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CARDIOVASCULAR SYSTEM › BETA BLOCKING AGENTS › BETA BLOCKING AGENTS, OTHER COMBINATIONS › Beta blocking agents and calcium channel blockers
nebivolol and amlodipine
C07FB12
Forms & Strengths
- Nebivolol/Amlodipine 5 mg/5 mg oral tablet
- Nebivolol/Amlodipine 5 mg/10 mg oral tablet
- Nebivolol/Amlodipine 10 mg/5 mg oral tablet
- Nebivolol/Amlodipine 10 mg/10 mg oral tablet
Adult Dosing
- Hypertension: Initial dose 5 mg/5 mg or 5 mg/10 mg once daily, titrated up to maximum 20 mg/10 mg once daily based on blood pressure response.
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established.
Indications
- Treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure.
Mechanism of Action
- Combination of nebivolol (cardioselective beta-1 adrenergic blocker with vasodilatory properties via L-arginine/NO pathway) and amlodipine (dihydropyridine calcium channel blocker that inhibits transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle).
Contraindications
- Severe bradycardia
- Heart block greater than first degree
- Decompensated cardiac failure
- Sick sinus syndrome (unless permanent pacemaker in place)
- Cardiogenic shock
- Severe hepatic impairment (Child-Pugh Class C)
- Hypersensitivity to nebivolol, amlodipine, or any component of the formulation
Adverse Reactions
- Edema (peripheral)
- Headache
- Fatigue
- Dizziness
- Nausea
- Bradycardia
- Orthostatic hypotension
- Asthenia
Drug Interactions
- CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) may increase amlodipine plasma concentrations.
- CYP3A4 inducers (e.g., rifampin, St. John's wort) may decrease amlodipine plasma concentrations.
- CYP2D6 inhibitors (e.g., fluoxetine, paroxetine) may increase nebivolol exposure.
- Strong negative inotropes and AV nodal blocking agents (e.g., digoxin, verapamil, diltiazem) increase risk of bradycardia and heart block.
- Co-administration with other antihypertensive agents increases hypotension risk.
Curated Content: Needs Vetting Before Put to Clinical Use