amlodipine/celecoxib (Rx)

Brand and Other Names:Consensi
  • Print

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

amlodipine/celecoxib

tablet

  • 2.5mg/200mg
  • 5mg/200mg
  • 10mg/200mg

Osteoarthritis & Hypertension

Indicated in adults for whom treatment with both amlodipine for hypertension and celecoxib for osteoarthritis are appropriate (also see Dosing Considerations)

Use the lowest effective dosage of celecoxib for the shortest duration consistent with individual patient treatment goals

Only 200 mg of celecoxib once daily is available for each dosage strength

Initial: 5 mg/200 mg PO qDay or 2.5 mg/200 mg in small, fragile, or elderly patients, or patients with mild hepatic insufficiency

Use 2.5 mg/200 mg amlodipine/celecoxib when adding to other antihypertensive therapy

Adjust amlodipine component dosage according to blood pressure goals; in general, wait 7-14 days between titration steps; if more rapid titration is clinically warranted, monitor closely

Not to exceed 10 mg/200 mg qDay

Dosage Modifications

Hepatic impairment

  • Mild (Child-Pugh A): Initiate at lower dose of 2.5 mg/200mg
  • Moderate (Child-Pugh B): Not recommended; daily recommended dose of celecoxib in patients with moderate hepatic impairment should be reduced by 50%, however, because the combination only has a single dosage strength of celecoxib 200 mg, it is not recommended
  • Severe (Child-Pugh C): Not recommended

Renal impairment

  • Mild or moderate: No dose adjustment required
  • Severe (CrCl <30 mL/min): Not recommended (NSAIDs are not recommended with severe renal insufficiency)

Dosing Considerations

Additional information regarding indications

  • Amlodipine is indicated for hypertension, to lower blood pressure; lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions
  • Amlodipine may be used alone or in combination with other antihypertensive agents
  • Celecoxib is indicated for the management of the signs and symptoms of osteoarthritis

Limitations of use

  • Inappropriate for short-term or intermittent treatment or to treat any conditions other than hypertension in patients taking celecoxib for osteoarthritis
  • Only available in a celecoxib strength of 200 mg and is only to be taken once daily

Safety and efficacy not established

Dosage Forms & Strengths

amlodipine/celecoxib tablets

2.5mg/200mg

5mg/200mg

10mg/200mg

Osteoarthritis & Hypertension

Indicated in adults for whom treatment with both amlodipine for hypertension and celecoxib for osteoarthritis are appropriate (also see Dosing Considerations)

Use the lowest effective dosage of celecoxib for the shortest duration consistent with individual patient treatment goals

Only 200 mg of celecoxib once daily is available for each dosage strength

Initial: 2.5 mg/200 mg PO qDay in small, fragile, or elderly patients, or patients with mild hepatic insufficiency

Dosing Considerations (additional information regarding indications)

Amlodipine is indicated for hypertension, to lower blood pressure; lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarctions

Amlodipine may be used alone or in combination with other antihypertensive agents

Celecoxib is indicated for the management of the signs and symptoms of osteoarthritis

Dosing Considerations (limitations of use)

Inappropriate for short-term or intermittent treatment or to treat any conditions other than hypertension in patients taking celecoxib for osteoarthritis

Only available in a celecoxib strength of 200 mg and is only to be taken once daily

Dosing Considerations (geriatric use)

Celecoxib: Elderly patients, compared with younger patients, are at greater risk for NSAID-associated serious CV, GI, and/or renal adverse reactions

Amlodipine: Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy; elderly patients have decreased amlodipine clearance with a resulting increased AUC of ~40-60%, and a lower initial dose is recommended

Next:

Interactions

Interaction Checker

and amlodipine/celecoxib

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (1)

            • dantrolene

              dantrolene, amlodipine. Either increases toxicity of the other by Mechanism: pharmacodynamic synergism. Contraindicated. Rare incidence of cardiovascular collapse and marked hyperkalemia observed when coadministered; may be higher risk with nondihydropyridine calcium channel blockers.

            Serious - Use Alternative (15)

            • abametapir

              abametapir will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.

            • apalutamide

              apalutamide will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.

            • chloramphenicol

              chloramphenicol will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • chloroquine

              chloroquine will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • conivaptan

              conivaptan will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Calcium channel blockers with depressant effects on the sinus and AV nodes could potentiate dronedarone's effects on conduction. Give a low dose of calcium channel blockers initially and increase only ECG is reviewed and tolerated.

            • diltiazem

              diltiazem will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Concomitant use with amlodipine and diltiazem reported an a 60% increase in amlodipine AUC. Monitor increased effects and toxicities (eg, bradycardia, sinus arrest, decreased cardiac output) if amiodarone is concomitantly used with nondihydropyridine calcium channel blocker (ie, diltiazem).

            • enzalutamide

              enzalutamide will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • fexinidazole

              fexinidazole will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.

            • idelalisib

              idelalisib will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates

            • ivosidenib

              ivosidenib will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternate therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.

            • lofexidine

              lofexidine, amlodipine. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid coadministration with other drugs that decrease pulse or blood pressure to mitigate risk of excessive bradycardia and hypotension.

            • lonafarnib

              amlodipine will increase the level or effect of lonafarnib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration of lonafarnib (a sensitive CYP3A substrate) with weak CYP3A inhibitors is unavoidable, reduce to, or continue lonafarnib at starting dose. Closely monitor for arrhythmias and events (eg, syncope, heart palpitations) since lonafarnib effect on QT interval is unknown.

              lonafarnib will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling.

            • nifedipine

              nifedipine will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • simvastatin

              amlodipine increases levels of simvastatin by Other (see comment). Avoid or Use Alternate Drug. Comment: Benefits of combination therapy should be carefully weighed against the potential risks of combination. Potential for increased risk of myopathy/rhabdomyolysis. Limit simvastatin dose to no more than 20 mg/day when used concurrently.

            • voxelotor

              voxelotor will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.

            Monitor Closely (128)

            • acebutolol

              acebutolol and amlodipine both increase anti-hypertensive channel blocking. Modify Therapy/Monitor Closely.

            • aldesleukin

              aldesleukin increases effects of amlodipine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • alfuzosin

              alfuzosin and amlodipine both increase anti-hypertensive channel blocking. Use Caution/Monitor.

            • amifostine

              amifostine, amlodipine. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration with blood pressure lowering agents may increase the risk and severity of hypotension associated with amifostine. When amifostine is used at chemotherapeutic doses, withhold blood pressure lowering medications for 24 hr prior to amifostine; if blood pressure lowering medication cannot be withheld, do not administer amifostine.

            • asenapine

              asenapine and amlodipine both increase anti-hypertensive channel blocking. Use Caution/Monitor.

            • atenolol

              atenolol, amlodipine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs lower blood pressure.

            • avanafil

              avanafil increases effects of amlodipine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • avapritinib

              amlodipine will increase the level or effect of avapritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • axitinib

              amlodipine increases levels of axitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • belzutifan

              belzutifan will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. If unable to avoid coadministration of belzutifan with sensitive CYP3A4 substrates, consider increasing the sensitive CYP3A4 substrate dose in accordance with its prescribing information.

            • betaxolol

              betaxolol, amlodipine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs lower blood pressure.

            • bisoprolol

              bisoprolol, amlodipine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs lower blood pressure.

            • bosentan

              bosentan will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor for decreased effects of amlodipine (CYP3A4 substrate) if bosentan is initiated/dose increased. Also, monitor toxicities of amlodipine if bosentan is discontinued/dose decreased.

            • bretylium

              amlodipine, bretylium. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Each drug may cause hypotension.

            • butabarbital

              butabarbital will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • butalbital

              butalbital will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • calcium acetate

              calcium acetate decreases effects of amlodipine by pharmacodynamic antagonism. Use Caution/Monitor.

            • calcium carbonate

              calcium carbonate decreases effects of amlodipine by pharmacodynamic antagonism. Use Caution/Monitor.

            • calcium chloride

              calcium chloride decreases effects of amlodipine by pharmacodynamic antagonism. Use Caution/Monitor.

            • calcium citrate

              calcium citrate decreases effects of amlodipine by pharmacodynamic antagonism. Use Caution/Monitor.

            • calcium gluconate

              calcium gluconate decreases effects of amlodipine by pharmacodynamic antagonism. Use Caution/Monitor.

            • carbamazepine

              carbamazepine will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

            • carbidopa

              carbidopa increases effects of amlodipine by pharmacodynamic synergism. Use Caution/Monitor. Therapy with carbidopa, given with or without levodopa or carbidopa-levodopa combination products, is started, dosage adjustment of the antihypertensive drug may be required.

            • carvedilol

              carvedilol and amlodipine both increase anti-hypertensive channel blocking. Modify Therapy/Monitor Closely.

            • celiprolol

              celiprolol, amlodipine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs lower blood pressure.

            • cenobamate

              cenobamate will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.

            • clarithromycin

              clarithromycin will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Increased effect of calcium channel blockers may lead to hypotension, edema, decreased HR, and acute kidney injury due to reduced renal blood flow

            • clevidipine

              amlodipine and clevidipine both increase anti-hypertensive channel blocking. Use Caution/Monitor.

            • cobicistat

              cobicistat will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • crizotinib

              crizotinib increases levels of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Dose reduction may be needed for coadministered drugs that are predominantly metabolized by CYP3A.

            • cyclosporine

              cyclosporine will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              amlodipine increases levels of cyclosporine by unspecified interaction mechanism. Modify Therapy/Monitor Closely. A prospective study in renal transplant recipients averaged a 40% increase in cyclosporine trough levels.

            • dabrafenib

              dabrafenib will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

            • darunavir

              darunavir will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • deferasirox

              deferasirox will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • dichlorphenamide

              dichlorphenamide and amlodipine both decrease serum potassium. Use Caution/Monitor.

            • diltiazem

              amlodipine and diltiazem both increase anti-hypertensive channel blocking. Use Caution/Monitor.

            • doxazosin

              doxazosin and amlodipine both increase anti-hypertensive channel blocking. Use Caution/Monitor.

            • dronedarone

              dronedarone will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Calcium channel blockers with depressant effects on the sinus and AV nodes could potentiate dronedarone's effects on conduction. Give a low dose of calcium channel blockers initially and increase only ECG is reviewed and tolerated.

            • efavirenz

              efavirenz will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • elagolix

              elagolix will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.

            • elvitegravir/cobicistat/emtricitabine/tenofovir DF

              elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Cobicistat is a CYP3A4 inhibitor; contraindicated with CYP3A4 substrates for which elevated plasma concentrations are associated with serious and/or life-threatening events.

            • encorafenib

              encorafenib, amlodipine. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.

            • erythromycin base

              erythromycin base will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • erythromycin ethylsuccinate

              erythromycin ethylsuccinate will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • erythromycin lactobionate

              erythromycin lactobionate will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • erythromycin stearate

              erythromycin stearate will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • eslicarbazepine acetate

              eslicarbazepine acetate will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • esmolol

              esmolol, amlodipine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs lower blood pressure.

            • fedratinib

              fedratinib will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

            • felodipine

              amlodipine and felodipine both increase anti-hypertensive channel blocking. Use Caution/Monitor.

            • finerenone

              amlodipine will increase the level or effect of finerenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Monitor serum potassium during initiation and dosage adjustment of either finererone or weak CYP3A4 inhibitors. Adjust finererone dosage as needed.

            • flibanserin

              amlodipine will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Increased flibanserin adverse effects may occur if coadministered with multiple weak CYP3A4 inhibitors.

            • fluconazole

              fluconazole will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • fosamprenavir

              fosamprenavir will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • fosphenytoin

              fosphenytoin will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • griseofulvin

              griseofulvin will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • iloperidone

              iloperidone and amlodipine both increase additive vasodilation. Use Caution/Monitor. Calcium channel blockers with iloperidone may potentiate the hypotensive effects.

            • isradipine

              amlodipine and isradipine both increase anti-hypertensive channel blocking. Use Caution/Monitor.

            • istradefylline

              istradefylline will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.

            • itraconazole

              itraconazole will increase the level or effect of amlodipine by Other (see comment). Modify Therapy/Monitor Closely. CCBs elicit negative inotropic effects which may be additive to those of itraconazole; additionally, itraconazole can inhibit the metabolism of calcium channel blockers. Monitor for adverse reactions. Concomitant drug dose reduction may be necessary.

            • ketoconazole

              ketoconazole will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • labetalol

              labetalol and amlodipine both increase anti-hypertensive channel blocking. Modify Therapy/Monitor Closely.

            • lemborexant

              amlodipine will increase the level or effect of lemborexant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Lower nightly dose of lemborexant recommended if coadministered with weak CYP3A4 inhibitors. See drug monograph for specific dosage modification.

            • lesinurad

              lesinurad decreases levels of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • letermovir

              letermovir increases levels of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • levodopa

              levodopa increases effects of amlodipine by pharmacodynamic synergism. Use Caution/Monitor. Consider decreasing dosage of antihypertensive agent.

            • lomitapide

              amlodipine increases levels of lomitapide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lomitapide dose should not exceed 30 mg/day.

            • lopinavir

              lopinavir will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • lorlatinib

              lorlatinib will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • lurasidone

              lurasidone increases effects of amlodipine by Other (see comment). Use Caution/Monitor. Comment: Potential for increased risk of hypotension with concurrent use. Monitor blood pressure and adjust dose of antihypertensive agent as needed.

            • magnesium supplement

              magnesium supplement, amlodipine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Calcium channel blockers may increase toxic effects of magnesium; magnesium may increase hypotensive effects of calcium channel blockers.

            • maraviroc

              maraviroc, amlodipine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of orthostatic hypotension.

            • mefloquine

              mefloquine increases levels of amlodipine by decreasing metabolism. Use Caution/Monitor. Risk of arrhythmia.

            • metformin

              amlodipine decreases effects of metformin by pharmacodynamic antagonism. Use Caution/Monitor. Patient should be closely observed for loss of blood glucose control; when drugs are withdrawn from a patient receiving metformin, patient should be observed closely for hypoglycemia.

            • methylphenidate

              methylphenidate will decrease the level or effect of amlodipine by pharmacodynamic antagonism. Use Caution/Monitor. Methylphenidate may diminish antihypertensive effects. Monitor BP.

            • midazolam intranasal

              amlodipine will increase the level or effect of midazolam intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of mild CYP3A4 inhibitors with midazolam intranasal may cause higher midazolam systemic exposure, which may prolong sedation.

            • mifepristone

              mifepristone will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • mitotane

              mitotane decreases levels of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.

            • moxisylyte

              moxisylyte and amlodipine both increase anti-hypertensive channel blocking. Use Caution/Monitor.

            • nadolol

              nadolol and amlodipine both increase anti-hypertensive channel blocking. Modify Therapy/Monitor Closely.

            • nebivolol

              nebivolol, amlodipine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs lower blood pressure.

            • nefazodone

              nefazodone will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

            • nevirapine

              nevirapine will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • nicardipine

              amlodipine and nicardipine both increase anti-hypertensive channel blocking. Use Caution/Monitor.

            • nifedipine

              amlodipine and nifedipine both increase anti-hypertensive channel blocking. Use Caution/Monitor.

            • nilotinib

              nilotinib will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • nisoldipine

              amlodipine and nisoldipine both increase anti-hypertensive channel blocking. Use Caution/Monitor.

            • nitroglycerin rectal

              nitroglycerin rectal, amlodipine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Marked orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used concomitantly. Observe for possible additive hypotensive effects during concomitant use. .

            • nitroglycerin sublingual

              amlodipine, nitroglycerin sublingual. Either increases toxicity of the other by additive vasodilation. Modify Therapy/Monitor Closely. Marked orthostatic hypotension reported with concomitant use.

            • nitroprusside sodium

              amlodipine increases effects of nitroprusside sodium by pharmacodynamic synergism. Use Caution/Monitor.

            • ombitasvir/paritaprevir/ritonavir & dasabuvir

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Decrease dose of calcium channel blocker; dose of amlodipine should be decreased by at least 50%; clinical monitoring of patients is recommended for edema and/or signs and symptoms of hypotension. if such events occur, consider further dose reduction of calcium channel blocker or switching to alternative to calcium channel blocker

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of amlodipine by altering metabolism. Modify Therapy/Monitor Closely. Decrease dose of calcium channel blocker; dose of amlodipine should be decreased by at least 50%; clinical monitoring of patients is recommended for edema and/or signs and symptoms of hypotension. if such events occur, consider further dose reduction of calcium channel blocker or switching to alternative to calcium channel blocker

            • penbutolol

              penbutolol and amlodipine both increase anti-hypertensive channel blocking. Modify Therapy/Monitor Closely.

            • pentobarbital

              pentobarbital will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • phenobarbital

              phenobarbital will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • phenoxybenzamine

              phenoxybenzamine and amlodipine both increase anti-hypertensive channel blocking. Use Caution/Monitor.

            • phentolamine

              phentolamine and amlodipine both increase anti-hypertensive channel blocking. Use Caution/Monitor.

            • phenytoin

              amlodipine will increase the level or effect of phenytoin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

            • pindolol

              pindolol and amlodipine both increase anti-hypertensive channel blocking. Modify Therapy/Monitor Closely.

            • posaconazole

              posaconazole will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • prazosin

              prazosin and amlodipine both increase anti-hypertensive channel blocking. Use Caution/Monitor.

            • primidone

              primidone will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • propranolol

              propranolol and amlodipine both increase anti-hypertensive channel blocking. Modify Therapy/Monitor Closely.

            • ribociclib

              ribociclib will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • rifabutin

              rifabutin will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • rifampin

              rifampin will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • rifapentine

              rifapentine will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • ritonavir

              ritonavir will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • rucaparib

              rucaparib will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.

            • saquinavir

              saquinavir increases levels of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Potential for increased toxicity. .

            • silodosin

              silodosin and amlodipine both increase anti-hypertensive channel blocking. Use Caution/Monitor.

            • sodium sulfate/?magnesium sulfate/potassium chloride

              amlodipine, sodium sulfate/?magnesium sulfate/potassium chloride. Either increases effects of the other by unknown mechanism. Use Caution/Monitor. Monitor for hypotension or muscle weakness in patients receiving calcium channel blockers with elevated serum magnesium concentrations.

            • sodium sulfate/potassium sulfate/magnesium sulfate

              amlodipine, sodium sulfate/potassium sulfate/magnesium sulfate. Either increases effects of the other by unknown mechanism. Use Caution/Monitor. Monitor for hypotension or muscle weakness in patients receiving calcium channel blockers with elevated serum magnesium concentrations.

            • sotalol

              sotalol and amlodipine both increase anti-hypertensive channel blocking. Modify Therapy/Monitor Closely.

            • St John's Wort

              St John's Wort will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.

            • stiripentol

              stiripentol, amlodipine. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.

            • tacrolimus

              amlodipine will increase the level or effect of tacrolimus by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Adjust dose when appropriate.

            • tadalafil

              tadalafil increases effects of amlodipine by pharmacodynamic synergism. Use Caution/Monitor. Risk of hypotension.

            • tazemetostat

              tazemetostat will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              amlodipine will decrease the level or effect of tazemetostat by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • tecovirimat

              tecovirimat will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.

            • temsirolimus

              amlodipine increases toxicity of temsirolimus by Other (see comment). Use Caution/Monitor. Comment: Combination of mTOR inhibitors with calcium channel blockers increases risk of angioedema.

            • terazosin

              terazosin and amlodipine both increase anti-hypertensive channel blocking. Use Caution/Monitor.

            • timolol

              timolol and amlodipine both increase anti-hypertensive channel blocking. Modify Therapy/Monitor Closely.

            • tinidazole

              amlodipine will increase the level or effect of tinidazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • tipranavir

              tipranavir increases levels of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Potential for increased toxicity. Tipranavir is used with ritonavir (boosted therapy) which is a potent CYP3A4 inhibitor.

            • trimagnesium citrate anhydrous

              trimagnesium citrate anhydrous, amlodipine. Either increases effects of the other by Other (see comment). Use Caution/Monitor. Comment: Possible additive effect of magnesium and calcium channel blockers on reduction of ionic calcium may increase risk of hypotension or muscle weakness.

            • verapamil

              amlodipine and verapamil both increase anti-hypertensive channel blocking. Use Caution/Monitor.

            • voriconazole

              voriconazole will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              voriconazole increases levels of amlodipine by decreasing metabolism. Use Caution/Monitor.

            • xipamide

              xipamide increases effects of amlodipine by pharmacodynamic synergism. Use Caution/Monitor.

            Minor (41)

            • agrimony

              agrimony increases effects of amlodipine by pharmacodynamic synergism. Minor/Significance Unknown.

            • amobarbital

              amobarbital will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • aprepitant

              aprepitant will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • armodafinil

              armodafinil will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • artemether/lumefantrine

              artemether/lumefantrine will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • atazanavir

              atazanavir will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • atracurium

              amlodipine increases effects of atracurium by pharmacodynamic synergism. Minor/Significance Unknown. Ca Channel Blockers interfere w/Ach release from prejunctional axon.

            • brimonidine

              brimonidine increases effects of amlodipine by pharmacodynamic synergism. Minor/Significance Unknown.

            • cisatracurium

              amlodipine increases effects of cisatracurium by pharmacodynamic synergism. Minor/Significance Unknown. Ca Channel Blockers interfere w/Ach release from prejunctional axon.

            • cornsilk

              cornsilk increases effects of amlodipine by pharmacodynamic synergism. Minor/Significance Unknown.

            • dasatinib

              dasatinib will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • dexamethasone

              dexamethasone will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • DHEA, herbal

              DHEA, herbal will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • etravirine

              etravirine will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • fo-ti

              fo-ti increases effects of amlodipine by pharmacodynamic synergism. Minor/Significance Unknown.

            • forskolin

              forskolin increases effects of amlodipine by pharmacodynamic synergism. Minor/Significance Unknown.

            • grapefruit

              grapefruit will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • incobotulinumtoxinA

              amlodipine increases effects of incobotulinumtoxinA by pharmacodynamic synergism. Minor/Significance Unknown. Ca Channel Blockers interfere w/Ach release from prejunctional axon.

            • lithium

              amlodipine increases toxicity of lithium by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of neurotoxicity.

            • maitake

              maitake increases effects of amlodipine by pharmacodynamic synergism. Minor/Significance Unknown.

            • metipranolol ophthalmic

              metipranolol ophthalmic increases effects of amlodipine by pharmacodynamic synergism. Minor/Significance Unknown.

            • modafinil

              modafinil will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • nelfinavir

              nelfinavir will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • octacosanol

              octacosanol increases effects of amlodipine by pharmacodynamic synergism. Minor/Significance Unknown.

            • onabotulinumtoxinA

              amlodipine increases effects of onabotulinumtoxinA by pharmacodynamic synergism. Minor/Significance Unknown. Ca Channel Blockers interfere w/Ach release from prejunctional axon.

            • oxcarbazepine

              oxcarbazepine will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • pancuronium

              amlodipine increases effects of pancuronium by pharmacodynamic synergism. Minor/Significance Unknown. Ca Channel Blockers interfere w/Ach release from prejunctional axon.

            • porfimer

              amlodipine decreases levels of porfimer by unspecified interaction mechanism. Minor/Significance Unknown.

            • quinupristin/dalfopristin

              quinupristin/dalfopristin will increase the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • rapacuronium

              amlodipine increases effects of rapacuronium by pharmacodynamic synergism. Minor/Significance Unknown. Ca Channel Blockers interfere w/Ach release from prejunctional axon.

            • reishi

              reishi increases effects of amlodipine by pharmacodynamic synergism. Minor/Significance Unknown.

            • rocuronium

              amlodipine increases effects of rocuronium by pharmacodynamic synergism. Minor/Significance Unknown. Ca Channel Blockers interfere w/Ach release from prejunctional axon.

            • rufinamide

              rufinamide will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • ruxolitinib

              amlodipine will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • secobarbital

              secobarbital will decrease the level or effect of amlodipine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

            • shepherd's purse

              shepherd's purse, amlodipine. Other (see comment). Minor/Significance Unknown. Comment: Theoretically, shepherd's purse may interfere with BP control.

            • succinylcholine

              amlodipine increases effects of succinylcholine by pharmacodynamic synergism. Minor/Significance Unknown. Ca Channel Blockers interfere w/Ach release from prejunctional axon.

            • tizanidine

              tizanidine increases effects of amlodipine by pharmacodynamic synergism. Minor/Significance Unknown. Risk of hypotension.

            • treprostinil

              treprostinil increases effects of amlodipine by pharmacodynamic synergism. Minor/Significance Unknown.

            • vecuronium

              amlodipine increases effects of vecuronium by pharmacodynamic synergism. Minor/Significance Unknown. Ca Channel Blockers interfere w/Ach release from prejunctional axon.

            • verteporfin

              amlodipine increases levels of verteporfin by pharmacodynamic synergism. Minor/Significance Unknown.

            Previous
            Next:

            Adverse Effects

            >10%

            Celecoxib

            • Headache (15.8%)

            Amlodipine

            • Edema (1.8-14.6%)

            1-10% (amlodipine)

            Fatigue (4.5%)

            Flushing (0.7-4.5%)

            Dizziness (1.1-3.4%)

            Palpitations (0.7-3.3%)

            Nausea (2.9%)

            Abdominal pain (1.6%)

            Somnolence (1.3-1.6%)

            1-10% (celecoxib)

            Dyspepsia (8.8%)

            Upper respiratory tract infection (8.1%)

            Diarrhea (5.6%)

            Sinusitis (5%)

            Abdominal pain (4.1%)

            Nausea (3.5%)

            Back pain (2.8%)

            Insomnia (2.3%)

            Pharyngitis (2.3%)

            Rash (2.2%)

            Flatulence (2.2%)

            Peripheral edema (2.1%)

            Dizziness (2%)

            Rhinitis (2%)

            Previous
            Next:

            Warnings

            Black Box Warnings

            Cardiovascular thrombotic events

            • NSAIDs cause an increased risk of serious CV thrombotic events, including MI and stroke, which can be fatal
            • This risk may occur early in the treatment and may increase with duration of use
            • NSAIDs are contraindicated in the setting of coronary artery bypass graft (CABG) surgery

            GI bleeding, ulceration, and perforation

            • NSAIDs cause an increased risk of serious 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

            Contraindications

            Known hypersensitivity (eg, anaphylactic reactions and serious skin reactions) to amlodipine, celecoxib, or any of the inactive ingredients

            History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs; severe, sometimes fatal, anaphylactic reactions to NSAIDs, have been reported in such patients

            Demonstrated allergic-type reactions to sulfonamides

            In the setting of CABG surgery

            Cautions

            Celecoxib may cause premature closure of the ductus arteriosus; avoid

            NSAIDs in pregnant women starting at 30 weeks of gestation

            Celecoxib may increase risk of bleeding events; anemia reported

            Because celecoxib reduces inflammation and possibly fever, diagnostic signs for detecting infection may be diminished

            Because serious GI bleeding, hepatotoxicity, and renal injury can occur without warning symptoms or signs, consider periodically monitoring patients on long-term NSAIDs with a complete CBC and a chemistry profile

            Cardiovascular events

            • Also see Black Box Warnings and Contraindications
            • Clinical trials of several cyclooxygenase-2 (COX-2) selective and nonselective NSAIDs have shown an increased risk of serious CV thrombotic events, including MI and stroke, which can be fatal
            • Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of MI and stroke; NSAIDs are contraindicated in the setting of CABG
            • Observational studies conducted in the Danish National Registry found patients treated with NSAIDs post-MI were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment; avoid NSAIDs in patients following recent MI
            • Randomized controlled trials demonstrated an approximately doubling in hospitalizations for heart failure (HF) in COX-2 selective-treated patients and nonselective NSAID treated patients; avoid use with severe HF
            • NSAIDs may lead to new-onset hypertension or worsening of preexisting hypertension
            • Amlodipine may worsen angina, and acute MI can develop after starting or increasing the dose, particularly in patients with severe obstructive coronary artery disease
            • Amlodipine may cause symptomatic hypotension, particularly in patients with severe aortic stenosis

            GI bleeding, ulceration, and perforation

            • Also see Black Box Warnings
            • NSAIDs, including celecoxib, cause serious GI adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal
            • Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic
            • Patients with a prior history of peptic ulcer disease and/or GI bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared with patients without these risk factors

            Hepatotoxicity and patients with hepatic impairment

            • Also see Dosage Modifications
            • Elevated ALT or AST (≥3 x ULN) reported in ~1% of NSAID-treated patients in clinical trials
            • Rare, sometimes fatal, cases of severe hepatic injury, including fulminant hepatitis, liver necrosis, and hepatic failure, have also been reported with NSAIDs
            • Amlodipine is extensively metabolized by the liver, and the plasma elimination half-life is 56 hr in patients with impaired hepatic function

            Renal toxicity and hyperkalemia

            • Long-term NSAID use has resulted in renal papillary necrosis and other renal injury
            • Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion
            • Patients at greatest risk are those with impaired renal function, dehydration, hypovolemia, heart failure, liver dysfunction; those taking diuretics, ACE-inhibitors, or ARBs; and elderly individuals
            • Increased serum potassium, including hyperkalemia, reported with NSAIDs, even without renal impairment; this is attributed to a hyporeninemic-hypoaldosteronism state

            Anaphylactic, asthma exacerbation, and serious skin reactions

            • Also see Contraindications
            • Celecoxib is a sulfonamide; has been associated with anaphylactic reactions, including in patients with aspirin-sensitive asthma
            • A subpopulation of patients with asthma may have aspirin-sensitive asthma, which may include chronic rhinosinusitis complicated by nasal polyps; severe, potentially fatal bronchospasm; and/or intolerance to aspirin and other NSAIDs
            • Serious skin reactions have occurred following treatment with celecoxib, including erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis; these serious events may occur without warning and can be fatal

            Drug reaction with eosinophilia and systemic symptoms (DRESS)

            • Drug Reaction reported in patients taking NSAIDs; some of these events have been fatal or life-threatening; DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling
            • Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis; sometimes symptoms of DRESS may resemble an acute viral infection
            • Eosinophilia is often present; because this disorder is variable in its presentation, other organ systems not noted here may be involved
            • Early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident; if such signs or symptoms are present, discontinue therapy and evaluate the patient immediately

            Drug interaction overview

            • Celecoxib
              • Coadministration with anticoagulants or antiplatelets (eg, ASA, SSRIs) have a synergistic effect on bleeding
              • NSAIDs may decrease antihypertensive effects of ACE inhibitors, ARBs, or beta-blockers
              • NSAIDs may reduce natriuretic effect of loop diuretics and thiazide diuretics
              • Celecoxib may prolong digoxin elimination half-life
              • NSAIDs may elevate plasma lithium levels and reduce renal lithium clearance
              • Coadministration with methotrexate may increase risk of methotrexate toxicity (eg, neutropenia, thrombocytopenia, renal dysfunction)
              • Coadministration with cyclosporine may increase cyclosporine’s risk for nephrotoxicity
              • Coadministration with other NSAIDs or salicylates increases risk of GI toxicity, with little or no increase in analgesic efficacy
              • Coadministration with corticosteroids may increase risk of GI ulceration or bleeding
              • Coadministration with pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity
              • Celecoxib metabolism is primarily via CYP2C9 in the liver; coadministration with CYP2C9 inhibitors or inducers may increase toxicity or reduce efficacy, respectively
              • Celecoxib may inhibit CYP2D6; may increase systemic exposure of CYP2D6 substrates
            • Amlodipine
              • Coadministration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction
              • If coadministered with CYP3A inducers, monitor blood pressure to assure efficacy
              • Amlodipine may increase systemic exposure of simvastatin; limit simvastatin dose to 20 mg/day if coadministered
              • Amlodipine may increase systemic exposure of cyclosporine or tacrolimus; monitor trough cyclosporine or tacrolimus levels and adjust dose when appropriate
            Previous
            Next:

            Pregnancy

            Pregnancy

            There are no adequate and well-controlled studies in pregnant women; data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive

            Clinical considerations

            • In animal studies, NSAIDs, including ibuprofen, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth

            Fetal toxicity

            • Use of NSAIDs 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 use between about 20 and 30 weeks of gestation and avoid use at about 30 weeks of gestation and later in pregnancy
            • Use of NSAIDs at about 30 weeks gestation or later in pregnancy increases risk of premature closure of fetal ductus arteriosus
            • Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment
            • There are no available data with use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage; however, there are published studies with each individual component of the drug combination
            • Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive
            • In animal reproduction studies, there were no clear developmental effects at doses up to 0.4-times the maximum recommended human dose (MRHD) in the rabbit and 0.5-times in the MRHD rat when dosed throughout gestation
            • In contrast, an increase in membranous ventricular septal defects was reported in rats treated on gestation days 9 & 10 with 0.8-times the MRHD
            • Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as ibuprofen, resulted in increased pre-and post-implantation loss
            • Prostaglandins also have been shown to have an important role in fetal kidney development; in published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses
            • Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, can cause premature closure of fetal ductus arteriosus
            • If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit use to lowest effective dose and shortest duration possible
            • If treatment is needed for a pregnant woman, consider monitoring with ultrasound for oligohydramnios; if oligohydramnios occurs, discontinue therapy and follow up according to clinical practice

            Labor or delivery

            • There are no studies on the effects of celecoxib during labor or delivery
            • In animal studies, NSAIDs inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth

            Infertility

            • Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin mediated follicular rupture required for ovulation
            • Consider withdrawal of NSAIDs in women who have difficulties conceiving or who are undergoing investigation of infertility

            Animal studies

            • Administration during pregnancy resulted in adverse effects on development, including increases in embryonic death and fetal malformations, at doses or maternal plasma drug exposures greater than those used clinically
            • Prostaglandins have shown an important role in endometrial vascular permeability, blastocyst implantation, and decidualization; in animal studies, administration of prostaglandin synthesis inhibitors resulted in increased pre-and postimplantation loss

            Amlodipine

            • Available data from postmarketing reports and a small study with amlodipine use in pregnant women with mild-to-moderate chronic hypertension did not identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
            • There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy

            Lactation

            The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child or from the underlying maternal condition

            Celecoxib

            • Limited data from 12 breastfeeding women showed low levels of celecoxib in breast milk
            • Calculated average daily infant dose was 10-40 mcg/kg/day, <1% of the weight-based therapeutic dose for a 2-year old child
            • There is no information available regarding effects of drug on milk production; the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

            Amlodipine

            • Estimated median infant dose 4.17 mcg/kg/day, which is ~1.7-3.3% of the recommended dose for an average 6-year-old (20 kg)

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

            Previous
            Next:

            Pharmacology

            Mechanism of Action

            Celecoxib: Inhibits cyclooxygenase (COX)-2; does not affect COX-1 (at therapeutic concentrations), thereby decreasing formation of prostaglandin synthesis; has analgesic, anti-inflammatory, and antipyretic properties

            Amlodipine: Inhibits transmembrane influx of extracellular calcium ions across membranes of myocardial cells and vascular smooth muscle cells without changing serum calcium concentrations; this inhibits cardiac and vascular smooth muscle contraction, thereby dilating main coronary and systemic arteries

            In clinical trials, the combination lowered diastolic and systolic blood pressure (both daytime and nighttime measurements) similarly to an equal dose of amlodipine

            Absorption

            Absolute bioavailability: 64-90% (amlodipine)

            Peak plasma time

            • Amlodipine: 6-12 hr
            • Celecoxib: 2-3 hr

            Distribution

            Vd: 400 L (celecoxib)

            Protein bound

            • Amlodipine: 93%
            • Celecoxib: 97%

            Metabolism

            Celecoxib: Primarily in liver by CYP2C9

            Amlodipine: Extensively (~90%) converted to inactive metabolites via hepatic metabolism

            Elimination

            Clearance: 500 mL/min (celecoxib)

            Half-life

            • Amlodipine: 30-50 hr
            • Celecoxib: 11 hr

            Excretion

            • Amlodipine: 10% (parent drug) and 60% metabolites in urine
            • Celecoxib: <3% unchanged drug in urine and feces

            Pharmacogenomics

            CYP2C9 activity is reduced in individuals with genetic polymorphisms that lead to reduced enzyme activity (eg, individuals who are homozygous for the CYP2C9*2 and CYP2C9*3 polymorphisms)

            Limited data from 4 published reports that included a total of 8 subjects with the homozygous CYP2C9*3/*3 genotype showed celecoxib systemic levels that were 3- to 7-fold higher in these subjects compared with subjects with CYP2C9*1/*1 or *I/*3 genotypes

            Pharmacokinetics of celecoxib have not been evaluated in subjects with other CYP2C9 polymorphisms (eg, *2, *5, *6, *9 and *11)

            Estimated frequency of the homozygous *3/*3 genotype is 0.3-1% in various ethnic groups

            Previous
            Next:

            Administration

            Oral Administration

            May take with or without food

            Discontinuation

            • If analgesic therapy is no longer indicated, discontinue amlodipine/celecoxib and initiate patient on alternative antihypertensive therapy
            • If amlodipine/celecoxib is stopped and replaced with an equal dose of amlodipine, monitor blood pressure carefully

            Replacement therapy

            • For patients receiving celecoxib and amlodipine from separate capsules and tablets, respectively, substitute amlodipine/celecoxib containing the same component doses; not to exceed 10mg/200 mg qDay
            • Monitor blood pressure carefully

            Storage

            Store at room temperature 20-25°C (68-77°F)

            Dispense in tight, light-resistant containers

            Previous
            Next:

            Images

            No images available for this drug.
            Previous
            Next:

            Patient Handout

            A Patient Handout is not currently available for this monograph.
            Previous
            Next:

            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous
            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.