Tekturna (Aliskiren Hemifumarate) - Indications and Dosage

INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

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).

HOW SUPPLIED

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     

Tablet	Color	Imprint	Imprint	NDC 0078-XXXX-XX
		Side 1	Side 2	Bottle of 30	Bottle of 90	Blister Packages of 100
150 mg	Light-pink	NVR	IL	0485-15	0485-34	0485-35
300 mg	Light-red	NVR	IU	0486-15	0486-34	0486-35

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

T2007-111

Distributed by:

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey 07936

©Novartis