Diovan Hct

Diovan Hct

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Uses


INDICATIONS AND USAGE

Diovan HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension.

Diovan HCT may be used in patients whose blood pressure is not adequately controlled on monotherapy.

Diovan HCT may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals.

The choice of Diovan HCT as initial therapy for hypertension should be based on an assessment of potential benefits and risks.

Patients with stage 2 hypertension are at a relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and should be shaped by considerations such as baseline blood pressure, the target goal and the incremental likelihood of achieving goal with a combination compared to monotherapy. Individual blood pressure goals may vary based upon the patient’s risk.


Data from the high dose multifactorial trial [See Clinical Studies (14.1)] provides estimates of the probability of reaching a target blood pressure with Diovan HCT compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with Diovan HCT 320/25 mg, based upon baseline systolic or diastolic blood pressure. The curve of each treatment group was estimated by logistic regression modeling. The estimated likelihood at the right tail of each curve is less reliable due to small numbers of subjects with high baseline blood pressures.

CHARTS
For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of less than 140 mmHg (systolic) and 60% likelihood of achieving less than 90 mmHg (diastolic) on valsartan alone and the likelihood of achieving these goals on HCTZ alone is about 50% (systolic) or 57% (diastolic). The likelihood of achieving these goals on Diovan HCT rises to about 84% (systolic) or 80% (diastolic). The likelihood of achieving these goals on placebo is about 23% (systolic) or 36% (diastolic).

History

There is currently no drug history available for this drug.

Other Information

11     DESCRIPTION

Diovan HCT (valsartan and hydrochlorothiazide, USP) is a combination of valsartan, an orally active, specific angiotensin II receptor blocker (ARB) acting on the AT1 receptor subtype, and hydrochlorothiazide, a diuretic.

Valsartan, a nonpeptide molecule, is chemically described as N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl)[1,1′-biphenyl]-4-yl]methyl]-L-Valine. Its empirical formula is C24H29N5O3, its molecular weight is 435.5, and its structural formula is

VALARTAN STRUCTURE

Valsartan is a white to practically white fine powder. It is soluble in ethanol and methanol and slightly soluble in water.

Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.

Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is

HYDROCHLOROTHIAZIDE STRUCTURE

Diovan HCT tablets are formulated for oral administration to contain valsartan and hydrochlorothiazide, USP 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.

Diovan Hct Manufacturers


  • Stat Rx Usa Llc
    Diovan Hct (Hydrochlorothiazide, Valsartan) Tablet, Film Coated [Stat Rx Usa Llc]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Diovan Hct (Valsartan And Hydrochlorothiazide) Tablet, Film Coated [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Pd-rx Pharmaceuticals, Inc.
    Diovan Hct (Valsartan And Hydrochlorothiazide) Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
  • Physicians Total Care, Inc.
    Diovan Hct (Valsartan And Hydrochlorothiazide) Tablet, Film Coated [Physicians Total Care, Inc.]
  • Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
    Diovan Hct (Valsartan And Hydrochlorothiazide) Tablet, Film Coated [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]
  • Pd-rx Pharmaceuticals, Inc.
    Diovan Hct (Valsartan And Hydrochlorothiazide) Tablet, Film Coated [Pd-rx Pharmaceuticals, Inc.]
  • Dispensing Solutions, Inc.
    Diovan Hct (Valsartan And Hydrochlorothiazide) Tablet, Film Coated [Dispensing Solutions, Inc.]
  • Dispensing Solutions, Inc.
    Diovan Hct (Valsartan And Hydrochlorothiazide) Tablet, Film Coated [Dispensing Solutions, Inc.]
  • Lake Erie Medical Dba Quality Care Products Llc
    Diovan Hct (Valsartan And Hydrochlorothiazide) Tablet, Film Coated [Lake Erie Medical Dba Quality Care Products Llc]
  • Cardinal Health
    Diovan Hct (Valsartan And Hydrochlorothiazide) Tablet, Film Coated [Cardinal Health]
  • Dispensing Solutions, Inc.
    Diovan Hct (Valsartan And Hydrochlorothiazide) Tablet, Film Coated [Dispensing Solutions, Inc.]
  • Novartis Pharmaceuticals Corporation
    Diovan Hct (Valsartan And Hydrochlorothiazide) Tablet, Film Coated [Novartis Pharmaceuticals Corporation]

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