Company:

Novartis

Antihypertensive (direct renin inhibitor + thiazide)

Aliskiren 150mg, hydrochlorothiazide (HCTZ) 12.5mg; tabs.

TEKTURNA HCT 150/25

Aliskiren 150mg, hydrochlorothiazide (HCTZ) 25mg; tabs.

TEKTURNA HCT 300/12.5

Aliskiren 300mg, hydrochlorothiazide (HCTZ) 12.5mg; tabs.

TEKTURNA HCT 300/25

Aliskiren 300mg, hydrochlorothiazide (HCTZ) 25mg; tabs.

Hypertension.

Tekturna HCT combines the antihypertensive drugs aliskiren, a direct renin inhibitor, and the thiazide diuretic, HCTZ. Aliskiren decreases plasma renin activity and inhibits the conversion of angiotensinogen to angiotensin I. Thiazide diuretics reduce electrolyte resorption in the renal tubules, resulting in increased diuresis along with electrolyte loss, notably potassium. Drugs that inhibit the renin-angiotensin system tend to blunt the potassium-losing effects of the thiazides.

An 8-week, placebo-controlled study involving >2700 patients with mild to moderate hypertension was conducted to evaluate the safety and efficacy of Tekturna HCT. Various dosage combinations of aliskiren and HCTZ were given once daily to patients in this parallel-group study. The combination of aliskiren and HCTZ resulted in additive decreases in blood pressure (BP) at trough compared to placebo. These reductions were greater than those attained with monotherapy.

One trial investigated the addition of 300 mg aliskiren in obese hypertensive patients who did not respond adequately to HCTZ 25 mg, and showed decreases of systolic and diastolic BP of approximately 7/4 mmHg.

Additive effects of Tekturna HCT with maximal doses of ACEIs and β-blockers have not been demonstrated.

Not for initial therapy. May substitute for previously titrated components, or switch to Tekturna HCT if inadequate response to either therapy alone, or if hypokalemia occurs with HCTZ monotherapy, or if dose-limiting effects occur with either component as monotherapy. Take consistently with regard to meals (absorption reduced by high-fat meals). ≥18yrs: One tablet once daily. May titrate up if BP uncontrolled after 2–4 weeks; max dose aliskiren 300mg/HCTZ 25mg.

<18yrs: not recommended.

Anuria. Sulfonamide allergy.

Severe renal impairment (CrCl<30mL/min): not recommended. Severe renal disease. Correct salt/volume depletion before starting, or monitor closely. Hepatic dysfunction. Asthma. SLE. Monitor electrolytes. Pregnancy (Cat.D). Nursing mothers: not recommended.

Lithium toxicity (avoid). Potentiates antihypertensives, possibly non-depolarizing muscle relaxants. Potentiated by ketoconazole, atorvastatin. Antagonized by irbesartan, NSAIDs. May antagonize furosemide. ACTH, corticosteroids increase hypokalemia risk. Adjust anti-diabetic drugs. Orthostatic hypotension potentiated by alcohol, CNS depressants.

Dizziness, diarrhea, cough, asthenia, arthralgia, elevated BUN/creatinine, ALT, uric acid; rare: angioedema (discontinue if occurs).

Tabs—30, 90

2/28/08