METOLAZONE tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Amici Pharmaceuticals LLC.

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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. 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.

ملخص المنتج:

Metolazone Tablets, USP for oral administration are available as: 2.5 mg:  Peach, round, biconvex tablets debossed with “I” on one side and “121” on the other side and supplied as: NDC 69292-562-01 bottles of 100 NDC 69292-562-10 bottles of 1000 5 mg:  Pink, round, biconvex tablets debossed with “I” on one side and “122” on the other side and supplied as: NDC 69292-564-01 bottles of 100 NDC 69292-564-10 bottles of 1000 10 mg:  Orange, round, biconvex tablets debossed with “I” on one side and “123” on the other side and supplied as: NDC 69292-566-01 bottles of 100 NDC 69292-566-10 bottles of 1000 STORAGE: Store at 20° to 25°C (68° to 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. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Manufactured by: Innogenix, LLC. Amityville, NY 11701 Distributed by: Amici Pharmaceuticals, LLC Melville, NY 11747 All brand names are the trademarks of their respective owners. Rev. 05/2021

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

METOLAZONE- METOLAZONE TABLET
AMICI PHARMACEUTICALS LLC.
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METOLAZONE TABLETS, USP
RX ONLY
DO NOT INTERCHANGE
DO NOT INTERCHANGE METOLAZONE TABLETS, USP, ZAROXOLYN TABLETS,
AND OTHER FORMULATIONS 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.
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 C16H16ClN3O3S, 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, magnesium stearate,
microcrystalline
cellulose and dye: 2 ½ mg o. 6; 5 mg - D&C Red #30; 10 mg - 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
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 excretion of
sodium in patients
with severely compromised glomerular