Adult Initially 10 mg once daily, may be increased to 20 mg once daily as the optimal dose. Max: 40 mg daily. Patient w/ mild to moderate renal impairment Max dose: 20 mg once daily. Patient w/ moderate hepatic impairment Initially 10 mg once daily. Max dose: 20 mg once daily.
Administration
May be taken with or without food: Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity. Biliary obstruction. Concomitant use w/ aliskiren-containing products in patients w/ DM or renal impairment (GFR <60 mL/min/1.73 m2). 2nd & 3rd trimesters of pregnancy.
Special Precautions
Symptomatic hypotension especially after the 1st dose in patients who are vol &/or Na-depleted. Patients whose vascular tone & renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (RAAS) eg, patients w/ severe CHF or underlying renal disease, including renal artery stenosis. Increased risk of severe hypotension & renal insufficiency in patients w/ bilateral artery stenosis or stenosis of the artery to a single functioning kidney. Periodically monitor serum K & creatinine levels in patients w/ renal impairment. Not recommended in patients w/ severe renal impairment or severe hepatic impairment. Risk of hyperkalaemia. Dual blockade of the RAAS w/ combined use of ACE inhibitors, angiotensin II receptor blockers or aliskiren. Concomitant administration w/ lithium is not recommended. Use w/ caution in patients suffering from aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy. Not recommended in patients w/ primary aldosteronism. Sprue-like enteropathy. BP-lowering effect is somewhat less in black patients. Patients w/ ischaemic heart disease or ischaemic cerebrovascular disease. Rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption. Minor or moderate influence on the ability to drive & use machines. Not recommended during 1st trimester of pregnancy & lactation. Paed population.
Increased BP-lowering effect w/ other antihypertensive medications. Higher frequency of adverse events w/ combined use of ACE inhibitors, angiotensin II receptor blockers or aliskiren. Increased serum K levels w/ K-sparing diuretics, K supplements, K-containing salt substitutes, or other drugs that may increase serum K levels (eg, heparin). Risk of acute renal failure & reduced antihypertensive effect leading to partial loss of efficacy w/ NSAIDs. Reduced systemic exposure & peak plasma conc w/ colesevelam. Modest reduction in bioavailability w/ antacid (Al Mg hydroxide). Reversible increases in serum lithium conc.
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