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Aceon

Generic Name: Perindopril Erbumine
Class: Angiotensin-Converting Enzyme Inhibitors
VA Class: CV800
Chemical Name: (2S - (1(R*(R*)),2α,3aβ,7aβ)) - 1 - (2 - ((1 - (Ethoxycarbonyl)butyl)amino) - 1 - oxopropyl)octahydro - 1H - indole - 2 - carboxylic acid
Molecular Formula: C19H32N2O5
CAS Number: 82834-16-0

Warning(s)

  • May cause fetal and neonatal morbidity and mortality if used during pregnancy.1 42 43 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

  • If pregnancy is detected, discontinue perindopril as soon as possible.1 43

Introduction

Nonsulfhydryl ACE inhibitor.1

Uses for Aceon

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).1 2 500

ACE inhibitors are recommended as one of several preferred drugs for the initial management of hypertension; other options include angiotensin II receptor antagonists, calcium-channel blockers, and thiazide diuretics.501 502 503 504 While there may be individual differences with respect to specific outcomes, these antihypertensive drug classes all produce comparable effects on overall mortality and cardiovascular, cerebrovascular, and renal outcomes.500 501 502 504 Individualize choice of therapy; consider patient characteristics (e.g., age, ethnicity/race, comorbidities, cardiovascular risk) as well as drug-related factors (e.g., ease of administration, availability, adverse effects, cost).500 501 502 503 504 515

ACE inhibitors may be preferred in hypertensive patients with heart failure, ischemic heart disease, diabetes mellitus, chronic kidney disease, or cerebrovascular disease or post-MI.500 501 502 504 520 523 524 525 526 527 534 535 536 543

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Black hypertensive patients generally tend to respond better to monotherapy with calcium-channel blockers or thiazide diuretics than to ACE inhibitors.1 18 19 39 40 500 501 504 However, diminished response to an ACE inhibitor is largely eliminated when administered concomitantly with a calcium-channel blocker or thiazide diuretic.500 504

The optimum BP threshold for initiating antihypertensive drug therapy is controversial.501 504 505 506 507 508 515 523 530 Further study needed to determine optimum BP thresholds/goals; individualize treatment decisions.501 503 507 515 526 530

JNC 7 recommends initiation of drug therapy in all patients with uncomplicated hypertension and BP ≥140/90 mm Hg;500 JNC 8 panel recommends SBP threshold of 150 mm Hg for patients ≥60 years of age.501 Although many experts agree that SBP goal of <150 mm Hg may be appropriate for patients ≥80 years of age,502 504 505 530 application of this goal to those ≥60 years of age is controversial, especially for those at higher cardiovascular risk.501 502 505 506 508 511 515

In the past, initial antihypertensive drug therapy was recommended for patients with diabetes mellitus or chronic kidney disease who had BP ≥130/80 mm Hg;500 503 current hypertension management guidelines generally recommend a BP threshold of 140/90 mm Hg for these individuals (same as for the general population of patients without these conditions), although a goal of <130/80 mm Hg may still be considered.501 502 503 504 520 530 535 536 541

Heart Failure

Management of heart failure, usually in conjunction with cardiac glycosides, diuretics, and β-adrenergic blocking agents.20 23 24 25 26 27

Diabetic Nephropathy

A recommended agent in the management of patients with diabetes mellitus and persistent albuminuria who have modestly elevated (30–300 mg/24 hours) or higher (>300 mg/24 hours) levels of urinary albumin excretion; slows rate of progression of renal disease in such patients.34 35 36 37 38 520 535 536

Aceon Dosage and Administration

General

BP Monitoring and Treatment Goals

  • Carefully monitor BP during initial titration or subsequent upward adjustment in dosage.500 501

  • When available, use evidence-based dosing information (i.e., dosages shown in randomized controlled trials to reduce complications of hypertension) to determine target dosages; target dosages usually can be achieved within 2–4 weeks but may take up to several months.501

  • If adequate BP response not achieved with a single antihypertensive agent, add a second drug with demonstrated benefit; if goal BP still not achieved with optimal dosages of 2 antihypertensive agents, add a third drug.501 May maximize dosage of the first drug before adding a second drug, or add a second drug before maximizing dosage of the initial drug.501

  • Consider initiating antihypertensive therapy with a combination of drugs if patient's BP exceeds goal BP by >20/10 mm Hg.500 501 503 504

  • Goal is to achieve and maintain optimal control of BP; individualize specific target BP based on consideration of multiple factors, including patient age and comorbidities, and currently available evidence from clinical studies.500 501 (See Hypertension under Uses.)

Administration

Oral Administration

Administer orally once or twice daily1 without regard to meals.2 In clinical studies, administration in 2 divided doses was only slightly more effective than once-daily dosing.1

Dosage

Available as perindopril erbumine; dosage expressed in terms of perindopril erbumine.1

Adults

Hypertension
Oral

Initially, 4 mg once daily in patients not receiving a diuretic.1

In patients currently receiving diuretic therapy, discontinue diuretic, reduce diuretic dosage, or increase salt intake, if possible, before initiating perindopril.600 If diuretic therapy cannot be altered, initiate therapy under close medical supervision for at least 2 hours and until BP has stabilized for an additional hour.600

Usual dosage: 4–8 mg once daily.1 2 500

If intolerable adverse effects occur, consider dosage reduction; if adverse effects worsen or fail to resolve, may need to discontinue and switch to another antihypertensive drug class.501

Prescribing Limits

Adults

Hypertension
Oral

Maximum 16 mg daily.1

Special Populations

Renal Impairment

Hypertension

Initially, 2 mg daily in patients with renal impairment (Clcr >30 mL/minute); titrate until BP is controlled or to maximum of 8 mg daily. (See Renal Impairment under Cautions.)1

Geriatric Patients

Hypertension

Initially, 4 mg daily, given in 1 dose or 2 divided doses.1 Adjust dosage to achieve BP control.1 Administer dosages >8 mg daily with caution and under close medical supervision.1

Cautions for Aceon

Contraindications

  • Known hypersensitivity (e.g., history of angioedema) to perindopril or another ACE inhibitor.1

Warnings/Precautions

Warnings

Hypotension

Possible symptomatic hypotension, particularly in volume- and/or salt-depleted patients (e.g., those treated with diuretics, undergoing dialysis, with diarrhea or vomiting).1 2 13

Risk of marked hypotension, sometimes associated with oliguria, azotemia, and, rarely, acute renal failure and death in patients with heart failure with or without associated renal insufficiency.1 Severe hypotension may result in MI or stroke in patients with ischemic cardiovascular or cerebrovascular disease.1

Hypotension may occur in patients undergoing surgery or during anesthesia with agents that produce hypotension; recommended treatment is fluid volume expansion.1

To minimize potential for hypotension, correct volume and/or salt depletion (e.g., by withholding diuretic therapy, decreasing diuretic dosage, increasing sodium intake) prior to initiation of perindopril.1 600 (See Dosage under Dosage and Administration.)

In patients at risk of excessive hypotension, initiate therapy under close medical supervision; monitor closely for first 2 weeks following initiation of perindopril or any increase in perindopril or diuretic dosage.1

If excessive hypotension occurs, immediately place patient in supine position and, if necessary, administer IV infusion of 0.9% sodium chloride injection.1 Perindopril therapy usually can be continued following restoration of volume and BP.1

Hematologic Effects

Neutropenia and agranulocytosis reported with captopril; risk appears to depend principally on presence of renal impairment and/or presence of collagen vascular disease (e.g., systemic lupus erythematosus, scleroderma); risk with perindopril is unknown.1

Fetal/Neonatal Morbidity and Mortality

Possible fetal and neonatal morbidity and mortality when used during pregnancy.1 (See Boxed Warning.)

Possible fetal and neonatal morbidity and mortality when used during pregnancy.1 43 (See Boxed Warning.) Such potential risks occur throughout pregnancy, especially during the second and third trimesters.43

Also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.42 43

Discontinue as soon as possible when pregnancy is detected, unless continued use is considered lifesaving.1 42 43 Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.13

Hepatic Effects

Clinical syndrome that usually is manifested initially by cholestatic jaundice and may progress to fulminant hepatic necrosis (occasionally fatal) reported rarely with ACE inhibitors.1

If jaundice or marked elevation of liver enzymes occurs, discontinue drug and monitor patient.1

Sensitivity Reactions

Anaphylactoid reactions and/or head and neck angioedema possible; angioedema associated with tongue, glottis, or larynx may be fatal.1 If angioedema occurs, promptly discontinue perindopril and observe patient until swelling disappears.1 Immediate medical intervention (e.g., epinephrine) for involvement of tongue, glottis, or larynx.1

Intestinal angioedema possible; consider in differential diagnosis of patients who develop abdominal pain.1

Anaphylactoid reactions reported in patients receiving ACE inhibitors while undergoing LDL apheresis with dextran sulfate absorption or following initiation of hemodialysis that utilized high-flux membrane.1

Life-threatening anaphylactoid reactions reported in at least 2 patients receiving ACE inhibitors while undergoing desensitization treatment with hymenoptera venom.1

Contraindicated in patients with a history of angioedema associated with ACE inhibitors.1

General Precautions

Renal Effects

Transient increases in BUN and Scr possible, especially in patients with preexisting renal impairment or those receiving concomitant diuretic therapy.1 Possible increases in BUN and Scr in patients with unilateral or bilateral renal artery stenosis; generally reversible following discontinuance of therapy.1

Possible oliguria, progressive azotemia, and, rarely, acute renal failure and/or death in patients with severe heart failure.1

Closely monitor renal function for the first few weeks of therapy in hypertensive patients with unilateral or bilateral renal-artery stenosis.1 Some patients may require dosage reduction or discontinuance of ACE inhibitor or diuretic.1

Hyperkalemia

Possible hyperkalemia, especially in patients with renal impairment or diabetes mellitus and those receiving drugs that can increase serum potassium concentration (e.g., potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes).1 (See Specific Drugs under Interactions.)

Monitor serum potassium concentration carefully in these patients.1

Cough

Persistent and nonproductive cough; resolves after drug discontinuance.1

Specific Populations

Pregnancy

Category C (1st trimester); Category D (2nd and 3rd trimesters).1 (See Boxed Warning.)

Lactation

Distributed into milk in rats; not known whether perindopril is distributed into milk in humans.1 Caution if used in nursing women.1

Pediatric Use

Safety and efficacy not established in pediatric patients.1

Geriatric Use

Possible lesser effect on BP in those >60 years of age than in younger patients.1 Increased plasma concentrations of perindopril and perindoprilat.1 Dizziness and possibly rash may occur more frequently in geriatric patients.1

Renal Impairment

Deterioration of renal function may occur (see Renal Effects under Cautions).1 Systemic exposure to perindoprilat may be increased with decreasing renal function.1

Initial dosage adjustment recommended in patients with renal impairment.1 (See Renal Impairment under Dosage and Administration.) Safety and efficacy not established and use not recommended in patients with Clcr <30 mL/minute.1 600

Hepatic Impairment

Increased bioavailability of perindoprilat.1

Black Patients

BP reduction may be smaller in black patients compared with nonblack patients.1 500 504 (See Hypertension under Uses.)

Higher incidence of angioedema reported with ACE inhibitors (as monotherapy) in black patients compared with other races.1 19 500

Common Adverse Effects

Cough, proteinuria, palpitation, sinusitis, viral infection, dyspepsia, fever, upper extremity pain, hypertonia.1

Dizziness reported at a rate similar to that with placebo, but incidence increases with increased dosage, suggesting causal relation to the drug.1

Interactions for Aceon

Specific Drugs

Drug

Interaction

Comments

Digoxin

No effect on digoxin concentrations; effect on perindopril/perindoprilat concentrations has not been excluded1

Diuretics

Increased hypotensive effect1

If possible, discontinue diuretic before initiating perindopril1 (see Dosage under Dosage and Administration)

Diuretics, potassium-sparing (amiloride, spironolactone, triamterene)

Enhanced hyperkalemic effect1

Use with caution; monitor serum potassium concentrations frequently1

Gentamicin

Possible interaction based on animal data; no studies in humans1

Use with caution1

Lithium

Increased serum lithium concentrations; possible toxicity1

Use with caution; monitor serum lithium concentrations frequently1

Potassium supplements or potassium-containing salt substitutes

Enhanced hyperkalemic effect1

Use with caution; monitor serum potassium concentrations frequently1

Aceon Pharmacokinetics

Absorption

Bioavailability

Absolute bioavailability of perindopril is 75%; mean bioavailability of perindoprilat is 25%.1

Peak plasma concentrations of perindopril and perindoprilat are achieved within 1 and 3–7 hours, respectively.1

Onset

Antihypertensive effects occur promptly, with effects increasing slightly over several weeks.1

Duration

Maximal antihypertensive effect (inhibition of 80–90% of ACE activity) persists for about 10–12 hours; at 24 hours, only 60% of ACE activity is blocked.1

Food

Food does not affect rate or extent of absorption of perindopril but reduces bioavailability of perindoprilat by about 35%.1

Special Populations

In patients with hepatic impairment, increased perindoprilat bioavailability.1

In patients with renal impairment, increased perindoprilat concentrations with decreasing renal function.1

In patients >70 years of age, increased plasma perindopril and perindoprilat concentrations (resulting from increased conversion of perindopril to perindoprilat and decreased renal excretion of perindoprilat).1

Distribution

Extent

Appears to cross the blood-brain barrier only slightly in rats.1

Crosses the placenta and is distributed into milk in rats.1

Plasma Protein Binding

Perindopril: 60%.1

Perindoprilat: 10–20%.1

Elimination

Metabolism

Extensively metabolized in the liver to 6 metabolites, including an active metabolite, perindoprilat.1

Elimination Route

Eliminated principally in urine (as metabolites).1

Removed by renal dialysis.1

Half-life

Perindopril: 0.8–1 hour.1

Perindoprilat: 3–10 hours.1

Special Populations

In patients with heart failure, decreased clearance and increased AUC of perindoprilat.1

Stability

Storage

Oral

Tablets

20–25°C.1 Protect from moisture.1

Actions

  • Prodrug; not pharmacologically active until hydrolyzed in the liver to perindoprilat.1 2

  • Suppresses the renin-angiotensin-aldosterone system.1

Advice to Patients

  • Risk of angioedema, anaphylactoid reactions, or other sensitivity reactions.1 Importance of reporting sensitivity reactions (e.g., edema of face, eyes, lips, tongue, or extremities; hoarseness; swallowing or breathing with difficulty) immediately to clinician and of discontinuing the drug.1

  • Importance of reporting signs of infection (e.g., sore throat, fever).1

  • Risk of hypotension.1 Importance of informing clinicians promptly if lightheadedness or fainting occurs.1

    Importance of adequate fluid intake; risk of volume depletion with excessive perspiration, dehydration, vomiting, or diarrhea.1

  • Risks of use during pregnancy.1 (See Boxed Warning.)

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (including salt substitutes containing potassium).1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of advising patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Perindopril Erbumine

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

2 mg*

Aceon (scored)

Xoma

Perindopril Erbumine Tablets

4 mg*

Aceon (scored)

Xoma

Perindopril Erbumine Tablets

8 mg*

Aceon (scored)

Xoma

Perindopril Erbumine Tablets

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2015. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Aceon 2MG Tablets (SOLVAY): 100/$199.00 or 200/$383.98

Aceon 4MG Tablets (SOLVAY): 30/$77.99 or 90/$207.97

Aceon 8MG Tablets (SOLVAY): 100/$278.49 or 200/$556.97

Perindopril Erbumine 2MG Tablets (AUROBINDO PHARMA): 100/$75.99 or 300/$199.98

Perindopril Erbumine 4MG Tablets (ROXANE): 100/$80.99 or 300/$211.98

Perindopril Erbumine 8MG Tablets (ROXANE): 100/$88.99 or 300/$227.97

AHFS DI Essentials. © Copyright, 2004-2015, Selected Revisions February 12, 2015. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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4. Reviewers’ comments in enalapril/enalaprilat (personal observations).

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535. Taler SJ, Agarwal R, Bakris GL et al. KDOQI US commentary on the 2012 KDIGO clinical practice guideline for management of blood pressure in CKD. Am J Kidney Dis. 2013; 62:201-13. [PubMed 23684145]

536. Kidney Disease: Improving Global Outcomes (KDIGO) Blood Pressure Work Group. KDIGO clinical practice guideline for the management of blood pressure in chronic kidney disease. Kidney Int Suppl. 2012: 2: 337-414.

541. Perk J, De Backer G, Gohlke H et al. European Guidelines on cardiovascular disease prevention in clinical practice (version 2012). The Fifth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of nine societies and by invited experts). Eur Heart J. 2012; 33:1635-701. [PubMed 22555213]

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600. Xoma. Aceon (perindopril erbumine) tablets prescribing information.Berkeley, CA; 2013 Mar.

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