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Amlodipine/Celecoxib

    DEA Class; Rx

    Common Brand Names; Consensi

    Calcium Channel Blockers, NSAIDs

    Oral combination of calcium channel blocker and nonsteroidal anti-inflammatory drug (NSAID)

    Used for treatment of hypertension and osteoarthritis

    Inappropriate for short-term or intermittent treatment

     

    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

    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

    >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%)

    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

    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

    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

    Adults

    10 mg/200 mg per day PO.

    Geriatric

    10 mg/200 mg per day PO.

    Adolescents

    Safety and efficacy have not been established.

    Children 

    Safety and efficacy have not been established

    Infant

    Safety and efficacy have not been established.

    Neonate

    Safety and efficacy have not been established.

    amlodipine/celecoxib

    Tablet

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