Valturna Dosage

2.1 Dose Selection

The recommended once-daily dose of Valturna is 150/160 mg or 300/320 mg. The recommended initial once-daily dose of Valturna is 150/160 mg. Titrate as needed to a maximum of 300/320 mg.

Patients switched from monotherapy to Valturna on average experience greater blood pressure reductions with use of the combination product.

2.2 Dose Titration

The antihypertensive effect of Valturna is largely attained within 2 weeks. If blood pressure remains uncontrolled after 2 to 4 weeks of therapy, the dose may be titrated up to a maximum of 300/320 mg.

2.3 Add-on Therapy

A patient whose blood pressure is not adequately controlled with aliskiren alone or valsartan (or another angiotensin receptor blocker) alone may be switched to combination therapy with Valturna. The usual recommended starting dose is 150/160 mg once daily as needed to control blood pressure.

2.4 Replacement Therapy

For convenience, patients receiving aliskiren and valsartan from separate tablets may instead wish to receive a single tablet of Valturna containing the same component doses.

2.5 Initial Therapy

The usual recommended starting dose of Valturna is 150/160 mg once daily as needed to control blood pressure. The dose may be titrated up to a maximum of 300/320 mg once daily.

Valturna is not recommended for use as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.3)].

2.6 Use with Other Antihypertensive Drugs

Valturna may be administered with other antihypertensive agents. There are no data available with use of Valturna with angiotensin-converting enzyme inhibitors or other renin-angiotensin-aldosterone blockers.

2.7 Relationship to Meals

Patients should establish a routine pattern for taking Valturna with regard to meals. High-fat meals decrease absorption substantially [see Clinical Pharmacology (12.3)].

2.8 Dosing in Specific Populations

Renal Impairment

Adjustment of the starting dose is not required in patients with mild-to-moderate renal impairment. Clinical experience with dosing Valturna in patients with moderate renal impairment is limited. No data are available in patients with severe renal impairment [see Warnings and Precautions (5.4)].

Hepatic Impairment

Adjustment of the starting dose is not necessary with mild or moderate hepatic impairment. Clinical experience with dosing Valturna in patients with severe hepatic impairment is limited [see Warnings and Precautions (5.5)].

Elderly Patients

Adjustment of the starting dose is not required for elderly patients.