METOLAZONE tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Alembic Pharmaceuticals Inc.

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 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 ari

Tuoteyhteenveto:

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. NDC 62332-532-31                Bottle of 100’s tablets NDC 62332-532-91                Bottle of 1000’s tablets 5 mg:   Blue colored, round tablets, debossed with ‘L49’ on one side and plain on other side. Tablets may have speckled appearance. NDC 62332-533-31                Bottle of 100’s tablets NDC 62332-533-91                Bottle of 1000’s tablets 10 mg: Yellow colored, round tablets, debossed with ‘L50’ on one side and plain on other side. Tablets may have speckled appearance. NDC 62332-534-31                Bottle of 100’s tablets NDC 62332-534-91                Bottle of 1000’s tablets 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. Bedminster, NJ 07921, USA Revised: 04/2022

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

METOLAZONE - METOLAZONE TABLET
ALEMBIC 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 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.
Metolazone tablets, USP meets USP _Dissolution Test 3_.
®
®
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 do not inhibit carbonic anhydrase. A
proximal action of
metolaz