Hydrochlorothiazide

5 mg tablets is indicated in the management of mild to moderate hypertension in patients who have been stabilised on the individual components given in the same proportions.

1 Special Populations ............................................................................................ 15 8 ADVERSE REACTIONS ..................................................................................................

1 Adverse Reaction Overview................................................................................ 2 Clinical Trial Adverse Reactions .......................................................................... 3 Less Common Clinical Trial Adverse Reactions ....................................................

4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ........................................................................................................ 5 Post-Market Adverse Reactions..........................................................................

18 9 DRUG INTERACTIONS.................................................................................................. 1 Serious Drug Interactions ...................................................................................

1 INDICATIONS AND USAGE Olmesartan medoxomil and hydrochlorothiazide is indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide is not indicated for the initial therapy of hypertension [see Dosage and Administration (2) ] .

Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs.

There are no controlled trials demonstrating risk reduction with olmesartan medoxomil and hydrochlorothiazide. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.