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| __NOTOC__
| | #REDIRECT [[Losartan#Warnings]] |
| {{Losartan}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Warnings and Precautions==
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| ===WARNINGS===
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| ====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 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 COZAAR as soon as possible. These adverse outcomes are usually associated with the 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.
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| If [[oligohydramnios ]]is observed, discontinue COZAAR, unless it is considered life-saving 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.
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| Closely observe infants with histories of in utero exposure to COZAAR for [[hypotension]], [[oliguria]], and [[hyperkalemia]] (see PRECAUTIONS, Pediatric Use).
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| Losartan potassium has been shown to produce adverse effects in rat fetuses and neonates, including decreased body weight, delayed physical and behavioral development, mortality and renal toxicity. With the exception of neonatal weight gain (which was affected at doses as low as 10 mg/kg/day), doses associated with these effects exceeded 25 mg/kg/day (approximately three times the maximum recommended human dose of 100 mg on a mg/m2 basis). These findings are attributed to drug exposure in late gestation and during lactation. Significant levels of losartan and its active metabolite were shown to be present in rat fetal plasma during late gestation and in rat milk. | |
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| ====Hypotension — Volume-Depleted Patients====
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| In patients who are intravascularly volume-depleted (e.g., those treated with diuretics), symptomatic [[hypotension]] may occur after initiation of therapy with COZAAR. These conditions should be corrected prior to administration of COZAAR, or a lower starting dose should be used (see DOSAGE AND ADMINISTRATION).
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| ===PRECAUTIONS===
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| ====General====
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| '''Hypersensitivity''': [[Angioedema]]. See ADVERSE REACTIONS, Postmarketing Experience.
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| ====Impaired Hepatic Function====
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| Based on pharmacokinetic data which demonstrate significantly increased plasma concentrations of losartan in cirrhotic patients, a lower dose should be considered for patients with impaired liver function (see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY, Pharmacokinetics).
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| ====Impaired Renal Function====
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| As a consequence of inhibiting the [[renin-angiotensin-aldosterone system]], changes in renal function have been reported in susceptible individuals treated with COZAAR; in some patients, these changes in renal function were reversible upon discontinuation of therapy.
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| In patients whose renal function may depend on the activity of the [[renin-angiotensin-aldosterone system]] (e.g., 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. Similar outcomes have been reported with COZAAR.
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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 (BUN) have been reported. Similar effects have been reported with COZAAR; in some patients, these effects were reversible upon discontinuation of therapy.
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| ====Electrolyte Imbalance====
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| Electrolyte imbalances are common in patients with renal impairment, with or without diabetes, and should be addressed. In a clinical study conducted in type 2 diabetic patients with [[proteinuria]], the incidence of [[hyperkalemia]] was higher in the group treated with COZAAR as compared to the placebo group; however, few patients discontinued therapy due to [[hyperkalemia]] (see ADVERSE REACTIONS).<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = COZAAR (LOSARTAN POTASSIUM) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5ac32c20-169d-475a-fc8a-934f758d6ab0 | publisher = | date = | accessdate = 20 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:Alcohols]]
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| [[Category:Angiotensin II receptor antagonists]]
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| [[Category:Imidazoles]]
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| [[Category:Organochlorides]]
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| [[Category:Tetrazoles]]
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| [[Category:Biphenyls]]
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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