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| __NOTOC__
| | #REDIRECT [[Olmesartan#Use in Specific Populations]] |
| {{Olmesartan}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Use In Specific Populations==
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| ===Pregnancy===
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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. 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 Benicar, 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 Benicar for [[hypotension]], [[oliguria ]], and [[hyperkalemia ]][see Use in Specific Populations (8.4)].
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| ===Nursing Mothers===
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| It is not known whether olmesartan is excreted in human milk, but olmesartan is secreted at low concentration in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
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| ===Pediatric Use===
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| Neonates with a history of in utero exposure to Benicar:
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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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| The antihypertensive effects of Benicar were evaluated in one randomized, double-blind clinical study in pediatric patients 1 to 16 years of age [see Clinical Studies(14.2)]. The pharmacokinetics of Benicar were evaluated in pediatric patients 1 to 16 years of age [see Clinical Pharmacology (12.3)]. Benicar was generally well tolerated in pediatric patients, and the adverse experience profile was similar to that described for adults.
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| Benicar has not been shown to be effective for [[hypertension ]]in children <6 years of age.
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| Children <1 year of age must not receive Benicar for [[hypertension ]][see Warnings and Precautions (5.2)]. The renin-angiotensin aldosterone system (RAAS) plays a critical role in kidney development. RAAS blockade has been shown to lead to abnormal kidney development in very young mice. Administering drugs that act directly on the renin- angiotensin aldosterone system (RAAS) can alter normal renal development.
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| ===Geriatric Use===
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| Of the total number of hypertensive patients receiving Benicar in clinical studies, more than 20% were 65 years of age and over, while more than 5% were 75 years of age and older. No overall differences in effectiveness or safety were observed between elderly patients and younger patients. 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 [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3)].
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| ===Hepatic Impairment===
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| Increases in AUC0-∞ and Cmax were observed in patients with moderate [[hepatic impairment]] compared to those in matched controls, with an increase in AUC of about 60%. No initial dosage adjustment is recommended for patients with moderate to marked hepatic dysfunction [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3)].
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| ===Renal Impairment===
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| Patients with [[renal insufficiency]] have elevated serum concentrations of olmesartan compared to subjects with normal renal function. After repeated dosing, the AUC was approximately tripled in patients with severe renal impairment (creatinine clearance <20 mL/min). No initial dosage adjustment is recommended for patients with moderate to marked renal impairment (creatinine clearance <40 mL/min) [see Dosage and Administration (2.1), Warnings and Precautions (5.4) and Clinical Pharmacology(12.3)].
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| ===Black Patients===
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| The antihypertensive effect of Benicar was smaller in black patients (usually a low renin population), as has been seen with ACE inhibitors, beta-blockers and other [[angiotensin receptor blockers]].<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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