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Eprosartan Mesylate

Class: Angiotensin II Receptor Antagonists
VA Class: CV805
Chemical Name: (E)-α-[[2-butyl-1-[(4-carboxyphenyl)methyl]-1H-imidazol-5-yl]methyl-ene]-2-thiophenepropanoic acid monomethanesulfonate
Molecular Formula: C23H24N2O4S•CH4
CAS Number: 144143-96-4
Brands: Teveten, Teveten HCT

Warning(s)

  • May cause fetal and neonatal morbidity and mortality if used during pregnancy.1 30 50 51 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

  • If pregnancy is detected, discontinue as soon as possible.1 30 51

Introduction

Angiotensin II receptor (AT1) antagonist.1 2 7 14

Uses for Eprosartan Mesylate

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).1 2 5 7 9 25 26 27 28 29 500

Angiotensin II receptor antagonists are recommended as one of several preferred agents for the initial management of hypertension; other options include ACE inhibitors, 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.501 502 503 504 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

Angiotensin II receptor antagonists or ACE inhibitors may be preferred in hypertensive patients with diabetes mellitus or chronic kidney disease; angiotensin II receptor antagonists also may be preferred, as an alternative to ACE inhibitors, in hypertensive patients with heart failure or ischemic heart disease and/or post-MI.500 501 502 504 520 523 524 527 534 535 536 543

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Black hypertensive patients generally tend to respond better to monotherapy with calcium-channel blockers or thiazide diuretics than to angiotensin II receptor antagonists.500 501 504 However, diminished response to an angiotensin II receptor antagonist 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

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.16 17 18 19 20 21 22 34 35 36 37 38 520 535 536

Heart Failure

Angiotensin II receptor antagonists are considered a reasonable alternative for inhibition of the renin-angiotensin system in patients with heart failure and reduced left ventricular ejection fraction (LVEF) who are intolerant of ACE inhibitors; because of their established benefits, ACE inhibitors are preferred.524 528

Eprosartan Mesylate Dosage and Administration

General

BP Monitoring and Treatment Goals

  • Carefully monitor BP during initial titration or subsequent upward adjustment in dosage.500 501

  • When available, use evidence-based dosing information (i.e., dosages shown in randomized controlled trials to reduce complications of hypertension) to determine target dosages; target dosages usually can be achieved within 2–4 weeks but may take up to several months.501

  • If adequate BP response not achieved with a single antihypertensive agent, add a second drug with demonstrated benefit; if goal BP still not achieved with optimal dosages of 2 antihypertensive agents, add a third drug.501 May maximize dosage of the first drug before adding a second drug, or add a second drug before maximizing dosage of the initial drug.501

  • Consider initiating antihypertensive therapy with a combination of drugs if patient's BP exceeds goal BP by >20/10 mm Hg.500 501 503 504

  • Goal is to achieve and maintain optimal control of BP; individualize specific target BP based on consideration of multiple factors, including patient age and comorbidities, and currently available evidence from clinical studies.500 501 (See Hypertension under Uses.)

Administration

Oral Administration

Administer orally once or twice daily without regard to meals.1 2 30

Dosage

Available as eprosartan mesylate; dosage expressed in terms of eprosartan.1 30

Adults

Hypertension
Eprosartan Therapy
Oral

JNC 8 expert panel recommends initial dosage of 400 mg daily and target dosage of 600–800 mg daily (given in 1 or 2 divided doses) based on dosages used in randomized controlled studies.501

Manufacturer recommends initial dosage of 600 mg once daily as monotherapy in adults without intravascular volume depletion.1 7

Manufacturer states usual dosage is 400–800 mg daily, given in 1 dose or 2 divided doses; limited experience with higher dosages.1 30

If effectiveness diminishes toward end of dosing interval in patients treated once daily, consider increasing dosage or administering drug in 2 divided doses.1 2 7

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

Eprosartan/Hydrochlorothiazide Fixed-combination Therapy
Oral

Manufacturer states fixed-combination preparation should not be used for initial antihypertensive therapy.30

If BP is not adequately controlled by monotherapy with eprosartan or hydrochlorothiazide, can switch to fixed-combination tablets (eprosartan 600 mg and hydrochlorothiazide 12.5 mg; then eprosartan 600 mg and hydrochlorothiazide 25 mg) administered once daily.30

If BP response diminishes toward the end of the dosing interval during once daily administration, increase dosage of the fixed-combination tablets to eprosartan 600 mg and hydrochlorothiazide 25 mg daily or add eprosartan 300 mg each evening.30

Special Populations

Hepatic Impairment

No initial dosage adjustment necessary.1 30

Renal Impairment

No initial dosage adjustment generally is necessary in patients with moderate or severe renal impairment; maximum 600 mg daily.1 30

Eprosartan/hydrochlorothiazide fixed combination not recommended in patients with anuria.30

Geriatric Patients

No initial dosage adjustment necessary.1

Volume- and/or Salt-Depleted Patients

Correct volume and/or salt depletion prior to initiation of therapy or initiate therapy under close medical supervision.1 30

Cautions for Eprosartan Mesylate

Contraindications

  • Known hypersensitivity to eprosartan or any ingredient in the formulation.1 7 8

Warnings/Precautions

Warnings

Fetal/Neonatal Morbidity and Mortality

Possible fetal and neonatal morbidity and mortality when used during pregnancy.1 30 51 (See Boxed Warning.) Such potential risks occur throughout pregnancy, especially during the second and third trimesters.51

Also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.50 51

Discontinue as soon as possible when pregnancy is detected, unless continued use is considered lifesaving.50 51 Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.13

Hypotension

Possible symptomatic hypotension, particularly in volume- and/or salt-depleted patients (e.g., those treated with diuretics or undergoing dialysis).1 30 (See Volume- and/or Salt-Depleted Patients under Dosage and Administration.)

Transient hypotension is not a contraindication to additional doses; may reinstate therapy cautiously after BP is stabilized (e.g., with volume expansion).1 30

Malignancies

In July 2010, FDA initiated a safety review of angiotensin II receptor antagonists after a published meta-analysis found a modest but statistically significant increase in risk of new cancer occurrence in patients receiving an angiotensin II receptor antagonist compared with control.120 121 123 126 However, subsequent studies, including a larger meta-analysis conducted by FDA, have not shown such risk.126 127 128 129 Based on currently available data, FDA has concluded that angiotensin II receptor antagonists do not increase the risk of cancer.126

Sensitivity Reactions

Anaphylactoid reactions and/or angioedema possible;1 3 8 not recommended in patients with a history of angioedema associated with or unrelated to ACE inhibitor or angiotensin II receptor antagonist therapy.10 132

General Precautions

Renal Effects

Possible oliguria, progressive azotemia and, rarely, acute renal failure and/or death in patients with severe heart failure.1 30

Increases in BUN and Scr possible in patients with unilateral or bilateral renal artery stenosis.1 30

Use of Fixed Combinations

When used in fixed combination with hydrochlorothiazide, consider the cautions, precautions, and contraindications associated with hydrochlorothiazide.30

Specific Populations

Pregnancy

Category C (1st trimester); Category D (2nd and 3rd trimesters).1 30 (See Boxed Warning.)

Lactation

Distributed into milk in rats; not known whether eprosartan is distributed into human milk.1 30 Discontinue nursing or the drug.1 30

Pediatric Use

Safety and efficacy not established.1 7 30

Geriatric Use

BP reduction with eprosartan monotherapy was slightly less in patients ≥65 years of age compared with younger patients.1 BP responses were similar in geriatric and younger patients receiving fixed-combination eprosartan/hydrochlorothiazide tablets.30 No substantial differences in safety relative to younger adults.1 30

Hepatic Impairment

Use with caution.1

Renal Impairment

Use with caution.1

Deterioration of renal function may occur.1 30 (See Renal Effects under Cautions.)

Use of eprosartan in fixed combination with hydrochlorothiazide is not recommended in patients with anuria.30

Black Patients

BP reduction may be smaller in black patients compared with nonblack patients.1 5 7 (See Hypertension under Uses.)

Common Adverse Effects

Upper respiratory tract infection, rhinitis, pharyngitis, cough, viral infection, urinary tract infection, abdominal pain, injury, arthralgia, fatigue, depression, dizziness,30 headache,30 back pain,30 hypertriglyceridemia.1 2 7

Interactions for Eprosartan Mesylate

Not metabolized by CYP isoenzymes.1 30 Does not inhibit CYP1A, 2A6, 2C9/8, 2C19, 2D6, 2E, or 3A in vitro.1 30

Drugs Affecting Hepatic Microsomal Enzymes

Pharmacokinetic interactions with inhibitors or inducers of CYP2C9 or CYP3A unlikely.1 2

Specific Drugs

Drug

Interaction

Comment

Digoxin

Pharmacokinetic interaction unlikely1 2

Diuretics, potassium-sparing (e.g., amiloride, spironolactone, triamterene)

Possible additive hyperkalemic effects30

Concomitant use not recommended30

Fluconazole

Pharmacokinetic interaction unlikely1 2

Glyburide

Pharmacologic interaction unlikely1 2

Hydrochlorothiazide

Pharmacokinetic interaction unlikely1 2 30

Additive hypotensive effects2

Ketoconazole

Pharmacokinetic interaction unlikely1 30

Nifedipine, extended-release

Interaction unlikely1

NSAIAs, including selective cyclooxygenase-2 (COX-2) inhibitors

Possible deterioration of renal function in geriatric, volume-depleted, or renally impaired patients1

Possible reduced antihypertensive effects1

Monitor renal function periodically1

Potassium supplements and potassium-containing salt substitutes

Possible additive hyperkalemic effect30

Concomitant use not recommended30

Ranitidine

Pharmacokinetic interaction unlikely1 2

Warfarin

Pharmacologic interaction unlikely1 2

Eprosartan Mesylate Pharmacokinetics

Absorption

Bioavailability

Peak plasma concentration generally achieved 1–2 hours after oral administration in fasting state.1 Absolute bioavailability is about 13%.1 30

Onset

Following a single oral dose, onset of antihypertensive effect evident within 1–2 hours.1 During chronic therapy, maximum antihypertensive effects generally achieved after 2–3 weeks.1 30

Food

Food delays absorption.1 30

Special Populations

In male patients with hepatic impairment, AUC after a single 100-mg oral dose increased by approximately 40%.1 30

In patients with moderate or severe renal impairment, AUC increased by 70–90% and peak plasma concentration increased by 30–50%.1

Distribution

Extent

Crosses the placenta and is distributed in the fetus in animals.1 30

Distributed into milk in rats; not known whether distributed into human milk.1 30

Plasma Protein Binding

Approximately 98%.1 30

Elimination

Metabolism

Not metabolized by CYP isoenzymes.1 2 30

No pharmacologically active metabolites detected.1 7

Elimination Route

Eliminated by biliary and renal excretion, mainly as unchanged drug.1 2 30

Half-life

Approximately 20 hours following multiple oral doses.1

Special Populations

Poorly removed by hemodialysis.1 30

Stability

Storage

Oral

Tablets

20–25°C.1 30

Actions

  • Blocks the physiologic actions of angiotensin II, including vasoconstrictor and aldosterone-secreting effects.1 30

  • Does not interfere with response to bradykinins and substance P.1 30

  • Does not share the ACE inhibitor common adverse effect of dry cough.1 30

Advice to Patients

  • Risks of use during pregnancy.1 30 50 51

  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1 30

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (including salt substitutes containing potassium).1 30

  • Importance of informing patients of other important precautionary information.1 30 (See Cautions.)

Preparations

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

Eprosartan Mesylate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

400 mg (of eprosartan)

Teveten

Abbott

600 mg (of eprosartan)

Teveten

Abbott

Eprosartan Mesylate Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

600 mg (of eprosartan) with Hydrochlorothiazide 12.5 mg

Teveten HCT

Abbott

600 mg (of eprosartan) with Hydrochlorothiazide 25 mg

Teveten HCT

Abbott

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.

Teveten 400MG Tablets (ABBOTT): 30/$90.99 or 90/$250.97

Teveten 600MG Tablets (ABBOTT): 30/$119.99 or 90/$323.97

Teveten HCT 600-12.5MG Tablets (ABBOTT): 30/$120.99 or 90/$335.97

Teveten HCT 600-25MG Tablets (ABBOTT): 30/$109.98 or 90/$309.98

AHFS DI Essentials. © Copyright, 2004-2015, Selected Revisions February 15, 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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526. Kernan WN, Ovbiagele B, Black HR et al. Guidelines for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2014; :. [PubMed 24788967]

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