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| __NOTOC__
| | #REDIRECT [[Olmesartan#Warnings]] |
| {{Olmesartan}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Warnings and Precautions==
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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]] 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 Benicar as soon as possible [see Use in specific Populations (8.1)].
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| ===Morbidity in Infants===
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| Children <1 year of age must not receive Benicar for [[hypertension]]. Drugs that act directly on the renin-angiotensin aldosterone system (RAAS) can have effects on the development of immature kidneys [see Use in Specific Populations (8.4)].
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| ===Hypotension in Volume- or Salt-Depleted Patients===
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| In patients with an activated renin-angiotensin aldosterone system, such as volume- and/or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic [[hypotension]] may be anticipated after initiation of treatment with Benicar. Initiate treatment under close medical supervision. If [[hypotension]] does occur, place the patient in the supine position and, if necessary, give an intravenous infusion of normal saline [see Dosage and Administration (2.1)]. 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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| ===Impaired Renal Function===
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| As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals treated with Benicar. In patients whose renal function may depend upon the activity of the renin angiotensin-aldosterone system (e.g., patients with severe congestive heart failure), treatment with angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor antagonists has been associated with oliguria and/or progressive azotemia and rarely with acute renal failure and/or death. Similar results may be anticipated in patients treated with Benicar [see Dosage and Administration (2.1), Drug Interactions (7), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
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| In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen (BUN) have been reported. There has been no long-term use of Benicar in patients with unilateral or bilateral renal artery stenosis, but similar results may be expected.
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| ===Sprue-like Enteropathy===
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| Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan, exclude other etiologies. Consider discontinuation of Benicar in cases where no other etiology is identified.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=33770d80-754f-11de-8dba-0002a5d5c51b | publisher = | date = | accessdate = 21 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:Tetrazoles]]
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| [[Category:Carboxylate esters]]
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| [[Category:Alcohols]]
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| [[Category:Biphenyls]]
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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