Tekturna® (aliskiren) is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Use with maximal doses of ACE inhibitors has not been adequately studied.

The usual recommended starting dose of Tekturna® (aliskiren) is 150 mg once daily. In patients whose blood pressure is not adequately controlled, the daily dose may be increased to 300 mg. Doses above 300 mg did not give an increased blood pressure response but increased the rate of diarrhea. The antihypertensive effect of a given dose is substantially attained (85%-90%) by 2 weeks.

Tekturna may be administered with other antihypertensive agents. Most exposure to date is with diuretics and an angiotensin receptor blocker (valsartan) and the drugs together have a greater effect at their maximum recommended doses than either drug alone. It is not known whether additive effects are present when aliskiren is used with angiotensin-converting enzyme inhibitors or beta blockers.

No initial dosage adjustment is required in elderly patients, for patients with mild-to-severe renal impairment, or for patients with mild-to-severe hepatic insufficiency. Care should be exercised when dosing Tekturna in patients with severe renal impairment, as clinical experience with such patients is limited.

Patients should establish a routine pattern for taking Tekturna with regard to meals. High fat meals decrease absorption substantially (see Absorption and Distribution).

Tekturna® (aliskiren) is supplied as a light-pink, biconvex unscored round tablet containing 150 mg of aliskiren, and as a light-red biconvex ovaloid tablet containing 300 mg of aliskiren. Tablets are imprinted with NVR on one side and IL, IU, on the other side of the 150, and 300 mg tablets, respectively. All strengths are packaged in bottles and unit-dose blister packages (10 strips of 10 tablets) as described below in Table 4.

Table 4: Tekturna Tablets Supply

Storage

Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

REV: DECEMBER 2007. Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. FDA rev date: 05/19/08

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