Benicar and Benicar HCT are indicated for the treatment of hypertension. Benicar lowers blood pressure by blocking the angiotensin II receptor. It also interrupts the release of the hormone which causes salt retention and increased blood volume. Benicar HCT combines Benicar with the diuretic (water pill) hydrochlorothiazide for additional blood pressure lowering.

Important Safety Information

USE IN PREGNANCY
When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, BENICAR or BENICAR HCT should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality in the prescribing information.

Hypotension in Volume- or Salt-Depleted Patients

In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (eg, those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with BENICAR. Treatment should start under close medical supervision. If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.

Impaired Renal Function

In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen (BUN) have been reported. There has been no long-term use of olmesartan medoxomil in patients with unilateral or bilateral renal artery stenosis, but similar results may be expected.

The prescribing information for Benicar HCT also includes the following warnings regarding its hydrochlorothiazide component:

Benicar HCT is not recommended in patients with severe renal impairment and is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.

Fetal/Neonatal Morbidity and Mortality

Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

Hepatic Impairment

Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Hypersensitivity Reaction

Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.

Systemic Lupus Erythematosus

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

Lithium Interaction

Lithium generally should not be given with thiazides.

Adverse Events

The withdrawal rates due to adverse events (AEs) were similar with BENICAR and BENICAR HCT to placebo: BENICAR (2.4% vs 2.7%); BENICAR HCT (2.0% vs 2.0%).

The incidence of AEs with BENICAR and BENICAR HCT was similar to placebo.

• The only AE that occurred in >1% of patients treated with BENICAR and more frequently than placebo was dizziness (3% vs 1%).
• AEs reported in >2% of patients taking BENICAR HCT and more frequently than placebo included nausea (3% vs 0%), hyperuricemia (4% vs 2%), dizziness (9% vs 2%), and upper respiratory tract infection (7% vs 0%).

Dosing and Administration

No initial dosage adjustments necessary with BENICAR in elderly or in moderate to marked renal impairment*/hepatic dysfunction.

In patients with possible depletion of intravascular volume (eg, patients on diuretics, particularly with impaired renal function), BENICAR should be initiated under close medical supervision and consideration given to use of a lower starting dose.

For BENICAR HCT, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosage range.

*Creatinine clearance <40 mL/min.
Please see full prescribing information for BENICAR and BENICAR HCT.