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Consensi Generic Name & Formulations
Legal Class
Rx
General Description
Amlodipine (as besylate), celecoxib; 2.5mg/200mg, 5mg/200mg, 10mg/200mg; tabs.
Pharmacological Class
Calcium channel blocker (CCB) + NSAID (COX-2 inhibitor).
How Supplied
Tabs—30, 500
Manufacturer
Generic Availability
NO
Consensi Indications
Indications
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.
Consensi Dosage and 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.
Consensi Contraindications
Contraindications
Sulfonamide, aspirin or NSAID allergy. Coronary artery bypass graft surgery.
Consensi Boxed Warnings
Boxed Warning
Risk of serious cardiovascular and gastrointestinal events.
Consensi Warnings/Precautions
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.
Consensi Pharmacokinetics
See Literature
Consensi Interactions
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.
Consensi Adverse Reactions
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.
Consensi Clinical Trials
See Literature
Consensi Note
Not Applicable
Consensi Patient Counseling
See Literature
Consensi Generic Name & Formulations
Legal Class
Rx
General Description
Amlodipine (as besylate), celecoxib; 2.5mg/200mg, 5mg/200mg, 10mg/200mg; tabs.
Pharmacological Class
Calcium channel blocker (CCB) + NSAID (COX-2 inhibitor).
How Supplied
Tabs—30, 500
Manufacturer
Generic Availability
NO
Consensi Indications
Indications
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.
Consensi Dosage and 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.
Consensi Contraindications
Contraindications
Sulfonamide, aspirin or NSAID allergy. Coronary artery bypass graft surgery.
Consensi Boxed Warnings
Boxed Warning
Risk of serious cardiovascular and gastrointestinal events.
Consensi Warnings/Precautions
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.
Consensi Pharmacokinetics
See Literature
Consensi Interactions
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.
Consensi Adverse Reactions
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.
Consensi Clinical Trials
See Literature
Consensi Note
Not Applicable
Consensi Patient Counseling
See Literature
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