METOLAZONE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Bayshore Pharmaceuticals LLC

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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.

Dettagli prodotto:

Metolazone Tablets, USP are available containing 2.5 mg, 5 mg and 10 mg of metolazone, USP. The 2.5 mg tablets are pink, round tablets, with pink speckles, debossed with "M" on one side and "2 ½" on reverse side. They are available as follows: NDC 76385-136-01 Bottle of 100's                                The 5 mg tablets are blue, round tablets, with blue speckles, debossed with "M" on one side and "5" on reverse side. They are available as follows: NDC 76385-137-01 Bottle of 100's                                The 10 mg tablets are yellow, round tablets, with yellow speckles, debossed with "M" on one side and "10" on reverse side. They are available as follows: NDC 76385-138-01 Bottle of 100's                                Storage 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. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. For Product Complaints, Medical Inquires or more information on Metolazone Tablets, USP call 888-514-4727. Manufactured by: Centaur Pharmaceuticals Pvt.Ltd, Plot No. 4, International Biotech Park,          Phase II, Hinjewadi, Pune – 411 057. INDIA Distributed by: Bayshore Pharmaceuticals LLC Short Hills, NJ 07078 USA All brand names are the trademarks of their respective owners. Issued: 06/2021

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

METOLAZONE - METOLAZONE TABLET
BAYSHORE PHARMACEUTICALS LLC
----------
METOLAZONE TABLETS, USP
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 very slightly 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 - D&C Red No. 30 lake; 5 mg - FD&C Blue No. 2
lake; 10 mg -
D&C Yellow No. 10 lake and FD&C Yellow No. 6 lake.
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
®
®
16
16
3
3
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 fr