Diovan HCT® (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).

The recommended starting dose of valsartan is 80 mg or 160 mg once daily when used as monotherapy in patients who are not volume depleted. Patients requiring greater reductions may be started at the higher dose. Valsartan may be used over a dose range of 80 mg to 320 mg daily, administered once-a-day. Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily, and can be given at doses of 12.5 mg to 25 mg as Diovan HCT® (valsartan and hydrochlorothiazide, USP).

To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.

The side effects (see WARNINGS) of valsartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of valsartan and hydrochlorothiazide will be associated with both sets of dose-independent side effects.

Replacement Therapy

The combination may be substituted for the titrated components.

Dose Titration by Clinical Effect

Diovan HCT tablets contain valsartan and hydrochlorothiazide, 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. A patient whose blood pressure is not adequately controlled with valsartan monotherapy (see above) may add hydrochlorothiazide by switching to Diovan HCT (80/12.5 mg, 160/12.5 mg or 320/12.5 mg valsartan/hydrochlorothiazide) once daily. If blood pressure remains uncontrolled after about 3-4 weeks of therapy, either valsartan or both components may be increased depending on clinical response. There are no studies evaluating doses of valsartan greater than 320 mg in combination with hydrochlorothiazide 25 mg.

A patient whose blood pressure is inadequately controlled by 25 mg once daily of hydrochlorothiazide, or is controlled but who experiences hypokalemia with this regimen, may be switched to Diovan HCT (valsartan 80 mg/hydrochlorothiazide 12.5 mg or valsartan 160 mg/hydrochlorothiazide 12.5 mg) once daily, reducing the dose of hydrochlorothiazide without reducing the overall expected antihypertensive response. The clinical response to Diovan HCT should be subsequently evaluated and if blood pressure remains uncontrolled after 3-4 weeks of therapy, the dose may be titrated up to a maximum of valsartan 320 mg/hydrochlorothiazide 25 mg.

The maximal antihypertensive effect is attained about 4 weeks after initiation of therapy.

Patients with Renal Impairment: The usual regimens of therapy with Diovan HCT may be followed as long as the patient's creatinine clearance is > 30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so Diovan HCT is not recommended.

Patients with Hepatic Impairment: Care should be exercised with dosing of Diovan HCT in patients with hepatic impairment.

Other: No initial dosage adjustment is required for elderly patients. Diovan HCT may be administered with other antihypertensive agents. Diovan HCT may be administered with or without food.

Diovan HCT® (valsartan and hydrochlorothiazide, USP) is available as tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. All strengths are packaged in bottles of 90 tablets and unit dose blister packages.

80/12.5 mg Tablet - Light orange, ovaloid with slightly convex faces debossed CG on one side and HGH on the other side.

Bottles of 90........................NDC 0078-0314-34
Unit Dose (blister pack)...............NDC 0078-0314-06
  Box of 100 (strips of 10)

160/12.5 mg Tablet - Dark red, ovaloid with slightly convex faces debossed CG on one side and HHH on the other side.

Bottles of 90................NDC 0078-0315-34
Unit Dose (blister pack).............NDC 0078-0315-06
  Box of 100 (strips of 10)

160/25 mg Tablet - Brown orange, ovaloid with slightly convex faces debossed NVR on one side and HXH on the other side.

Bottles of 90..................NDC 0078-0383-34
Unit Dose (blister pack)..............NDC 0078-0383-06
  Box of 100 (strips of 10)

320/12.5 mg Tablet - Pink, ovaloid with beveled edge, debossed NVR on one side and HIL on the other side.

Bottles of 90................NDC 0078-0471-34
Unit Dose (blister pack).............NDC 0078-0471-06
  Box of 100 (strips of 10)

320/25 mg Tablet - Yellow, ovaloid with beveled edge, debossed NVR on one side and CTI on the other side.

Bottles of 90.....................NDC 0078-0472-34
Unit Dose (blister pack)................NDC 0078-0472-06
  Box of 100 (strips of 10)

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Protect from moisture. Dispense in tight container (USP).

Distributed by: Novartis Pharmaceuticals Corp. East Hanover, NJ 07936. NOVEMBER 2006. FDA rev date: 9/6/2007

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