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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 are recommended 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
Please see full prescribing information for BENICAR and BENICAR HCT.

About Daiichi Sankyo, Inc.
Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is the U.S. subsidiary of Daiichi Sankyo Co., Ltd., Japan's second largest pharmaceutical company and a global leader in pharmaceutical innovation since 1899. The company is dedicated to the discovery, development and commercialization of innovative medicines that improve the lives of patients throughout the world.

The primary focus of Daiichi Sankyo's research and development is cardiovascular disease, including therapies for dyslipidemia, hypertension, diabetes, and acute coronary syndrome. The company is also pursuing the discovery of new medicines in the areas of glucose metabolic disorders, infectious diseases, cancer, bone and joint diseases, and immune disorders. For more information, please visit www.dsus.com.