Essential HTN in adults, & HTN in childn & adolescents 6-18 yr. Symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hr to 10 days) MI in clinically stable adult patients. Symptomatic heart failure in adults when ACE inhibitors are not tolerated or in β-blocker intolerant patients as add-on therapy to ACE inhibitors when mineralocorticoid receptor antagonist cannot be used.
Dosage/Direction for Use
Adult Recent MI May be initiated as early as 12 hr after MI. Initially 20 mg bd, titrated to 40, 80, & 160 mg bd over the next few wk. Heart failure Initially 40 mg bd, titrated to 80 & 160 mg bd at intervals of at least 2 wk. HTN Initially 80 mg once daily, can be increased to 160 mg. Max: 320 mg. Childn & adolescent 6-18 yr Paed HTN Initially 40 mg once for childn <35 kg. Initially 80 mg once daily for childn ≥35 kg.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). Severe hepatic impairment, biliary cirrhosis & cholestasis. 2nd & 3rd trimester of pregnancy.
Special Precautions
Observe caution when initiating therapy in post-MI or heart failure patients. May be associated w/ renal function impairment. Reports of angioedema. Patients suffering from aortic or mitral stenosis, or hypertrophic obstructive cardiomyopathy; patients w/ CrCl <10 mL/min & undergoing dialysis; mild to moderate hepatic impairment w/o cholestasis; bilateral renal artery stenosis or stenosis to a solitary kidney; patients who have recently undergone kidney transplantation. Should not be used in patients w/ primary hyperaldosteronism. Not recommended w/ concomitant use of K supplements, K-sparing diuretics, salt substitutes containing K, or other agents that may increase K levels. Correct Na &/or vol depletion before starting valsartan treatment. Not recommended w/ ACE inhibitor in post-MI patients. ACE inhibitors & angiotensin II receptor blockers should not be used concomitantly in patients w/ diabetic nephropathy. Triple combination w/ ACE inhibitor & a β-blocker, or w/ ACE inhibitor & a mineralocorticoid receptor antagonist in heart failure patients is not recommended. Dual blockade of renin-angiotensin-aldosterone system through the combined use of ACE inhibitors, angiotensin II receptor blockers or aliskiren is not recommended. May affect ability to drive & use machines. Should not be initiated during pregnancy. Not recommended during the 1st trimester of pregnancy & during breastfeeding. Not recommended in paed patients w/ CrCl <30 mL/min & undergoing dialysis.
Higher frequency of adverse events w/ combined use of ACE inhibitors, angiotensin II receptor blockers or aliskiren. Increased conc & toxicity of lithium. Hyperkalemia w/ K supplements, K-sparing diuretics, salt substitutes containing K, or other agents that may increase K levels. Attenuated antihypertensive efficacy w/ NSAIDs, including selective COX-2 inhibitors, ASA (>3 g/day), & non-selective NSAIDs. Increased risk of worsening of renal function & increased serum K w/ NSAIDs. Potential increase in systemic exposure w/ inhibitors of OATP1B1/OATP1B3 (eg, rifampin, ciclosporin) or MRP2 efflux transporter (eg, ritonavir).
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