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Monopril

Pronunciation

Generic Name: Fosinopril Sodium
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 Monopril

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).1 2 3 25

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.46

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Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.46

CHF

Management of symptomatic CHF, usually in conjunction with cardiac glycosides, diuretics, and β-adrenergic blocking agents.1

Diabetic Nephropathy

A first-line agent in the treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes mellitus.25 50 51 52 53 54 55 56 57

Monopril Dosage and Administration

General

Hypertension

  • Fosinopril/hydrochlorothiazide fixed combinations should not be used for initial treatment of hypertension.43

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

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
Oral

Initially, 10 mg once daily as monotherapy.1 12 25 46 Adjust dosage at approximately monthly intervals (more aggressively in high-risk patients) to achieve BP control.25 46

In patients currently receiving diuretic therapy, discontinue diuretic, if possible, 2–3 days before initiating fosinopril.1 3 May cautiously resume diuretic therapy if BP not controlled adequately with fosinopril alone.1 If diuretic cannot be discontinued, can increase sodium intake prior to initiating fosinopril.1 4 25 Manufacturer states that fosinopril may be initiated at the usual dose of 10 mg under close medical supervision for several hours until BP has stabilized; however, consider the desirability of initiating therapy at reduced dosage to minimize risk of hypotension.1 4 25

Usual dosage: 20–40 mg daily, given in 1 dose or 2 divided doses daily.1 2 25 46 Increasing dosage to 80 mg daily occasionally may result in further BP response.1

If effectiveness diminishes toward end of dosing interval in patients treated once daily, consider increasing dosage or administering drug in divided doses.1 25

Fosinopril/Hydrochlorothiazide Combination Therapy
Oral

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

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

CHF
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

CHF
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.47

CHF

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 Monopril

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 CHF 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 CHF under close medical supervision; monitor closely for first 2 weeks following initiation of fosinopril or any increase in fosinopril 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.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 CHF.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 CHF 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

Blacks

BP reduction may be smaller in black patients compared with nonblack patients;44 45 however, no apparent population difference during combined therapy with ACE inhibitor and thiazide diuretic.12 25 Use in combination with a diuretic.12 25

Higher incidence of angioedema reported with ACE inhibitors in blacks compared with other races.1 45 46

Common Adverse Effects

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

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

Interactions for Monopril

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

Monopril 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*

Monopril (with povidone; scored)

Bristol-Myers Squibb

20 mg*

Monopril (with povidone)

Bristol-Myers Squibb

40 mg*

Monopril (with povidone)

Bristol-Myers Squibb

Fosinopril Sodium Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

10 mg with Hydrochlorothiazide 12.5 mg

Fosinopril Sodium and Hydrochlorothiazide Tablets

Monopril-HCT ()

Bristol-Myers Squibb

20 mg with Hydrohlorothiazide 12.5 mg

Fosinopril Sodium and Hydrochlorothiazide Tablets

Monopril-HCT ()

Bristol-Myers Squibb

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. 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, 2004-2014, Selected Revisions April 1, 2008. 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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