METOLAZONE tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Mylan Institutional Inc.

INN (Nama Antarabangsa):

METOLAZONE

Komposisi:

METOLAZONE 2.5 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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 ® tablets and other formulations of metolazone that share its slow and incomplete bioavailability, in the treatment of hypertension. 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

Ringkasan produk:

Metolazone Tablets, USP are available containing 2.5 mg and 5 mg of metolazone, USP. The 2.5 mg tablets are peach, round, biconvex, unscored tablets debossed with M on one side of the tablet and 172 on the other side. They are available as follows: NDC 51079-023-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 5 mg tablets are orange, round, biconvex, unscored tablets debossed with M on one side of the tablet and 173 on the other side. They are available as follows: NDC 51079-024-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Laboratories Limited Hyderabad — 500 096, India Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12710 5/21

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

METOLAZONE- METOLAZONE TABLET
MYLAN INSTITUTIONAL INC.
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DO NOT INTERCHANGE: DO NOT INTERCHANGE ZAROXOLYN TABLETS AND
OTHER FORMULATIONS OF METOLAZONE THAT SHARE ITS 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.
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DESCRIPTION
Metolazone Tablets, USP for oral administration contain 2.5 mg, 5 mg
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: colloidal silicon dioxide,
FD&C Yellow #6 Lake
HT, magnesium stearate and microcrystalline cellulose. In addition,
the 10 mg strength
contains D&C Yellow #10 Lake HT and FD&C Blue #2 Lake HT.
_Meets USP Dissolution Test 2._
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
®1
®2
®
®
Zaroxolyn ® is a registered trademark of Celltech Pharmaceuticals,
Inc.
Mykrox ® is a registered trademark of Celltech Pharmaceuticals, Inc.
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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 m