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Fosinopril Sodium

Pronunciation

Class: Angiotensin-Converting Enzyme Inhibitors
VA Class: CV800
Molecular Formula: C30H46NO7P
CAS Number: 88889-14-9

Warning(s)

  • May cause fetal and neonatal morbidity and mortality if used during pregnancy.1 62 63 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

  • If pregnancy is detected, discontinue fosinopril as soon as possible.1 63

Introduction

Nonsulfhydryl ACE inhibitor.1 2 3

Uses for Fosinopril Sodium

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).1 2 3 500

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.44 45 60 61 500 501 504 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 symptomatic heart failure, usually in conjunction with cardiac glycosides, diuretics, and β-adrenergic blocking agents.1 15 34

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.53 54 55 56 57 520 535 536

Fosinopril Sodium 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 daily.1 Manufacturer makes no specific recommendations regarding administration with meals.1 43

Dosage

Available as fosinopril sodium; dosage expressed in terms of the salt.1

May minimize risk of hypotension in patients currently receiving diuretic therapy by discontinuing the diuretic, reducing diuretic dosage, or increasing salt intake prior to initiating fosinopril; if these changes are not possible, reduce initial fosinopril sodium dosage and observe patient closely for several hours until BP has stabilized.600 (See Hypotension under Cautions and see the individual dosage sections in Dosage and Administration.)

Pediatric Patients

Hypertension
Oral

Children ≥6 years of age and weighing >50 kg: 5–10 mg once daily.1 59 Increase dosage until desired BP goal is achieved (up to maximum dosage of 40 mg daily).59 A dosage form suitable for providing an appropriate dosage for children weighing <50 kg is not commercially available in the US.1

Adults

Hypertension
Fosinopril Therapy
Oral

Initially, 10 mg once daily in patients not receiving a diuretic.600 Adjust dosage based on BP response.600

In patients currently receiving diuretic therapy, discontinue diuretic, if possible, 2–3 days before initiating fosinopril.3 600 May resume diuretic therapy if BP not controlled adequately with fosinopril alone.600 If usual initial dosage of 10 mg daily is used in patients receiving a diuretic, administer under close medical supervision for several hours until BP has stabilized.600

Usual maintenance dosage: 20–40 mg daily.600 Higher dosages (e.g., 80 mg daily) reportedly have resulted in increased response in some patients.600

If effectiveness diminishes toward end of dosing interval in patients treated once daily, consider increasing dosage or administering drug in divided doses.600

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

Fosinopril/Hydrochlorothiazide Fixed-combination Therapy
Oral

Manufacturer states fixed-combination preparation should not be used for initial antihypertensive therapy.43

If BP is not adequately controlled by monotherapy with fosinopril, can switch to the fixed-combination preparation containing fosinopril sodium 10 mg and hydrochlorothiazide 12.5 mg, or alternatively, fosinopril sodium 20 mg and hydrochlorothiazide 12.5 mg.43 43

On average, antihypertensive effect of fosinopril sodium 10 mg and hydrochlorothiazide 12.5 mg is similar to that of fosinopril sodium 40 mg or hydrochlorothiazide 37.5 mg as monotherapy.43

Heart Failure
Oral

Initially, 10 mg daily.1 If patient has been treated vigorously with diuretics, 5 mg initially.1 Monitor closely for ≥2 hours until BP has stabilized.1 To minimize risk of hypotension, reduce diuretic dosage, if possible.1

Adjust dosage gradually over several weeks to maximum tolerated dosage (up to 40 mg daily).1

Usual dosage: 20–40 mg once daily.1

Prescribing Limits

Pediatric Patients

Hypertension
Oral

Maximum 40 mg daily.1 59

Adults

Heart Failure
Oral

Maximum 40 mg daily.1

Special Populations

Hepatic Impairment

No specific dosage recommendations.1 (See Special Populations under Pharmacokinetics.)

Renal Impairment

Hypertension

Dosage adjustment not required.1

Fosinopril/hydrochlorothiazide fixed combinations are not recommended in patients with Clcr <30 mL/minute or Scr ≥3 mg/dL.601

Heart Failure

Initially, 5 mg in patients with moderate to severe renal impairment.1

Geriatric Patients

Select dosage carefully; monitoring renal function may be useful.1

Cautions for Fosinopril Sodium

Contraindications

  • Known hypersensitivity to fosinopril or any ingredient in the formulation 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 or undergoing dialysis, patients with diarrhea or vomiting).1

Risk of marked hypotension, sometimes associated with oliguria, azotemia, and, rarely, death, in patients with heart failure with or without associated renal insufficiency.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, consider recent antihypertensive therapy, extent of BP elevation, sodium intake, fluid status, and other clinical conditions.1

May minimize potential for hypotension by correcting volume and/or salt depletion prior to initiating fosinopril therapy.1

Initiate therapy in patients with heart failure under close medical supervision; monitor closely for first 2 weeks following initiation of fosinopril or any increase in fosinopril or diuretic dosage.1 Consider reduced diuretic dosage in patients with low to normal BP who are hyponatremic or have received vigorous diuretic therapy.600

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

Fetal/Neonatal Morbidity and Mortality

Possible fetal and neonatal morbidity and mortality when used during pregnancy.1 63 (See Boxed Warning.) Such potential risks occur throughout pregnancy, especially during the second and third trimesters.63

Also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.62 63

Discontinue as soon as possible when pregnancy is detected, unless continued use is considered lifesaving.63 Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.31 33

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

Hematologic Effects

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

Consider monitoring leukocytes in patients with collagen vascular disease, especially if renal impairment exists.1

Sensitivity Reactions

Anaphylactoid reactions and/or head and neck angioedema possible; angioedema involving 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 43

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 ACE inhibitor and/or diuretic.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 43 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

Monitor serum potassium concentration carefully in these patients.1

Cough

Persistent and nonproductive cough; resolves after drug discontinuance.1

Use of Fixed Combinations

When used in fixed combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with hydrochlorothiazide.43

Specific Populations

Pregnancy

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

Lactation

Distributed into milk.1 Use not recommended.1

Pediatric Use

Safety and efficacy not established in children <6 years of age.1 Fosinopril is not recommended for pediatric patients with CLcr <30 mL/minute per 1.73 m2.59

Safety and efficacy of fosinopril in combination with hydrochlorothiazide not established in children.43

Geriatric Use

Insufficient experience in patients >65 years of age to determine whether geriatric patients respond differently than younger adults.1

Select dosage with caution because of greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy in the elderly.1

Hepatic Impairment

Systemic exposure to fosinoprilat may be increased (see Special Populations under Pharmacokinetics), but no specific dosage recommendations.1

Renal Impairment

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

Dosage adjustment generally not required in patients with hypertension.1 Decrease initial dose in patients with heart failure and moderate to severe renal impairment.1 (See Renal Impairment under Dosage and Administration.)

Fosinopril/hydrochlorothiazide fixed combinations are not recommended in patients with Clcr <30 mL/minute or Scr ≥3 mg/dL.43

Black Patients

BP reduction may be smaller in black patients compared with nonblack patients.44 45 (See Hypertension under Uses.)

Higher incidence of angioedema reported with ACE inhibitors in black patients compared with other races.1 45 500

Common Adverse Effects

Patients with hypertension: Cough, dizziness, nausea/vomiting.1

Patients with heart failure: Dizziness, cough, hypotension, musculoskeletal pain, nausea/vomiting, diarrhea, chest pain (noncardiac).1

Interactions for Fosinopril Sodium

Specific Drugs

Drug

Interaction

Comments

Antacids (aluminum-, magnesium-, and simethicone-containing)

Possible decreased fosinopril absorption1

Administer 2 hours apart1

Aspirin

Effect on fosinopril bioavailability unlikely1

Cimetidine

Effect on fosinopril bioavailability unlikely1

Digoxin

Effect on fosinopril bioavailability unlikely1

Diuretics

Increased hypotensive effect1

If possible, discontinue diuretic before initiating fosinopril1 (See Dosage under Dosage and Administration)

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

Enhanced hyperkalemic effect1

Use with caution; monitor serum potassium concentration frequently1

Lithium

Increased lithium concentrations; possible toxicity1

Use with caution, monitor lithium concentrations frequently1

Potassium supplements or potassium-containing salt substitutes

Enhanced hyperkalemic effect1

Use with caution; monitor serum potassium concentrations frequently1

Propantheline

Effect on fosinopril bioavailability unlikely1

Propranolol

Effect on fosinopril bioavailability unlikely1

Warfarin

Pharmacokinetic or pharmacologic interaction unlikely1

Fosinopril Sodium Pharmacokinetics

Absorption

Bioavailability

About 36% of oral dose is absorbed.1 Peak plasma concentration is achieved in approximately 3 hours.1

Onset

Following a single oral dose, antihypertensive effects are observed within 1 hour, with peak BP reductions at 2–6 hours.1

Duration

Antihypertensive effect of a single dose persists for about 24 hours.1

Food

Food may decrease rate but not extent of absorption.1 2

Distribution

Extent

Does not appear to cross blood-brain barrier.1

Crosses the placenta in animals.1 Distributed into human milk.1

Plasma Protein Binding

Fosinoprilat: About 99%.1

Elimination

Metabolism

Metabolized in the liver and gut wall, principally to an active metabolite (fosinoprilat).1

Elimination Route

Eliminated approximately equally by the liver and kidney.1

Not appreciably removed by hemodialysis or peritoneal dialysis.1

Half-life

Fosinoprilat: Approximately 12 hours.1

Special Populations

In patients with alcoholic or biliary cirrhosis, rate but not extent of metabolism of fosinopril may be decreased; clearance of fosinoprilat is approximately one-half that in patients with normal hepatic function.1

In patients with Clcr of 10–80 mL/minute, clearance of fosinoprilat is not appreciably altered.1 In patients with Clcr <10 mL/minute, clearance of fosinoprilat is approximately one-half that in patients with normal renal function.1

Stability

Storage

Oral

Tablets

15–30°C; protect from moisture.1 43

Actions

  • Prodrug; has little pharmacologic activity until hydrolyzed to fosinoprilat.1 2 3

  • 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. 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 62 63

  • 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 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

Fosinopril Sodium

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

10 mg*

Fosinopril Sodium Tablets

20 mg*

Fosinopril Sodium Tablets

40 mg*

Fosinopril Sodium Tablets

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

Fosinopril Sodium Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

10 mg with Hydrochlorothiazide 12.5 mg*

Fosinopril Sodium and Hydrochlorothiazide Tablets

20 mg with Hydrochlorothiazide 12.5 mg*

Fosinopril Sodium and Hydrochlorothiazide 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.

Fosinopril Sodium 10MG Tablets (SANDOZ): 60/$70.99 or 180/$211.97

Fosinopril Sodium 20MG Tablets (SANDOZ): 60/$68.99 or 180/$205.97

Fosinopril Sodium 40MG Tablets (SANDOZ): 30/$35.99 or 60/$68.97

Fosinopril Sodium-HCTZ 10-12.5MG Tablets (GLENMARK PHARMACEUTICALS): 60/$99.99 or 180/$279.96

Fosinopril Sodium-HCTZ 20-12.5MG Tablets (GLENMARK PHARMACEUTICALS): 60/$89.99 or 180/$249.97

Monopril 40MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 60/$97.99 or 180/$279.98

Monopril HCT 10-12.5MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 60/$94.99 or 180/$259.49

AHFS DI Essentials. © Copyright, 2004-2015, Selected Revisions January 26, 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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