Spironolactone And Hydrochlorothiazide Tablet
NDC Package 0378-0403-01

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

100 EA

Spironolactone And Hydrochlorothiazide

Hydrochlorothiazide; Spironolactone

Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Oral - Administration to or by way of the mouth.

Spironolactone has been shown to be a tumorigen in chronic toxicity studies in rats (see PRECAUTIONS section). Spironolactone and hydrochlorothiazide tablets, USP should be used only in those conditions described below. Unnecessary use of this drug should be avoided.Spironolactone and hydrochlorothiazide tablets are indicated for:Edematous conditions for patients with:Congestive heart failure:•For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures; •The treatment of diuretic-induced hypokalemia in patients with congestive heart failure when other measures are considered inappropriate; •The treatment of patients with congestive heart failure taking digitalis when other therapies are considered inadequate or inappropriate.Cirrhosis of the liver accompanied by edema and/or ascites:•Aldosterone levels may be exceptionally high in this condition. Spironolactone and hydrochlorothiazide tablets are indicated for maintenance therapy together with bed rest and the restriction of fluid and sodium.The nephrotic syndrome:•For nephrotic patients when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics do not provide an adequate response.Essential hypertension:•For patients with essential hypertension in whom other measures are considered inadequate or inappropriate; •In hypertensive patients for the treatment of a diuretic-induced hypokalemia when other measures are considered inappropriate;•Spironolactone and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. 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 classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with spironolactone and hydrochlorothiazide tablets. 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.

Mylan Pharmaceuticals Inc.

Human Prescription Drug

ANDA086513

ANDA - A product marketed under an approved Abbreviated New Drug Application.

08-03-1979

12-31-2027

N

No