Generic Hyzaar

What it is used for

1 INDICATIONS AND USAGE Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: • Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) • Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2) • Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3) 1.1 Hypertension Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal 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. Control of high blood pressure should be part of comprehensive car

How it is taken

2 DOSAGE AND ADMINISTRATION Hypertension • Usual adult dose: 50 mg once daily. (2.1) • Usual pediatric starting dose: 0.7 mg per kg once daily (up to 50 mg). (2.1) Hypertensive Patients with Left Ventricular Hypertrophy • Usual starting dose: 50 mg once daily. (2.2) • Add hydrochlorothiazide 12.5 mg and/or increase losartan potassium to 100 mg followed by an increase to hydrochlorothiazide 25 mg if further blood pressure response is needed. (2.2 , 14.2) Nephropathy in Type 2 Diabetic Patients • Usual dose: 50 mg once daily. (2.3) • Increase dose to 100 mg once daily if further blood pressure response is needed. (2.3) 2.1 Hypertension Adult Hypertension The usual starting dose of losartan potassium tablets is 50 mg once daily. The dosage can be increased to a maximum dose of 100 mg once daily as needed to control blood pressure [see Clinical Studies (14.1) ]. A starting dose of 25 mg is recommended for patients with possible intravascular depletion (e.g., on diuretic therapy). Pediatric Hypertension The usual recommended starting dose is 0.7 mg per kg once daily (up to 50 mg total) administered as a tablet or a suspension [see Dosage and Administration (2.5) ]. Dosage should be adju

Warnings

5 WARNINGS AND PRECAUTIONS • Hypotension: Correct volume or salt depletion prior to administration of losartan potassium. (5.2) • Monitor renal function and potassium in susceptible patients. (5.3 , 5.4) 5.1 Fetal Toxicity Losartan potassium can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue losartan potassium as soon as possible [see Use in Specific Populations (8.1) ]. 5.2 Hypotension in Volume- or Salt-Depleted Patients In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with losartan potassium. Correct volume or salt depletion prior to administration of losartan potassium [see

Source: openFDA / DailyMed. Provided for information only — always follow the directions given by your own prescriber.