Monopril

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

• 
  

  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

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 Cl_cr <30 mL/minute or S_cr ≥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 S_cr possible, especially in patients with preexisting renal impairment or those receiving concomitant diuretic therapy.¹ Possible increases in BUN and S_cr 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 CL_cr <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 Cl_cr <30 mL/minute or S_cr ≥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 Cl_cr of 10–80 mL/minute, clearance of fosinoprilat is not appreciably altered.¹ In patients with Cl_cr <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}

ActionsActions

• 
  

  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	Andrx, Ranbaxy, Sandoz, Watson
			Monopril-HCT (with povidone)	Bristol-Myers Squibb
		20 mg with Hydrohlorothiazide 12.5 mg	Fosinopril Sodium and Hydrochlorothiazide Tablets	Andrx, Ranbaxy, Sandoz, Watson
			Monopril-HCT (with povidone)	Bristol-Myers Squibb

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. 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 (TEVA PHARMACEUTICALS USA): 60/$59.99 or 180/$179.96

Fosinopril Sodium 20MG Tablets (RANBAXY PHARMACEUTICALS): 60/$59.99 or 180/$179.97

Fosinopril Sodium 40MG Tablets (RANBAXY PHARMACEUTICALS): 30/$30.99 or 60/$59.97

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/$99.99 or 180/$279.96

Monopril 10MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 60/$92.01 or 180/$263.17

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

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions April 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

1. Bristol-Myers Squibb. Monopril (fosinopril sodium) tablets prescribing information. Princeton, NJ; 2003 Jul.

2. Murdoch D, McTavish D. Fosinopril. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in essential hypertension. Drugs. 1992; 43:123-40. [PubMed 1372856]

3. McAreavey D, Robertson JIS. Angiotensin converting enzyme inhibitors and moderate hypertension. Drugs. 1990; 40:326-45. [PubMed 2226219]

4. Bristol-Myers Squibb, Princeton, NJ: Personal communication.

5. Squibb. Capoten (captopril) tablets prescribing information. In: Physician’s desk reference. 47th ed. Montvale, NJ: Medical Economics Company Inc; 1993:2356-62.

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

7. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The 1984 Report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1984; 144:1045-57. [IDIS 184763] [PubMed 6143542]

8. Anon. Drugs for hypertension. Med Lett Drugs Ther. 1984; 26:107-12. [PubMed 6150424]

9. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The 1988 Report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Arch Intern Med. 1988; 148:1023-38. [IDIS 242588] [PubMed 3365073]

10. US Food and Drug Administration. Dangers of ACE inhibitors during second and third trimesters of pregnancy. FDA Med Bull. 1992; 22:2.

11. Sica DA, Cutler RE, Parmer RJ et al. Comparison of the steady-state pharmacokinetics of fosinopril, lisinopril and enalapril in patients with chronic renal insufficiency. Clin Pharmacokinet. 1991; 20:420-7. [PubMed 1652404]

12. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. The fifth report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC V). Arch Intern Med. 1993; 153:154-83. [IDIS 309043] [PubMed 8422206]

13. Oster JR, Materson BL. Renal and electrolyte complications of congestive heart faiulure and effects of therapy with angiotensin-converting enzyme inhibitors. Arch Intern Med. 1992; 152:704-10. [IDIS 295733] [PubMed 1558426]

14. Leonetti G. Cuspidi C. Choosing the right ACE inhibitor: a guide to selection. Drugs. 1995; 49:516-35. [PubMed 7789286]

15. Brown EJ Jr, Chew PH, MacLean A et al for the Fosinopril Heart Failure Study Group. Effects of fosinopril on exercise tolerance and clinical deterioration in patients with chronic congestive heart failure not taking digitalis. Am J Cardiol. 1995; 75:596-600. [IDIS 344153] [PubMed 7887385]

16. Mason N. Angiotensin-converting enzyme inhibitors and renal function. DICP. 1990; 24:496-505. [IDIS 266588] [PubMed 2188438]

17. Baker DW, Konstam MA, Bottorff M. Management of heart failure. JAMA. 1994; 272:1361-6. [IDIS 337704] [PubMed 7933398]

18. Packer M, Lee WH, Yushak M. Comparison of captopril and enalapril in patients with severe chronic heart failure. N Engl J Med. 1986; 315:847-53. [IDIS 221364] [PubMed 3018566]

19. Zannad F, van den Broek SA, Bory M. Comparison of treatment with lisinopril versus enalapril for congestive heart failure. Am J Cardiol. 1992; 70:78-83C. [PubMed 1377441]

20. Young JB. Angiotensin-converting enzyme inhibitors in heart failure: new strategies justified by recent clinical trials. Int J Cardiol. 1994; 43:151-63. [PubMed 8181869]

21. Sharpe N. ACE inhibitors versus diuretics: when to choose which drug? Cardiovasc Drugs Ther. 1993; 7:877-9. Abstract.

22. Riegger GAJ. The effects of ACE inhibitors on exercise capacity in the treatment of congestive heart failure. J Cardiovasc Pharmacol. 1990; 15(Suppl 2): S41-6.

23. Erhardt L, Haunsol S, Luomanmaki K et al. Fosinopril attenuates clinical deterioration and improves exercise tolerance in patients with heart failure. Eur Heart J. 1994; 15(Suppl):341.

24. Deedwania PC. Clinical profile of fosinopril, a novel phosphinic acid ACE inhibitor, for the treatment of heart failure. Heart Failure. 1995; 11:125-36.

25. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI). Bethesda, MD: National Institutes of Health; 1997 Nov. (NIH publication No. 98-4080.)

26. Rey E, LeLorier J, Burgess E et al. Report of the Canadian Hypertension Society consensus conference: 3. pharmacologic treatment of hypertensive disorders in pregnancy. CMAJ. 1997; 157:1245-54. [IDIS 396283] [PubMed 9361646]

27. American College of Obstetricians and Gynecologists. ACOG technical bulletin No. 219: hypertension in pregnancy. 1996 Jan.

28. Hanssens M, Keirse MJ, Van Assche FA. Fetal and neonatal effects of treatment with angiotensin-converting enzyme inhibitors in pregnancy. Obstet Gynecol. 1991; 78:128-35. [IDIS 284531] [PubMed 2047053]

29. Brent RL, Beckman D. Angiotensin-converting enzyme inhibitors, an embryopathic class of drugs with unique properties: information for clincial teratology counselors. Teratology. 1991; 43:543-6. [PubMed 1882342]

30. Piper JM, Ray WA, Rosa FW. Pregnancy outcome following exposure to angiotensin-converting enzyme inhibitors. Obstet Gynecol. 1992; 80:429-32. [IDIS 300973] [PubMed 1495700]

31. Sibai BM. Treatment of hypertension in pregnant women. N Engl J Med. 1996; 335:257-65. [IDIS 369138] [PubMed 8657243]

32. Barr M, Cohen MM. ACE inhibitor fetopathy and hypocalvaria: the kidney-skull connection. Teratology. 1991; 44:485-95. [PubMed 1771591]

33. US Food and Drug Administration. Dangers of ACE inhibitors during pregnancy. FDA Med Bull. 1992; 22:2.

34. Anon. Consensus recommendations for the management of chronic heart failure. On behalf of the membership of the advisory council to improve outcomes nationwide in heart failure. Part II. Management of heart failure: approaches to the prevention of heart failure. Am J Cardiol. 1999; 83:9A-38A.

35. Packer M, Poole-Wilson PA, Armstrong PW et al. Comparative effects of low and high doses of the angiotensin-converting enzyme inhibitor, lisinopril, on morbidity and mortality in chronic heart failure. Circulation. 1999; 100:2312-8. [IDIS 440440] [PubMed 10587334]

36. Pitt B, Zannad F, Remme WJ et al. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. N Engl J Med. 1999; 341(10): 709-17. [IDIS 431313] [PubMed 10471456]

37. Weber KT. Aldosterone and spironolactone in heart failure. N Engl J Med. 1999;341:753-4.

38. Anon. Spironolactone for heart failure. Med Lett Drugs Ther. 1999; 41:81-2. [PubMed 10505071]

39. Izzo JL, Levy D, Black HR. Importance of systolic blood pressure in older Americans. Hypertension. 2000; 35:1021-4. [PubMed 10818056]

40. Frohlich ED. Recognition of systolic hypertension for hypertension. Hypertension. 2000; 35:1019-20. [PubMed 10818055]

41. Bakris GL, Williams M, Dworkin L et al. Preserving renal function in adults with hypertension and diabetes: a consensus approach. Am J Kidney Dis. 2000; 36:646-61. [IDIS 452007] [PubMed 10977801]

42. Associated Press (American Diabetes Association). Diabetics urged: drop blood pressure. Chicago, IL; 2000 Aug 29. Press Release from web site.

43. Bristol-Myers Squibb. Monopril-HCT (fosinopril sodium–hydrochlorothiazide) tablets prescribing information. 2003 May.

44. Appel LJ. The verdict from ALLHAT—thiazide diuretics are the preferred initial therapy for hypertension. JAMA. 2002; 288:3039-60. [IDIS 490723] [PubMed 12479770]

45. The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002; 288:2981-97. [IDIS 490721] [PubMed 12479763]

46. National Heart, Lung, and Blood Institute National High Blood Pressure Education Program. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC VII) Express. Bethesda, MD: May 14 2003. From NIH website. (Also published in JAMA. 2003; 289.

47. American Diabetes Association. Treatment of hypertension in adults with diabetes. Diabetes Care. 2003; 26(Suppl 1):S80-2.

48. Guidelines Committee. 2003 European Society of Hypertension–European Society of Cardiology guidelines for the management of arterial hypertension. J Hypertension. 2003; 21:1011-53.

49. Novartis. Diovan (valsartan) tablets prescribing information. East Hanover, NJ; 2002 Aug.

50. American Diabetes Association. Treatment of hypertension in adults with diabetes. Diabetes Care. 2002; 25:134-47. [IDIS 479088] [PubMed 11772914]

51. American Diabetes Association. Standards of medical care for patients with diabetes mellitus. Diabetes Care. 2002; 25(Suppl 1):S33-43.

52. American Diabetes Association. Clinical Practice Recommendations 2002. Position Statement. Diabetic nephropathy. Diabetes Care. 2002; 25(Suppl 1):S85-9.

53. Lewis EJ, Hunsicker LG, Bain RP et al. The effect of angiotensin-converting-enzyme inhibition on diabetic nephropathy. N Engl J Med. 1993; 329:1456-62. [IDIS 321612] [PubMed 8413456]

54. Remuzzi G. Slowing the progression of diabetic nephropathy. N Engl J Med. 1993; 329:1496-7. [PubMed 8413463]

55. Kaplan NM. Choice of initial therapy for hypertension. JAMA. 1996; 275:1577-80. [IDIS 365188] [PubMed 8622249]

56. Viberti G, Mogensen CE, Groop LC et al. Effect of captopril on progression to clinical proteinuria in patients with insulin-dependent diabetes mellitus and microalbuminuria. JAMA. 1994; 271:275-9. [IDIS 324307] [PubMed 8295285]

57. Fournier A. The effect of angiotensin-converting-enzyme inhibition on diabetic nephropathy. N Engl J Med. 1994; 330:937. [PubMed 8114873]

59. National High Blood Pressure Education Program Working Group on Hypertension Control in Children and Adolescents. The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents. Pediatrics. 2004; 114(Suppl 2):555-76.

60. Wright JT, Dunn JK, Cutler JA et al. Outcomes in hypertensive black and nonblack patients treated with chlorthalidone, amlodipine, and lisinopril. JAMA. 2005; 293:1595-607. [IDIS 531054] [PubMed 15811979]

61. Neaton JD, Kuller LH. Diuretics are color blind. JAMA. 2005; 293:1663-6. [IDIS 531056] [PubMed 15811986]

62. Cooper WO, Hernandez-Diaz S, Arbogast PG et al. Major congenital malformations after first-trimester exposure to ACE inhibitors. N Engl J Med. 2006; 354:2443-51. [PubMed 16760444]

63. Food and Drug Administration. FDA public health advisory: angiotensin-converting enzyme inhibitor (ACE inhibitor) drugs and pregnancy. From FDA website.

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• Monopril Side Effects (in more detail)
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• Monopril MedFacts Consumer Leaflet (Wolters Kluwer)


• Fosinopril Prescribing Information (FDA)

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