Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Worsening angina and acute myocardial infarction, particularly in patients with severe obstructive coronary artery disease, is possible. Physicians should avoid use of Consensi in patients with severe heart failure.
Physicians should monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia, and avoid the use of Consensi in patients with advanced renal disease. Patients should seek emergency help if an anaphylactic reaction occurs. Consensi is contraindicated in patients with aspirin-sensitive asthma. Consensi is not recommended in patients with moderate or severe hepatic impairment or severe renal insufficiency.
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