Benazepril

Benazepril is an angiotensin-converting enzyme (ACE) inhibitor used to treat patients with high blood pressure (hypertension).

• Benazepril is available under the following different brand names: Lotensin.

Adult and Pediatric Dosage Forms and Strengths

Tablet

• 5 mg
• 10 mg
• 20 mg
• 40 mg

Dosage Considerations – Should be Given as Follows:

Hypertension

Adult:

• Patients taking a diuretic: 5 mg/day orally initially, to avoid excessive hypotension
• Patients not taking a diuretic: 10 mg/day orally
• May increase to a maintenance dose of 20-40 mg/day orally once/day or divided every 12 hours

Geriatric:

• 5-10 mg/day orally initially in single or divided doses
• Maintenance: 20-40 mg/day orally adjust for renal function

Pediatric:

• Children under 6 years: Safety and efficacy not established
• Children 6 years and older: 0.1-0.6 mg/kg orally once/day initially, not to exceed 5 mg/day; THEN
• Adjust dose based on blood pressure response; not to exceed 0.6 mg/kg/day or 40 mg/day
• Suspension preparation
  • The following prepares 150 mL of 2 mg/mL oral suspension
  • Add 75 mL of Ora-Plus oral suspending vehicle to an amber polyethylene terephthalate (PET) bottle containing fifteen benazepril 20 mg tablets, and shake for at least 2 minutes
  • Allow the suspension to stand for a minimum of 1 hour
  • After the standing time, shake the suspension for a minimum of 1 additional minute, then add 75 mL of Ora-Sweet oral syrup vehicle to the bottle and shake the suspension to disperse the ingredients
  • Store refrigerated at 2-8°C (36-46°F) for up to 30 days in the PET bottle with a child-resistant screw-cap closure
  • Shake the suspension before each use

Nephropathy-Nondiabetic (Off-label)

• 10-20 mg orally once/day

Dosing Modifications

Renal Impairment, Adult

• CrCl less than 30 mL/min: 5 mg orally once/day initially; not to exceed 40 mg/day

Renal impairment, Pediatric

• CrCl less than 30 mL/min: Insufficient data to recommend dosage adjustment

Hepatic Impairment

• Not studied

Geriatric

• Adjust dose for renal function; benazepril and benazeprilat are substantially excreted by the kidney
• Because elderly patients are more likely to have decreased renal function, take care in dose selection; it may be useful to monitor renal function

Dosing Considerations

• Consider starting an ACE inhibitor in high-risk patients, even if no hypertension or congestive heart failure (CHF)
• No sexual dysfunction side effect
• Good choice in hyperlipidemia patients
• Requires weeks for full effect; to start, use a low dose and titrate every 1-2 weeks
• Abrupt discontinuance is not associated with the rapid increase in blood pressure
• Beneficial for many patients at risk for heart disease
• Reduces risk of heart attack (myocardial infarction [MI]), stroke, diabetic nephropathy, microalbuminuria, new-onset diabetes mellitus
• May preserve renal function in diabetes mellitus
• It may help to prevent migraine headaches

Side effects of benazepril include:

• Cough
• Headache
• Dizziness
• Fatigue
• Dizziness upon standing
• Serum creatinine increased
• Drowsiness
• Nausea
• Abnormal renal function if renal artery stenosis

Less common side effects of benazepril include:

Serious side effects of benazepril include:

Postmarketing side effects of benazepril reported include:

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Severe Interactions of benazepril include:
  • sacubitril/valsartan
• Benazepril has serious interactions with at least 40 different drugs.
• Benazepril has moderate interactions with at least 180 different drugs.
• Benazepril has mild interactions with at least 39 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.

Warnings

• Discontinue as soon as possible when pregnancy is detected; affects the renin-angiotensin system, causing oligohydramnios, which may result in fetal injury and/or death
• This medication contains benazepril. Do not take Lotensin if you are allergic to benazepril or any ingredients contained in this drug
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
• Do not take Lexapro if you are allergic to benazepril or any ingredients contained in this drug

Contraindications

• Hypersensitivity
• History of hereditary or idiopathic angioedema
• Concomitant administration with aliskiren in patients with diabetes mellitus or with renal impairment

Effects of Drug Abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Benazepril?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Benazepril?"

Cautions

• Excessive low blood pressure (hypotension) with or without fainting (syncope) may occur if hypovolemia/hyponatremia is present or if coadministered with diuretics
• 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 the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy; avoid combined use of RAS inhibitors; closely monitor blood pressure, renal function, and electrolytes in patients on benazepril and other agents that affect the RAS
• Not for coadministration with aliskiren in patients with diabetes; avoid the use of aliskiren with benazepril in patients with renal impairment (GFR less than 60 ml/min/1.73 m²)
• ACE inhibition causes increased bradykinin levels, which putatively mediates angioedema (higher incidence in black patients)
• Cough may occur due to increased bradykinin levels
• Cholestatic jaundice was reported with the use
• Avoid use in bilateral renal artery stenosis
• Angioedema may occur; co-administration with mTOR inhibitors (e.g., temsirolimus) may increase the risk for angioedema; discontinue therapy and treat appropriately if angioedema occurs
• Discontinue immediately if pregnancy occurs
• ACE inhibitors are less effective in black patients
• Renal impairment may occur
• Rare cases of agranulocytosis reported ACE inhibitor therapy
• May cause hypotension during surgery; additive hypotensive effects may occur with anesthetic agents that produce hypotension (correct by volume expansion)
• Deterioration of renal function may occur; may consider discontinuation of therapy in patients with progressive and/or significant deterioration in renal function
• Monitor for jaundice or signs of liver failure

Pregnancy and Lactation

• Use benazepril during pregnancy only in LIFE-THREATENING emergencies when no safer drug is available. There is positive evidence of human fetal risk. Discontinue benazepril as soon as pregnancy is detected; during the second and third trimesters of pregnancy, drugs that act directly on the renin-angiotensin system have been associated with a fetal injury that includes hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death
• A minimal amount of benazepril is excreted in breast milk; use caution if breastfeeding