HYZAAR- losartan potassium and hydrochlorothiazide tablet, film coated
Merck Sharp & Dohme Corp.
WARNING: FETAL TOXICITY
When pregnancy is detected, discontinue HYZAAR as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1)].
1 INDICATIONS AND USAGE
1.1 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).
DOSAGE AND ADMINISTRATION
2.1 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 (14.2)].
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.
