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| __NOTOC__
| | #REDIRECT [[Valsartan#Warnings]] |
| {{Valsartan}}
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| {{CMG}}; {{AE}} {{SS}}
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| ==Warnings 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 Diovan as soon as possible. [see Use in Specific Populations (8.1)].
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| ===5.2 Hypotension===
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| Excessive hypotension was rarely seen (0.1%) in patients with uncomplicated [[hypertension]] treated with Diovan alone. In patients with an activated [[renin-angiotensin system]], such as volume- and/or salt-depleted patients receiving high doses of [[diuretics]], symptomatic [[hypotension]] may occur. This condition should be corrected prior to administration of Diovan, or the treatment should start under close medical supervision.
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| Caution should be observed when initiating therapy in patients with [[heart failure]] or post-[[myocardial infarction]] patients. Patients with [[heart failure]] or post-[[myocardial infarction]] patients given Diovan commonly have some reduction in blood pressure, but discontinuation of therapy because of continuing symptomatic [[hypotension]] usually is not necessary when dosing instructions are followed. In controlled trials in [[heart failure]] patients, the incidence of [[hypotension]] in valsartan-treated patients was 5.5% compared to 1.8% in placebo-treated patients. In the Valsartan in Acute Myocardial Infarction Trial (VALIANT), [[hypotension]] in post-[[myocardial infarction]] patients led to permanent discontinuation of therapy in 1.4% of valsartan-treated patients and 0.8% of captopril-treated patients.
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| If excessive [[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.
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| ===5.3 Impaired Renal Function===
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| Changes in renal function including [[acute renal failure]] can be caused by drugs that inhibit the [[renin-angiotensin system]] and by [[diuretics]]. Patients whose renal function may depend in part on the activity of the [[renin-angiotensin system]] (e.g. patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on Diovan. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on Diovan [See Drug Interactions (7)].
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| ===5.4 Hyperkalemia===
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| Some patients with heart failure have developed increases in potassium. These effects are usually minor and transient, and they are more likely to occur in patients with pre-existing renal impairment. Dosage reduction and/or discontinuation of Diovan may be required. [see Adverse Reactions (6.1)]<ref name="dailymed.nlm.nih.gov">{{Citace elektronické monografie | příjmení = | jméno = | titul = DIOVAN (VALSARTAN) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5ddba454-f3e6-43c2-a7a6-58365d297213 | vydavatel = | datum vydání = | datum aktualizace = | datum přístupu = 2014-02-24 }}</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:Amides]]
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| [[Category:Angiotensin II receptor antagonists]]
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| [[Category:Biphenyls]]
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| [[Category:Carboxylic acids]]
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| [[Category:Novartis]]
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| [[Category:Tetrazoles]]
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| [[Category:Cardiovascular Drugs]]
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| [[Category:Drugs]]
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