mykrox tablets- metolazone tablets tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

metolazone (UNII: TZ7V40X7VX) (metolazone - UNII:TZ7V40X7VX)

Available from:

Celltech Pharmaceuticals, Inc.

INN (International Name):

metolazone tablets

Pharmaceutical form:

TABLET

Composition:

500 ug

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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

Product summary:

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.

Summary of Product characteristics

MYKROX TABLETS- METOLAZONE TABLETS TABLET
CELLTECH PHARMACEUTICALS, INC.
----------
MYKROX® TABLETS
(METOLAZONE TABLETS, USP)
DO NOT INTERCHANGE:
MYKROX TABLETS ARE A RAPIDLY AVAILABLE FORMULATION OF METOLAZONE
FOR ORAL ADMINISTRATION. MYKROX TABLETS AND OTHER FORMULATIONS OF
METOLAZONE THAT SHARE ITS MORE RAPID AND COMPLETE BIOAVAILABILITY
ARE NOT THERAPEUTICALLY EQUIVALENT TO ZAROXOLYN® TABLETS AND
OTHER FORMULATIONS OF METOLAZONE THAT SHARE ITS SLOW AND
INCOMPLETE BIOAVAILABILITY. FORMULATIONS BIOEQUIVALENT TO MYKROX
AND FORMULATIONS BIOEQUIVALENT TO ZAROXOLYN SHOULD NOT BE
INTERCHANGED FOR ONE ANOTHER.
DESCRIPTION
MYKROX Tablets (metolazone tablets, USP) for oral administration
contain ½ mg of metolazone, USP,
a diuretic/saluretic/antihypertensive drug of the quinazoline class.
Metolazone has the molecular formula C
H ClN O S, the chemical name 7-chloro-1, 2, 3, 4-
tetrahydro-2-methyl-3-(2-methylphenyl)-4-oxo-6-quinazolinesulfonamide,
and a molecular weight of
365.83. The structural formula is:
Metolazone is only sparingly soluble in water, but more soluble in
plasma, blood, alkali, and organic
solvents.
Inactive Ingredients: Dibasic calcium phosphate, magnesium stearate,
microcrystalline cellulose,
pregelatinized starch, sodium starch glycolate.
CLINICAL PHARMACOLOGY
MYKROX (metolazone) is a quinazoline diuretic, with properties
generally similar to the thiazide
diuretics. The actions of MYKROX result from interference with the
renal tubular mechanism of
electrolyte reabsorption. MYKROX acts primarily to inhibit sodium
reabsorption at the cortical diluting
site and to a lesser extent in the proximal convoluted tubule. Sodium
and chloride ions are excreted in
approximately equivalent amounts. The increased delivery of sodium to
the distal tubular exchange site
results in increased potassium excretion. MYKROX does not inhibit
carbonic anhydrase. A proximal
action of metolazone has been shown in humans by increased excretion
of phosphate and magnesium
ions and by a markedly increased fractional excretion of