Hydrochlorothiazide and Losartan

HYZAAR is a combination of losartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide, a diuretic indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. 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.

Losartan Potassium Angiotensin II [formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II)], is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Losartan and its principal active metabolite block the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT 1 receptor found in many tissues (e.g., vascular smooth muscle, adrenal gland). There is also an AT 2 receptor found in many tissues but it is not known to be associated with cardiovascular homeostasis.

Hypertension Usual starting dose: 50/12.5 mg once daily. Titrate as needed to a maximum dose of 100/25 mg. Hypertensive Patients with Left Ventricular Hypertrophy Not controlled on monotherapy: Initiate with 50/12.5 mg. Titrate as needed to a maximum of 100/25 mg.

HYZAAR is contraindicated: In patients who are hypersensitive to any component of this product. In patients with anuria For coadministration with aliskiren in patients with diabetes Hypersensitivity to any component of HYZAAR. Anuria. Coadministration with aliskiren in patients with diabetes.

Boxed 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. Hypotension: Correct volume or salt depletion prior to administration of HYZAAR. Monitor renal function and potassium in susceptible patients. Observe for clinical signs of fluid or electrolyte imbalance. Acute angle-closure glaucoma. Exacerbation of systemic lupus erythematosus.

Most common adverse reactions (incidence ≥2% and greater than placebo) are dizziness, upper respiratory infection, cough, and back pain.

Agents increasing serum potassium: Risk of hyperkalemia. Lithium: Risk of lithium toxicity. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): increased risk of renal impairment and reduced diuretic, natriuretic, and antihypertensive effects. Dual inhibition of the renin-angiotensin system: increased risk of renal impairment, hypotension, syncope, and hyperkalemia. Antidiabetic drugs: dosage adjustment of antidiabetic may be required. Cholestyramine and colestipol: Reduced absorption of thiazides.

Store at 77°F (25°C), excursions permitted to 59°F to 86°F (15°C to 30°C). Protect from light.