For: Hypertension, Osteoarthritis
Consensi (amlodipine and celecoxib) is a calcium channel blocker and nonsteroidal anti-inflammatory drug combination for the treatment of both hypertension and pain associated with osteoarthritis. CONSENSI tablets are white and biconvex, non-coated, non-scored, with the tablet strength debossed on one side, available as follows:
Amlodipine Celecoxib Shape NDC
Bottle of 30 tablets Bottle of 500 tablets
2.5 mg 200 mg Elongated oval 69101- 502-30 69101- 502-50
5 mg 200 mg Caplet 69101- 505-30 69101- 505-50
10 mg 200 mg Round 69101- 510-30 69101- 510-50
Storage
Store at room temperature 20�C to 25�C (68�F to 77�F); [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers (USP). These highlights do not include all the information needed to use CONSENSI safely and effectively. See full prescribing information for CONSENSI.
CONSENSI� (amlodipine and celecoxib) tablets, for oral administration. Initial U.S. Approval: 2018
WARNING: RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS
See full prescribing information for complete boxed warning.
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. ( 5.1)
CONSENSI is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. ( 4, 5.1)
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. ( 5.2)
INDICATIONS AND USAGE
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. ( 1.1)
Limitations of Use
CONSENSI is only available in a celecoxib strength of 200 mg and is only to be taken once daily. ( 1.1)
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage of celecoxib for the shortest duration consistent with individual treatment goals. If analgesic therapy is no longer indicated, discontinue CONSENSI and initiate patient on alternative antihypertensive therapy. ( 2.1, 2.2)
Start at (amlodipine/celecoxib) 5 mg/200 mg (2.5 mg/200 mg for small, elderly, or frail patients or hepatic impairment) orally once daily. Titrate to 5 mg/200 mg or 10 mg/200 mg once daily as needed for blood pressure control. ( 2.1)
CONSENSI may be substituted for its individual components. ( 2.3)
DOSAGE FORMS AND STRENGTHS
Tablets (amlodipine/celecoxib): 2.5 mg/200 mg, 5 mg/200 mg, or 10 mg/200 mg ( 3)
CONTRAINDICATIONS
Known hypersensitivity to amlodipine, celecoxib, or any inactive ingredients of CONSENSI ( 4)
History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs ( 4)
In the setting of CABG surgery ( 4)
Demonstrated allergic-type reactions to sulfonamides ( 4)
WARNINGS AND PRECAUTIONS
Hepatotoxicity and Patients with Hepatic Failure: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. ( 5.3)
Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure. ( 5.4, 7)
Hypotension: Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. ( 5.5)
Increased Angina or Myocardial Infarction: Worsening angina and acute myocardial infarction, particularly in patients with severe obstructive coronary artery disease. ( 5.6)
Heart Failure and Edema: Avoid use of CONSENSI in patients with severe heart failure. ( 5.7)
Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of CONSENSI in patients with advanced renal disease ( 5.8)
Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs. ( 5.9)
Exacerbation of Asthma Related to Aspirin Sensitivity: CONSENSI is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity). ( 5.10)
Serious Skin Reactions: Discontinue CONSENSI at first appearance of skin rash or other signs of hypersensitivity. ( 5.11)
Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnant women starting at 30 weeks of gestation. ( 5.12, 8.1)
Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia. ( 5.13, 7)
ADVERSE REACTIONS
Most common adverse reactions to celecoxib in arthritis trials (>2% and >placebo): abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, rash. ( 6.1)
Most common adverse reaction to amlodipine is edema which occurred in a dose related manner. Other adverse experiences to amlodipine that were not dose related but that were reported with an incidence >1.0% are fatigue, nausea, abdominal pain, and somnolence. ( 6)
To report SUSPECTED ADVERSE REACTIONS, contact Burke Therapeutics, LLC at 1-888-275-1264 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Drugs that Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking CONSENSI with drugs that interfere with hemostasis. Concomitant use of CONSENSI and analgesic doses of aspirin is not generally recommended. ( 7)
ACE Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers: Concomitant use with CONSENSI may diminish the antihypertensive effect of these drugs. Monitor blood pressure. ( 7)
ACE Inhibitors and ARBs: Concomitant use with CONSENSI in elderly, volume depleted, or those with renal impairment may result in deterioration of renal function. In such high risk patients, monitor for signs of worsening renal function. ( 7)
Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects. ( 7)
Digoxin: Concomitant use with CONSENSI can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels. ( 7)
Simvastatin: Do not exceed 20 mg of simvastatin per day in patients taking amlodipine. ( 7)
USE IN SPECIFIC POPULATIONS
Infertility: NSAIDs are associated with reversible infertility. ( 8.3)
Hepatic or Renal Impairment: Not recommended in patients with moderate or severe hepatic impairment or severe renal insufficiency.
Poor Metabolizers of CYP2C9 Substrates: Not recommended.
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 12/2019
