Select therapeutic use:

Arthritis/rheumatic disorders:

Indications for CONSENSI:

In adults for whom treatment with both amlodipine for hypertension and celecoxib for osteoarthritis are appropriate.

Limitations of Use:

Not for short-term or intermittent treatment, or to treat any conditions other than hypertension in patients taking celecoxib for osteoarthritis. Only for once-daily administration.

Adult:

Use lowest effective celecoxib dose for shortest duration. Initially 5mg/200mg once daily. Small or fragile patients, elderly, mild hepatic impairment, or concomitant other antihypertensive: initially 2.5mg/200mg once daily. Adjust amlodipine dose based on BP goals; wait 7–14 days between titration. Max 10mg/200mg once daily. If analgesic therapy no longer needed, discontinue and initiate on alternative antihypertensive (eg, amlodipine monotherapy).

Children:

Not established.

Contraindications:

Sulfonamide, aspirin or NSAID allergy. Coronary artery bypass graft surgery.

Boxed Warning:

Risk of serious cardiovascular and gastrointestinal events.

Warnings/Precautions:

Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation); discontinue and evaluate if suspected. History of ulcer disease and/or GI bleeding; consider alternatives if active bleeding. Discontinue if signs/symptoms of liver disease or systemic manifestations develop, or if abnormal LFTs persist or worsen. Hyper- or hypotension; monitor BP during therapy and adjust dose accordingly. Severe aortic stenosis. Severe obstructive coronary artery disease. Dehydration. Hypovolemia. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic and renal function in long-term therapy. Pre-existing asthma. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Advanced or severe renal impairment, moderate/severe hepatic impairment, poor CYP2C9 metabolizers: not recommended. Elderly. Debilitated. Labor & delivery. Pregnancy (≥30 weeks gestation); avoid. Nursing mothers.

Pharmacologic Class:

Calcium channel blocker (CCB) + NSAID (COX-2 inhibitor).

Interactions:

Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. Increased risk of GI bleed with warfarin, anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or ß-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. May be potentiated by CYP3A or CYP2C9 inhibitors (eg, fluconazole) and antagonized by CYP2C9 inducers (eg, rifampin); may need to adjust dose; monitor. May potentiate CYP2D6 substrates (eg, atomoxetine), tacrolimus; monitor and adjust dose as appropriate. Concomitant CYP3A inducers; monitor BP. Concomitant simvastatin: limit simvastatin dose to 20mg/day.

Adverse Reactions:

Abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper RTI, rash, fatigue, nausea; cardiovascular thrombotic events, bleeding, hepatotoxicity, renal toxicity, hematological toxicity, anaphylaxis, serious skin reactions.

Generic Availability:

NO

How Supplied:

Tabs—30, 500

Hypertension:

Indications for CONSENSI:

In adults for whom treatment with both amlodipine for hypertension and celecoxib for osteoarthritis are appropriate.

Limitations of Use:

Not for short-term or intermittent treatment, or to treat any conditions other than hypertension in patients taking celecoxib for osteoarthritis. Only for once-daily administration.

Adult:

Use lowest effective celecoxib dose for shortest duration. Initially 5mg/200mg once daily. Small or fragile patients, elderly, mild hepatic impairment, or concomitant other antihypertensive: initially 2.5mg/200mg once daily. Adjust amlodipine dose based on BP goals; wait 7–14 days between titration. Max 10mg/200mg once daily. If analgesic therapy no longer needed, discontinue and initiate on alternative antihypertensive (eg, amlodipine monotherapy).

Children:

Not established.

Contraindications:

Sulfonamide, aspirin or NSAID allergy. Coronary artery bypass graft surgery.

Boxed Warning:

Risk of serious cardiovascular and gastrointestinal events.

Warnings/Precautions:

Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation); discontinue and evaluate if suspected. History of ulcer disease and/or GI bleeding; consider alternatives if active bleeding. Discontinue if signs/symptoms of liver disease or systemic manifestations develop, or if abnormal LFTs persist or worsen. Hyper- or hypotension; monitor BP during therapy and adjust dose accordingly. Severe aortic stenosis. Severe obstructive coronary artery disease. Dehydration. Hypovolemia. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic and renal function in long-term therapy. Pre-existing asthma. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Advanced or severe renal impairment, moderate/severe hepatic impairment, poor CYP2C9 metabolizers: not recommended. Elderly. Debilitated. Labor & delivery. Pregnancy (≥30 weeks gestation); avoid. Nursing mothers.

Pharmacologic Class:

Calcium channel blocker (CCB) + NSAID (COX-2 inhibitor).

Interactions:

Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. Increased risk of GI bleed with warfarin, anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or ß-blockers; monitor closely. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. May be potentiated by CYP3A or CYP2C9 inhibitors (eg, fluconazole) and antagonized by CYP2C9 inducers (eg, rifampin); may need to adjust dose; monitor. May potentiate CYP2D6 substrates (eg, atomoxetine), tacrolimus; monitor and adjust dose as appropriate. Concomitant CYP3A inducers; monitor BP. Concomitant simvastatin: limit simvastatin dose to 20mg/day.

Adverse Reactions:

Abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper RTI, rash, fatigue, nausea; cardiovascular thrombotic events, bleeding, hepatotoxicity, renal toxicity, hematological toxicity, anaphylaxis, serious skin reactions.

Generic Availability:

NO

How Supplied:

Tabs—30, 500