Ace Inhibitors

Note: Patients taking diuretics should have them discontinued 2-3 days prior to starting benazepril. If they cannot be discontinued, then initial dose should be 5 mg; restart after blood pressure is stabilized if needed.

Maximum:  80 mg per day.
Supplied: [5, 10, 20, 40mg tablets]

CHF: Start 6.25 to 12.5 mg three times daily. Initial dose depends upon patient's fluid/electrolyte status.  Target: 50 mg 3 times/day.

Prevention of LV dysfunction following MI: Oral: Initial: 6.25 mg; followed by 12.5 mg 3 times/day; increase to 25 mg 3 times/day over the next few days; following by gradual increase to a goal of 50 mg tid.

Acute hypertension (urgency/emergency): Oral: 12.5 to 25 mg, may repeat as needed (may be given sublingually, but no therapeutic advantage demonstrated)

Maximum:  450 mg/day.

Renal Dosing:
CrCl 10-50 mL/minute: Administer 75% of normal dose.
CrCl <10 mL/minute: Administer 50% of normal dose.

Supplied: [12.5 mg, 25 mg, 50 mg, 100 mg tablets]

Hypertension:
Start (Oral): 2.5-5 mg/day then increase as required, usually at 1- to 2-week intervals; usual dose range (JNC 7): 2.5-40 mg/day in 1-2 divided doses. Note: Initiate with 2.5 mg if patient is taking a diuretic which cannot be discontinued. May add a diuretic if blood pressure cannot be controlled with enalapril alone.

I.V. (Start): 1.25 mg/dose, given over 5 minutes every 6 hours; doses as high as 5 mg/dose every 6 hours have been tolerated for up to 36 hours. Note: If patients are concomitantly receiving diuretic therapy, begin with 0.625 mg I.V. over 5 minutes; if the effect is not adequate after 1 hour, repeat the dose and administer 1.25 mg at 6-hour intervals thereafter; if adequate, administer 0.625 mg I.V. every 6 hours.

Asymptomatic left ventricular dysfunction: Oral: 2.5 mg twice daily, titrated as tolerated to 20 mg/day

Heart failure:  Oral: Initial: 2.5 mg once or twice daily (usual range: 5-40 mg/day in 2 divided doses). Titrate slowly at 1- to 2-week intervals. Target dose: 10-20 mg twice daily (ACC/AHA 2005 Heart Failure Guidelines).

Renal Dosing:   Hypertension: CrCl 30-80 mL/minute:  Oral: Administer 5 mg/day titrated upwards to maximum of 40 mg. CrCl <30 mL/minute: Oral:  Administer 2.5 mg day titrated upward until blood pressure is controlled up to a maximum of 40 mg.  For heart failure patients with sodium <130 mEq/L or serum creatinine >1.6 mg/dL, initiate dosage with 2.5 mg/day, increasing to twice daily as needed; increase further in increments of 2.5 mg/dose at >4-day intervals to a maximum daily dose of 40 mg.    I.V.:  CrCl >30 mL/minute: Initiate with 1.25 mg every 6 hours and increase dose based on response.  CrCl <30 mL/minute: Initiate with 0.625 mg every 6 hours and increase dose based on response.

Supplied: [2.5 mg, 5 mg, 10 mg, 20 mg tablets. Injection (soln): 1.25 mg/mL (1 mL, 2 mL)].

Drug UPDATES:  EPANED ® (enalapril maleate) oral solution
[Drug information  /  PDF]     REVIEW PACKAGE INSERT FOR POSSIBLE UPDATES
PACKAGE INSERT -Dosing:  Click (+) next to Dosage and Administration section (drug info link)

BOXED WARNING:  WARNING: FETAL TOXICITY
• When pregnancy is detected, discontinue EPANED® as soon as possible. [See Warnings and Precautions (5.1)]
• Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Initial U.S. Approval:  2016

INDICATIONS AND USAGE:
EPANED is an angiotensin-converting enzyme inhibitor indicated for:

•treatment of hypertension in adults and children older than one month, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1)
•treatment of symptomatic heart failure. ( 1.2)
•treatment of asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure. ( 1.3)

DOSAGE AND ADMINISTRATION:
Hypertension
Adult: recommended initial dose is 5 mg once daily. Maximum dose is 40 mg daily.
Pediatrics: recommended starting dose is 0.08 mg/kg (up to 5 mg) once daily.

Heart Failure: Initiate at 2.5 mg twice daily. Titrate up to 20 mg twice daily as tolerated.

Asymptomatic Left Ventricular Dysfunction: Initiate at 2.5 mg twice daily. Titrate up to 10 mg twice daily.
EPANED Oral Solution is a ready-to-use solution intended for oral use only.

HOW SUPPLIED:
EPANED is a ready-to-use solution that contains 1 mg/mL of enalapril maleate. It is a clear, colorless oral solution with a mixed berry flavor, packaged in a 150-mL, white, round, high-density polyethylene bottle with a white, polypropylene, child-resistant cap and tamper-evident seal. Each bottle contains 150 mL.
NDC 52652-4001-1
Store refrigerated (2°-8°C/36°-46°F) in a tightly closed container. Protect from freezing and excessive heat. Patients may store EPANED at room temperature (20°-25°C/68°-77°F) for up to 60 days.

CHF: Start 10 mg orally once a day (5 mg if renal dysfunction present) and increase, as needed, to a maximum of 40 mg once daily over several weeks. Usual dose: 20-40 mg/day. If hypotension, orthostasis, or azotemia occurs during titration, consider decreasing concomitant diuretic dose, if any.

Supplied: [10 mg, 20 mg, 40 mg tabs]

CHF: Start 2.5 to 5 mg once daily; then increase by no more than 10 mg increments at intervals no less than 2 weeks to a maximum daily dose of 40 mg. Usual maintenance: 5-40 mg/day as a single dose. Target dose: 20-40 mg once daily (ACC/AHA 2005 Heart Failure Guidelines)   Note: If patient has hyponatremia (serum sodium <130 meq/L) or renal impairment (CrCl <30 mL/minute or creatinine >3 mg/dL), then initial dose should be 2.5 mg/day.

Acute myocardial infarction (within 24 hours in hemodynamically stable patients): Oral: 5 mg immediately, then 5 mg at 24 hours, 10 mg at 48 hours, and 10 mg every day thereafter for 6 weeks.

Supplied: [2.5mg, 5mg, 10mg, 20mg, 40mg tablets]

Supplied: [7.5mg, 15 mg tabs]

Congestive heart failure: Oral: Initial: 2 mg once daily; increase at 1- to 2-week intervals; target dose: 8 to 16 mg once daily (ACC/AHA 2005 Heart Failure Guidelines)

Renal Dosing:
CrCl >30 mL/minute: Initial: 2 mg/day; maintenance dosing not to exceed 8 mg/day.
CrCl <30 mL/minute: Safety and efficacy not established.

Supplied: [2 mg, 4 mg, 8 mg tabs]

CHF / Post MI: Start 5 mg once or twice daily, titrated at weekly intervals to 20-40 mg daily in 2 divided doses; target dose (heart failure): 20 mg twice daily (ACC/AHA 2005 Heart Failure Guidelines).

Renal Dosing:
Hypertension: Oral: Start:  CrCl >60 mL/minute: Administer 10 mg/day.  CrCl 30-60 mL/minute: Administer 5 mg/day.  CrCl 10-30 mL/minute: Administer 2.5 mg/day.

Congestive heart failure: Oral: Start:  CrCl >30 mL/minute: Administer 5 mg/day.  CrCl 10-30 mL/minute: Administer 2.5 mg/day.

Supplied: [5 mg, 10 mg, 20 mg, 40 mg tablets]

CHF: Start 1.25-2.5 mg once daily. Target dose: 10 mg once daily. Note: The dose of any concomitant diuretic should be reduced. If the diuretic cannot be discontinued, initiate therapy with 1.25 mg. After the initial dose, the patient should be monitored carefully until blood pressure has stabilized.

Left ventricular dysfunction Post MI: Oral: Initial: 2.5 mg twice daily titrated upward, if possible, to 5 mg twice daily.

Reduce the risk of MI, stroke, and death from cardiovascular causes: Oral: Initial: 2.5 mg once daily for 1 week, then 5 mg once daily for the next 3 weeks, then increase as tolerated to 10 mg once daily (may be given as divided dose)

Renal Dosing:
CrCl <40 mL/minute: Administer 25% of normal dose. Renal failure and hypertension: Administer 1.25 mg once daily, titrated upward as possible. Renal failure and heart failure: Administer 1.25 mg once daily, increasing to 1.25 mg twice daily up to 2.5 mg twice daily as tolerated.

Supplied: [1.25 mg, 2.5 mg, 5 mg, 10 mg capsules]

CHF/post MI: Start 1 mg/day; titrate patients (as tolerated) towards the target dose of 4 mg/day. If a 4 mg dose is not tolerated, patients can continue therapy with the greatest tolerated dose.

Supplied: [1 mg, 2 mg, 4 mg tablets]

"The renin-angiotensin system (RAS) is activated in several diseases, and angiotensin II mediates a number of putative detrimental effects through activation of the angiotensin II type 1 receptor, while the clinical role of the type 2 receptor has not yet been settled. Inhibition of the RAS is either achieved by the use of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor antagonists (AIIA). Although a combined inhibitory therapy might seem attractive, thus far limited data has emerged to support such a strategy. In hypertension, losartan has proven slightly more efficient than atenolol to prevent cardiovascular complications, overall mortality was however identical. In heart failure, AIIA should only be considered in ACE inhibitor-intolerant patients. Both ACE inhibitors and AIIA have proven efficient in diabetic microalbuminuria and in proteinuria. ACE inhibitors are first-line treatment in type 1 diabetic nephropathy and in nondiabetic nephropathy, while AIIA are highly efficient in type 2 diabetic nephropathy. Combination therapy might be superior to monotherapy in nondiabetic nephropathy." SOURCE:

Initial U.S. Approval:  2015

INDICATIONS AND USAGE:
Prestalia is a combination of perindopril, an angiotensin converting enzyme inhibitor, and amlodipine, a dihydropyridine calcium channel blocker, indicated for the treatment of hypertension to lower blood pressure:

In patients not adequately controlled with monotherapy .
As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.

Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions (see package insert).

HOW SUPPLIED: Tablets (perindopril arginine/amlodipine): 3.5/2.5 mg, 7/5 mg and 14/10 mg