Olmesartan Medoxomil And Hydrochlorothiazide Tablet, Film Coated
NDC 70518-4577

The NDC code 70518-4577 is assigned by the FDA to the product Olmesartan Medoxomil And Hydrochlorothiazide. This pharmaceutical product is labeled by Remedyrepack Inc. and is currently categorized as listed product. The medication is a tablet, film coated administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 70518-4577-0. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

Olmesartan medoxomil and hydrochlorothiazide tablet is indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide tablet is not indicated for the initial therapy of hypertension [seeDosage 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 tablet. 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 Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.Olmesartan medoxomil and hydrochlorothiazide tablet may be used alone, or in combination with other antihypertensive drugs.

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

• HYDROCHLOROTHIAZIDE 25 mg/1 - A thiazide diuretic often considered the prototypical member of this class. It reduces the reabsorption of electrolytes from the renal tubules. This results in increased excretion of water and electrolytes, including sodium, potassium, chloride, and magnesium. It is used in the treatment of several disorders including edema, hypertension, diabetes insipidus, and hypoparathyroidism.
• OLMESARTAN MEDOXOMIL 40 mg/1 - An ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKER that is used to manage HYPERTENSION.

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

• RxCUI: 403855 - olmesartan medoxomil 40 MG / hydroCHLOROthiazide 25 MG Oral Tablet
• RxCUI: 403855 - hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral Tablet
• RxCUI: 403855 - HCTZ 25 MG / olmesartan medoxomil 40 MG Oral Tablet

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

• Angiotensin 2 Receptor Antagonists - [MoA] (Mechanism of Action)
• Angiotensin 2 Receptor Blocker - [EPC] (Established Pharmacologic Class)
• Increased Diuresis - [PE] (Physiologic Effect)
• Thiazide Diuretic - [EPC] (Established Pharmacologic Class)
• Thiazides - [CS]