Classes
DEA Class; Rx
Common Brand Names; Consensi
Calcium Channel Blockers, NSAIDs
Description
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
Indications
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
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
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%)
Warnings
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 and Lactation
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
Maximum Dosage
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.
How supplied
amlodipine/celecoxib
Tablet
- 2.5mg/200mg
- 5mg/200mg
- 10mg/200mg