Indicated for:

Hypertension:

• 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.

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.

HYZAAR may be administered with other antihypertensive agents.

Hypertensive Patients with Left Ventricular Hypertrophy:

• 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.

Do not co-administer aliskiren with HYZAAR in patients with diabetes.

HYZAAR is contraindicated in patients with anuria.

Avoid use of aliskiren with HYZAAR in patients with renal impairment (GFR <60 mL/min).

HYZAAR contains hydrochlorothiazide which can cause hypokalemia, hyponatremia and hypomagnesemia.

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 HYZAAR. Correct volume or salt depletion prior to administration of HYZAAR. Do not use HYZAAR as initial therapy in patients with intravascular volume depletion.

Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on HYZAAR.

Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides.

Hyperuricemia may occur or frank gout may be precipitated in patients receiving thiazide therapy.

Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma.

Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.

Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium.

The antihypertensive effects of the drug may be enhanced in the post-sympathectomy patient.

Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of angiotensin II receptor antagonists or thiazide diuretics.

Concomitant use of other drugs that may increase serum potassium may lead to hyperkalemia.

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised
renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II
receptor antagonists (including losartan) may result in deterioration of renal function, including possible
acute renal failure.

The antihypertensive effect of angiotensin II receptor antagonists, including losartan, may be attenuated by NSAIDs, including selective COX-2 inhibitors.

The administration of a non-steroidal anti-inflammatory agent including a selective COX-2 inhibitor can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics.

Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy.

Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively. Stagger the dosage of hydrochlorothiazide and the resin such that hydrochlorothiazide is administered at least 4 hours before or 4 to 6 hours after the administration of the resin.

HYZAAR 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 HYZAAR as soon as possible.

It is not known whether losartan is excreted in human milk, but significant levels of losartan and its active
metabolite were shown to be present in rat milk. Thiazides appear in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

GoToSource

• Use in patients under 18 years of age. GoToSource

Increased risk of cancer. GoToSource

New-onset diabetes. GoToSource

Angioedema (rapid swelling), agranulocytosis (reduced white blood cells), thrombocytopenia (low blood platelet count) and lichen planus (skin disease). GoToSource 

Fetal and neonatal morbidity and death. GoToSource

Hyperkalemia (high potassium level). GoToSource

Hypotension (low blood pressure). GoToSource

Syncope (sudden loss of consciousness). GoToSource

Acute transient myopia (nearsightedness). GoToSource

Liver injury. GoToSource

Hyponatremia (low blood sodium level). GoToSource

Gout. GoToSource

Hypomagnesemia (low blood magnesium level). GoToSource

Acute angle-closure glaucoma. GoToSource

Lawsuits filed for cancer-causing impurities in Losartan.