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Mykrox (Metolazone) - Indications and Dosage

 
 



INDICATIONS AND USAGE

MYKROX Tablets are indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class.

MYKROX TABLETS HAVE NOT BEEN EVALUATED FOR THE TREATMENT OF CONGESTIVE HEART FAILURE OR FLUID RETENTION DUE TO RENAL OR HEPATIC DISEASE AND THE CORRECT DOSAGE FOR THESE CONDITIONS AND OTHER EDEMA STATES HAS NOT BEEN ESTABLISHED.

SINCE A SAFE AND EFFECTIVE DIURETIC DOSE HAS NOT BEEN ESTABLISHED, MYKROX TABLETS SHOULD NOT BE USED WHEN DIURESIS IS DESIRED.

Usage in Pregnancy

The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no evidence that they are useful in the treatment of developed toxemia (see PRECAUTIONS).

Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. MYKROX is not indicated for the treatment of edema in pregnancy. Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may be appropriate.

DOSAGE AND ADMINISTRATION

Therapy should be individualized according to patient response.

For initial treatment of mild to moderate hypertension, the recommended dose is one MYKROX Tablet (½ mg) once daily, usually in the morning. If patients are inadequately controlled with one ½ mg tablet, the dose can be increased to two MYKROX Tablets (1 mg) once a day. An increase in hypokalemia may occur. Doses larger than 1 mg do not give increased effectiveness.

The same dose titration is necessary if MYKROX Tablets are to be substituted for other dosage forms of metolazone in the treatment of hypertension.

If blood pressure is not adequately controlled with two MYKROX Tablets alone, the dose should not be increased; rather, another antihypertensive agent with a different mechanism of action should be added to therapy with MYKROX Tablets.

HOW SUPPLIED

MYKROX Tablets (metolazone tablets, USP), ½ mg are white, flat-faced, round tablets, debossed “MYKROX” on one side, and “½” on reverse side.

NDC 53014-847-71        Bottle of 100’s

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from light. Keep out of the reach of children.

Celltech Pharmaceuticals, Inc.

Rochester, NY 14623 USA

® Celltech Manufacturing, Inc.

© 2003, Celltech Pharmaceuticals, Inc.

All rights reserved.

Rev. 2/03

R528B

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