(metolazone tablets, USP)
MYKROX Tablets (metolazone tablets, USP) for oral administration contain ½ mg of metolazone, USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class.
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.
Published Studies Related to Mykrox (Metolazone)
The evaluation of the diuretic action of parenteral formulations of metolazone. [2007.01]
BACKGROUND AND OBJECTIVES: This study was design to compare the diuretic and natriuretic effects of the 2 parenteral formulations of metolazone and the combination of these 2 formulations of metolazone with the parenteral administration of furosemide. Metolazone is an anthracrene acid derivate and manifests a dual diuretic effect on the proximal and distal tubule with a minimal kaluretic effect. It is currently only marketed in an orally administrable formulation, and this has limited its utility in critically ill patients. Metolazone given orally and furosemide given orally or parenterally are frequently administrated together when furosemide alone is clinically inadequate at producing a desired diuresis... CONCLUSION: Combining metolazone and furosemide can cause an increase in urine volume and sodium excretion. Metolazone administrated parenterally in combination with the parenteral administration of furosemide appears to have an important clinical potential.
Beneficial effects of metolazone in a rat model of preeclampsia. [2006.09]
Preeclampsia is a disorder that continues to exact a significant toll with respect to maternal morbidity and mortality as well as fetal wastage...
Combination therapy with metolazone and loop diuretics in outpatients with refractory heart failure: an observational study and review of the literature. [2005.08]
CONCLUSION: The literature review and the observational study support the use of low-dose metolazone (< or =5 mg) on top of oral loop diuretics, as an effective and relatively safe treatment in contemporary outpatients with refractory HF.
Clinical Trials Related to Mykrox (Metolazone)
A Comparison of Hydrochlorothiazide and Metolazone in Combination With Furosemide in Congestive Heart Failure Patients [Recruiting]
The purpose of this research study is to compare the effectiveness of hydrochlorothiazide or
metolazone in combination with furosemide. Patients with heart failure suffer from swelling
because of too much fluid in the body. Furosemide, hydrochlorothiazide, and metolazone are
all water pills used to treat the swelling. For most patients, taking furosemide alone is
successful. However, sometimes patients need to add another water pill. Doctors usually
add either metolazone or hydrochlorothiazide. It is not clear which water pill is better
when added to furosemide. The purpose of this study is to determine which water pill when
added to furosemide is the best at reducing excess fluid in the body.
Stop Hypernatremia, Use Metolazone, for Aggressive, Controlled, Effective Diuresis [Recruiting]
Patients who are on mechanical ventilation in an intensive care unit often require diursis
as part of their pre-extubation regimen. The drug of choice for diuresis has traditionally
been furosemide. However, this drug cause hypernatremia (a rise in serum sodium) in a
significant proportion of patients. Hypernatremia is traditionally treated by providing free
water supplementation to the patient. This strategy creates a vicious and unproductive cycle
of giving free water, and then diuresing it off. We propose a strategy for breaking this
cycle by using a second diuretic-- metolazone-- which has a tendency to rid the body of more
sodium, thereby minimizing hypernatremia.
Oral Metolazone and Intermittent Intravenous Furosemide Versus Continuous Infusion Furosemide in Acute Heart Failure [Recruiting]
The purpose of this prospective, randomized, open-label study is to compare two diuretic
strategies in patients with acute decompensated heart failure (ADHF): the addition of an
oral thiazide diuretic to intravenous bolus (IVB) loop diuretic will be compared to
transition from IVB to continuous infusion (CI) loop diuretic.
Fasting Study of Metolazone Tablets 5 mg and Zaroloxyn® Tablets 5 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan metolazone 5 mg
tablets to Celltech Zaroxolyn® 5 mg tablets following a single, oral 10 mg (2 x 5 mg) dose
administration under fasting conditions.
Fasting Study of Metolazone Tablets 10 mg and Zaroloxyn® Tablets 10 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan metolazone 10 mg
tablets to Celltech Zaroxolyn® 10 mg tablets following a single, oral 10 mg (1 x 10 mg) dose
administration under fasting conditions.
Page last updated: 2007-05-03