ZAROXOLYN- metolazone tablet

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

metolazone (UNII: TZ7V40X7VX) (metolazone - UNII:TZ7V40X7VX)

Доступно од:

Carilion Materials Management

INN (Међународно име):

metolazone

Састав:

metolazone 2.5 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

ZAROXOLYN is 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. ZAROXOLYN is 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 in the treatment of hypertension. See package circular for MYKROX Tablets (UCB). 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

Резиме производа:

NDC:68151-2943-7 in a PACKAGE of 1 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.

Статус ауторизације:

New Drug Application

Карактеристике производа

ZAROXOLYN- METOLAZONE TABLET
CARILION MATERIALS MANAGEMENT
----------
ZAROXOLYN® TABLETS (METOLAZONE TABLETS, USP)
Rx Only
DO NOT INTERCHANGE ZAROXOLYN TABLETS AND OTHER FORMULATIONS OF
METOLAZONE THAT SHARE ITS SLOW AND INCOMPLETE BIOAVAILABILITY AND
ARE 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 BE INTERCHANGED FOR
ONE ANOTHER. DO NOT INTERCHANGE:
NOTNOT
DESCRIPTION
ZAROXOLYN Tablets (metolazone tablets, USP) for oral administration
contain 2½ or 5 mg of
metolazone, USP, a diuretic/saluretic/antihypertensive drug of the
quinazoline class.
Metolazone has the molecular formula C H ClN 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: 2½ mg-D&C Red No. 33;
5 mg-FD&C Blue No. 2.
CLINICAL PHARMACOLOGY
ZAROXOLYN (metolazone) is a quinazoline diuretic, with properties
generally similar to the thiazide
diuretics. The actions of ZAROXOLYN result from interference with the
renal tubular mechanism of
electrolyte reabsorption. ZAROXOLYN 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. ZAROXOLYN 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 filtration. This ac