March 29, 2017
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Demadex

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Demadex




Indications
Dosage
How Supplied

INDICATIONS

Edema

DEMADEX is indicated for the treatment of edema associated with heart failure, renal disease or hepatic disease.

Hypertension

DEMADEX is 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 class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with DEMADEX.

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.

The antihypertensive effects of DEMADEX are on the average greater in black patients than in nonblack patients [see CLINICAL PHARMACOLOGY]. 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.

DEMADEX can be used alone or in combination with other antihypertensive agents.

DOSAGE AND ADMINISTRATION

Treatment Of Edema

Edema Associated With Heart Failure

The recommended initial dose is 10 mg or 20 mg oral DEMADEX once daily. If the diuretic response is inadequate, titrate upward by approximately doubling until the desired diuretic response is obtained. Doses higher than 200 mg have not been adequately studied.

Edema Associated With Chronic Renal Failure

The recommended initial dose is 20 mg oral DEMADEX once daily. If the diuretic response is inadequate, titrate upward by approximately doubling until the desired diuretic response is obtained. Doses higher than 200 mg have not been adequately studied.

Edema Associated With Hepatic Cirrhosis

The recommended initial dose is 5 mg or 10 mg oral DEMADEX once daily, administered together with an aldosterone antagonist or a potassium-sparing diuretic. If the diuretic response is inadequate, titrate upward by approximately doubling until the desired diuretic response is obtained. Doses higher than 40 mg have not been adequately studied in this population.

Treatment Of Hypertension

The recommended initial dose is 5 mg once daily. If the 5 mg dose does not provide adequate reduction in blood pressure within 4 to 6 weeks, increase to 10 mg once daily. If the response to 10 mg is insufficient, add another antihypertensive agent to the treatment regimen.

HOW SUPPLIED

Dosage Forms And Strengths

DEMADEX is available as white scored tablets in 5-, 10-, 20-, and 100-mg strengths.

Storage And Handling

DEMADEX for oral administration is available as white, scored tablets as follows:

Dose Shape Debossing NDC 0037-xxxx-xx
Side 1 Side 2 Bottle/100
5 mg elliptical 5 5005 3505-01
10 mg elliptical 10 5010 3510-01
20 mg elliptical 20 5020 3520-01
100 mg capsule shaped 100 5001 3500-01

Store at 15° to 30°C (59° to 86°F).

Manufactured By: Meda Manufacturing GmbH, Cologne, Germany For: Meda Pharmaceuticals Meda Pharmaceuticals Inc. Somerset, NJ 08873-4120. Revised: Feb 2017

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/17/2017

Indications
Dosage
How Supplied

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Hypertension

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