METOLAZONE tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

American Health Packaging

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Metolazone tablets, USP, 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, 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 pregn

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. Unit dose packages of 100 (10 x 10) NDC 60687-536-01 5 mg, blue, debossed "644" on one side, and "5" on reverse side. Unit dose packages of 100 (10 x 10) NDC 60687-547-01 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 YOUR PROTECTION: Do not use if blister is torn or broken. For more information about Metolazone Tablets, USP call 1-844-834-0530. All brand names are the trademarks of their respective owners.

Status kebenaran:

New Drug Application Authorized Generic

Ciri produk

METOLAZONE- METOLAZONE TABLET
AMERICAN HEALTH PACKAGING
----------
METOLAZONE TABLETS, USP
8453601/1219
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 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.
®
®
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