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| __NOTOC__
| | #REDIRECT [[Telmisartan#Use in Specific Populations]] |
| {{Telmisartan}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Use in Specific Populations==
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| ===8.1 Pregnancy===
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| ===Pregnancy Category D. [See Warnings and Precautions (5.1)].===
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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. 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]] 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 examinations to assess the intra-amniotic environment. If [[oligohydramnios]] is observed, discontinue MICARDIS, 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 MICARDIS for [[hypotension]], [[oliguria]], and [[hyperkalemia]] [see Use in Specific Populations (8.4)].
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| ===8.3 Nursing Mothers===
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| It is not known whether telmisartan is excreted in human milk, but telmisartan was shown to be present in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, decide whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
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| ===8.4 Pediatric Use===
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| Neonates with a history of in utero exposure to MICARDIS:
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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 [see Clinical Pharmacology (12.3)] .
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| ===8.5 Geriatric Use===
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| Of the total number of patients receiving MICARDIS in [[hypertension]] clinical studies, 551 (19%) were 65 to 74 years of age and 130 (4%) were 75 years or older. No overall differences in effectiveness and safety were observed in these patients compared to younger patients and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
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| Of the total number of patients receiving MICARDIS in the cardiovascular risk reduction study (ONTARGET), the percentage of patients ≥65 to <75 years of age was 42%; 15% of patients were ≥75 years old. No overall differences in effectiveness and safety were observed in these patients compared to younger patients and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
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| ===8.6 Hepatic Insufficiency===
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| Monitor carefully and uptitrate slowly in patients with biliary obstructive disorders or [[hepatic insufficiency]] [see Warnings and Precautions (5.4)].<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></div>
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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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