Azilsartan warnings and precautions: Difference between revisions

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__NOTOC__
#REDIRECT [[Azilsartan kamedoxomil#Warnings]]
{{Azilsartan}}
{{CMG}}; {{AE}} {{SS}}
 
==Warnings and Precautions==
 
===Fetal Toxicity===
 
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 Edarbi as soon as possible [see Use in Specific Populations (8.1)].
 
===[[hypotension ]]in Volume- or Salt-Depleted Patients===
 
In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g., those being treated with high doses of [[diuretics]]), symptomatic [[hypotension ]]may occur after initiation of treatment with Edarbi. Correct volume or salt depletion prior to administration of Edarbi, or start treatment at 40 mg. If [[hypotension ]]does occur, 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.
 
===Impaired Renal Function===
 
As a consequence of inhibiting the renin-angiotensin system, changes in renal function may be anticipated in susceptible individuals treated with Edarbi. In patients whose renal function may depend on the activity of the renin-angiotensin system (e.g., patients with severe congestive heart failure, renal artery stenosis, or volume depletion), treatment with angiotensin-converting enzyme inhibitors and angiotensin receptor blockers has been associated with oliguria or progressive azotemia and rarely with acute renal failure and death. Similar results may be anticipated in patients treated with Edarbi [see Drug Interactions (7), Use in Specific Populations (8.6), 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 have been reported. There has been no long-term use of Edarbi in patients with unilateral or bilateral renal artery stenosis, but similar results may be expected.<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = EDARBI (AZILSARTAN KAMEDOXOMIL) TABLET [TAKEDA PHARMACEUTICALS AMERICA, INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=75b16bfc-38c1-4133-bd7d-13258d54edec | publisher =  | date =  | accessdate = 19 February 2014 }}</ref>
 
==References==
{{Reflist}}
 
[[Category:Angiotensin II receptor antagonists]]
[[Category:Benzimidazoles]]
[[Category:Carbamates]]
[[Category:Ethers]]
[[Category:Cardiovascular Drugs]]
[[Category:Drugs]]

Latest revision as of 03:09, 22 July 2014