Aprovel

HTN, alone or in combination w/ other antihypertensive agents eg, thiazide diuretics, β-adrenergic blocking agents, long-acting Ca-channel blocking agents. Renal disease in patients w/ HTN & type 2 diabetes.

Initially 150 mg once daily. May be increased to 300 mg once daily if further BP reduction is required. HTN & type 2 diabetic renal disease Maintenance: 300 mg once daily.

May be taken with or without food.

Hypersensitivity. Co-administration w/ aliskiren-containing medicines in patients w/ diabetes or w/ moderate to severe renal impairment (GFR <60 mL/min/1.73 m²); ACE inhibitors in patients w/ diabetic nephropathy.

Correct vol- &/or Na-depletion (eg, in patients w/ vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting) prior to administration. Increased risk of severe hypotension & renal insufficiency in patients w/ bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney. Effects are particularly less favourable in women & non-white subjects w/ advanced renal disease. Dual blockade of renin-angiotensin-aldosterone system (RAAS) through combined use w/ ACE inhibitors, ARBs or aliskiren is not recommended. Not to be used concomitantly w/ ACE inhibitors in patients w/ diabetic nephropathy. Hyperkalaemia may occur especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, &/or heart failure. May induce hypoglycemia particularly in diabetic patients. Caution in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy. Acute hypotension, azotaemia, oliguria, or rarely acute renal failure in patients whose vascular tone & renal function depend predominantly on the activity of the RAAS eg, patients w/ severe CHF or underlying renal disease, including renal artery stenosis. Excessive BP decrease in patients w/ ischaemic cardiopathy or ischaemic CV disease could result in MI or stroke. Not recommended in patients w/ primary aldosteronism. Less effective in BP lowering in black people than in non-blacks. Periodic monitoring of K & creatinine serum levels is recommended in patients w/ renal impairment. No experience in patients w/ recent kidney transplantation. Combination w/ lithium is not recommended. Should not be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Take into account that occasional dizziness or weariness may occur during treatment of HTN when driving vehicles or operating machines. Should not be initiated during pregnancy; discontinue treatment as soon as possible when pregnancy is detected. Discontinue nursing or discontinue drug taking into account the importance of therapy to the mother & potential risk to infant. Safety & effectiveness in ped patients have not been established.

Hyperkalaemia. Dizziness, orthostatic dizziness; orthostatic hypotension; nausea/vomiting; musculoskeletal pain; fatigue; increased plasma creatine kinase.

May increase serum K w/ K-sparing diuretics, K supplements, salt substitutes containing K or other medicinal products that may increase kalaemia. May result in deterioration of renal function including possible acute renal failure w/ NSAIDs including selective COX-2 inhibitors in the elderly, those who are vol-depleted (including those on diuretic therapy), or w/ compromised renal function. Antihypertensive effect may be attenuated w/ NSAIDs including selective COX-2 inhibitors. Increased serum lithium conc & toxicity. Increased C_max & AUC of repaglinide. Combination w/ aliskiren-containing medicinal products & ACE inhibitors.

Angiotensin II Antagonists

C09CA04 - irbesartan ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.

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