Essential HTN in adults. Renal disease in adults w/ HTN & type 2 DM as part of antihypertensive regimen.
Dosage/Direction for Use
Initial & maintenance dose: 150 mg once daily. Can be increased to 300 mg in case of insufficient control. Hypertensive patient w/ type 2 DM Initial dose: 150 mg once daily. Maintenance dose: Titrate up to 300 mg once daily. Haemodialysed patient & elderly >75 yr Initial dose: 75 mg.
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). Pregnancy (2nd & 3rd trimester).
Special Precautions
Correct intravascular vol depletion before treatment. Increased risk of renovascular HTN in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Periodically monitor K & creatinine serum levels in patients w/ impaired renal function. Closely monitor serum K in patients at risk of hyperkalaemia. May induce hypoglycaemia, particularly in diabetic patients. Dual blockade of renin-angiotensin-aldosterone system (RAAS) through the combined use of ACE inhibitors, ARBs or aliskiren is not recommended. Do not concomitantly use ACE inhibitors & ARBs in patients w/ diabetic nephropathy. Combination w/ lithium is not recommended. Patients w/ recent kidney transplantation; aortic & mitral valve stenosis, or obstructive hypertrophic cardiomyopathy. Patients whose vascular tone & renal function depend predominantly on RAAS activity. Not recommended in patients w/ primary aldosteronism. Patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. May affect ability to drive or operate machinery. Patients w/ severe hepatic impairment. Not recommended during the 1st trimester of pregnancy. Not recommended during breastfeeding. Safety & efficacy in childn 0-18 yr have not been established. Black patients.
Adverse Reactions
Hyperkalaemia (especially in diabetic patients). Dizziness, orthostatic dizziness; orthostatic hypotension; nausea/vomiting; musculoskeletal pain; fatigue; significant increase in plasma creatine kinase.
Increased hypotensive effects w/ other antihypertensives. Vol depletion & risk of hypotension w/ high-dose diuretics. Dual blockade of RAAS through the combined use of ACE inhibitors, ARBs or aliskiren is associated w/ a higher frequency of adverse events. Increased serum K w/ K-sparing diuretics, K supplements, salt substitutes containing K or other medicinal products that may increase K level (eg, heparin). Reversible increase in serum lithium conc & toxicity. Attenuated antihypertensive effect, increased risk of worsening renal function, & increased serum K w/ NSAIDs (ie, selective COX-2 inhibitors, ASA >3 g/day & non-selective NSAIDs).
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