Hydrochlorothiazide and Olmesartan

BENICAR HCT (olmesartan medoxomil and hydrochlorothiazide) is indicated for the treatment of hypertension, to lower blood pressure. BENICAR HCT is not indicated for the initial therapy of hypertension. 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 BENICAR HCT. 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.

Olmesartan medoxomil Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II). Angiotensin II is the principal pressor agent of the renin-angiotensin system, with effects that include vasoconstriction, stimulation of synthesis and release of aldosterone, cardiac stimulation and renal reabsorption of sodium. Olmesartan blocks the vasoconstrictor effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT 1 receptor in vascular smooth muscle. Its action is, therefore, independent of the pathways for angiotensin II synthesis. An AT 2 receptor is found also in many tissues, but this receptor is not known to be associated with cardiovascular homeostasis. Olmesartan has more than a 12,500-fold greater affinity for the AT 1 receptor than for the AT 2 receptor.

The recommended starting dose of BENICAR HCT 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 BENICAR HCT 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. Patients titrated to the individual components (olmesartan and hydrochlorothiazide) may instead receive the corresponding dose of BENICAR HCT.

BENICAR HCT is contraindicated: In patients with hypersensitivity to any component of BENICAR HCT In patients with anuria For coadministration with aliskiren in patients with diabetes [ s ee Drug Interactions ]. Hypersensitivity to any component of BENICAR HCT. Anuria. Do not co-administer aliskiren with BENICAR HCT in patients with diabetes.

Boxed warning (fetal toxicity): When pregnancy is detected, discontinue BENICAR HCT 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-depletion prior to administration. Monitor renal function and potassium in susceptible patients. Observe for signs of fluid or electrolyte imbalance. Acute angle-closure glaucoma. Sprue-like enteropathy has been reported. Consider discontinuation of Benicar HCT in cases where no other etiology is found

The following adverse reactions with BENICAR HCT are described elsewhere: Hypotension in Volume- or Salt-Depleted Patients Impaired Renal Function Hypersensitivity Reactions Electrolyte and Metabolic Imbalances Acute Myopia and Secondary Angle-Closure Glaucoma Systemic Lupus Erythematosus Sprue-Like Enteropathy Most common adverse reactions (incidence ≥2%) are nausea, hyperuricemia, dizziness, and upper respiratory infection

Lithium: Risk of lithium toxicity. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): Reduced diuretic, natriuretic and antihypotensive effects, increased risk of renal toxicity. Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose. Antidiabetic drugs: Dosage adjustment may be required. Cholestyramine and colestipol: Reduced absorption of thiazides

Storage Store at 20-25ºC (68-77ºF).