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Uses

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).

One of several preferred initial therapies in hypertensive patients with heart failure, postmyocardial infarction, high coronary disease risk, diabetes mellitus, chronic renal failure, and/or cerebrovascular disease.

Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.

Addition of benazepril to amlodipine usually does not provide additional antihypertensive effects in blacks but appears to reduce development of amlodipine-associated edema regardless of race.

CHF

Management of symptomatic CHF†, usually in conjunction with cardiac glycosides, diuretics, and β-adrenergic blocking agents.

Diabetic Nephropathy

A first-line agent in the treatment of diabetic nephropathy† in hypertensive patients with type 2 diabetes mellitus.

Dosage and Administration

General

Hypertension

• Benazepril/amlodipine and benazepril/hydrochlorothiazide fixed combinations should not be used for initial treatment of hypertension.

Administration

Oral Administration

Administer orally once or twice daily without regard to meals. Administer as extemporaneously prepared oral suspension in pediatric patients unable to swallow tablets or in those for whom the calculated daily dosage does not correspond to the available tablet strengths.

Reconstitution

Preparation of extemporaneous suspension containing benazepril 2 mg/mL: Add 75 mL of suspending vehicle (Ora-Plus^®) to a polyethylene terephthalate (PET) bottle containing fifteen 20-mg tablets of benazepril hydrochloride; shake the contents for ≥2 minutes. Allow concentrated suspension to stand for a minimum of 60 minutes following reconstitution, then shake for a minimum of 1 additional minute. Dilute the concentrated suspension with 75 mL of syrup (Ora-Sweet^®); shake the container to disperse the ingredients. Shake suspension before dispensing each dose.

Dosage

Available as benazepril hydrochloride; dosage expressed in terms of benazepril.

Pediatric Patients

Hypertension

Oral

Children ≥6 years of age: Initially, 0.2 mg/kg (up to 10 mg) once daily. Adjust dosage until the desired BP goal is achieved (up to maximum dosage of 0.6 mg/kg or 40 mg daily).

Adults

Hypertension

Oral

Initially, 10 mg once daily as monotherapy. Adjust dosage at approximately monthly intervals (more aggressively in high-risk patients) to achieve BP control.

In patients currently receiving diuretic therapy, discontinue diuretic, if possible, 2–3 days before initiating benazepril. May cautiously resume diuretic therapy if BP not controlled adequately with benazepril alone. If diuretic cannot be discontinued, increase sodium intake and give lower initial benazepril dose (5 mg) under close medical supervision.

Usual dosage: 20–40 mg daily, given in 1 dose or 2 divided doses.

If effectiveness diminishes toward end of dosing interval in patients treated once daily, consider increasing dosage or administering drug in 2 divided doses.

Benazepril/Hydrochlorothiazide Combination Therapy

Oral

If BP is not adequately controlled by monotherapy with benazepril, can switch to the fixed-combination preparation containing benazepril 10 mg and hydrochlorothiazide 12.5 mg or, alternatively, benazepril 20 mg and hydrochlorothiazide 12.5 mg. Adjust dosage of either or both drugs according to patient’s response.

If BP is controlled by monotherapy with hydrochlorothiazide 25 mg daily but potassium loss is problematic, can switch to fixed-combination preparation containing benazepril 5 mg and hydrochlorothiazide 6.25 mg.

Benazepril/Amlodipine Combination Therapy

Oral

Reduce amlodipine dosage in nonblack patients when benazepril is initiated.

Adjust dosage of benazepril/amlodipine fixed combination according to patient’s response; consider that steady-state plasma concentrations of benazepril and amlodipine are reached after 2 and 7 days, respectively.

Prescribing Limits

Pediatric Patients

Hypertension

Oral

Maximum 0.6 mg/kg or 40 mg daily.

Adults

Hypertension

Oral

Maximum 80 mg daily.

Special Populations

Dosage in Renal Impairment

Initially, 5 mg once daily in adults with severe renal impairment (Cl_cr <30 mL/minute or S_cr >3 mg/dL); titrate until BP is controlled or to maximum of 40 mg daily. Use not recommended in pediatric patients with Cl_cr <30 mL/minute per 1.73 m².

Benazepril/hydrochlorothiazide and benazepril/amlodipine fixed combinations are not recommended in patients with severe renal impairment.

Volume- and/or Salt-depleted Patients

Correct volume and/or salt depletion prior to initiation of therapy or initiate therapy under close medical supervision using lower initial dosage.