Generic Name and Formulations:
Aliskiren, hydrochlorothiazide; 150mg/12.5mg, 150mg/25mg, 300mg/12.5mg, 300mg/25mg; tabs.
Company:
Novartis Pharmaceuticals Corp
Hypertension.
Take consistently with regard to meals (absorption reduced by high-fat meals). ≥18yrs: 1 tablet once daily. Add-on or initial therapy and not volume-depleted: initially 150mg/12.5mg; may increase after 2–4 weeks up to max 300mg/25mg. Replacement therapy: may be substituted for the titrated components. Maximum effect usually seen at 4 weeks.
<18yrs: not recommended.
Direct renin inhibitor + thiazide.
Concomitant ARBs or ACEIs in diabetes. Anuria. Sulfonamide allergy.
Fetal toxicity may develop; discontinue if pregnancy is detected. Correct salt/volume depletion before starting therapy or start under close supervision. Moderate renal impairment (CrCl <60mL/min): avoid concomitant with ARBs or ACEIs. Impaired renal function: monitor serum creatinine periodically. Renal artery stenosis. Severe CHF. Monitor for electrolyte disturbances. Hepatic dysfunction. Asthma. SLE. Gout. Acute myopia. Secondary acute angle-closure glaucoma. Neonates. Pregnancy (Cat.D); monitor. Nursing mothers: not recommended.
Concomitant cyclosporine, itraconazole: not recommended. Concomitant lithium (risk of toxicity): monitor. Caution with ACEIs, ARBs, NSAIDs, K+ sparing diuretics, K+ containing salt substitutes; may cause hyperkalemia. Potentiates antihypertensives, possibly non-depolarizing muscle relaxants. May be antagonized by, and renal toxicity potentiated by NSAIDs (including COX-2 inhibitors): monitor renal function in elderly and/or volume-depleted. Adjust antidiabetic drugs. Orthostatic hypotension potentiated by alcohol, CNS depressants. Decreased absorption by cholestyramine, colestipol resins (separate dosing by at least 4 hours).
Dizziness, flu-like symptoms, diarrhea, cough, vertigo, asthenia, arthralgia, elevated BUN/creatinine, ALT, cholesterol, uric acid; rare: angioedema (discontinue if occurs).
Tabs—30, 90