ZAROXOLYN Tablet Ref.[9620] Active ingredients: Metolazone

Source: Health Products and Food Branch (CA)  Revision Year: 2020  Publisher: sanofi-aventis Canada Inc., 2905 Place Louis-R.-Renaud, Laval, Quebec, H7V 0A3

Product name and form

ZAROXOLYN (Metolazone Tablets, USP).

Pharmaceutical Form

Tablets.

ZAROXOLYN (metolazone) 2.5 mg is available as a pink, slightly biconvex tablet, debossed with its numeric strength on one side and “ZAROXOLYN” on the other and contains 2.5 mg metolazone.

Qualitative and quantitative composition

ZAROXOLYN 2.5 mg tablets contain 2.5 mg of the active ingredient metolazone.

Chemical name: 7-chloro-1,2,3,4-tetrahydro-2-methyl-3-(2-methylphenyl)-4-oxo-6-quinazolinesulfonamide

Molecular Formula: C16H16ClN3O3S

Molecular Weight: 365.83

Description: white to off-white crystalline powder

Solubility: in water (gm/mL): 2.4 × 10-5, 25°C in 95% ethanol (gm/mL): 9 × 10-3, 25°C in serum (gm/mL): 4.2 × 10-5, 37°C

pKa: 9.7

Melting Point: 253-259°C

Active Ingredient Description
Metolazone

Metolazone is a diuretic antihypertensive drug for the treatment of edema. 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.

List of Excipients

Non-medicinal ingredients:

D&C Red #33 aluminum lake
Magnesium stearate
Microcrystalline cellulose

Alcohol-, gluten-, lactose-, paraben-, sucrose- and tartrazine- free.

Pack sizes and marketing

The tablets are available in high density polyethylene bottles of 100 tablets.

Marketing authorization holder

sanofi-aventis Canada Inc., 2905 Place Louis-R.-Renaud, Laval, Quebec, H7V 0A3

Marketing authorization dates and numbers

Submission Control No.: 211229

Drugs

Drug Countries
ZAROXOLYN Canada, Estonia

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