Eprosartan
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: João André Alves Silva, M.D. [2]
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Black Box Warning
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WARNING: FETAL TOXICITY
See full prescribing information for complete Boxed Warning.
Condition Name:
See full prescribing information for complete boxed warning.
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Overview
Eprosartan is an angiotensin II receptor blocker that is FDA approved for the {{{indicationType}}} of hypertension. There is a Black Box Warning for this drug as shown here. Common adverse reactions include abdominal pain, myalgia, dizziness, upper respiratory infection and fatigue.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Condition 1
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Condition 2
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Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition 1
- Developed by: (Organisation)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
- Dosing Information/Recommendation
- (Dosage)
Condition 2
- Developed by: (Organisation)
- Class of Recommendation: (Class) (Link)
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Non–Guideline-Supported Use
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Condition 3
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Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
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Condition 2
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Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition 1
- Developed by: (Organisation)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
- Dosing Information/Recommendation
- (Dosage)
Condition 2
- Developed by: (Organisation)
- Class of Recommendation: (Class) (Link)
- Strength of Evidence: (Category A/B/C) (Link)
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Non–Guideline-Supported Use
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Contraindications
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Warnings
|
WARNING: FETAL TOXICITY
See full prescribing information for complete Boxed Warning.
Condition Name:
See full prescribing information for complete boxed warning.
|
Conidition 1
(Description)
Adverse Reactions
Clinical Trials Experience
Central Nervous System
- (list/description of adverse reactions)
Cardiovascular
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Respiratory
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Gastrointestinal
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Hypersensitive Reactions
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Miscellaneous
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Condition 2
Central Nervous System
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Cardiovascular
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Respiratory
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Gastrointestinal
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Hypersensitive Reactions
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Miscellaneous
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Postmarketing Experience
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Drug Interactions
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Drug 1
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Drug 2
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Drug 3
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Drug 4
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Drug 5
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Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
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Pregnancy Category (AUS):
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Labor and Delivery
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Nursing Mothers
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Pediatric Use
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Geriatic Use
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Gender
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Race
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Renal Impairment
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Hepatic Impairment
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Females of Reproductive Potential and Males
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Immunocompromised Patients
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Others
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Administration and Monitoring
Administration
(Oral/Intravenous/etc)
Monitoring
Condition 1
(Description regarding monitoring, from Warnings section)
Condition 2
(Description regarding monitoring, from Warnings section)
Condition 3
(Description regarding monitoring, from Warnings section)
IV Compatibility
Solution
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Not Tested
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Variable
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Incompatible
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Y-Site
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Not Tested
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Variable
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Incompatible
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Admixture
Compatible
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Not Tested
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Variable
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Incompatible
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Syringe
Compatible
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Not Tested
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Variable
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Incompatible
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TPN/TNA
Compatible
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Not Tested
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Variable
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Incompatible
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Overdosage
Acute Overdose
Signs and Symptoms
(Description)
Management
(Description)
Chronic Overdose
Signs and Symptoms
(Description)
Management
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Pharmacology
Eprosartan
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Mechanism of Action
- Angiotensin II (formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme [kininase II]), a potent vasoconstrictor, is the principal pressor agent of the renin-angiotensin system. Angiotensin II also stimulates aldosterone synthesis and secretion by the adrenal cortex, cardiac contraction, renal resorption of sodium, activity of the sympathetic nervous system, and smooth muscle cell growth.
- Eprosartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues (e.g., vascular smooth muscle, adrenal gland). There is also an AT2 receptor found in many tissues but it is not known to be associated with cardiovascular homeostasis.
- Eprosartan does not exhibit any partial agonist activity at the AT1 receptor. Its affinity for the AT1 receptor is 1,000 times greater than for the AT2 receptor. In vitro binding studies indicate that eprosartan is a reversible, competitive inhibitor of the AT1 receptor.
- Blockade of the AT1 receptor removes the negative feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and circulating angiotensin II do not overcome the effect of eprosartan on blood pressure.
- Eprosartan mesylate does not inhibit kininase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin; whether this has clinical relevance is not known. It does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Structure
- Eprosartan mesylate is a non-biphenyl non-tetrazole angiotensin II receptor (AT1) antagonist. A selective non-peptide molecule, eprosartan mesylate is chemically described as the monomethanesulfonate of (E )-2-butyl-1-(p-carboxybenzyl)-α-2-thienylmethylimid-azole-5-acrylic acid.
- Its empirical formula is C23H24N2O4S•CH4O3S and molecular weight is 520.625. Its structural formula is:
- Eprosartan mesylate is a white to off-white free-flowing crystalline powder that is insoluble in water, freely soluble in ethanol, and melts between 248°C and 250°C.
- Eprosartan mesylate is available as aqueous film-coated tablets containing eprosartan mesylate equivalent to 400 mg or 600 mg eprosartan zwitterion (pink, oval, non-scored tablets or white, non-scored, capsule-shaped tablets, respectively).
- Inactive Ingredients:
- The 400 mg tablet contains the following: croscarmellose sodium, hypromellose, iron oxide red, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, and titanium dioxide. The 600 mg tablet contains crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, and titanium dioxide.
Pharmacodynamics
(Description)
Pharmacokinetics
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Nonclinical Toxicology
(Description)
Clinical Studies
Condition 1
(Description)
Condition 2
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Condition 3
(Description)
How Supplied
- TEVETEN® is available as aqueous film-coated tablets as follows:
- 400 mg pink, non-scored, oval tablets, debossed with “5044” on one side.
- NDC 0074–3025–11 (bottles of 100)
- 600 mg white, non-scored, capsule-shaped tablets, debossed with “5046” on one side.
- NDC 0074–3040–11 (bottles of 100)
Storage
Store at controlled room temperature 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
(Patient Counseling Information)
Precautions with Alcohol
- Some patients previously exposed to eprosartan showed signs of alcohol intolerance, however, it is not possible to confirm if eprosartan was directly involved in the adverse reaction.
Brand Names
Teveten®
Look-Alike Drug Names
N/A
Drug Shortage Status
Drug Shortage
Price
References
The contents of this FDA label are provided by the National Library of Medicine.