Teveten

Generic Name: 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

• 
  

  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 Teveten

Hypertension

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

One of several preferred initial therapies in hypertensive patients with chronic kidney disease, diabetes mellitus, or heart failure.⁴⁴

Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.⁴⁴

Diabetic Nephropathy

First-line agent in the treatment of diabetic nephropathy† in hypertensive patients with type 2 diabetes mellitus.

CHF

Second-line agent in the treatment of CHF†; should be used only in those intolerant of ACE inhibitors.

Teveten Dosage and Administration

General

Hypertension

• 
  

  Fixed-combination eprosartan/hydrochlorothiazide tablets should not be used for initial treatment of hypertension.³⁰

  
  

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

Monotherapy

Oral

Initially, 600 mg once daily in adults without intravascular volume depletion.^{1 7} Adjust dosage at approximately monthly intervals (more aggressively in high-risk patients) to achieve BP control.⁴⁴

Usual dosage: 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}

Combination Therapy

Oral

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 Teveten

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 CHF.^{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 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

Blacks

BP reduction may be smaller in black patients compared with nonblack patients; use in combination with a diuretic.^{1 5 7}

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 Teveten

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

Teveten Pharmacokinetics

Absorption

Bioavailability

Peal 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 01/2012. 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/$109.99 or 90/$295.98

Teveten HCT 600-12.5MG Tablets (ABBOTT): 30/$120.99 or 90/$333.95

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

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, 1959-2012, Selected Revisions December 23, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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20. Weekers L, Krzesinski JM. [Clinical study of the month. Nephroprotective role of angiotensin II receptor antagonists in type 2 diabetes: results of IDNT and RENAAL trials.] (French, with English abstract.) Rev Med Liege. 2001; 56:723-6.

21. Parving HH, Lehnert H, Brochner-Mortensen J et al and the Irbesartan in Patients with Type 2 Diabetes and Microalbuminuria Study Group. The effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes. N Engl J Med. 2001; 345:870-8. [IDIS 469608] [PubMed 11565519]

22. Walser M. Angiotensin-receptor blockers, type 2 diabetes, and renoprotection. N Engl J Med. 2002; 346:706.

23. Levine B and the Eprosartan Multinational Study Group. Effect of eprosartan and enalapril in the treatment of black hypertensive patients: subgroup analysis of a 26-week, double-blind, multicentre study. Curr Med Res Opin. 1999; 15:25-32. [PubMed 10216808]

24. AstraZeneca, Wayne, PA: personal communication on candesartan.

25. Gradman AH, Gray J, Maggiacomo F et al. Assessment of once daily eprosartan, an angiotensin II antagonist, in patients with systemic hypertension. Clin Ther. 1999; 21:442-53. [IDIS 427443] [PubMed 10321414]

26. Hedner T, Himmelman A for the Eprosartan Multinational Study Group. The efficacy and tolerance of one or two daily doses of eprosartan in essential hypertension. J Hyepertens. 1999; 17:129-36.

27. Weber M. Efficacy and safety of eprosartan in patients with essential hypertension: results of an 8-week, double-blind, placebo-controlled, multicenter trial. J Hypertens. 1998; 16(Suppl 2):245. [PubMed 9535153]

28. White WB, Anwar YA, Sica DA. Once daily effects of the angiotensin receptor blocker, eprosartan on 24-hour blood pressure in patients with systemic hypertension. Am J Hypertens. 1999; 12(4 Part 2):27A.

29. White WB, Mansoor GA, Lessem J et al. Assessment of the angiotensin II receptor antagonist eprosartan, by office and ambulatory BP monitoring. Am J Hypertens. 1995; 8(4 Part 2):179A.

30. Biovail Pharmaceuticals. Teveten-HCT (eprosartan mesylate-hydrochlorothiazide) tablets prescribing information. Morrisville, NC; 2002 Jun.

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

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

33. Hunt SA, Baker DW, Chin MH et al. ACC/AHA guidelines for the evaluation and management of chronic heart failure in the adult. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1995 Guidelines for the Evaluation and Management of Heart Failure). 2001. Available from website. Accessed July 25, 2002.

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

35. 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]

36. 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]

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

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

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

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

50. 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]

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

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121. Sipahi I, Debanne SM, Rowland DY et al. Angiotensin-receptor blockade and risk of cancer: meta-analysis of randomised controlled trials. Lancet Oncol. 2010; 11:627-36. [PubMed 20542468]

122. Nissen SE. Angiotensin-receptor blockers and cancer: urgent regulatory review needed. Lancet Oncol. 2010; 11:605-6. [PubMed 20542469]

123. Sica DA. Angiotensin receptor blockers and the risk of malignancy: a note of caution. Drug Saf. 2010; 33:709-12. [PubMed 20701404]

126. Food and Drug Administration. FDA drug safety communication: No increase in risk of cancer with certain blood pressure drugs-angiotensin receptor blockers (ARBs). Rockville, MD; 2011 Jun 2. Available from FDA website. Accessed 2011 Jun 15.

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128. ARB Trialists Collaboration. Effects of telmisartan, irbesartan, valsartan, candesartan, and losartan on cancers in 15 trials enrolling 138,769 individuals. J Hypertens. 2011; 29:623-35. [PubMed 21358417]

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132. Howes LG, Tran D. Can angiotensin receptor antagonists be used safely in patients with previous ACE inhibitor-induced angioedema? Drug Saf. 2002; 25:73-6.

More Teveten resources

• Teveten Side Effects (in more detail)
• Teveten Use in Pregnancy & Breastfeeding
• Drug Images
• Teveten Drug Interactions
• Teveten Support Group
• 0 Reviews for Teveten - Add your own review/rating

• Teveten Prescribing Information (FDA)


• Teveten MedFacts Consumer Leaflet (Wolters Kluwer)


• Teveten Concise Consumer Information (Cerner Multum)


• Teveten Advanced Consumer (Micromedex) - Includes Dosage Information


• Eprosartan Prescribing Information (FDA)

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