April 28, 2016
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Hyzaar

"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...

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Hyzaar




Indications
Dosage
How Supplied

INDICATIONS

Hypertension

HYZAAR® is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan and hydrochlorothiazide.

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 also have 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 (for example, 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.

This fixed dose combination is not indicated for initial therapy of hypertension, except when the hypertension is severe enough that the value of achieving prompt blood pressure control exceeds the risk of initiating combination therapy in these patients [see Clinical Studies and DOSAGE AND ADMINISTRATION].

HYZAAR may be administered with other antihypertensive agents.

Hypertensive Patients With Left Ventricular Hypertrophy

HYZAAR is indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients. [See Use In Specific Populations, CLINICAL PHARMACOLOGY, and DOSAGE AND ADMINISTRATION]

DOSAGE AND ADMINISTRATION

Hypertension

The usual starting dose of HYZAAR is 50/12.5 (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily. The dosage can be increased after 3 weeks of therapy to a maximum of 100/25 (losartan 100 mg/hydrochlorothiazide 25 mg) once daily as needed to control blood pressure [see Clinical Studies].

Initiate a patient whose blood pressure is not adequately controlled with losartan 50 mg monotherapy with HYZAAR 50/12.5 once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dosage may be increased to two tablets of HYZAAR 50/12.5 once daily or one tablet of HYZAAR 100/25 once daily.

Initiate a patient whose blood pressure is not adequately controlled with losartan 100 mg monotherapy with HYZAAR 100/12.5 (losartan 100 mg/hydrochlorothiazide 12.5 mg) once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, increase the dose to two tablets of HYZAAR 50/12.5 once daily or one tablet of HYZAAR 100/25 once daily.

Initiate a patient whose blood pressure is inadequately controlled with hydrochlorothiazide 25 mg once daily, or is controlled but who experiences hypokalemia with this regimen, on HYZAAR 50/12.5 once daily, reducing the dose of hydrochlorothiazide without reducing the overall expected antihypertensive response. Evaluate the clinical response to HYZAAR 50/12.5 and, if blood pressure remains uncontrolled after about 3 weeks of therapy, increase the dose to two tablets of HYZAAR 50/12.5 once daily or one tablet of HYZAAR 100/25 once daily.

Hypertensive Patients With Left Ventricular Hypertrophy

In patients whose blood pressure is not adequately controlled on 50 mg losartan potassium, initiate treatment with HYZAAR 50/12.5. If additional blood pressure reduction is needed, increase the dose to HYZAAR 100/12.5, followed by HYZAAR 100/25. For further blood pressure reduction add other antihypertensives [see Clinical Studies].

HOW SUPPLIED

Dosage Forms And Strengths

  • HYZAAR 50/12.5 are yellow, oval, film-coated tablets, with code 717 on one side.
  • HYZAAR 100/12.5 are white, oval, film-coated tablets, with code 745 on one side.
  • HYZAAR 100/25 are light yellow, oval, film-coated tablets, with code 747 on one side.

Storage And Handling

HYZAAR is supplied as a film-coated tablet.

Losartan/ Hydrochlorothiazide Color Shape Engraving NDC 0006-xxxx-xx
Bottle/ 30 Bottle/ 90 Bottle/ 1000
50/12.5 mg yellow oval 717 0717-31 0717-54 0717-82
100/12.5 mg white oval 745 0745-31 0745-54 0745-82
100/25 mg light yellow oval 747 0747-31 0747-54 n/a

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light.

Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. Revised: Dec 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 12/26/2015

Indications
Dosage
How Supplied

Hyzaar - User Reviews

Hyzaar User Reviews

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Hypertension

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