|
|
| Line 1: |
Line 1: |
| __NOTOC__
| | #REDIRECT [[Irbesartan#Warnings]] |
| {{Irbesartan}}
| |
| {{CMG}}; {{AE}} {{SS}}
| |
| | |
| ==Warnings and Precautions==
| |
| | |
| ===WARNINGS===
| |
| | |
| ====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 AVAPRO as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimesters 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.
| |
| | |
| 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 AVAPRO, 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 AVAPRO for [[hypotension]], [[oliguria]], and [[hyperkalemia]] (see PRECAUTIONS: Pediatric Use).
| |
| | |
| When pregnant rats were treated with irbesartan from day 0 to day 20 of gestation (oral doses of 50 mg/kg/day, 180 mg/kg/day, and 650 mg/kg/day), increased incidences of renal pelvic cavitation, hydroureter and/or absence of renal papilla were observed in fetuses at doses ≥50 mg/kg/day (approximately equivalent to the maximum recommended human dose [MRHD], 300 mg/day, on a body surface area basis). Subcutaneous edema was observed in fetuses at doses ≥180 mg/kg/day (about 4 times the MRHD on a body surface area basis). As these anomalies were not observed in rats in which irbesartan exposure (oral doses of 50, 150, and 450 mg/kg/day) was limited to gestation days 6 to 15, they appear to reflect late gestational effects of the drug. In pregnant rabbits, oral doses of 30 mg irbesartan/kg/day were associated with maternal mortality and abortion. Surviving females receiving this dose (about 1.5 times the MRHD on a body surface area basis) had a slight increase in early resorptions and a corresponding decrease in live fetuses. Irbesartan was found to cross the placental barrier in rats and rabbits.
| |
| | |
| Radioactivity was present in the rat and rabbit fetus during late gestation and in rat milk following oral doses of radiolabeled irbesartan.
| |
| | |
| ====Hypotension in Volume- or Salt-Depleted Patients====
| |
| | |
| Excessive reduction of blood pressure was rarely seen (<0.1%) in patients with uncomplicated [[hypertension]]. Initiation of [[antihypertensive]] therapy may cause symptomatic [[hypotension]] in patients with intravascular volume- or sodium-depletion, eg, in patients treated vigorously with diuretics or in patients on [[dialysis]]. Such volume depletion should be corrected prior to administration of AVAPRO, or a low starting dose should be used (see DOSAGE AND ADMINISTRATION).
| |
| | |
| If hypotension occurs, 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.
| |
| | |
| ===PRECAUTIONS===
| |
| | |
| ====Impaired Renal Function====
| |
| | |
| As a consequence of inhibiting the [[renin-angiotensin-aldosterone system]], changes in renal function may be anticipated in susceptible individuals. In patients whose renal function may depend on the activity of the [[renin-angiotensin-aldosterone system]] (eg, patients with severe congestive heart failure), treatment with angiotensin-converting-enzyme inhibitors has been associated with [[oliguria]] and/or progressive azotemia and (rarely) with acute renal failure and/or death. AVAPRO would be expected to behave similarly.
| |
| | |
| In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or BUN have been reported. There has been no known use of AVAPRO in patients with unilateral or bilateral renal artery stenosis, but a similar effect should be anticipated.
| |
| | |
| ====Information for Patients====
| |
| | |
| =====Pregnancy=====
| |
| | |
| Female patients of childbearing age should be told about the consequences of exposure to AVAPRO during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = AVAPRO (IRBESARTAN) TABLET [SANOFI-AVENTIS U.S. LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=7885b2a8-be4e-48ab-8113-4e6ab791eb98 | publisher = | date = | accessdate = 20 February 2014 }}</ref>
| |
| | |
| ==References==
| |
| | |
| {{Reflist}}
| |
| | |
| {{Angiotensin II receptor antagonists}}
| |
| | |
| [[Category:Angiotensin II receptor antagonists]]
| |
| [[Category:Sanofi]]
| |
| [[Category:Bristol-Myers Squibb]]
| |
| [[Category:Tetrazoles]]
| |
| [[Category:Biphenyls]]
| |
| [[Category:Lactams]]
| |
| [[Category:Spiro compounds]]
| |
| [[Category:Nitrogen heterocycles]]
| |
| [[Category:Cardiovascular Drugs]]
| |
| [[Category:Drugs]]
| |