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| __NOTOC__
| | #REDIRECT [[Telmisartan#Warnings]] |
| {{Telmisartan}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==wWarnings and Precautions==
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| ===5.1 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 MICARDIS as soon as possible [see Use in Specific Populations (8.1)].
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| ===5.2 [[hypotension]]===
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| In patients with an activated [[renin-angiotensin system]], such as volume- or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic [[hypotension]] may occur after initiation of therapy with MICARDIS. Either correct this condition prior to administration of MICARDIS, or start treatment under close medical supervision with a reduced dose.
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| 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.
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| ===5.3 Hyperkalemia===
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| [[Hyperkalemia]] may occur in patients on ARBs, particularly in patients with advanced renal impairment, [[heart failure]], on renal replacement therapy, or on potassium supplements, potassium-sparing [[diuretics]], potassium-containing salt substitutes or other drugs that increase potassium levels. Consider periodic determinations of serum electrolytes to detect possible electrolyte imbalances, particularly in patients at risk.
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| ===5.4 Impaired Hepatic Function===
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| As the majority of telmisartan is eliminated by biliary excretion, patients with biliary obstructive disorders or [[hepatic insufficiency]] can be expected to have reduced clearance. Initiate telmisartan at low doses and titrate slowly in these patients [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
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| ===5.5 Impaired Renal Function===
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| As a consequence of inhibiting the [[renin-angiotensin-aldosterone system]], anticipate changes in renal function in susceptible individuals. In patients whose renal function may depend on the activity of the [[renin-angiotensin-aldosterone system]] (e.g., patients with severe congestive heart failure or renal dysfunction), 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 have been reported with MICARDIS [see 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 were observed. There has been no long term use of MICARDIS in patients with unilateral or bilateral renal artery stenosis, but anticipate an effect similar to that seen with ACE inhibitors.
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| ===5.6 Dual Blockade of the renin-angiotensin-aldosterone system===
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| As a consequence of inhibiting the [[renin-angiotensin-aldosterone system]], changes in renal function (including acute renal failure) have been reported. Dual blockade of the [[renin-angiotensin-aldosterone system]] (e.g., by adding an ACE-inhibitor to an angiotensin II receptor antagonist) should include close monitoring of renal function.
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| The ONTARGET trial enrolled 25,620 patients ≥55 years old with atherosclerotic disease or diabetes with end-organ damage, randomizing them to telmisartan only, ramipril only, or the combination, and followed them for a median of 56 months. Patients receiving the combination of MICARDIS and ramipril did not obtain any additional benefit compared to monotherapy, but experienced an increased incidence of renal dysfunction (e.g., [[acute renal failure]]) compared with groups receiving telmisartan alone or [[ramipril]] alone. Concomitant use of MICARDIS and [[ramipril]] is not recommended.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = MICARDIS (TELMISARTAN) TABLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=cfb9309f-e0df-4a55-9542-0e869fce05fb | publisher = | date = | accessdate = 24 February 2014 }}</ref>
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| ==References==
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| {{reflist|2}}
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| {{Angiotensin II receptor antagonists}}
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| [[Category:Angiotensin II receptor antagonists]]
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| [[Category:Benzimidazoles]]
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| [[Category:Benzoic acids]]
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| [[Category:Biphenyls]]
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| [[Category:PPAR agonists]]
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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