Essential HTN in adults & HTN in childn & adolescents 6-18 yr. Clinically stable adults w/ symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hr to 10 days) MI. Adults w/ symptomatic heart failure when ACE inhibitors are not tolerated or in β-blocker-intolerant patients as add-on therapy to ACE inhibitors when mineralocorticoid receptor antagonists cannot be used.
Adult HTN 80 mg once daily, can be increased to 160 mg. Max: 320 mg. Recent MI Initiate as early as 12 hr after MI. Initially 20 mg bd, titrate to 40 mg (½ tab), 80 mg, & 160 mg bd over the next few wk. Target max dose: 160 mg bd. Heart failure 40 mg bd, titrate to 80 mg & 160 mg bd at 2-wk intervals to the highest tolerated dose. Max: 320 mg daily in divided doses. Childn & adolescent 6-18 yr HTN Initial dose: Weighing ≥35 kg 80 mg once daily, <35 kg 40 mg once daily. Max dose: Weighing 80-160 kg 320 mg, 35 to <80 kg 160 mg, 18 to <35 kg 80 mg. Adult & paed patient w/ mild to moderate hepatic impairment w/o cholestasis Max: 80 mg.
Risk of hyperkalaemia. Na &/or vol depletion should be corrected before starting treatment. Immediately discontinue & do not re-administer in patients who develop angioedema. Combination w/ an ACE inhibitor is not recommended in post-MI patients. Triple combination w/ an ACE inhibitor & a β-blocker or mineralocorticoid receptor antagonist is not recommended in patients w/ heart failure. ACE inhibitors & angiotensin II receptor blockers should not be used concomitantly in patients w/ diabetic nephropathy. Dual blockade of renin-angiotensin-aldosterone system (RAAS) through the combined use of ACE inhibitors, angiotensin II receptor blockers or aliskiren is not recommended. May be associated w/ renal impairment. Monitor K & renal function especially in paed patients w/ renal impairment. Patients w/ bilateral renal artery stenosis or stenosis to a solitary kidney; recent kidney transplantation; aortic or mitral stenosis, or hypertrophic obstructive cardiomyopathy; heart failure. Should not be used in patients w/ primary hyperaldosteronism. May impair ability to drive or operate machinery. Patients w/ CrCl <10 mL/min & undergoing dialysis; mild to moderate hepatic impairment w/o cholestasis. Not recommended during breastfeeding & 1st trimester of pregnancy. Childn 1-6 yr. Not recommended in paed patients w/ CrCl <30 mL/min & undergoing dialysis; for treatment of heart failure or recent MI in childn & adolescents <18 yr.
Higher frequency of adverse events w/ dual blockade of RAAS through the combined use of ACE inhibitors, angiotensin II receptor blockers or aliskiren. Reversible increases in serum lithium conc & toxicity. Not recommended w/ K-sparing diuretics, K supplements, K-containing salt substitutes & other substances that may increase K levels. Attenuated antihypertensive effect w/ NSAIDs, including selective COX-2 inhibitors, acetylsalicylic acid >3 g/day, & non-selective NSAIDs. Increased risk of renal function worsening & increased serum K w/ NSAIDs. Potential increase in systemic exposure w/ uptake (eg, rifampicin, ciclosporin) or efflux (eg, ritonavir) transporter inhibitors.
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