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Accupril

Pronunciation

Generic Name: Quinapril Hydrochloride
Class: Angiotensin-Converting Enzyme Inhibitors
VA Class: CV800
Chemical Name: [3S-[2[R*(R)],3R*]]-2-[2-[[1-Ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2 ,3,4-tetrahydro-3-isoquinolinecarboxylic acid monohydrochloride
Molecular Formula: C25H30N2O5•HCl
CAS Number: 82586-55-8

Warning(s)

  • May cause fetal and neonatal morbidity and mortality if used during pregnancy.1 47 65 66 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

  • If pregnancy is detected, discontinue quinapril as soon as possible.1 47 66

Introduction

Nonsulfhydryl ACE inhibitor.1 2 3 47

Uses for Accupril

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).1 2 4 28 47 500

ACE inhibitors are recommended as one of several preferred agents 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.24 28 63 64 500 501 504 However, diminished response to an ACE inhibitor is largely eliminated when administered concomitantly with a calcium-channel blocker or thiazide diuretic.24 26 27 28 47 500 504

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 symptomatic heart failure, usually in conjunction with cardiac glycosides, diuretics, and β-adrenergic blocking agents.1 2 12 18 38

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.57 58 59 60 61 520 535 536

Accupril 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 daily.1 47

Manufacturer makes no specific recommendation regarding administration of quinapril with meals;1 47 administer quinapril/hydrochlorothiazide fixed combinations without regard to meals.47 (See Food under Pharmacokinetics.)

Dosage

Available as quinapril hydrochloride; dosage expressed in terms of quinapril.1 47

May minimize risk of hypotension in patients currently receiving diuretic therapy by discontinuing the diuretic, reducing diuretic dosage, or cautiously increasing salt intake prior to initiating quinapril; if diuretic therapy cannot be discontinued, initiate quinapril at a reduced dosage.600 (See Hypotension under Cautions and see the individual dosage sections in Dosage and Administration.)

Pediatric Patients

Hypertension
Oral

Some experts recommend an initial dosage of 5–10 mg once daily.62 Increase dosage as necessary to a maximum dosage of 80 mg once daily.62

Adults

Hypertension
Quinapril Therapy
Oral

Initially, 10 or 20 mg once daily in patients not receiving a diuretic.2 3 28 600 Adjust dosage at ≥2-week intervals to achieve BP control.1

In patients currently receiving diuretic therapy, discontinue diuretic, if possible, 2–3 days before initiating quinapril.600 May resume diuretic therapy if BP not controlled adequately with quinapril alone.600 If diuretic cannot be discontinued, initiate quinapril at a dose of 5 mg under close medical supervision for several hours until BP has stabilized.600

Usual maintenance dosage: 20–80 mg daily, given in 1 dose or 2 divided doses.28 600

If effectiveness diminishes toward end of dosing interval in patients treated once daily, consider increasing dosage or administering drug in 2 divided doses.1 28

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

Quinapril/Hydrochlorothiazide Fixed-combination Therapy
Oral

Manufacturer states fixed-combination preparation should not be used for initial antihypertensive therapy.47

If BP is not adequately controlled by monotherapy with quinapril or hydrochlorothiazide, can switch to the fixed-combination preparation containing quinapril 10 mg and hydrochlorothiazide 12.5 mg or, alternatively, quinapril 20 mg and hydrochlorothiazide 12.5 mg.47 Adjust dosage of either or both drugs according to patient’s response.47

If BP is controlled by monotherapy with hydrochlorothiazide 25 mg daily but potassium loss is problematic, can switch to fixed-combination preparation containing quinapril 10 mg and hydrochlorothiazide 12.5 mg or, alternatively, quinapril 20 mg and hydrochlorothiazide 12.5 mg.47

If BP is controlled with quinapril 20 mg and hydrochlorothiazide 25 mg (administered separately) and if no clinically important electrolyte disturbance is observed, can switch to the fixed-combination preparation containing these corresponding doses for convenience.47

Heart Failure
Oral

Initially, 5 mg twice daily.1 Monitor closely for ≥2 hours until BP has stabilized.1 To minimize risk of hypotension, reduce diuretic dosage, if possible.1

Adjust dosage at weekly intervals to reach usual dosage.1

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

Prescribing Limits

Pediatric Patients

Hypertension
Oral

Maximum 80 mg daily.62

Special Populations

Renal Impairment

Hypertension
Oral

Initially, 10 mg once daily in adults with Clcr >60 mL/minute; 5 mg once daily in those with Clcr 30–60 mL/minute; or 2.5 mg once daily in those with Clcr 10–30 mL/minute.1 Titrate at 2-week intervals until BP is controlled.1 (See Renal Impairment under Cautions.)

Quinapril/hydrochlorothiazide fixed combinations are not recommended in patients with severe renal impairment (Clcr ≤30 mL/minute or Scr >3 mg/dL).47

Heart Failure
Oral

Initially (first day), 5 mg in patients with moderate renal impairment (Clcr >30 mL/minute) or 2.5 mg in patients with severe renal impairment (Clcr 10–30 mL/minute) under close medical supervision.1 If well tolerated, administer as twice-daily regimen on subsequent days.1 Titrate at weekly intervals based on clinical and hemodynamic response.1

Geriatric Patients

Hypertension
Oral

Initially, 10 mg once daily as monotherapy.1 Adjust dosage at ≥2-week intervals to achieve BP control.1

Cautions for Accupril

Contraindications

  • Known hypersensitivity (e.g., history of angioedema) to quinapril or another ACE inhibitor.1 47

Warnings/Precautions

Warnings

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 47

If jaundice or marked elevation of liver enzymes occurs, discontinue drug and monitor patient.1 47

Hypotension

Possible symptomatic hypotension.1 47 Risk of marked hypotension, sometimes associated with oliguria and/or progressive azotemia and, rarely, acute renal failure and/or death, in patients with heart failure, hyponatremia, or severe volume and/or salt depletion; patients undergoing dialysis; and those receiving diuretic therapy with high doses, recent increase in dosage, or recent intensive diuresis.600 Potential for MI or stroke in patients with ischemic cardiovascular or cerebrovascular disease.1 47

Hypotension may occur in patients undergoing surgery or during anesthesia with agents that produce hypotension; recommended treatment is fluid volume expansion.1 47

To minimize potential for hypotension, consider recent antihypertensive therapy, extent of BP elevation, sodium intake, fluid status, and other clinical conditions.1 47 May minimize potential for hypotension in patients at risk of excessive hypotension by withholding diuretic therapy (except in patients with heart failure), reducing diuretic dosage, and/or cautiously increasing sodium intake (except in patients with heart failure) prior to initiation of quinapril.1 47 600 (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 quinapril or any increase in quinapril or diuretic dosage.1 47

If excessive hypotension occurs, immediately place patient in supine position and, if necessary, administer IV infusion of 0.9% sodium chloride solution.1 47 Quinapril therapy usually can be continued following restoration of volume and BP.1 47 If symptomatic hypotension develops, dosage reduction or discontinuance of quinapril or diuretic may be necessary.1 47

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.1 47 Data insufficient to rule out similar incidence of agranulocytosis with quinapril.1 47

Consider monitoring leukocytes in patients with collagen vascular disease and/or renal disease.1 47

Fetal/Neonatal Morbidity and Mortality

Possible fetal and neonatal morbidity and mortality when used during pregnancy.1 47 65 66 (See Boxed Warning.) Such potential risks occur throughout pregnancy, especially during the second and third trimesters.66

Also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.65 66

Discontinue as soon as possible when pregnancy is detected, unless continued use is considered lifesaving.66 Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.1 47

Sensitivity Reactions

Anaphylactoid reactions and/or head and neck angioedema possible; if associated with laryngeal edema, may be fatal.1 47 b Immediate medical intervention (e.g., epinephrine) for involvement of tongue, glottis, or larynx.1 47

Intestinal angioedema reported; sometimes occurs in patients with no prior history of facial angioedema.1 b Manifestations include abdominal pain (with or without nausea or vomiting).1 b Consider intestinal angioedema in the differential diagnosis of patients receiving ACE inhibitors presenting with abdominal pain.1 b

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 47

Life-threatening anaphylactoid reactions reported in at least 2 patients receiving ACE inhibitors while undergoing desensitization treatment with hymenoptera venom.1 47

Contraindicated in patients with a history of angioedema associated with ACE inhibitors.1 47

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 47 Possible increases in BUN and Scr in patients with unilateral or bilateral renal artery stenosis; generally reversible following discontinuance of ACE inhibitor and/or diuretic.1 47

Possible oliguria, progressive azotemia, and, rarely, acute renal failure and/or death in patients with severe heart failure.1 47

Closely monitor renal function for the first few weeks of therapy in hypertensive patients with unilateral or bilateral renal-artery stenosis.1 47 Some patients may require dosage reduction or discontinuance of ACE inhibitor or diuretic.1 47

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 47 (See Specific Drugs under Interactions.)

Monitor serum potassium concentration carefully in these patients.1 47

Cough

Persistent and nonproductive cough; resolves after drug discontinuance.1 47

Use of Fixed Combinations

When used in fixed combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with hydrochlorothiazide.47

Specific Populations

Pregnancy

Category C (1st trimester); Category D (2nd and 3rd trimesters).1 47 (See Fetal/Neonatal Morbidity and Mortality under Cautions and see Boxed Warning.)

Lactation

Distributed into milk.1 47 Caution if used in nursing women.47 3 4

Pediatric Use

Safety and efficacy remain to be fully established in children;1 47 however, some experts have recommended dosages for hypertension based on current limited clinical experience.62

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.1 47 However, cautious dosing recommended due to greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly.1 47

Renal Impairment

Deterioration of renal function may occur. (See Renal Effects under Cautions.)1 47

Initial dosage adjustment recommended in patients with renal impairment.1 (See Renal Impairment under Dosage and Administration.) Safety and efficacy not established in patients with Clcr <10 mL/minute.1 47

Quinapril/hydrochlorothiazide fixed combinations are not recommended in patients with severe renal impairment (Clcr ≤30 mL/minute or Scr >3 mg/dL).47

Hepatic Impairment

Use with caution in patients with hepatic impairment or progressive liver disease.47

Black Patients

BP reduction may be smaller in black patients compared with nonblack patients.1 24 25 47 48 49 (See Hypertension under Uses.)

Higher incidence of angioedema reported with ACE inhibitors in black patients compared with other races.1 47 49 500

Common Adverse Effects

Patients with hypertension: Headache, dizziness, fatigue, cough, nausea, vomiting, abdominal pain.1 47 With fixed combination preparation, myalgia, virus infection, rhinitis, back pain, diarrhea, upper respiratory tract infection, insomnia, somnolence, bronchitis, dyspepsia, asthenia, pharyngitis, vasodilation, vertigo, chest pain.47

Patients with heart failure: Dizziness, cough, fatigue, nausea, vomiting, chest pain, hypotension, dyspnea, diarrhea, headache, myalgia, rash, back pain, increased serum creatinine concentration, increased BUN.1

Interactions for Accupril

Drugs That Interact with Magnesium

Possible decreased absorption of drugs that interact with magnesium, possibly due to high magnesium content in quinapril-containing preparations.1 47

Specific Drugs

Drug

Interaction

Comments

Atorvastatin

Pharmacokinetic interaction unlikely1

Cimetidine

Pharmacokinetic interaction unlikely1 47

Digoxin

Pharmacokinetic interaction unlikely1 47

Diuretics

Increased hypotensive effect1 47

If possible, discontinue diuretic before initiating quinapril1 47 (See Dosage under Dosage and Administration)

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

Enhanced hyperkalemic effect1 47

Use with caution; monitor serum potassium concentrations frequently1 47

Lithium

Increased serum lithium concentrations; possible toxicity1 47

Monitor serum lithium concentrations frequently1 47

Potassium supplements or potassium-containing salt substitutes

Enhanced hyperkalemic effect1 47

Use with caution; monitor serum potassium concentrations frequently1 47

Propranolol

Pharmacokinetic interaction unlikely1 47

Tetracycline

Decreased tetracycline absorption1 47

Warfarin

Pharmacologic interaction unlikely1 47

Accupril Pharmacokinetics

Absorption

Bioavailability

About 60% of oral dose is absorbed.1 47

Peak plasma concentrations of quinapril and quinaprilat are achieved within 1 and 2 hours, respectively.1 47

Onset

Following a single oral dose, antihypertensive effects are observed within 1 hour, with peak BP reduction at 2–4 hours.1 47

During chronic therapy, maximum antihypertensive effect is achieved after 1–2 weeks.1 47

Duration

Inhibition of >80% of ACE activity persists for about 24 hours.1 47 Inhibition of 75% of the pressor response to angiotensin I persists for about 4 hours.1 47

Food

High-fat meals result in moderate (25–30%) reductions in rate and extent of absorption of quinapril.1 47 When quinapril/hydrochlorothiazide combination is administered with high-fat meals, rate of quinapril absorption is reduced by 14%, but extent of absorption is unaffected.47

Special Populations

Decreased quinaprilat concentrations in patients with alcoholic cirrhosis.1 47

Distribution

Extent

Quinapril and quinaprilat do not cross the blood-brain barrier.1 47

Crosses the placenta in rats.1 47 Distributed into human milk.1 47

Plasma Protein Binding

97% for both quinapril and quinaprilat.1 47

Elimination

Metabolism

Metabolized principally to an active metabolite, quinaprilat (approximately 38% of oral dose).1 47

Elimination Route

Eliminated principally in urine (as metabolites).1 47

Not removed by hemodialysis or peritoneal dialysis.1 47

Half-life

Quinaprilat: Elimination: 2 hours; prolonged terminal phase of 25 hours.1 47

Special Populations

In patients with renal impairment, elimination half-life increases with decreasing Clcr.1 47

Decreased elimination of quinaprilat in patients ≥65 years of age.1 47

Stability

Storage

Oral

Tablets

Conventional tablets: 15–30°C.1 Protect from light.1

Fixed combination tablets: 20–25°C.47

Actions

  • Prodrug; not pharmacologically active until hydrolyzed in the liver to quinaprilat.1 2 3 47

  • Suppresses the renin-angiotensin-aldosterone system.1 47

Advice to Patients

  • Risk of angioedema, anaphylactoid reactions, or other sensitivity reactions.1 47 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 47

  • Importance of reporting signs of infection (e.g., sore throat, fever).1 47

  • Risk of hypotension.1 47 Importance of informing clinicians promptly if lightheadedness or fainting occurs.1 47

  • Importance of adequate fluid intake; risk of volume depletion with excessive perspiration, dehydration, vomiting, or diarrhea.1 47

  • Risks of use during pregnancy.1 47 65 66 (See Boxed Warning.)

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (including salt substitutes containing potassium).1 47

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 47

  • Importance of advising patients of other important precautionary information.1 47 (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

Quinapril Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

5 mg (of quinapril)*

Accupril (scored)

Pfizer

Quinapril Hydrochloride Tablets

10 mg (of quinapril)*

Accupril

Pfizer

Quinapril Hydrochloride Tablets

20 mg (of quinapril)*

Accupril

Pfizer

Quinapril Hydrochloride Tablets

40 mg (of quinapril)*

Accupril

Pfizer

Quinapril Hydrochloride Tablets

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

Quinapril Hydrochloride Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

10 mg (of quinapril) with Hydrochlorothiazide 12.5 mg*

Accuretic (scored)

Pfizer

Quinapril Hydrochloride and Hydrochlorothiazide Tablets

Quinaretic

Amide

20 mg (of quinapril) with Hydrochlorothiazide 12.5 mg*

Accuretic

Pfizer

Quinapril Hydrochloride and Hydrochlorothiazide Tablets

Quinaretic

Amide

20 mg (of quinapril) with Hydrochlorithiazide 25 mg*

Accuretic

Pfizer

Quinapril Hydrochloride and Hydrochlorothiazide Tablets

Quinaretic

Amide

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.

Accupril 10MG Tablets (PFIZER U.S.): 30/$62.99 or 90/$179.97

Accupril 20MG Tablets (PFIZER U.S.): 30/$67.99 or 90/$182.97

Accupril 40MG Tablets (PFIZER U.S.): 30/$67.99 or 90/$185.97

Accupril 5MG Tablets (PFIZER U.S.): 30/$69.27 or 90/$176.24

Accuretic 10-12.5MG Tablets (PFIZER U.S.): 30/$66.99 or 90/$200.98

Accuretic 20-12.5MG Tablets (PFIZER U.S.): 30/$67.41 or 90/$174.54

Accuretic 20-25MG Tablets (PFIZER U.S.): 30/$64.04 or 90/$192.12

Quinapril HCl 10MG Tablets (GREENSTONE): 30/$19.99 or 90/$50.97

Quinapril HCl 20MG Tablets (LUPIN PHARMACEUTICALS): 30/$26.97 or 90/$59.97

Quinapril HCl 40MG Tablets (LUPIN PHARMACEUTICALS): 30/$21.99 or 90/$50.97

Quinapril HCl 5MG Tablets (LUPIN PHARMACEUTICALS): 30/$23.99 or 90/$54.97

Quinapril-Hydrochlorothiazide 10-12.5MG Tablets (MYLAN): 30/$35.99 or 90/$89.97

Quinapril-Hydrochlorothiazide 20-12.5MG Tablets (GREENSTONE): 90/$86.99 or 100/$94.96

Quinapril-Hydrochlorothiazide 20-25MG Tablets (MYLAN): 90/$90.99 or 100/$100.97

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.

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