METOLAZONE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Aarkish Pharmaceuticals NJ Inc.

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 metolazone 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. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Metolazone is indicated in pregnancy when edema is due to pathologic causes, just as it is in the absence of pregnancy (see PRECAUTIONS). Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased  recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may be appropriate. Anuria, hepatic coma or precoma, known allergy or hypersensitivity to metolazone.

Resumo do produto:

Metolazone tablets, USP, are shallow biconvex, round tablets, and are available in three strengths: 2.5 mg, pink, debossed "S9" on one side, and plain on the other side. NDC 81005-124-01 Bottle of 100's NDC 81005-124-10 Bottle of 1000's 5 mg, light blue, debossed "S10" on one side, and plain on the other side. NDC 81005-125-01 Bottle of 100's NDC 81005-125-10 Bottle of 1000's 10 mg, light yellow, debossed "S11" on one side, and plain on the other side. NDC 81005-126-01 Bottle of 100's NDC 81005-126-10 Bottle of 1000's Storage  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 1-888-985-4970. Distributed by: Aarkish Pharmaceuticals NJ Inc. Fairfield, NJ 07004 All brand names are the trademarks of their respective owners. Rev.00, 07/23

Status de autorização:

Abbreviated New Drug Application

Características técnicas

METOLAZONE- METOLAZONE TABLET
AARKISH PHARMACEUTICALS NJ INC.
----------
METOLAZONE TABLETS, USP
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 NOTTHERAPEUTICALLY 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 NOTBE INTERCHANGED FOR ONE ANOTHER.
DESCRIPTION
​
Metolazone tablets, USP, for oral administration contain 2.5, 5, or 10
mg of metolazone,
USP, a diuretic/saluretic/antihypertensive drug of the quinazoline
class.Metolazone has
the molecular formula C
H
CIN
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, colloidal silicon dioxide and dye: 2.5 mg - FD&C Red No. 40
and FD&C Blue No.
2; 5 mg - FD&C Blue No. 2; 10 mg - D&C Yellow No. 10.
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 pat