Generic Name and Formulations:
Aliskiren 150mg, 300mg; tabs.
Noden Pharma USA Inc.
Indications for TEKTURNA:
≥18yrs: initially 150mg once daily, may increase to 300mg once daily if BP not adequately controlled. May be given with other antihypertensives (see full labeling).
<18yrs: not established.
Concomitant ARBs or ACEIs in diabetes.
Fetal toxicity may develop; discontinue if pregnancy is detected. Correct salt/volume depletion before starting therapy or start under close supervision. Discontinue if angioedema or laryngeal edema occurs (have SC epinephrine available). Moderate renal impairment (CrCl <60mL/min): avoid concomitant ARBs or ACEIs. Monitor BP, electrolytes, and renal function periodically. Consider withholding or discontinuing if significant renal dysfunction develops. Renal artery stenosis. Severe HF. Post-MI. Diabetes. Neonates. Pregnancy: avoid. Nursing mothers: not recommended.
Direct renin inhibitor.
Avoid concomitant cyclosporine, itraconazole. Caution with NSAIDs, K+ supplements, K+ sparing diuretics, K+ containing salt substitutes; may cause hyperkalemia. May be antagonized by, and renal toxicity potentiated by NSAIDs (including COX-2 inhibitors): monitor renal function in elderly and/or volume-depleted. Dual inhibition of the renin-angiotensin system with ARBs or ACEIs may increase risk of hypotension, hyperkalemia, renal function changes. Concomitant furosemide; monitor. Decreased absorption with high fat meals.
Diarrhea, hypotension, cough, rash, edema, elevated uric acid, gout, renal stones; rare: angioedema.