Diovan (Valsartan) - Indications and Dosage

INDICATIONS AND USAGE

Diovan is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

DOSAGE AND ADMINISTRATION

The recommended starting dose of Diovan is 80 mg once daily when used as monotherapy in patients who are not volume-depleted. Diovan may be used over a dose range of 80 mg to 320 mg daily, administered once-a-day.

      The antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks. If additional antihypertensive effect is required, the dosage may be increased to 160 mg or 320 mg or a diuretic may be added. Addition of a diuretic has a greater effect than dose increases beyond 80 mg.

      No initial dosage adjustment is required for elderly patients, for patients with mild or moderate renal impairment, or for patients with mild or moderate liver insufficiency. Care should be exercised with dosing of Diovan in patients with hepatic or severe renal impairment.

      Diovan may be administered with other antihypertensive agents.

      Diovan may be administered with or without food.

HOW SUPPLIED

Diovan is available as capsules containing valsartan 80 mg or 160 mg. Both strengths are packaged in bottles of 100 capsules and unit dose blister packages. Capsules are imprinted as follows:

80 mg Capsule - Light grey/light pink opaque, imprinted CG FZF

      Bottles of 100……………………………………………………NDC 0083-4000-01

      Unit Dose (blister pack)………………………………………….NDC 0083-4000-61

      Box of 100 (strips of 10)

160 mg Capsule - Dark grey/light pink opaque, imprinted CG GOG

      Bottles of 100 …………………………………………………...NDC 0083-4001-01

      Unit Dose (blister pack)………………………………………….NDC 0083-4001-61

      Box of 100 (strips of 10)

Store at 25ºC (77ºF); excursions permitted to 15ºC-30ºC (59ºF-86ºF). Protect from moisture.

Dispense in tight container (USP).

T2000-31

89004202

Distributed by
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936

© 2000 Novartis