METOLAZONE tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Marlex Pharmaceuticals, Inc.

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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

उत्पाद समीक्षा:

Metolazone tablets, USP, are shallow biconvex, round tablets, and are available in three strengths: 2.5 mg, pink, debossed "S9" on one side, and plain on the other side. NDC 10135-0765-01 Bottle of 100's NDC 10135-0765-10 Bottle of 1000's 5 mg, light blue, debossed "S10" on one side, and plain on the other side. NDC 10135-0766-01 Bottle of 100's NDC 10135-0766-10 Bottle of 1000's 10 mg, light yellow, debossed "S11" on one side, and plain on the other side. NDC 10135-0767-01 Bottle of 100's NDC 10135-0767-10 Bottle of 1000's Storage 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. All brand names are the trademarks of their respective owners. Manufactured for/ Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 Rev. 11/22 AP

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

METOLAZONE- METOLAZONE TABLET
MARLEX PHARMACEUTICALS, INC.
----------
METOLAZONE TABLETS, USP
Rx Only
DO NOT INTERCHANGE
DO NOT INTERCHANGE METOLAZONE TABLETS, USP, ZAROXOLYN® TABLETS,
AND OTHER FORMULATIONS OF METOLAZONE THAT SHARE THEIR SLOW AND
INCOMPLETE BIOAVAILABILITY AND ARE NOTTHERAPEUTICALLY 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 NOTBE INTERCHANGED FOR ONE ANOTHER.
DESCRIPTION
Metolazone tablets, USP, for oral administration contain 2.5, 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 water, but more soluble in
plasma, blood, alkali,
and organic solvents.
Inactive Ingredients: Magnesium stearate, microcrystalline cellulose,
colloidal silicon
dioxide and dye: 2.5 mg - FD&C Red No. 40 and FD&C Blue No. 2; 5 mg -
FD&C Blue No.
2; 10 mg - D&C Yellow No. 10.
16
16
3
3
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
s