METOLAZONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Major Pharmaceuticals

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Metolazone tablets are indicated for the treatment of salt and water retention including: 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 and other formulations of metolazone 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 is indicated in pregnancy when edema is due to patholog

Product summary:

Metolazone tablets, USP are available in three strengths: 2.5 mg: Pink colored, round tablets, debossed with ‘L48’ on one side and plain on other side. Tablets may have speckled appearance. Available in: Cartons of 100 tablets (10 tablets per blister pack x 10), NDC 0904-7138-61 Available in: 5 mg:   Blue colored, round tablets, debossed with ‘L49’ on one side and plain on other side. Tablets may have speckled appearance. Cartons of 100 tablets (10 tablets per blister pack x 10), NDC 0904-7139-61 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Keep out of the reach of children. ZAROXOLYN® and MYKROX® are registered trademarks of UCB Manufacturing, Inc. Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA Distributed By: MAJOR® PHARMACEUTICALS Livonia, MI 48152 Refer to package label for Distributor's NDC Number Revised: 08/2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METOLAZONE- METOLAZONE TABLET
MAJOR PHARMACEUTICALS
----------
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 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 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 365.83. The structural formula is:
Metolazone is very slightly soluble in water, sparingly soluble in
methanol, slightly soluble
in ethyl acetate, very slightly soluble in methylene chloride.
Inactive Ingredients: Microcrystalline cellulose, magnesium stearate
and colorants 2.5
mg -D&C Red No. 27 Aluminum Lake, 5 mg - FD&C Blue No. 2 Aluminum Lake
and 10
mg - D&C Yellow No. 10 Aluminum Lake and FD&C Yellow No. 6 Aluminum
Lake.
_FDA approved dissolution specification differs from the USP
dissolution specification._
CLINICAL PHARMACOLOGY
®
®
16
16
3
3
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 do not inhibit carbonic anhydrase. A
p