Thursday, September 29, 2016

Benazepril Hydrochloride



Class: Angiotensin-Converting Enzyme Inhibitors
VA Class: CV400
Chemical Name: [S* - (R*,R*)] - 3 - [[1[(ethoxycarbonyl) - 3 - phenylpropyl]amino] - 2,3,4,5 - tetrahydro - 2 - oxo - 1 - H - 1benzazepine - 1 - acetic acid monohydrochloride
CAS Number: 86541-74-4
Brands: Lotensin, Lotensin HCT, Lotrel



  • Benazepril may cause fetal and neonatal morbidity and mortality if used during pregnancy.1 11 12 48 49 51 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)




  • If pregnancy is detected, discontinue benazepril as soon as possible.1 11 12 51




Introduction

Benazepril is a nonsulfhydryl ACE inhibitor.1 2 3 4


Uses for Benazepril Hydrochloride


Hypertension


Benazepril is used for management of hypertension (alone or in combination with other classes of antihypertensive agents);1 4 10 13 28 may be used in fixed combination with amlodipine or hydrochlorothiazide when such combined therapy is indicated.11 12


ACE inhibitors are 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.28


Benazepril can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.28


Addition of benazepril to amlodipine usually does not provide additional antihypertensive effects in blacks but appears to reduce development of amlodipine-associated edema regardless of race.12


CHF


ACE inhibitors are used for management of symptomatic CHF, usually in conjunction with cardiac glycosides, diuretics, and β-adrenergic blocking agents.27 31 32 33 34 35


Diabetic Nephropathy


ACE inhibitors or angiotensin II receptor antagonists are first-line agents in the treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes mellitus.37 38 39 50


Benazepril Hydrochloride Dosage and Administration


General


Hypertension



  • Benazepril/amlodipine and benazepril/hydrochlorothiazide fixed combinations should not be used for initial treatment of hypertension.11 12



Administration


Oral Administration


Administer benazepril orally once or twice daily without regard to meals.1


Administer benazepril as extemporaneously prepared oral suspension in pediatric patients unable to swallow tablets or in those for whom the calculated daily dosage does not correspond to the available tablet strengths.1


Reconstitution

Preparation of extemporaneous suspension containing benazepril hydrochloride 2 mg/mL: Add 75 mL of suspending vehicle (Ora-Plus) to a polyethylene terephthalate (PET) bottle containing fifteen 20-mg tablets of benazepril hydrochloride; shake the contents for ≥2 minutes.1 Allow concentrated suspension to stand for a minimum of 60 minutes following reconstitution, then shake for a minimum of 1 additional minute.1 Dilute the concentrated suspension with 75 mL of syrup (Ora-Sweet); shake the container to disperse the ingredients.1 Shake suspension before dispensing each dose.1


Dosage


Benazepril is available as benazepril hydrochloride; dosage expressed in terms of the salt.1 11 12


Pediatric Patients


Hypertension

Benazepril Therapy for Hypertension

Oral

Children ≥6 years of age: Initially, benazepril hydrochloride 0.2 mg/kg (up to 10 mg) once daily.1 45 Adjust dosage until the desired BP goal is achieved (up to maximum dosage of 0.6 mg/kg or 40 mg daily).1 45


Adults


Hypertension

Benazepril Therapy for Hypertension

Oral

Initially, benazepril hydrochloride 10 mg once daily as monotherapy.1 4 10 13 Adjust dosage at approximately monthly intervals (more aggressively in high-risk patients) to achieve BP control.13


In patients currently receiving diuretic therapy, discontinue diuretic, if possible, 2–3 days before initiating benazepril.1 May cautiously resume diuretic therapy if BP not controlled adequately with benazepril alone.1 If diuretic cannot be discontinued, increase sodium intake and give lower initial benazepril hydrochloride dose (5 mg) under close medical supervision.1 13


Usual benazepril hydrochloride dosage: 20–40 mg daily, given in 1 dose or 2 divided doses.1 10 13


If effectiveness diminishes toward end of dosing interval in patients treated once daily, consider increasing dosage or administering benazepril in 2 divided doses.1 13


Benazepril/Hydrochlorothiazide Fixed-combination Therapy for Hypertension

Oral

In studies using benazepril/hydrochlorothiazide fixed combination in dosages of benazepril hydrochloride 5–20 mg daily and hydrochlorothiazide 6.25–25 mg daily, BP response increased with increasing dosages of the drugs.11


If BP is not adequately controlled by monotherapy with benazepril, can switch to the fixed-combination preparation containing benazepril hydrochloride 10 mg and hydrochlorothiazide 12.5 mg or, alternatively, benazepril hydrochloride 20 mg and hydrochlorothiazide 12.5 mg.11 Adjust dosage of either or both drugs according to patient’s response.11


If BP is controlled by monotherapy with hydrochlorothiazide 25 mg daily but potassium loss is problematic, can switch to fixed-combination preparation containing benazepril hydrochloride 5 mg and hydrochlorothiazide 6.25 mg.11


If BP is controlled with benazepril and hydrochlorothiazide (administered separately), can switch to the fixed-combination preparation containing the corresponding individual doses for convenience.11


Benazepril/Amlodipine Fixed-combination Therapy for Hypertension

Oral

In studies using benazepril/amlodipine fixed combination in dosages of benazepril hydrochloride 10–40 mg daily and amlodipine 2.5–10 mg daily, BP response increased with increasing amlodipine dosage in all patient groups and increased with increasing benazepril dosage in nonblack patient groups.12


If BP is not adequately controlled by monotherapy with benazepril (or another ACE inhibitor) or amlodipine (or another dihydropyridine-derivative calcium-channel blocker), can switch to benazepril/amlodipine fixed combination.12


If BP is adequately controlled by monotherapy with amlodipine, but edema has developed, can switch to benazepril/amlodipine fixed combination to achieve similar or better BP control without edema.12 May be prudent to reduce amlodipine dosage, especially in nonblack patients, when benazepril is initiated to avoid excessive antihypertensive response.12


If BP is controlled with benazepril and amlodipine (administered separately), can switch to the fixed-combination preparation containing the corresponding individual doses for convenience.12


Adjust dosage of benazepril/amlodipine fixed combination according to patient’s response; consider that steady-state plasma concentrations of benazepril and amlodipine are reached after 2 and 7 days, respectively.12


In small or frail individuals, preparations containing benazepril in fixed combination with 5 or 10 mg of amlodipine exceed the initial recommended dosage (2.5 mg daily) of amlodipine.12


Prescribing Limits


Pediatric Patients


Hypertension

Oral

Maximum 0.6 mg/kg or 40 mg of benazepril hydrochloride daily.1 45


Adults


Hypertension

Oral

Maximum 80 mg of benazepril hydrochloride daily.1


Special Populations


The following information addresses dosage of benazepril in special populations. Dosages of drugs administered in fixed combination with benazepril also may require adjustment in certain patient populations; the need for such dosage adjustments must be considered in the context of cautions, precautions, and contraindications specific to that population and drug.11 12


Hepatic Impairment


Preparations containing benazepril in fixed combination with 5 or 10 mg of amlodipine exceed the initial recommended dosage of amlodipine (2.5 mg daily) in patients with hepatic impairment.12


Renal Impairment


Initially, benazepril hydrochloride 5 mg once daily in adults with Clcr <30 mL/minute or Scr >3 mg/dL; titrate until BP is controlled or to maximum of 40 mg daily.1 Use of benazepril not recommended in pediatric patients with Clcr <30 mL/minute per 1.73 m2.1 45


Preparations containing benazepril in fixed combination with hydrochlorothiazide are not recommended in patients with Clcr ≤30 mL/minute or Scr >3 mg/dL.11 Loop diuretics are preferred to thiazides in these patients.11


Preparations containing benazepril in fixed combination with amlodipine are not recommended in patients with Clcr ≤30 mL/minute or Scr >3 mg/dL.12


Geriatric Patients


Select dosage of benazepril carefully.1 11 12 (See Geriatric Use under Cautions.)


Preparations containing benazepril in fixed combination with 5 or 10 mg of amlodipine exceed the initial recommended dosage (2.5 mg daily) of amlodipine in geriatric patients.12


Volume- and/or Salt-depleted Patients


Correct volume and/or salt depletion prior to initiation of benazepril therapy or initiate therapy under close medical supervision using lower initial dosage.1


Cautions for Benazepril Hydrochloride


Contraindications



  • Known hypersensitivity (e.g., history of angioedema) to benazepril or another ACE inhibitor.1 11 12




  • When benazepril is used in fixed combination with hydrochlorothiazide or amlodipine, consider contraindications associated with the concomitant agent.11 12



Warnings/Precautions


Warnings


Hypotension

Possible symptomatic hypotension with ACE inhibitors, particularly in volume- and/or salt-depleted patients (e.g., those treated with diuretics) or patients with CHF with or without associated renal insufficiency.1 11 12


Hypotension may occur in patients undergoing surgery or during anesthesia with agents that produce hypotension; recommended treatment is fluid volume expansion.1 11 12


To minimize potential for hypotension, consider recent antihypertensive therapy, extent of BP elevation, sodium intake, fluid status, and other clinical conditions.1 7 May minimize potential for hypotension by withholding diuretic therapy and/or increasing sodium intake for 2–3 days prior to initiation of benazepril.1 13 (See Dosage and also Special Populations under Dosage and Administration.)


Transient hypotension is not a contraindication to additional doses; may reinstate benazepril therapy cautiously after BP is stabilized (e.g., with volume expansion).1 11 12


Initiate benazepril therapy in patients with CHF (with or without associated renal insufficiency) under close medical supervision; monitor closely for first 2 weeks following initiation of benazepril or diuretic therapy or any increase in benazepril or diuretic dosage.1 11 12


Fetal/Neonatal Morbidity and Mortality

Possible fetal and neonatal morbidity and mortality when benazepril is used during pregnancy.1 11 12 13 14 15 16 17 18 19 20 49 51 (See Boxed Warning.) Such potential risks occur throughout pregnancy, especially during the second and third trimesters.49 Benazepril also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.1 11 12 48 49


Discontinue benazepril as soon as possible when pregnancy is detected, unless continued use is considered lifesaving.1 11 12 49 Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.8 19


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 11 12


If jaundice or marked elevation of liver enzymes occurs, discontinue drug and monitor patient.1 11 12


Hematologic Effects

Neutropenia and agranulocytosis reported with captopril; risk of neutropenia appears to depend principally on degree of renal impairment and presence of collagen vascular disease (e.g., systemic lupus erythematosus, scleroderma); risk with benazepril is unknown.1 11 12


Consider monitoring leukocytes in patients with collagen vascular disease, especially if renal impairment exists.1 11 12


Sensitivity Reactions


Anaphylactoid reactions and/or angioedema possible with ACE inhibitors; if associated with laryngeal edema, may be fatal.1 11 12 Institute immediate medical intervention (e.g., epinephrine) for involvement of tongue, glottis, or larynx.1 11 12


Intestinal angioedema possible with ACE inhibitors; consider in differential diagnosis of patients who develop abdominal pain.1 11 12


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 11 12


Life-threatening anaphylactoid reactions reported in at least 2 patients receiving ACE inhibitors while undergoing desensitization treatment with hymenoptera venom.1 11 12


Benazepril is contraindicated in patients with a history of angioedema associated with ACE inhibitors.1 11 12


General Precautions


Use of Fixed Combinations

When benazepril is used in fixed combination with hydrochlorothiazide or amlodipine, consider cautions, precautions, contraindications, and interactions associated with the concomitant agent.11 12 Consider cautionary information applicable to specific populations (e.g., pregnant or nursing women, individuals with hepatic or renal impairment, geriatric patients) for each drug in the fixed combination.11 12


Renal Effects

Transient increases in BUN and Scr possible with benazepril, especially in patients with preexisting renal impairment or those receiving concomitant diuretic therapy.1 11 12 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 11 12


Oliguria, progressive azotemia, and, rarely, acute renal failure and/or death reported in patients with severe CHF receiving benazepril.1 11 12


Closely monitor renal function following initiation of benazepril therapy in such patients.1 Some patients may require dosage reduction or discontinuance of ACE inhibitor or diuretic and/or adequate sodium repletion.1


Hyperkalemia

Hyperkalemia reported with benazepril, 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 11 12 (See Specific Drugs under Interactions.)


Monitor serum potassium concentration carefully in these patients.1


Cough

ACE inhibitors associated with persistent and nonproductive cough; resolves after drug discontinuance.1 11 12


Specific Populations


Pregnancy

Benazepril: Category D.1 11 12 (See Fetal/Neonatal Morbidity and Mortality under Cautions and see Boxed Warning.)


Lactation

Benazepril and benazeprilat are distributed into milk in minimal amounts.1 11 12 Discontinue nursing or the drug.1 11 12


Pediatric Use

Safety and efficacy of benazepril not established in children <6 years of age1 or in those with Clcr <30 mL/minute per 1.73 m2.1 45


Safety and efficacy of benazepril in fixed combination with amlodipine or hydrochlorothiazide not established in children.11 12


Geriatric Use

Safety and efficacy profiles of benazepril alone or in fixed combination with hydrochlorothiazide or amlodipine are similar to those in younger adults.1 11 12 However, possible decreased elimination of benazepril due to age-related changes in renal function; cautious dosing recommended.1 11 12


Renal Impairment

Systemic exposure to benazeprilat may be increased.1 (See Absorption: Special Populations, under Pharmacokinetics.) Initial benazepril dosage adjustment recommended in patients with severe renal impairment.1 (See Renal Impairment under Dosage and Administration.)


Deterioration of renal function may occur.1 11 12 Possible increased risk of hyperkalemia.1 Theoretical risk of neutropenia/agranulocytosis.1 11 12 (See Warnings and also General Precautions under Cautions.)


Use of preparations containing benazepril in fixed combination with amlodipine12 or hydrochlorothiazide11 is not recommended in patients with severe renal impairment. (See Renal Impairment under Dosage and Administration.)


Blacks

BP reduction with ACE inhibitors may be smaller in black patients compared with nonblack patients;10 13 however, no apparent population difference during combined therapy with ACE inhibitor and thiazide diuretic.10 13 Use in combination with a diuretic.10 13


Higher incidence of angioedema reported with ACE inhibitors in blacks compared with other races.1 26 28


Common Adverse Effects


Benazepril: Headache, dizziness, fatigue, somnolence, postural dizziness, nausea, cough.1


Interactions for Benazepril Hydrochloride


The following information addresses potential interactions with benazepril. When benazepril is used in fixed combination with hydrochlorothiazide or amlodipine, consider interactions associated with the concomitant agent.11 12


Specific Drugs
























Drug



Interaction



Comments



Anticoagulants, oral



Interaction unlikely1



Antidiabetic agents (insulin, oral agents)



Possible hypoglycemia1 11



Advise diabetic patients about the possibility of hypoglycemia; monitor appropriately1 11



Diuretics



Increased hypotensive effect1



If possible, discontinue diuretic before initiating benazepril1 (see General and also Dosage under Dosage and Administration)



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



Enhanced hyperkalemic effect1



Use with caution; monitor serum potassium concentrations frequently1



Lithium



Increased serum lithium concentrations; possible toxicity1



Use with caution; monitor serum lithium concentrations frequently1



Potassium supplements or potassium-containing salt substitutes



Enhanced hyperkalemic effect1



Use with caution; monitor serum potassium concentrations frequently1


Benazepril Hydrochloride Pharmacokinetics


Absorption


Bioavailability


About 37% of oral benazepril dose is absorbed.1 Peak plasma concentrations of benazepril and benazeprilat are achieved within 0.5–1 and 1–2 hours, respectively.1


Onset


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


During chronic benazepril therapy, maximum antihypertensive effect with any dose is achieved after 1–2 weeks.1


Duration


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


Food


Food does not affect absorption of benazepril.1


Peak plasma concentrations of benazeprilat are attained within 2–4 hours following oral administration of benazepril with food.1


Special Populations


In patients with cirrhosis, benazeprilat concentrations essentially unchanged.1


In patients with severe renal impairment, increased peak serum benazeprilat concentrations and increased time to steady-state benazeprilat concentrations.1


Distribution


Extent


In animal studies, benazepril and its metabolites crossed the blood-brain barrier only slightly.1 11


Benazepril crosses the placenta and is distributed into breast milk.1


Plasma Protein Binding


Benazepril: 96.7%.1


Benazeprilat: 95.3%.1


Elimination


Metabolism


Benazepril is metabolized in the liver, principally to an active metabolite, benazeprilat.1


Elimination Route


Benazepril is eliminated principally in urine (as metabolites) and to lesser extent via biliary excretion.1


Half-life


Benazeprilat: 10–11 hours.1


Special Populations


In patients with renal failure, biliary clearance of benazeprilat may compensate to some extent for reduced renal clearance.1


Stability


Storage


Oral


Extemporaneous Suspension

Benazepril hydrochloride 2 mg/mL in Ora-Sweet and Ora-Plus (see Reconstitution under Dosage and Administration): Up to 30 days at 2–8°C.1


Tablets

Benazepril: Tight container at ≤30°C.1


Benazepril/hydrochlorothiazide fixed combination: Tight, light-resistant container at ≤30ºC.11


Capsules

Benazepril/amlodipine fixed combination: Tight container at 25ºC (may be exposed to 15–30ºC).12


ActionsActions



  • Benazepril is a prodrug; not pharmacologically active until hydrolyzed in the liver to benazeprilat.1 2 3 4




  • Benazepril suppresses the renin-angiotensin-aldosterone system.1



Advice to Patients



  • When benazepril is used in fixed combination with hydrochlorothiazide or amlodipine, importance of advising patients of important precautionary information about the concomitant agent.11 12




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




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




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




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




  • Risks of use during pregnancy.1 11 12 48 49 (See Boxed Warning.)




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




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




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



Preparations


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


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
















































Benazepril Hydrochloride

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Tablets, film-coated



5 mg*



Benazepril Hydrochloride Tablets



Lotensin



Novartis



10 mg*



Benazepril Hydrochloride Tablets



Lotensin



Novartis



20 mg*



Benazepril Hydrochloride Tablets



Lotensin



Novartis



40 mg*



Benazepril Hydrochloride Tablets



Lotensin



Novartis


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


































































































Benazepril Hydrochloride Combinations

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Capsules



10 mg with Amlodipine Besylate 2.5 mg (of amlodipine)*



Amlodipine Besylate and Benazepril Hydrochloride Capsules (combination)



Lotrel



Novartis



10 mg with Amlodipine Besylate 5 mg (of amlodipine)*



Amlodipine Besylate and Benazepril Hydrochloride Capsules (combination)



Lotrel



Novartis



20 mg with Amlodipine Besylate 5 mg (of amlodipine)*



Amlodipine Besylate and Benazepril Hydrochloride Capsules (combination)



Lotrel



Novartis



20 mg with Amlodipine Besylate 10 mg (of amlodipine)*



Amlodipine Besylate and Benazepril Hydrochloride Capsules (combination)



Lotrel



Novartis



40 mg with Amlodipine Besylate 5 mg (of amlodipine)



Lotrel



Novartis



40 mg with Amlodipine Besylate 10 mg (of amlodipine)



Lotrel



Novartis



Tablets, film-coated



5 mg with Hydrochlorothiazide 6.25 mg*



Benazepril with Hydrochlorothiazide Tablets



Lotensin HCT (scored)



Novartis



10 mg with Hydrochlorothiazide 12.5 mg*



Benazepril with Hydrochlorothiazide Tablets



Lotensin HCT (scored)



Novartis



20 mg with Hydrochlorothiazide 12.5 mg*



Benazepril with Hydrochlorothiazide Tablets



Lotensin HCT (scored)



Novartis



20 mg with Hydrochlorothiazide 25 mg*



Benazepril with Hydrochlorothiazide Tablets



Lotensin HCT (scored)



Novartis


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.


Amlodipine Besy-Benazepril HCl 2.5-10MG Capsules (TEVA PHARMACEUTICALS USA): 30/$69.99 or 90/$199.96


Amlodipine Besy-Benazepril HCl 5-20MG Capsules (SANDOZ): 30/$69.99 or 90/$195.97


Benazepril HCl 10MG Tablets (SANDOZ): 30/$25.99 or 90/$69.97


Benazepril HCl 20MG Tablets (SANDOZ): 30/$25.99 or 90/$69.97


Benazepril HCl 40MG Tablets (SANDOZ): 30/$23.99 or 90/$64.97


Benazepril HCl 5MG Tablets (TEVA PHARMACEUTICALS USA): 90/$64.97 or 180/$129.94


Benazepril-Hydrochlorothiazide 10-12.5MG Tablets (SANDOZ): 30/$22.99 or 90/$56.96


Benazepril-Hydrochlorothiazide 20-12.5MG Tablets (SANDOZ): 30/$26.99 or 90/$69.96


Benazepril-Hydrochlorothiazide 20-25MG Tablets (SANDOZ): 30/$26.99 or 90/$69.96


Benazepril-Hydrochlorothiazide 5-6.25MG Tablets (SANDOZ): 30/$25.91 or 90/$67.18


Lotensin 10MG Tablets (NOVARTIS): 30/$67.99 or 90/$172.97


Lotensin 20MG Tablets (NOVARTIS): 30/$72.99 or 90/$188.97


Lotensin 40MG Tablets (NOVARTIS): 30/$67.99 or 90/$177.98


Lotensin 5MG Tablets (NOVARTIS): 30/$62.8 or 90/$163.34


Lotensin HCT 10-12.5MG Tablets (NOVARTIS): 30/$62.99 or 90/$175.98


Lotensin HCT 20-12.5MG Tablets (NOVARTIS): 30/$63.99 or 90/$168.97


Lotensin HCT 20-25MG Tablets (NOVARTIS): 30/$62.99 or 90/$170.97


Lotrel 10-20MG Capsules (NOVARTIS): 30/$158.99 or 90/$461.99


Lotrel 10-40MG Capsules (NOVARTIS): 30/$164.85 or 90/$469.19


Lotrel 2.5-10MG Capsules (NOVARTIS): 30/$123.99 or 90/$345.98


Lotrel 5-10MG Capsules (NOVARTIS): 30/$123.99 or 90/$340.97


Lotrel 5-20MG Capsules (NOVARTIS): 30/$128.99 or 90/$360.95


Lotrel 5-40MG Capsules (NOVARTIS): 30/$123 or 90/$348.73



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 December 2009. 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. Novartis. Lotensin (benazepril hydrochloride) tablets prescribing information. East Hanover, NJ; 2007 Nov.



2. Kaiser G, Ackermann R, Sioufi A. Pharmacokinetics of a new angiotensin-converting enzyme inhibitor, benazepril hydrochloride, in special populations. Am Heart J. 1989; 117:746-51. [IDIS 252976] [PubMed 2919553]



3. Kaiser G. Benazepril—pharmacokinetic profile in specific subpopulations. In: Brunner HR, Salvetti A, Sever PS, eds. Benazepril: profile of a new ACE inhibitor. Royal Society of Medicine Services International Congress and Symposium Series No. 166. London: Royal Society of Medicine Services Limited; 1990:29-39.



4. Balfour JA, Goa KL. Benazepril. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in hypertension and congestive heart failure. Drugs. 1991; 42:511-39. [PubMed 1720384]



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 Enalaprilat/Enalapril 24:32.04 (personal observations).



7. 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]



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



9. Ciba Pharmaceutical Company, Summit, NJ: Personal communication.



10. 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]



11. Novartis. Lotensin HCT (benazepril hydrochloride/hydrochlorothiazide) tablets prescribing information. East Hanover, NJ; 2007 Nov.



12. Novartis. Lotrel (amlodipine besylate and benazepril hydrochloride) capsules prescribing information. East Hanover, NJ; 2007 Jun.



13. 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.)



14. 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]



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



16. 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]



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



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



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



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



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



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



23. 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]



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



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



26. 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]



27. 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.



28. 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.



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



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



31. Merck & Co. Vasotec tablets (enalapril maleate) prescribing information. Whitehouse Station, NJ; 2002 Jan.



32. Bristol-Myers Squibb. Monopril (fosinopril sodium) tablets prescribing information. Princeton, NJ; 2002 Feb.



33. Merck

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