METOLAZONE TABLETS, USP
2.5 mg, 5 mg and 10 mg
Metolazone Tablets, USP for oral administration contain 2.5 mg, 5 mg or 10 mg of metolazone, USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class.
Metolazone tablets are indicated for the treatment of salt and water retention including:
- edema accompanying congestive heart failure;
- edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function.
Metolazone tablets are also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. Mykrox® tablets, a more rapidly available form of metolazone, are intended for the treatment of new patients with mild to moderate hypertension. A dose titration is necessary if Mykrox® tablets are to be substituted for Zaroxolyn® tablets and other formulations of metolazone that share its slow and incomplete bioavailability, in the treatment of hypertension.
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.
Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Metolazone tablets are indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (see PRECAUTIONS). 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.
Clinical Trials Related to Metolazone
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.
Fasting Study of Metolazone Tablets 2.5 mg and Zaroloxyn® Tablets 2.5 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan metolazone 2. 5 mg
tablets to Celltech Zaroxolyn® 2. 5 mg tablets following a single, oral 10 mg (4 x 2. 5 mg)
dose administration under fasting conditions.
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.
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.
Reports of Suspected Metolazone Side Effects
Renal Failure Acute (38),
Toxicity TO Various Agents (30),
Confusional State (24),
Blood Creatinine Increased (11),
Disease Progression (10),
Torsade DE Pointes (9), more >>
Page last updated: 2006-06-09