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DIOVAN HCT

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Overview

What is DIOVAN HCT?

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

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

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 -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-2-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.

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



What does DIOVAN HCT look like?



What are the available doses of DIOVAN HCT?

Sorry No records found.

What should I talk to my health care provider before I take DIOVAN HCT?

Sorry No records found

How should I use DIOVAN HCT?

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.

The side effects of valsartan are generally rare and appear independent of dose. Those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter [].

Dose once-daily. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.

Diovan HCT may be administered with or without food.

Diovan HCT may be administered with other antihypertensive agents.

Elderly patients

:

 

Renal impairment

:

Hepatic impairment

:

S

ee Impaired Hepatic Function (5.3)

.

A patient whose blood pressure is not adequately controlled with valsartan (or another ARB) alone or hydrochlorothiazide alone may be switched to combination therapy with Diovan HCT.

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to Diovan HCT containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to Diovan HCT should be subsequently evaluated and if blood pressure remains uncontrolled after 3 to 4 weeks of therapy, the dose may be titrated up to a maximum of 320/25 mg.

Diovan HCT may be substituted for the titrated components.


What interacts with DIOVAN HCT?

Sorry No Records found


What are the warnings of DIOVAN HCT?

Sorry No Records found


What are the precautions of DIOVAN HCT?

Sorry No Records found


What are the side effects of DIOVAN HCT?

Sorry No records found


What should I look out for while using DIOVAN HCT?

Diovan HCT (valsartan and hydrochlorothiazide, USP) is contraindicated in patients who are hypersensitive to any component of this product.

Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

When pregnancy is detected,

discontinue

Diovan

HCT

as soon as possible.

Drugs that act directly on the renin

angiotensin system can cause injury and even death to the developing fetus

.

[

See

Warnings and Precautions

(5.1)

]


What might happen if I take too much DIOVAN HCT?

Valsartan – Hydrochlorothiazide

:

Valsartan is not removed from the plasma by dialysis.

The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. The most common signs and symptoms observed in patients are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.

In rats and marmosets, single oral doses of valsartan up to 1524 and 762 mg/kg in combination with hydrochlorothiazide at doses up to 476 and 238 mg/kg, respectively, were very well tolerated without any treatment-related effects. These no adverse effect doses in rats and marmosets, respectively, represent 46.5 and 23 times the maximum recommended human dose (MRHD) of valsartan and 188 and 113 times the MRHD of hydrochlorothiazide on a mg/m basis. (Calculations assume an oral dose of 320 mg/day valsartan in combination with 25 mg/day hydrochlorothiazide and a 60-kg patient.)

Valsartan

:

Hydrochlorothiazide

:


How should I store and handle DIOVAN HCT?

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. strengths are available as follows.80/12.5mg Tablet      Bottles of 90       NDC 0078-0314-34      Unit Dose (blister pack)       NDC 0078-0314-06      Box of 100 (strips of 10)160/12.5mg Tablet      Bottles of 90       NDC 0078-0315-34      Unit Dose (blister pack)       NDC 0078-0315-06      Box of 100 (strips of 10)      Unit Dose (blister Pack of 30)       NDC 0078-0315-15160/25 mgTablet      Bottles of 90       NDC 0078-0383-34      Unit Dose (blister pack)       NDC 0078-0383-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0383-15320/12.5mg Tablet      Bottles of 90       NDC 0078-0471-34      Unit Dose (blister pack)       NDC 0078-0471-06   Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0471-15320/25 mgTablet      Bottles of 90       NDC 0078-0472-34      Unit Dose (blister pack)       NDC 0078-0472-06      Box of 100 (strips of 10)      Unit Dose (blister pack of 30)       NDC 0078-0472-15Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].Protect from moisture.Dispense in tight container (USP).


×

Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

12

 

 

CLINICAL PHARMACOLOGY

12.1

Mechanism of Action

Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation, and renal reabsorption of sodium. Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for angiotensin II synthesis.

There is also an AT receptor found in many tissues, but AT is not known to be associated with cardiovascular homeostasis. Valsartan has much greater affinity (about 20,000-fold) for the AT receptor than for the AT receptor. The primary metabolite of valsartan is essentially inactive with an affinity for the AT receptor about one 200th that of valsartan itself.

Blockade of the renin-angiotensin system with ACE inhibitors, which inhibit the biosynthesis of angiotensin II from angiotensin I, is widely used in the treatment of hypertension. ACE inhibitors also inhibit the degradation of bradykinin, a reaction also catalyzed by ACE. Because valsartan does not inhibit ACE (kininase II) it does not affect the response to bradykinin. Whether this difference has clinical relevance is not yet known. Valsartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.

Blockade of the angiotensin II receptor inhibits the negative regulatory feedback of angiotensin II on renin secretion, but the resulting increased plasma renin activity and angiotensin II circulating levels do not overcome the effect of valsartan on blood pressure.

Hydrochlorothiazide is a thiazide diuretic. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. Indirectly, the diuretic action of hydrochlorothiazide reduces plasma volume, with consequent increases in plasma renin activity, increases in aldosterone secretion, increases in urinary potassium loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II, so coadministration of an angiotensin II receptor antagonist tends to reverse the potassium loss associated with these diuretics.

The mechanism of the antihypertensive effect of thiazides is unknown.

Valsartan

:

Removal of the negative feedback of angiotensin II causes a 2- to 3-fold rise in plasma renin and consequent rise in angiotensin II plasma concentration in hypertensive patients. Minimal decreases in plasma aldosterone were observed after administration of valsartan; very little effect on serum potassium was observed.

In multiple-dose studies in hypertensive patients with stable renal insufficiency and patients with renovascular hypertension, valsartan had no clinically significant effects on glomerular filtration rate, filtration fraction, creatinine clearance, or renal plasma flow.

In multiple-dose studies in hypertensive patients, valsartan had no notable effects on total cholesterol, fasting triglycerides, fasting serum glucose, or uric acid.

Hydrochlorothiazide

Valsartan

:

Hydrochlorothiazide

:

Geriatric

:

See

Dosage and Administration

(2

1

)

Gender

:

Race

:

Renal Insufficiency

:

See

Dosage and Administration

(2

1)

In a study of patients with impaired renal function (mean creatinine clearance of 19 mL/min), the half-life of hydrochlorothiazide elimination was lengthened to 21 hours.

Hepatic Insufficiency

:

See

Dosage and Administration

(2

1)

Distribution

Valsartan

:

Hydrochlorothiazide

:

Metabolism

Valsartan

:

Hydrochlorothiazide

:

Excretion

Valsartan

:

Following intravenous administration, plasma clearance of valsartan is about 2 L/h and its renal clearance is 0.62 L/h (about 30% of total clearance).

Non-Clinical Toxicology
Diovan HCT (valsartan and hydrochlorothiazide, USP) is contraindicated in patients who are hypersensitive to any component of this product.

Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

When pregnancy is detected,

discontinue

Diovan

HCT

as soon as possible.

Drugs that act directly on the renin

angiotensin system can cause injury and even death to the developing fetus

.

[

See

Warnings and Precautions

(5.1)

]

Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

Hypertension

Diovan HCT (valsartan and hydrochlorothiazide, USP) has been evaluated for safety in more than 5,700 patients, including over 990 treated for over 6 months, and over 370 for over 1 year. Adverse experiences have generally been mild and transient in nature and have only infrequently required discontinuation of therapy. The overall incidence of adverse reactions with Diovan HCT was comparable to placebo.

The overall frequency of adverse reactions was neither dose-related nor related to gender, age, or race. In controlled clinical trials, discontinuation of therapy due to side effects was required in 2.3% of valsartan-hydrochlorothiazide patients and 3.1% of placebo patients. The most common reasons for discontinuation of therapy with Diovan HCT were headache and dizziness.

The only adverse reaction that occurred in controlled clinical trials in at least 2% of patients treated with Diovan HCT and at a higher incidence in valsartan-hydrochlorothiazide (n=4372) than placebo (n=262) patients was nasopharyngitis (2.4% vs. 1.9%).

Dose-related orthostatic effects were seen in fewer than 1% of patients. In individual trials, a dose-related increase in the incidence of dizziness was observed in patients treated with Diovan HCT.

Other adverse reactions that have been reported with valsartan-hydrochlorothiazide (>0.2% of valsartan-hydrochlorothiazide patients in controlled clinical trials) without regard to causality, are listed below:

Cardiovascular: Palpitations and tachycardia

Ear and Labyrinth: Tinnitus and vertigo

Gastrointestinal: Dyspepsia, diarrhea, flatulence, dry mouth, nausea, abdominal pain, abdominal pain upper, and vomiting

General and Administration Site Conditions: Asthenia, chest pain, fatigue, peripheral edema and pyrexia

Infections and Infestations: Bronchitis, bronchitis acute, influenza, gastroenteritis, sinusitis, upper respiratory tract infection and urinary tract infection

Investigations: Blood urea increased

Musculoskeletal: Arthralgia, back pain, muscle cramps, myalgia, and pain in extremity

Nervous System: Dizziness postural, paresthesia, and somnolence

Psychiatric: Anxiety and insomnia

Renal and Urinary: Pollakiuria

Reproductive System: Erectile dysfunction

Respiratory, Thoracic and Mediastinal: Dyspnea, cough, nasal congestion, pharyngolaryngeal pain and sinus congestion

Skin and Subcutaneous Tissue: Hyperhidrosis and rash

Vascular: Hypotension

Other reported reactions seen less frequently in clinical trials included abnormal vision, anaphylaxis, bronchospasm, constipation, depression, dehydration, decreased libido, dysuria, epistaxis, flushing, gout, increased appetite, muscle weakness, pharyngitis, pruritus, sunburn, syncope, and viral infection

Valsartan: In trials in which valsartan was compared to an ACE inhibitor with or without placebo, the incidence of dry cough was significantly greater in the ACE inhibitor group (7.9%) than in the groups who received valsartan (2.6%) or placebo (1.5%). In a 129-patient trial limited to patients who had had dry cough when they had previously received ACE inhibitors, the incidences of cough in patients who received valsartan, hydrochlorothiazide, or lisinopril were 20%, 19%, 69% respectively (p less than 0.001).

Other reported reactions seen less frequently in clinical trials included chest pain, syncope, anorexia, vomiting, and angioedema.

Hydrochlorothiazide: Other adverse reactions that have been reported with hydrochlorothiazide, without regard to causality, are listed below:

Body As A Whole: weakness

Digestive: pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation;

Hematologic: aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia;

Hypersensitivity: purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions;

Metabolic: hyperglycemia, glycosuria, hyperuricemia;

Musculoskeletal: muscle spasm;

Nervous System/Psychiatric: restlessness;

Renal: renal failure, renal dysfunction, interstitial nephritis;

Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis;

Special Senses: transient blurred vision, xanthopsia.

Initial Therapy - Hypertension

In a clinical study in patients with severe hypertension (diastolic blood pressure greater than or equal  to 110 mmHg and systolic blood pressure greater than or equal to 140 mmHg), the overall pattern of adverse reactions reported through six weeks of follow-up was similar in patients treated with Diovan HCT as initial therapy and in patients treated with valsartan as initial therapy. Comparing the groups treated with Diovan HCT (force-titrated to 320/25 mg) and valsartan (force-titrated to 320 mg), dizziness was observed in 6% and 2% of patients, respectively. Hypotension was observed in 1% of those patients receiving Diovan HCT and 0% of patients receiving valsartan. There were no reported cases of syncope in either treatment group. Laboratory changes with Diovan HCT as initial therapy in patients with severe hypertension were similar to those reported with Diovan HCT in patients with less severe hypertension [See Clinical Studies (14.2) and Drug Interactions (7.3)].

The following additional adverse reactions have been reported in valsartan or valsartan/hydrochlorothiazide postmarketing experience:      

Hypersensitivity: There are rare reports of angioedema;

Digestive: Elevated liver enzymes and very rare reports of hepatitis;

Renal: Impaired renal function;

Clinical Laboratory Tests: Hyperkalemia;

Dermatologic: Alopecia;

Vascular: Vasculitis;

Nervous System: Syncope.

Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure

×

Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

Tips

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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).