Daiichi Sankyo Benicar

What it is used for

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. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Preven

How it is taken

2 DOSAGE AND ADMINISTRATION The recommended starting dose of olmesartan medoxomil and hydrochlorothiazide is 40/12.5 mg once daily in patients whose blood pressure is not adequately controlled with olmesartan monotherapy. Dose can be titrated up to 40 /25 mg if necessary. The recommended starting dose of olmesartan medoxomil and hydrochlorothiazide is 20/12.5 mg once daily in patients whose blood pressure is not adequately controlled with HCT monotherapy or who experience dose-limiting adverse reactions with hydrochlorothiazide. Dose can be titrated up to 40 /25 mg if necessary. Patients titrated to the individual components (olmesartan and hydrochlorothiazide) may instead receive the corresponding dose of olmesartan medoxomil and hydrochlorothiazide. Recommended starting dose in patients not adequately controlled with olmesartan monotherapy, 40/12.5 mg ( 2 ) Recommended starting dose in patients not adequately controlled with hydrochlorothiazide monotherapy, 20/12.5 mg ( 2 ) Adjust dose after 2 to 4 weeks, as needed, to a maximum of 40 mg / 25 mg olmesartan / hydrochlorothiazide ( 2 )

Warnings

5 WARNINGS AND PRECAUTIONS Hypotension: Correct volume-depletion prior to administration. ( 5.2 ) Monitor renal function and potassium in susceptible patients ( 5.3 ) Observe for signs of fluid or electrolyte imbalance. ( 5.4 ) Acute angle-closure glaucoma ( 5.5 ) Sprue-like enteropathy has been reported. Consider discontinuation of olmesartan medoxomil and hydrochlorothiazide in cases where no other etiology is found ( 5.7 ) 5.1 Fetal Toxicity Pregnancy Category D 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 olmesartan medoxomil and hydrochlorothiazide as soon as possible [ see Use in Specific Populations (8.1) ]. Thiazides cross the placental barrier and appear in cord blood. Adverse reactions include fetal or neonatal jaundice and thrombocytopenia [ s ee Use in Specific Populations (8.1) ] . 5.2

Source: openFDA / DailyMed. Provided for information only — always follow the directions given by your own prescriber.