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| __NOTOC__
| | #REDIRECT [[Eprosartan#Warnings]] |
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| {{Eprosartan}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Warnings and Precautions==
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| ===WARNINGS===
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| ====Fetal Toxicity====
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| ====Pregnancy Category D====
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| Use of drugs that act on the [[renin-[[angiotensin]]system]]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 TEVETEN 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]]system from other [[antihypertensive]]agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus.
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| 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 TEVETEN, 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 TEVETEN for [[hypotension]], [[oliguria]], and [[hyperkalemia ]](see PRECAUTIONS, Pediatric Use).
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| 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.). | |
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| ====hypotension in Volume- and/or Salt-Depleted Patients====
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| 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 TEVETEN®, 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.
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| ===PRECAUTIONS===
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| ====Risk of Renal Impairment====
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| As a consequence of inhibiting the [[renin-angiotensin-aldosterone system]], changes in renal function have been reported in susceptible individuals treated with [[angiotensin]]II antagonists; in some patients, these changes in renal function were reversible upon discontinuation of therapy. In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure), treatment with angiotensin-converting enzyme inhibitors and [[angiotensin]]II receptor antagonists has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. TEVETEN® would be expected to behave similarly.
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| In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or BUN have been reported. Similar effects have been reported with [[angiotensin]]II antagonists; in some patients, these effects were reversible upon discontinuation of therapy.
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| ====Pregnancy====
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| Female patients of childbearing age should be told about the consequences of exposure to TEVETEN during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.
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| ====Nursing Mothers====
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| Eprosartan is excreted in animal milk; it is not known whether eprosartan is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from eprosartan, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
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| ====Pediatric Use====
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| Neonates with a history of in utero exposure to TEVETEN:
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| If oliguria or [[hypotension]] occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing [[hypotension]] and/or substituting for disordered renal function.
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| Safety and effectiveness in pediatric patients have not been established.
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| ====Geriatric Use====
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| Of the total number of patients receiving TEVETEN® in clinical studies, 29% (681 of 2,334) were 65 years and over, while 5% (124 of 2,334) were 75 years and over. Based on the pooled data from randomized trials, the decrease in diastolic blood pressure and systolic blood pressure with TEVETEN® was slightly less in patients ≥65 years of age compared to younger patients. In a study of only patients over the age of 65, TEVETEN® at 200 mg twice daily (and increased optionally up to 300 mg twice daily) decreased diastolic blood pressure on average by 3 mmHg (placebo corrected). Adverse experiences were similar in younger and older patients.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = TEVETEN (EPROSARTAN MESYLATE) TABLET [ABBOTT LABORATORIES] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7cde57a7-eded-4c22-b1c7-98afc5546997 | publisher = | date = | accessdate = 20 February 2014 }}</ref>
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| ==References==
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| {{Reflist}}
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| {{[[angiotensin]]II receptor antagonists}}
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| [[Category:[[angiotensin]]II receptor antagonists]]
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| [[Category:Imidazoles]]
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| [[Category:Thiophenes]]
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| [[Category:Benzoic acids]]
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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