Hypertension. Not for initial therapy.
Take once daily. Titrate at 2-week intervals; max one 300/10/25mg tablet daily. Replacement: may substitute for individually titrated components. Add-on/switch: if not adequately controlled on any two of the following: aliskiren, dihydropyridine CCB, thiazide diuretics. May switch with a lower dose of any component that causes dose-limiting ADRs. ≥75 years or severe hepatic impairment: initially amlodipine 2.5mg/day (not available). Concomitant simvastatin: see Interactions.
Renin inhibitor + dihydropyridine calcium channel blocker (CCB) + thiazide diuretic.
Concomitant ARBs or ACEIs in diabetes. Anuria. Sulfonamide allergy.
Fetal toxicity may develop; discontinue if pregnancy is detected. Correct salt/volume depletion before starting or start under close supervision. Severe obstructive coronary disease: increased risk of angina or MI with CCB dose change. Moderate renal dysfunction (CrCl <60mL/min): avoid concomitant with ARBs or ACEIs. Impaired renal function: monitor serum creatinine periodically. Renal artery stenosis. Heart failure. Monitor for electrolyte disturbances. Hepatic dysfunction. Asthma. SLE. Gout. Acute myopia. Secondary angle-closure glaucoma. Neonates. Pregnancy (Cat.D); monitor. Nursing mothers: not recommended.
Aliskiren: concomitant cyclosporine, itraconazole: not recommended. Caution with ACEIs, ARBs, NSAIDs, K+ sparing diuretics, K+ containing salt substitutes; may cause hyperkalemia. Decreased absorption with high fat meals. HCTZ: concomitant lithium (risk of toxicity): monitor; potentiates antihypertensives, possibly non-depolarizing muscle relaxants; orthostatic hypotension with alcohol, other CNS depressants; may need to adjust antidiabetic agents; decreased absorption by cholestyramine, colestipol resins (separate dosing by at least 4 hours). Both Aliskiren + HCTZ: may be antagonized by, and renal toxicity potentiated by NSAIDs (including COX-2 inhibitors): monitor renal function in elderly and/or volume-depleted. Amlodipine potentiates simvastatin; limit simvastatin dose to max 20mg daily.
Peripheral edema, dizziness, headache, nasopharyngitis; rare: angioedema (discontinue if occurs, do not restart).
Tabs—30, 90, 100