Essential HTN. HTN in childn & adolescents 6-<18 yr. Heart failure & impaired left ventricular systolic function (left ventricular ejection fraction ≤40%) when ACE inhibitors are not tolerated; as add-on therapy to ACE inhibitors in patients w/ symptomatic heart failure, despite optimal therapy, when mineralocorticoid receptor antagonists are not tolerated.
HTNAdult Initially 8 mg once daily, may be increased to 16 mg once daily & to a max of 32 mg once daily. Patient w/ intravascular depletion, renal & hepatic impairment Initially 4 mg once daily. Childn & adolescent 6-<18 yr Initially 4 mg once daily, weighing ≥50 kg May increase dose to 8 mg once daily & then to 16 mg once daily if needed, <50 kg May increase dose to max of 8 mg once daily. Heart failure Initially 4 mg once daily, up-titration to target dose of 32 mg once daily (max dose).
View Frepan overdosage for action to be taken in the event of an overdose.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Pregnancy. Severe hepatic impairment &/or cholestasis. Concomitant use of angiotensin II receptor antagonists or ACE inhibitors w/ aliskiren in patients w/ type 2 DM.
Periodic monitoring of serum K & creatinine levels in hypertensive patients. Very severe or end-stage renal impairment (CrCl <15 mL/min). Assessment of renal function in patients w/ heart failure especially in elderly ≥75 yr & impaired renal function. Childn w/ glomerular filtration <30 mL/min/1.73 m2; childn w/ possible intravascular vol depletion; severe renal impairment (GFR <30 mL/min). Monitor hyperkalaemia. Monitor BP in patients on haemodialysis. Bilateral renal artery stenosis or stenosis of the artery to a solitary kidney; undergone kidney transplantation; hypotension; hypotension during anaesth & surgery; aortic & mitral valve stenosis or obstructive hypertrophic cardiomyopathy; primary hyperaldosteronism; Monitor serum K especially when in concomitant w/ K-sparing diuretics, K supplements, salt substitutes containing K or drugs that may increase K levels & ACE inhibitor. Dual blockade of RAAS eg, ACE inhibitors or aliskiren. Patients whose vascular tone & renal function depend on RAAS activity eg, severe CHF or underlying renal disease including renal artery stenosis; excessive BP decreases in patients w/ ischaemic cardiopathy or ischaemic cerebrovascular disease. Dizziness or weariness may occur during treatment. Lactation.
May increase K levels w/ K-sparing diuretics, K supplements, salt substitutes containing K, other medicinal products eg, heparin. Increases serum lithium conc & toxicity. Attenuation of antihypertensive effect may occur w/ NSAIDs eg, selective COX-2 inhibitors, ASA (>3 g/day). Increased risk of worsening of renal function & acute renal failure w/ NSAIDs. Dual blockade of RAAS w/ AIIRAs, ACE inhibitors or aliskiren which may increase incidence of hypotension, hyperkalemia & changes in renal function.
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