METOLAZONE tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

METOLAZONE (UNII: TZ7V40X7VX) (METOLAZONE - UNII:TZ7V40X7VX)

Beschikbaar vanaf:

Ingenus Pharmaceuticals LLC

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 metolazone tablets in the treatment of hypertension.  See package circular for MYKROX Tablets. 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

Product samenvatting:

Metolazone tablets, USP, are bevel edged, round tablets, and are available in three strengths: 2½ mg, pink, debossed “ZNM” on one side, and “2½” on reverse side.             NDC 50742-349-01   Bottle of 100’s 5 mg, white to off white, debossed “ZNM” on one side, and “5” on reverse side.             NDC 50742-350-01   Bottle of 100’s 10 mg, pale yellow to yellow, debossed “ZNM” on one side, and “10” on reverse side.             NDC 50742-351-01   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. For more information about Metolazone Tablets call 1-877-748-1970. Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32811 Made in India Revised: 04/2023 All brand names are the trademarks of their respective owners.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

METOLAZONE - METOLAZONE TABLET
INGENUS PHARMACEUTICALS LLC
----------
METOLAZONE TABLETS, USP
Rx Only
DO NOT INTERCHANGE
DO NOT INTERCHANGE METOLAZONE TABLETS ZAROXOLYN TABLETS, AND
OTHER FORMULATIONS OF METOLAZONE THAT SHARE THEIR SLOW AND
INCOMPLETE BIOAVAILABILITY AND ARE NOT THERAPEUTICALLY EQUIVALENT
AT THE SAME DOSES TO MYKROX TABLETS, A MORE RAPIDLY AVAILABLE
AND COMPLETELY BIOAVAILABLE METOLAZONE PRODUCT. FORMULATIONS
BIOEQUIVALENT TO ZAROXOLYN AND FORMULATIONS BIOEQUIVALENT TO
MYKROX SHOULD NOT BE INTERCHANGED FOR ONE ANOTHER.
DESCRIPTION
Metolazone tablets, USP, for oral administration contain 2½, 5, or 10
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 methanol and insoluble in
water.
Inactive Ingredients: colloidal silicon dioxide, magnesium stearate,
microcrystalline
cellulose, iron oxide red and iron oxide yellow.
CLINICAL PHARMACOLOGY
Metolazone is a quinazoline diuretic, with properties generally
similar to the thiazide
diuretics. The actions of metolazone result from interference with the
renal tubular
mechanism of electrolyte reabsorption. Metolazone 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. Metolazone 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
sodium in
®
®
16
16
3
3
patients with severely compromised glomerular filtration. This action
has been
demonstrated in anima