METOLAZONE tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

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Download Ciri produk (SPC)
23-08-2022

Bahan aktif:

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

Boleh didapati daripada:

Major Pharmaceuticals

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Metolazone tablets, USP, are indicated for the treatment of salt and water retention including: Metolazone tablets, USP, 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, USP, 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 from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Metolazone tablets, USP, are indicated in pregnancy wh

Ringkasan produk:

Metolazone tablets, USP, are shallow biconvex, round tablets, and are available in three strengths: 2½ mg, pink, debossed "643" on one side, and "2½" on reverse side.  NDC 0904-6916-61    Carton of 100 tablets (10 tablets each blister pack x 10) 5 mg, blue, debossed "644" on one side, and "5" on reverse side.  NDC 0904-6915-61    Carton of 100 tablets (10 tablets each blister pack x 10) 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, USP call 1-844-834-0530.

Status kebenaran:

New Drug Application Authorized Generic

Ciri produk

                                METOLAZONE- METOLAZONE TABLET
MAJOR PHARMACEUTICALS
----------
METOLAZONE TABLETS, USP
Rx Only
DO NOT INTERCHANGE
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 water, but more soluble in
plasma, blood, alkali,
and organic solvents.
Inactive Ingredients: Magnesium stearate, microcrystalline cellulose
and dye: 2 ½ mg -
FD&C Red No. 40, D&C Red No. 27 and FD&C Blue No. 1; 5 mg - FD&C Blue
No. 2; 10
mg - D&C Yellow No. 10 and FD&C Yellow No. 6.
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
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.
16
16
3
3
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 excretio
                                
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