Dosing & Uses
Dosage Forms & Strengths
1 tablet (2.5-10 mg amlodipine; 10-40mg benazepril) PO qDay; titrate with appropriate dosage combination to control BP; not to exceed 10 mg/day amlodipine, 80 mg/day benazepril
Renal impairment: Decrease dose if CrCl <30 mL/min, severe liver impairment, or coadministered with diuretic
Hepatic impairment: 2.5 mg based on amlodipine initially
Safety and efficacy not established
The recommended initial dose of amlodipine in elderly patients is 2.5 mg
Serious - Use Alternative
Significant - Monitor Closely
- Peripheral edema (2-15%)
- Pulmonary edema (7-15%)
- None indicated
- Abdominal pain (1.6%)
- Dizziness (1.1-3.4%)
- Dyspepsia (1-2%)
- Fatigue (4.5%)
- Flushing (0.7-2.6%)
- Headache (7.3%)
- Male sexual dysfunction (1-2%)
- Muscle cramps (1-2%)
- Nausea (2.9%)
- Palpitation (0.7-4.5%)
- Rash (1-2%)
- Somnolence (1-2%)
- Weakness (1-2%)
- ARF if renal artery stenosis
- Cough (1-10%)
- Dizziness (4%)
- Fatigue (2%)
- Headache (6%)
- Nausea (1%)
- Postural dizziness (2%)
- Serum creatinine increased (2%)
- Somnolence (2%)
- Gingival hyperplasia
- Hepatic enzyme elevations
- Acute interstitial nephritis
- Stevens-Johnson syndrome
- Hemolytic anemia
- ECG changes
- Hemolytic anemia
Black Box Warnings
Discontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system, causing oligohydramnios, which may result in fetal injury and/or death
History of angioedema with or without previous ACE inhibitor therapy
Hereditary or idiopathic angioedema
Concomitant use with Aliskiren in patients with diabetes mellitus
Pregnancy (2nd and 3rd trimesters): Significant risk of fetal/neonatal morbidity and mortality; discontinue as soon as pregnancy detected
Use with caution in CHF
Use with caution in patients with aortic stenosis, ischemic heart disease or cerebrovascular disease
Use with caution in patients with unstented unilateral/bilateral renal artery stenosis; avoid use due to elevated risk of deterioration in renal function
Persistent, progressive dermatologic reactions
Exacerbation of angina (during initiation of treatment, after dose increase, or withdrawal of beta blocker)
Use caution in hepatic impairment (may require lower starting dose)
Excessive hypotension if concomitant diuretics, hypovolemia, hyponatremia
Risk of hyperkalemia, especially with renal impairment or DM or in patients taking concomitant K+-elevating drugs; assess for hypotension and hyperkalemia
Dual blockade of the renin-angiotensin system with ARBs, ACE inhibitors, or aliskiren associated with increased risk for hypotension, hyperkalemia, and renal function changes (including acute renal failure), compared with monotherapy; most patients receiving combination of two renin-angiotensin system (RAS) inhibitors do not obtain additional benefit compared to monotherapy; in general, avoid combined use of RAS inhibitors
Black patients receiving ACE inhibitors have higher incidence of angioedema compared with nonblacks
Titrate slowly with hepatic impairment; amlodipine extensively metabolized by liver (half-life is 56 hr with hepatic impairment)
Rare reports of cholestatic hepatitis and acute liver failure (some fatal)
Patients receiving coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy may be at increased risk for angioedema
Myocardial infarction or increased angina in patients with obstructive coronary artery disease may occur
Avoid with severe renal impairment (ie, CrCl <30 mL/min); avoid in patients with severe heart failure, whose renal function may depend on the activity of the renin-angiotensin-aldosterone system; treatment with ACE inhibitor causes oliguria or progressive azotemia and (rarely) with acute renal failure and/or death
Pregnancy & Lactation
Pregnancy category: D
Lactation: Minimal amounts of benazepril enters milk, but excretion of amlodipine is not known; not recommended
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.
Mechanism of Action
Amlodipine: Ca channel blocker; inhibits the transmembrane influx of extracellular Ca ions across the membranes of myocardial cells and vascular smooth muscle cells without changing serum calcium concentrations, resulting in inhibition of cardiac and vascular smooth muscle contraction, thereby dilating the main coronary and systemic arteries
Benazepril: Competitively inhibits angiotensin-converting enzymes, resulting in decreased plasma angiotensin II concentrations; consequently, blood pressure may be reduced in part through decreased vasoconstriction, increased renin activity, and decreased aldosterone secretion
Bioavailability: Benazepril (37%); amlodipine (64-90%)
Peak plasma time: Benazepril (0.5-2 hr); amlodipine (6-12 hr)
Protein bound: >90% for each component
Vd: Benazepril (0.7 L/kg); amlodipine (21 L/kg)
Benazepril by hepatic metabolism to active metabolite (benazeprilat)
Amlodipine is extensively metabolized in liver
Half-life, elimination: Benazeprilat (10-11 hr); amlodipine (~48 hr)
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