Eprosartan Mesylate
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Questions & Answers
Side Effects & Adverse Reactions
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue eprosartan mesylate as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus.
In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examination to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue eprosartan mesylate, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to eprosartan mesylate for hypotension, oliguria, and hyperkalemia (see PRECAUTIONS: Pediatric Use).
Eprosartan mesylate has been shown to produce maternal and fetal toxicities (maternal and fetal mortality, low maternal body weight and food consumption, resorptions, abortions and litter loss) in pregnant rabbits given oral doses as low as 10 mg eprosartan/kg/day. No maternal or fetal adverse effects were observed at 3 mg/kg/day; this oral dose yielded a systemic exposure (AUC) to unbound eprosartan 0.8 times that achieved in humans given 400 mg b.i.d. No adverse effects on in utero or postnatal development and maturation of offspring were observed when eprosartan mesylate was administered to pregnant rats at oral doses up to 1000 mg eprosartan/kg/day (the 1000 mg eprosartan/kg/day dose in non-pregnant rats yielded systemic exposure to unbound eprosartan approximately 0.6 times the exposure achieved in humans given 400 mg b.i.d.).
In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g., those being treated with diuretics), symptomatic hypotension may occur. These conditions should be corrected prior to administration of eprosartan, or the treatment should start under close medical supervision. If hypotension occurs, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Eprosartan mesylate tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensives such as diuretics and calcium channel blockers.
History
There is currently no drug history available for this drug.
Other Information
Eprosartan mesylate is a non-biphenyl non-tetrazole angiotensin II receptor (AT1) antagonist. A selective non-peptide molecule, eprosartan mesylate is chemically described as (E)-[2-Butyl]-1-[(4-carboxyphenyl)-methyl]imidazol-5yl]-2-(2-thienylmethyl)-2-propenoic acid monomethane sulfonate.
Its molecular formula is C24H28N2O7S2 and molecular weight is 520.62. Its structural formula is:
Eprosartan mesylate is a white to off-white crystalline powder that is insoluble in water, freely soluble in ethanol, and melts between 248°C and 250°C.
Eprosartan mesylate tablets are available as film-coated tablets containing eprosartan mesylate equivalent to 600 mg eprosartan zwitterion (white to off-white capsule shaped, unscored tablets).
The 600 mg tablets contain the following: ammonium hydroxide, black iron oxide, colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch (corn), propylene glycol, shellac glaze and titanium dioxide.
Sources
Eprosartan Mesylate Manufacturers
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Mylan Pharmaceuticals Inc.
![Eprosartan Mesylate Tablet, Film Coated [Mylan Pharmaceuticals Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Eprosartan Mesylate | Mylan Pharmaceuticals Inc.
The usual recommended starting dose of eprosartan mesylate tablets is 600 mg once daily when used as monotherapy in patients who are not volume-depleted (see WARNINGS: Hypotension in Volume- and/or Salt-depleted Patients). Eprosartan mesylate tablets can be administered once or twice daily with total daily doses ranging from 400 mg to 800 mg. There is limited experience with doses beyond 800 mg/day.
If the antihypertensive effect measured at trough using once-daily dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response. Achievement of maximum blood pressure reduction in most patients may take 2 to 3 weeks.
Eprosartan mesylate tablets may be used in combination with other antihypertensive agents such as thiazide diuretics or calcium channel blockers if additional blood-pressure-lowering effect is required. Discontinuation of treatment with eprosartan does not lead to a rapid rebound increase in blood pressure.
Elderly, Hepatically Impaired or Renally Impaired Patients: No initial dosing adjustment is generally necessary for elderly or hepatically impaired patients or those with renal impairment. No initial dosing adjustment is generally necessary in patients with moderate and severe renal impairment, with maximum dose not exceeding 600 mg daily.
Eprosartan mesylate tablets may be taken with or without food.
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