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.

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).

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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

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

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

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Valsartan And Hydrochlorothiazide Manufacturers

Remedyrepack Inc.

Valsartan And Hydrochlorothiazide | Remedyrepack Inc.

Dose once daily. Titrate as needed to a maximum dose of 320/25mg (2)
May be used as add-on/switch therapy for patients not adequately controlled on any of the components (valsartan or HCTZ) (2) May be substituted for titrated components (2.3)

The usual starting dose is valsartan and hydrochlorothiazide tablets USP, 160/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320/25 tablet once daily as needed to control blood pressure [see CLINICAL STUDIES (14.2)]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.

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 valsartan and hydrochlorothiazide tablets USP.

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to valsartan and hydrochlorothiazide tablets USP containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to valsartan and hydrochlorothiazide tablets USP 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.

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

Valsartan and hydrochlorothiazide tablets USP are not recommended as initial therapy in patients with intravascular volume depletion [see WARNINGS AND PRECAUTIONS (5.2)].

Valsartan and hydrochlorothiazide tablets USP may be administered with other antihypertensive agents.

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Proficient Rx Lp

Valsartan And Hydrochlorothiazide | Supervalu Inc

• for itching of skin irritation, inflammation, and rashes: • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily • children under 2 years of age: do not use, ask a doctor • for external anal and genital itching, adults: • when practical, clean the affected area with mild soap and warm water and rinse thoroughly • gently dry by patting or blotting with toilet tissue or a soft cloth before applying • apply to affected area not more than 3 to 4 times daily • children under 12 years of age: ask a doctor

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Proficient Rx Lp

Valsartan And Hydrochlorothiazide | Proficient Rx Lp

2.1 General Considerations
The usual starting dose is valsartan and hydrochlorothiazide tablets 160 mg/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320 mg/25 mg tablet once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.
2.2 Add-On Therapy
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 valsartan and hydrochlorothiazide tablets.

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to valsartan and hydrochlorothiazide tablets containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to valsartan and hydrochlorothiazide tablets 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 mg/25 mg.
2.3 Replacement Therapy
Valsartan and hydrochlorothiazide tablets may be substituted for the titrated components.
2.4 Initial Therapy
Valsartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].
2.5 Use with Other Antihypertensive Drugs
Valsartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

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Proficient Rx Lp

Valsartan And Hydrochlorothiazide | Proficient Rx Lp

2.1 General Considerations
The usual starting dose is valsartan and hydrochlorothiazide tablets 160/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320/25 tablet once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.
2.2 Add-On Therapy
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 valsartan and hydrochlorothiazide tablets.

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to valsartan and hydrochlorothiazide tablets containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to valsartan and hydrochlorothiazide tablets 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.
2.3 Replacement Therapy
Valsartan and hydrochlorothiazide tablets may be substituted for the titrated components.
2.4 Initial Therapy
Valsartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].
2.5 Use with Other Antihypertensive Drugs
Valsartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

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Sandoz Inc

Valsartan And Hydrochlorothiazide | Sandoz Inc

2.1     General Considerations
The usual starting dose is Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320/25 tablet once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.
2.2     Add-On Therapy
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 valsartan and hydrochlorothiazide.

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to valsartan and hydrochlorothiazide containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to valsartan and hydrochlorothiazide 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.
2.3     Replacement Therapy
Valsartan and Hydrochlorothiazide Tablets, USP may be substituted for the titrated components.
2.4     Initial Therapy
Valsartan and Hydrochlorothiazide Tablets, USP are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].
2.5     Use with Other Antihypertensive Drugs
Valsartan and Hydrochlorothiazide Tablets, USP may be administered with other antihypertensive agents.

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American Health Packaging

Valsartan And Hydrochlorothiazide | Novartis Pharmaceuticals Corporation

2.1       Recommended Dosage Range
The recommended dosage range of SIGNIFOR is 0.3 to 0.9 mg by subcutaneous injection twice a day. The recommended initial dose is either 0.6 mg or 0.9 mg twice a day. Titrate dose based on response and tolerability.

Patients should be evaluated for a treatment response [clinically meaningful reduction in 24-hour urinary free cortisol (UFC) levels and/or improvement in signs or symptoms of the disease] and should continue receiving therapy with SIGNIFOR as long as benefit is derived [see Clinical Studies (14)]. Maximum urinary free cortisol reduction is typically seen by two months of treatment [see Clinical Studies (14)]. For patients who are started on 0.6 mg twice a day, a dosage increase to 0.9 mg twice a day may be considered based on the response to the treatment, as long as the 0.6 mg dosage is well tolerated by the patient.

Management of suspected adverse reactions may require temporary dose reduction of SIGNIFOR. Dose reduction by 0.3 mg decrements per injection is suggested.
2.2       Recommendations Prior to Initiation of SIGNIFOR
Prior to the start of SIGNIFOR, patients should have baseline levels of the following:
fasting plasma glucose [see Warnings and Precautions (5.2)]
hemoglobin A1c [see Warnings and Precautions (5.2)]
liver tests [see Warnings and Precautions (5.4)] serum potassium and magnesium levels [see Warnings and Precautions (5.3)]
Patients should also have a baseline electrocardiogram and gallbladder ultrasound [see Warnings and Precautions (5.3, 5.5)].

Treatment of patients with poorly controlled diabetes mellitus should be intensively optimized with anti-diabetic therapy prior to starting SIGNIFOR [see Warnings and Precautions (5.2)].
2.3       Dosage in Patients with Hepatic Impairment
For patients with moderate hepatic impairment (Child-Pugh B), the recommended initial dosage is 0.3 mg twice a day and the maximum dosage is 0.6 mg twice a day. Avoid the use of SIGNIFOR in patients with severe hepatic impairment (Child-Pugh C) [see Use in Specific Populations (8.6)].
2.4       Important Administration Instructions
Instruct patients to:
Refer to the FDA-approved patient labeling (Instructions for Use) for detailed administration instructions.
Prior to injection, visually inspect the product for particulate matter and discoloration. Do not use if particulates and/or discoloration are observed.
Avoid injection in sites showing signs of inflammation or irritation.
Prior to injection, gently pinch the skin at the injection site and hold the needle/syringe at an angle of approximately 45 degrees.
Administer SIGNIFOR subcutaneously by self-injection into the top of the thigh or the abdomen.
Avoid multiple subcutaneous injections at the same site within short periods of time. Use of the same injection site for two consecutive injections is not recommended.

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Qualitest Pharmaceuticals

Valsartan And Hydrochlorothiazide | Qualitest Pharmaceuticals

2.1 General Considerations
The usual starting dose is valsartan and hydrochlorothiazide tablet 160/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320/25 tablet once daily as needed to control blood pressure [see Clinical Studies (14.2)].

Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.
2.2 Add-On Therapy
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 valsartan and hydrochlorothiazide tablet.
A patient who experiences dose-limiting adverse reactions on either component alone may be switched to valsartan and hydrochlorothiazide tablet containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to valsartan and hydrochlorothiazide tablet 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.
2.3 Replacement Therapy
Valsartan and hydrochlorothiazide tablet may be substituted for the titrated components.
2.4 Initial Therapy
Valsartan and hydrochlorothiazide tablet is not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].
2.5 Use with Other Antihypertensive Drugs
Valsartan and hydrochlorothiazide tabletmay be administered with other antihypertensive agents.

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Mylan Institutional Inc.

Valsartan And Hydrochlorothiazide | Devita Int'l Inc.

Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply every 90 minutes and immediately after swimming, sweating or towel drying. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other skin protection measures including: Limit time in the sun, espesially from 10 a.m.-2 p.m.; wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months: ask a doctor

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Watson Laboratories, Inc.

Valsartan And Hydrochlorothiazide | Watson Laboratories, Inc.

2.1 General Considerations
The usual starting dose is valsartan and hydrochlorothiazide tablets 160 mg/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320 mg/25 mg tablet once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.
2.2 Add-On Therapy
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 valsartan and hydrochlorothiazide tablets.

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to valsartan and hydrochlorothiazide tablets containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to valsartan and hydrochlorothiazide tablets 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 mg/25 mg.
2.3 Replacement Therapy
Valsartan and hydrochlorothiazide tablets may be substituted for the titrated components.
2.4 Initial Therapy
Valsartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].
2.5 Use with Other Antihypertensive Drugs
Valsartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

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Dispensing Solutions, Inc.

Valsartan And Hydrochlorothiazide | Dispensing Solutions, Inc.

2.1 General Considerations
The usual starting dose is valsartan and hydrochlorothiazide tablets USP, 160/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320/25 tablet once daily as needed to control blood pressure [see CLINICAL STUDIES (14.2)]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.
2.2 Add-On Therapy
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 valsartan and hydrochlorothiazide tablets USP.

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to valsartan and hydrochlorothiazide tablets USP containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to valsartan and hydrochlorothiazide tablets USP 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.
2.3 Replacement Therapy
Valsartan and hydrochlorothiazide tablets USP may be substituted for the titrated components.
2.4 Initial Therapy
Valsartan and hydrochlorothiazide tablets USP are not recommended as initial therapy in patients with intravascular volume depletion [see WARNINGS AND PRECAUTIONS (5.2)].
2.5 Use with Other Antihypertensive Drugs
Valsartan and hydrochlorothiazide tablets USP may be administered with other antihypertensive agents.

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Dispensing Solutions, Inc.

Valsartan And Hydrochlorothiazide | Dispensing Solutions, Inc.

2.1 General Considerations
The usual starting dose is valsartan and hydrochlorothiazide tablets 160/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320/25 tablet once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.
2.2 Add-On Therapy
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 valsartan and hydrochlorothiazide.

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to valsartan and hydrochlorothiazide containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to valsartan and hydrochlorothiazide 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.
2.3 Replacement Therapy
Valsartan and hydrochlorothiazide may be substituted for the titrated components.
2.4 Initial Therapy
Valsartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].
2.5 Use with Other Antihypertensive Drugs
Valsartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

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Remedyrepack Inc.

Valsartan And Hydrochlorothiazide | Remedyrepack Inc.

Dose once daily. Titrate as needed to a maximum dose of 320 mg/25 mg (2)
May be used as add-on/switch therapy for patients not adequately controlled on any of the components (valsartan or HCTZ) (2)
May be substituted for titrated components (2.3)

The usual starting dose is valsartan and hydrochlorothiazide tablets 160 mg/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320 mg/25 mg tablet once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.

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 valsartan and hydrochlorothiazide tablets.

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to valsartan and hydrochlorothiazide tablets containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to valsartan and hydrochlorothiazide tablets 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 mg/25 mg.

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

Valsartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].

Valsartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

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Remedyrepack Inc.

Valsartan And Hydrochlorothiazide | Remedyrepack Inc.

Dose once daily. Titrate as needed to a maximum dose of 320 mg/25 mg (2)
May be used as add-on/switch therapy for patients not adequately controlled on any of the components (valsartan or HCTZ) (2)
May be substituted for titrated components (2.3)

The usual starting dose is valsartan and hydrochlorothiazide tablets 160 mg/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320 mg/25 mg tablet once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.

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 valsartan and hydrochlorothiazide tablets.

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to valsartan and hydrochlorothiazide tablets containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to valsartan and hydrochlorothiazide tablets 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 mg/25 mg.

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

Valsartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].

Valsartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

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Lake Erie Medical Dba Quality Care Products Llc

Valsartan And Hydrochlorothiazide | Lake Erie Medical Dba Quality Care Products Llc

2.1 General Considerations
The usual starting dose is valsartan and hydrochlorothiazide tablets USP, 160/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320/25 tablet once daily as needed to control blood pressure [see CLINICAL STUDIES (14.2)]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.
2.2 Add-On Therapy
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 valsartan and hydrochlorothiazide tablets USP.

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to valsartan and hydrochlorothiazide tablets USP containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to valsartan and hydrochlorothiazide tablets USP 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.
2.3 Replacement Therapy
Valsartan and hydrochlorothiazide tablets USP may be substituted for the titrated components.
2.4 Initial Therapy
Valsartan and hydrochlorothiazide tablets USP are not recommended as initial therapy in patients with intravascular volume depletion [see WARNINGS AND PRECAUTIONS (5.2)].
2.5 Use with Other Antihypertensive Drugs
Valsartan and hydrochlorothiazide tablets USP may be administered with other antihypertensive agents.

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Mylan Pharmaceuticals Inc.

Valsartan And Hydrochlorothiazide | Letco Medical

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Macleods Pharmaceuticals Limited

Valsartan And Hydrochlorothiazide | Macleods Pharmaceuticals Limited

2.1 General Considerations
The usual starting dose is valsartan and hydrochlorothiazide tablets 160/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320/25 tablet once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.
2.2 Add-On Therapy
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 valsartan and hydrochlorothiazide tablets.

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to valsartan and hydrochlorothiazide tablets containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to valsartan and hydrochlorothiazide tablets 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.

2.3 Replacement Therapy
Valsartan and hydrochlorothiazide tablets may be substituted for the titrated components.
2.4 Initial Therapy
Valsartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].
2.5 Use with Other Antihypertensive Drugs
Valsartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

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Lupin Pharmaceuticals, Inc.

Valsartan And Hydrochlorothiazide | Lupin Pharmaceuticals, Inc.

2.1 General Considerations
The usual starting dose is valsartan and hydrochlorothiazide tablets USP, 160/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320/25 tablet once daily as needed to control blood pressure [see CLINICAL STUDIES (14.2)]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.
2.2 Add-On Therapy
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 valsartan and hydrochlorothiazide tablets USP.

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to valsartan and hydrochlorothiazide tablets USP containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to valsartan and hydrochlorothiazide tablets USP 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.
2.3 Replacement Therapy
Valsartan and hydrochlorothiazide tablets USP may be substituted for the titrated components.
2.4 Initial Therapy
Valsartan and hydrochlorothiazide tablets USP are not recommended as initial therapy in patients with intravascular volume depletion [see WARNINGS AND PRECAUTIONS (5.2)].
2.5 Use with Other Antihypertensive Drugs
Valsartan and hydrochlorothiazide tablets USP may be administered with other antihypertensive agents.

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Aurobindo Pharma Limited

Valsartan And Hydrochlorothiazide | Aurobindo Pharma Limited

2.1 General Considerations
The usual starting dose is valsartan and hydrochlorothiazide tablets 160 mg/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320 mg/25 mg tablet once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.
2.2 Add-On Therapy
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 valsartan and hydrochlorothiazide tablets.

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to valsartan and hydrochlorothiazide tablets containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to valsartan and hydrochlorothiazide tablets 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 mg/25 mg.
2.3 Replacement Therapy
Valsartan and hydrochlorothiazide tablets may be substituted for the titrated components.
2.4 Initial Therapy
Valsartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].
2.5 Use with Other Antihypertensive Drugs
Valsartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

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Apotex Corp.

Valsartan And Hydrochlorothiazide | Ritedose Pharmaceuticals, Llc

The recommended dose of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is one 3 mL vial administered 4 times per day via nebulization with up to 2 additional 3 mL doses allowed per day, if needed. Safety and efficacy of additional doses or increased frequency of administration of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution beyond these guidelines has not been studied and the safety and efficacy of extra doses of albuterol sulfate or ipratropium bromide in addition to the recommended doses of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution have not been studied.

The use of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution can be continued as medically indicated to control recurring bouts of bronchospasm. If a previously effective regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of worsening COPD, which would require reassessment of therapy.

A Pari-LC-Plus™ nebulizer (with face mask or mouthpiece) connected to a PRONEB™ compressor was used to deliver Ipratropium Bromide and Albuterol Sulfate Inhalation Solution to each patient in one U.S. clinical study. The safety and efficacy of Ipratropium Bromide and Albuterol Sulfate Inhalation Solution delivered by other nebulizers and compressors have not been established.

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be administered via jet nebulizer connected to an air compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask.

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Northwind Pharmaceuticals

Valsartan And Hydrochlorothiazide | Northwind Pharmaceuticals

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Bryant Ranch Prepack

Valsartan And Hydrochlorothiazide | Bryant Ranch Prepack

2.1 General Considerations
The usual starting dose is valsartan and hydrochlorothiazide tablets 160 mg/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320 mg/25 mg tablet once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.
2.2 Add-On Therapy
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 valsartan and hydrochlorothiazide tablets.

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to valsartan and hydrochlorothiazide tablets containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to valsartan and hydrochlorothiazide tablets 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 mg/25 mg.
2.3 Replacement Therapy
Valsartan and hydrochlorothiazide tablets may be substituted for the titrated components.
2.4 Initial Therapy
Valsartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].
2.5 Use with Other Antihypertensive Drugs
Valsartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

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Bryant Ranch Prepack

Valsartan And Hydrochlorothiazide | Bryant Ranch Prepack

2.1 General Considerations
The usual starting dose is valsartan and hydrochlorothiazide tablets 160 mg/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320 mg/25 mg tablet once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.
2.2 Add-On Therapy
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 valsartan and hydrochlorothiazide tablets.

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to valsartan and hydrochlorothiazide tablets containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to valsartan and hydrochlorothiazide tablets 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 mg/25 mg.
2.3 Replacement Therapy
Valsartan and hydrochlorothiazide tablets may be substituted for the titrated components.
2.4 Initial Therapy
Valsartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].
2.5 Use with Other Antihypertensive Drugs
Valsartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

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Avkare, Inc.

Valsartan And Hydrochlorothiazide | Avkare, Inc.

2.1 General Considerations
The usual starting dose is valsartan and hydrochlorothiazide tablets 160 mg/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320 mg/25 mg tablet once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.
2.2 Add-On Therapy
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 valsartan and hydrochlorothiazide tablets.

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to valsartan and hydrochlorothiazide tablets containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to valsartan and hydrochlorothiazide tablets 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 mg/25 mg.
2.3 Replacement Therapy
Valsartan and hydrochlorothiazide tablets may be substituted for the titrated components.
2.4 Initial Therapy
Valsartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].
2.5 Use with Other Antihypertensive Drugs
Valsartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

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Proficient Rx Lp

Valsartan And Hydrochlorothiazide | Proficient Rx Lp

2.1 General Considerations
The usual starting dose is valsartan and hydrochlorothiazide tablets 160 mg/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 320 mg/25 mg tablet once daily as needed to control blood pressure [see Clinical Studies (14.2)]. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose.
2.2 Add-On Therapy
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 valsartan and hydrochlorothiazide tablets.

A patient who experiences dose-limiting adverse reactions on either component alone may be switched to valsartan and hydrochlorothiazide tablets containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions. The clinical response to valsartan and hydrochlorothiazide tablets 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 mg/25 mg.
2.3 Replacement Therapy
Valsartan and hydrochlorothiazide tablets may be substituted for the titrated components.
2.4 Initial Therapy
Valsartan and hydrochlorothiazide tablets are not recommended as initial therapy in patients with intravascular volume depletion [see Warnings and Precautions (5.2)].
2.5 Use with Other Antihypertensive Drugs
Valsartan and hydrochlorothiazide tablets may be administered with other antihypertensive agents.

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