Aliskiren Dosage

Usual Adult Dose for Hypertension

Initial: 150 mg orally once a day
Maintenance: the dosage may be increased to 300 mg daily if blood pressure is not adequately controlled.

Aliskiren may be used alone or in combination with other antihypertensive agents.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

No dosage adjustment is recommended based on age or race. No differences in pharmacokinetics were reported in pharmacokinetic studies conducted in elderly patients, Blacks, Japanese, and Caucasian patients.

Precautions

Drugs, like aliskiren, that act directly on the renin-angiotensin-aldosterone (RAA) system can cause fetal and neonatal morbidity and death when administered during pregnancy. Several dozen cases have been reported in the world literature in patients who were taking similar drugs, the ACE inhibitors. A committee of the National Institutes of Health has recommended that these drugs be avoided during pregnancy. When pregnancy is detected or expected, aliskiren should be discontinued as soon as possible.

Aliskiren should not be used in patients with bilateral renal artery stenosis or in patients who rely on angiotensin II to maintain adequate glomerular filtration.

Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with aliskiren, and can occur at any time during treatment. Although angioedema rates associated with ACE inhibitors are higher in Black than in non-black patients, it is not known if this is the case with aliskiren. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Emergency therapy, including but not necessarily limited to, subcutaneous administration of a 1:1000 solution of epinephrine and measures necessary to ensure a patent airway should be promptly instituted.

Symptomatic hypotension can occur in patients treated with aliskiren, particularly in volume- or salt-depleted patients. This condition should be corrected prior to aliskiren treatment. Excessive decreases in blood pressure are rarely seen in patients treated for uncomplicated hypertension with aliskiren. If an excessive fall in blood pressure occurs, the patient should be placed in the supine position and, if necessary, given intravenous fluids. A transient hypotensive response is not a contraindication to further aliskiren treatment, and can usually be continued without difficulty once the blood pressure has stabilized.

Caution should be exercised in patients with greater than moderate renal dysfunction due to the lack of safety information with aliskiren in these patients and the potential for other drugs acting on the renin-angiotensin system to increase serum creatinine and blood urea nitrogen.

Increases in serum potassium levels (greater than 5.5 mEq/L) were infrequently observed in patients receiving aliskiren alone. These increases were more frequent when aliskiren was used in combination with an ACE inhibitor in a diabetic population. Routine monitoring of electrolytes and renal function is recommended in those instances.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

Other Comments

Since high fat meals substantially decrease the absorption of aliskiren, patients should be instructed to establish a routine pattern for administration with regard to meals. However, although absorption may be affected by food, pharmacodynamic data suggest that aliskiren may be taken without regard to meals.

Periodic monitoring of blood pressure and electrolytes has been suggested.

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