today [150:<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 have been used in the management of heart failure † . 524 528 700 Because of their established benefits, ACE inhibitors have been the preferred drugs for inhibition of the renin-angiotensin-aldosterone (RAA) system in patients with heart failure and reduced left ventricular ejection fraction (LVEF); 524 however, some evidence indicates that therapy with an ACE inhibitor (enalapril) may be less effective than angiotensin receptor-neprilysin inhibitor (ARNI) therapy (e.g., sacubitril/valsartan) in reducing cardiovascular death and heart failure-related hospitalization. 700 701 702 703 Angiotensin II receptor antagonists may be used as an alternative for those patients in whom an ACE inhibitor or ARNI is inappropriate. 524 700 No additional therapeutic benefit when angiotensin II receptor antagonist used in combination with an ACE inhibitor. a ACCF, AHA, and the Heart Failure Society of America (HFSA) recommend that patients with chronic symptomatic heart failure and reduced LVEF (NYHA class II or III) who are able to tolerate an ACE inhibitor or angiotensin II receptor antagonist be switched to therapy containing an ARNI to further reduce morbidity and mortality. 700 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 Concomitant use of eprosartan and aliskiren in patients with diabetes mellitus. 550 a (See Specific Drugs under Interactions.) 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 Sensitivity Reactions Facial edema reported with eprosartan; 1 2 anaphylactoid reactions and/or angioedema reported with other angiotensin II receptor antagonists. 1 3 8 Eprosartan not recommended in patients with a history of angioedema associated with or unrelated to ACE inhibitor or angiotensin II receptor antagonist therapy. 10 132 Other Warnings and Precautions 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 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 S cr 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 D. a (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 than in patients of other races. 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 ACE Inhibitors Increased risk of renal impairment, hyperkalemia, and hypotension 550 Generally, avoid concomitant use; monitor BP, renal function, and electrolytes if used concomitantly a Aliskiren Increased risk of renal impairment, hyperkalemia, and hypotension a 550 Generally, avoid concomitant use; monitor BP, renal function, and electrolytes if used concomitantly a 550 Concomitant use contraindicated in patients with diabetes mellitus a 550 Avoid concomitant use in patients with GFR> <60 mL/minute a 550 Angiotensin II receptor antagonists Increased risk of renal impairment, hyperkalemia, and hypotension a Generally, avoid concomitant use; monitor BP, renal function, and electrolytes if used concomitantly a Digoxin Pharmacokinetic interaction unlikely 1 2 Diuretics, potassium-sparing (e.g., amiloride, spironolactone, triamterene) Possible additive hyperkalemic effects 30 Concomitant use not recommended 30 Fluconazole Pharmacokinetic interaction unlikely 1 2 Glyburide Pharmacologic interaction unlikely 1 2 Hydrochlorothiazide Pharmacokinetic interaction unlikely 1 2 30 Additive hypotensive effects 2 Ketoconazole Pharmacokinetic interaction unlikely 1 30 Nifedipine, extended-release Interaction unlikely 1 NSAIAs, including selective cyclooxygenase-2 (COX-2) inhibitors Possible deterioration of renal function in geriatric, volume-depleted, or renally impaired patients 1 Possible reduced antihypertensive effects 1 Monitor renal function periodically 1 Potassium supplements and potassium-containing salt substitutes Possible additive hyperkalemic effect 30 Concomitant use not recommended 30 Ranitidine Pharmacokinetic interaction unlikely 1 2 Warfarin Pharmacologic interaction unlikely 1 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. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Eprosartan Mesylate Routes Dosage Forms Strengths Brand Names Manufacturer Oral Tablets, film-coated 400 mg (of eprosartan) Teveten AbbVie 600 mg (of eprosartan) Teveten AbbVie 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 AbbVie 600 mg (of eprosartan) with Hydrochlorothiazide 25 mg Teveten HCT AbbVie AHFS DI Essentials. Copyright 2017, Selected Revisions May 3, 2017. 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Next Interactions Print this page Add to My Med List More about eprosartan Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Images Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: angiotensin receptor blockers Consumer resources Eprosartan Eprosartan (Advanced Reading) Professional resources Eprosartan (FDA) Eprosartan (Wolters Kluwer) Other brands: Teveten Related treatment guides High Blood Pressure> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only D Pregnancy Category Positive evidence of risk N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Mylan Pharmaceuticals Inc. 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