Valsartan And Hydrochlorothiazide

Valsartan And Hydrochlorothiazide

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Uses

Valsartan and hydrochlorothiazide tablet USP is the combination tablet of valsartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide (HCTZ), a diuretic.

Valsartan and hydrochlorothiazide tablet USP is indicated for the treatment of hypertension, to lower blood pressure:

  • In patients not adequately controlled with monotherapy (1)
  • As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals (1)

Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

 

Valsartan and hydrochlorothiazide tablet USP is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with valsartan and hydrochlorothiazide tablets USP.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality have also been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

 

Add-On Therapy

Valsartan and hydrochlorothiazide tablets USP may be used in patients whose blood pressure is not adequately controlled on monotherapy.

Replacement Therapy

Valsartan and hydrochlorothiazide tablets USP may be substituted for the titrated components.

Initial Therapy

Valsartan and hydrochlorothiazide tablets USP may be used as initial therapy in patients who are likely to need multiple drugs to achieve blood pressure goals.

The choice of valsartan and hydrochlorothiazide tablets USP 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 valsartan and hydrochlorothiazide tablets USP compared to valsartan or hydrochlorothiazide monotherapy. The figures below provide estimates of the likelihood of achieving systolic or diastolic blood pressure control with valsartan and hydrochlorothiazide tablets USP, 320 mg/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.

MM1

For example, a patient with a baseline blood pressure of 160/100 mmHg has about a 41% likelihood of achieving a goal of <140 mmHg (systolic) and 60% likelihood of achieving <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 valsartan and hydrochlorothiazide tablets USP 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

Valsartan and hydrochlorothiazide tablet 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

MM2

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

MM3

Valsartan and hydrochlorothiazide tablets USP are formulated for oral administration to contain valsartan and hydrochlorothiazide, 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, and 320 mg/25 mg. The inactive ingredients of the tablets are colloidal silicon dioxide, croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, titanium dioxide and additional colorants as below.

80 mg/12.5 mg: iron oxide red and iron oxide yellow

160 mg/12.5 mg: iron oxide red

160 mg/25 mg: iron oxide black, iron oxide red and iron oxide yellow

320 mg/12.5 mg: iron oxide black and iron oxide red

320 mg/25 mg: iron oxide yellow

 

Valsartan And Hydrochlorothiazide Manufacturers


  • Remedyrepack Inc.
    Valsartan And Hydrochlorothiazide Tablet, Film Coated [Remedyrepack Inc. ]
  • Proficient Rx Lp
    Valsartan And Hydrochlorothiazide Tablet, Film Coated [Proficient Rx Lp]
  • Proficient Rx Lp
    Valsartan And Hydrochlorothiazide Tablet, Film Coated [Proficient Rx Lp]
  • Proficient Rx Lp
    Valsartan And Hydrochlorothiazide Tablet, Film Coated [Proficient Rx Lp]
  • Sandoz Inc
    Valsartan And Hydrochlorothiazide Tablet, Film Coated [Sandoz Inc]
  • American Health Packaging
    Valsartan And Hydrochlorothiazide Tablet, Film Coated [American Health Packaging]
  • Qualitest Pharmaceuticals
    Valsartan And Hydrochlorothiazide Tablet, Film Coated [Qualitest Pharmaceuticals]
  • Mylan Institutional Inc.
    Valsartan And Hydrochlorothiazide Tablet, Film Coated [Mylan Institutional Inc.]
  • Watson Laboratories, Inc.
    Valsartan And Hydrochlorothiazide Tablet, Film Coated [Watson Laboratories, Inc.]
  • Dispensing Solutions, Inc.
    Valsartan And Hydrochlorothiazide Tablet, Film Coated [Dispensing Solutions, Inc.]
  • Dispensing Solutions, Inc.
    Valsartan And Hydrochlorothiazide Tablet, Film Coated [Dispensing Solutions, Inc.]
  • Remedyrepack Inc.
    Valsartan And Hydrochlorothiazide Tablet, Film Coated [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Valsartan And Hydrochlorothiazide Tablet, Film Coated [Remedyrepack Inc. ]
  • Lake Erie Medical Dba Quality Care Products Llc
    Valsartan And Hydrochlorothiazide Tablet, Film Coated [Lake Erie Medical Dba Quality Care Products Llc]
  • Mylan Pharmaceuticals Inc.
    Valsartan And Hydrochlorothiazide Tablet, Film Coated [Mylan Pharmaceuticals Inc.]
  • Macleods Pharmaceuticals Limited
    Valsartan And Hydrochlorothiazide Tablet, Film Coated Valsartan And Hydrochlorothiazide Tablet [Macleods Pharmaceuticals Limited]
  • Lupin Pharmaceuticals, Inc.
    Valsartan And Hydrochlorothiazide Tablet, Film Coated [Lupin Pharmaceuticals, Inc.]
  • Aurobindo Pharma Limited
    Valsartan And Hydrochlorothiazide Tablet, Film Coated [Aurobindo Pharma Limited]
  • Apotex Corp.
    Valsartan And Hydrochlorothiazide Tablet, Film Coated [Apotex Corp.]
  • Northwind Pharmaceuticals
    Valsartan And Hydrochlorothiazide Tablet [Northwind Pharmaceuticals]
  • Bryant Ranch Prepack
    Valsartan And Hydrochlorothiazide Tablet, Film Coated [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Valsartan And Hydrochlorothiazide Tablet, Film Coated [Bryant Ranch Prepack]
  • Avkare, Inc.
    Valsartan And Hydrochlorothiazide (Valsartan And Hydrochlorothiazide) Tablet, Film Coated [Avkare, Inc.]
  • Proficient Rx Lp
    Valsartan And Hydrochlorothiazide Tablet, Film Coated [Proficient Rx Lp]

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