Benazepril/Amlodipine

DEA Class; Rx

Common Brand Names; Lotrel

• Antihypertensive Combos, Other; 
• ACEI/CCB Combos; 
• Calcium Channel Blockers, Dihydropyridine

Oral combination product containing a dihydropyridine calcium-channel blocker (amlodipine) and an angiotensin-converting enzyme (ACE) inhibitor (benazepril)
Used for hypertension in adults
Used after titration of individual medication components

Indicated for the treatment of hypertension in patients who do not respond to monotherapy.

Hypersensitivity

History of angioedema with or without previous ACE inhibitor therapy

Hereditary or idiopathic angioedema

Coadministration of neprilysin inhibitors (eg, sacubitril) with ACE inhibitors may increase angioedema risk; do not administer ACE inhibitors within 36 hr of switching to or from sacubitril/valsartan

Concomitant use with Aliskiren in patients with diabetes mellitus

Amlodipine

• Peripheral edema (2-15%)
• Pulmonary edema (7-15%)
• 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%)

Benazepril

• None indicated

• 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%)

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

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)

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

Therapy can cause fetal harm when administered to a pregnant woman; use of drugs that act on RAS during second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death

Minimal amounts of unchanged benazepril and of benazeprilat are excreted into the breast milk of lactating women treated with benazepril, so that a newborn child ingesting nothing but breast milk would receive less than 0.1% of maternal doses of benazepril and benazeprilat