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| __NOTOC__
| | #REDIRECT [[Valsartan#Use in Specific Populations]] |
| {{Valsartan}}
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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===
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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. 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.
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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 Diovan, 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 Diovan 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 Diovan is excreted in human milk. Diovan was excreted in the milk of lactating rats; however, animal breast milk drug levels may not accurately reflect human breast milk levels. Because many drugs are excreted into human milk and because of the potential for adverse reactions in nursing infants from Diovan, 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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| ===8.4 Pediatric Use===
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| The antihypertensive effects of Diovan have been evaluated in two randomized, double-blind clinical studies in pediatric patients from 1-5 and 6-16 years of age [see Clinical Studies(14.1)]. The pharmacokinetics of Diovan have been evaluated in pediatric patients 1 to 16 years of age[see Pharmacokinetics, Special Populations, Pediatric (12.3)]. Diovan was generally well tolerated in children 6-16 years and the adverse experience profile was similar to that described for adults.
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| In children and adolescents with [[hypertension]] where underlying renal abnormalities may be more common, renal function and serum potassium should be closely monitored as clinically indicated.
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| Diovan is not recommended for pediatric patients under 6 years of age due to safety findings for which a relationship to treatment could not be excluded [see Adverse Reactions, Pediatric Hypertension (6.1)].
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| No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate <30 mL/min/1.73 m2.
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| There is limited clinical experience with Diovan in pediatric patients with mild to moderate [[hepatic impairment]] [See Warnings and Precautions (5.3)].
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| Daily oral dosing of neonatal/juvenile rats with valsartan at doses as low as 1 mg/kg/day (about 10% of the maximum recommended pediatric dose on a mg/m2 basis) from postnatal day 7 to postnatal day 70 produced persistent, irreversible kidney damage. These kidney effects in neonatal rats represent expected exaggerated pharmacological effects that are observed if rats are treated during the first 13 days of life. Since this period coincides with up to 44 weeks after conception in humans, it is not considered to point toward an increased safety concern in 6 to 16 year old children.
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| Neonates with a history of in utero exposure to Diovan:
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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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| ===8.5 Geriatric Use===
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| In the controlled clinical trials of valsartan, 1,214 (36.2%) hypertensive patients treated with valsartan were ≥65 years and 265 (7.9%) were ≥75 years. No overall difference in the efficacy or safety of valsartan was observed in this patient population, but greater sensitivity of some older individuals cannot be ruled out.
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| Of the 2,511 patients with [[heart failure]] randomized to valsartan in the Valsartan Heart Failure Trial, 45% (1,141) were 65 years of age or older. In the Valsartan in Acute Myocardial Infarction Trial (VALIANT), 53% (2,596) of the 4,909 patients treated with valsartan and 51% (2,515) of the 4,885 patients treated with valsartan + captopril were 65 years of age or older. There were no notable differences in efficacy or safety between older and younger patients in either trial.
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| ===8.6 Renal Impairment===
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| Safety and effectiveness of Diovan in patients with severe renal impairment (CrCl ≤ 30 mL/min) have not been established. No dose adjustment is required in patients with mild (CrCl 60-90 mL/min) or moderate (CrCl 30-60) renal impairment.
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| ===8.7 Hepatic Impairment===
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| No dose adjustment is necessary for patients with mild-to-moderate liver disease. No dosing recommendations can be provided for patients with severe liver disease.<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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