METOLAZONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, Inc dba Vangard Labs

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 Zaroxolyn® tablets and other formulations of metolazone that share its slow and incomplete bioavailability, in the treatment of hypertension. 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 use

Product summary:

Metolazone Tablets USP for oral administration are available as: 2.5 mg: Pink, shallow biconvex, modified oval tablets, debossed “E50” on one side, plain on the other side and supplied as: NDC 0615-6501-39 blistercards of 30 5 mg: Blue, shallow biconvex, modified oval tablets, debossed “E55” on one side, plain on the other side and supplied as: NDC 0615-6502-39 blistercards of 30 10 mg: Yellow, shallow biconvex, modified oval tablets, debossed “E56” on one side, plain on the other side. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Keep out of the reach of children. Zaroxolyn® and Mykrox® are registered trademarks of UCB Manufacturing, Inc., Rochester, NY 14623. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Sandoz Inc. Princeton, NJ 08540 OS8065 Rev. 02/11 MF0050REV02/11 MG #18531

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METOLAZONE- METOLAZONE TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
RX ONLY
DO NOT INTERCHANGE:
DO NOT INTERCHANGE ZAROXOLYN® TABLETS AND OTHER FORMULATIONS OF
METOLAZONE 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 2.5 mg, 5 mg 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-4-oxo-3-o-tolyl-6-quinazolinesulfonamide, and a
molecular weight of 365.84. 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:
2.5 mg - D&C red No. 30 and FD&C blue No. 2; 5 mg - FD&C blue No. 2;
10 mg - D&C yellow No.
10 and 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
16
16
3
3
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 wi