|
|
| (One intermediate revision by one other user not shown) |
| Line 1: |
Line 1: |
| __NOTOC__
| | #REDIRECT [[Olmesartan#Warnings]] |
| {{Olmesartan}}
| |
| {{CMG}}; {{AE}} {{SS}}
| |
| | |
| ==Warnings and Precautions==
| |
| | |
| ===Fetal Toxicity===
| |
| | |
| ===Pregnancy Category D ===
| |
| | |
| 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)].
| |
| | |
| ===Morbidity in Infants===
| |
| | |
| 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)].
| |
| | |
| ===Hypotension in Volume- or Salt-Depleted Patients===
| |
| | |
| 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.
| |
| | |
| ===Impaired Renal Function===
| |
| | |
| 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)].
| |
| | |
| 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.
| |
| | |
| ===Sprue-like Enteropathy===
| |
| | |
| 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></div>
| |
| ==References==
| |
| | |
| {{Reflist}}
| |
| | |
| {{Angiotensin II receptor antagonists}}
| |
| | |
| [[Category:Angiotensin II receptor antagonists]]
| |
| [[Category:Imidazoles]]
| |
| [[Category:Tetrazoles]]
| |
| [[Category:Carboxylate esters]]
| |
| [[Category:Alcohols]]
| |
| [[Category:Biphenyls]]
| |
| [[Category:Cardiovascular Drugs]]
| |
| [[Category:Drugs]]
| |