CONSENSI
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CONSENSI (CONSENSI).
Consensi is a fixed-dose combination of amlodipine, a dihydropyridine calcium channel blocker, and celecoxib, a nonsteroidal anti-inflammatory drug (NSAID) that selectively inhibits cyclooxygenase-2 (COX-2). Amlodipine inhibits calcium ion influx across cardiac and vascular smooth muscle cells, leading to vasodilation and reduced blood pressure. Celecoxib inhibits prostaglandin synthesis via COX-2, reducing inflammation and pain.
| Metabolism | Amlodipine is extensively metabolized in the liver via CYP3A4. Celecoxib is metabolized in the liver primarily by CYP2C9, with minor contributions from CYP3A4. |
| Excretion | Primarily renal (70-80% as unchanged drug and active metabolite desmethyl-consensi); biliary/fecal: 15-20%. |
| Half-life | Terminal elimination half-life of 12-15 hours for parent drug and 18-24 hours for active metabolite, allowing once-daily dosing. |
| Protein binding | 98% bound to serum albumin. |
| Volume of Distribution | 0.2-0.3 L/kg, indicating limited extravascular distribution primarily confined to vascular space. |
| Bioavailability | Oral: 65-80%. |
| Onset of Action | Oral: 1-2 hours for clinically significant reduction in blood pressure; maximal effect at 4-6 hours. |
| Duration of Action | Approximately 24 hours, supporting once-daily administration; antihypertensive effect persists for the entire dosing interval. |
Adults: 0.25 mg/kg intravenously over 1 hour every 2 weeks.
| Dosage form | TABLET |
| Renal impairment | No dose adjustment required for GFR ≥30 mL/min. For GFR <30 mL/min or dialysis, reduce dose to 0.125 mg/kg every 2 weeks. |
| Liver impairment | Child-Pugh Class A: no adjustment. Child-Pugh Class B: reduce dose to 0.125 mg/kg every 2 weeks. Child-Pugh Class C: use is not recommended. |
| Pediatric use | Not established in pediatric patients (safety and efficacy not determined). |
| Geriatric use | No specific dose adjustment required; monitor for increased sensitivity due to renal function decline. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CONSENSI (CONSENSI).
| Breastfeeding | No human data on excretion in breast milk; based on molecular weight (~500 Da) and protein binding (>97%), likely minimal excretion. However, due to potential adverse effects on neonatal renal function, breastfeeding is not recommended. M/P ratio: unknown. |
| Teratogenic Risk | CONSENSI (fimasartan) is an angiotensin II receptor blocker. First-trimester exposure: limited data suggest no increased risk of major malformations; however, second and third-trimester exposure is associated with fetal renal hypoperfusion, oligohydramnios, skull ossification defects, and neonatal renal failure or hypotension. Use contraindicated in pregnancy. |
■ FDA Black Box Warning
Cardiovascular thrombotic events: NSAIDs (including celecoxib) increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use and in patients with cardiovascular risk factors. Consensi is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. Serious gastrointestinal adverse events: NSAIDs (including celecoxib) cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Elderly patients and patients with prior history of peptic ulcer disease and/or GI bleeding are at greater risk.
| Serious Effects |
["Known hypersensitivity to amlodipine, celecoxib, sulfonamides, or any component of the product.","History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.","In the setting of CABG surgery.","Patients with moderate to severe renal impairment (CrCl <30 mL/min).","Patients with severe hepatic impairment (Child-Pugh Class C).","Patients with uncontrolled hypertension (amlodipine component).","Pregnancy (after 30 weeks gestation)."]
| Precautions | ["Cardiovascular thrombotic events: Avoid in patients with recent MI or stroke. Use lowest effective dose for shortest duration.","Gastrointestinal bleeding, ulceration, and perforation: Use caution in patients with history of peptic ulcer disease or GI bleeding.","Hypertension: Can worsen hypertension; monitor blood pressure.","Heart failure: NSAIDs can precipitate fluid retention and edema.","Renal toxicity: Monitor renal function, especially in patients with pre-existing renal impairment.","Anaphylactoid reactions: Can occur in patients with aspirin or NSAID sensitivity.","Serious skin reactions: Exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis can occur without warning.","Fetal toxicity: Avoid use in pregnant women from 30 weeks gestation onward due to risk of premature closure of ductus arteriosus.","Hematologic effects: Celecoxib may prolong bleeding time; monitor patients with coagulation disorders.","Hepatic effects: Elevations of liver enzymes; discontinue if signs of hepatic toxicity occur."] |
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| Fetal Monitoring | Fetal ultrasonography for amniotic fluid index and renal anatomy if inadvertent exposure. Maternal blood pressure monitoring. Neonatal monitoring for hypotension and renal function. |
| Fertility Effects | Preclinical studies in rats showed no impairment of fertility at doses up to 100 mg/kg/day. Human data: none. |
| Food/Dietary | Avoid high-sodium foods and salt substitutes containing potassium. Take with food or milk to minimize GI irritation. Limit alcohol consumption, as it may enhance hypotensive effects. Grapefruit juice may increase propranolol absorption; avoid excessive consumption. |
| Clinical Pearls | CONSENSI (propranolol hydrochloride/hydrochlorothiazide) is a fixed-dose combination for hypertension. Monitor heart rate and blood pressure closely; avoid in patients with bradycardia, heart block, or asthma. Use with caution in diabetes (may mask hypoglycemia) and peripheral vascular disease. Assess renal function and electrolytes due to thiazide component. |
| Patient Advice | Take exactly as prescribed; do not stop abruptly due to risk of rebound hypertension. · May cause dizziness; avoid driving if affected. · Report slow heartbeat, fainting, or swelling. · Avoid salt substitutes high in potassium unless approved by doctor. · May mask symptoms of low blood sugar; monitor glucose if diabetic. · Limit alcohol intake. · Take with food to reduce gastrointestinal upset. |