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ZAROXOLYN Tablets (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

ZAROXOLYN (Metolazone Tablets, USP).

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: C<sub> ...

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.

Therapeutic indications

ZAROXOLYN (metolazone) is indicated for the treatment of edema accompanying congestive heart failure and edema accompanying renal diseases including the nephrotic syndrome, and states of diminished renal ...

Posology and method of administration

Effective dosage of ZAROXOLYN (metolazone) should be individualized according to indications and patient response. A single daily dose is recommended. Therapy with ZAROXOLYN should be titrated to gain ...

Contraindications

ZAROXOLYN (metolazone) is contraindicated in anuria, in hepatic coma or pre-coma, and in cases of known allergy and hypersensitivity to metolazone.

Special warnings and precautions for use

Warnings Rarely, the rapid onset of severe hyponatremia and/or hypokalemia has been reported following initial doses of thiazide and non-thiazide diuretics. When symptoms consistent with severe electrolyte ...

Interaction with other medicinal products and other forms of interaction

Drug Interactions Alcohol, barbiturates, or narcotics: See PRECAUTIONS. Antihypertensives: See WARNINGS and PRECAUTIONS. When metolazone is used with other antihypertensive drugs, particular care must ...

Pregnancy and lactation

Use in Pregnancy Since metolazone crosses the placenta and appears in cord blood, its administration to women of childbearing age requires that the potential benefits of the drug be weighed against its ...

Undesirable effects

The following adverse reactions have been reported. Several are single or comparably rare occurrences. Adverse reactions are listed in decreasing order of severity within body systems. Cardiovascular: ...

Overdose

Signs and Symptoms Orthostatic hypotension, dizziness, drowsiness, syncope, diuresis with accompanying electrolyte abnormalities, hemoconcentration and hemodynamic changes due to plasma volume depletion ...

Pharmacodynamic properties

Actions and clinical pharmacology ZAROXOLYN (metolazone) is a diuretic antihypertensive drug for the treatment of edema. ZAROXOLYN is a quinazoline diuretic, with properties generally similar to the thiazide ...

Pharmacokinetic properties

Metolazone is absorbed rapidly; however, rate and extent of absorption is dependent on the formulation. The table below shows that bioavailability of ZAROXOLYN is different from MYKROX (another product ...

Preclinical safety data

Acute Toxicology A single oral dose of 10 gm/kg was not lethal in rats, and a single intraperitoneal dose of 5 gm/kg was not lethal in mice. Acute effects in susceptible animals include electrolyte imbalance. ...

List of excipients

Non-medicinal ingredients: D&C Red #33 aluminum lake Magnesium stearate Microcrystalline cellulose Alcohol-, gluten-, lactose-, paraben-, sucrose- and tartrazine- free.

Special precautions for storage

ZAROXOLYN (metolazone) should be stored at room temperature and protected from light. ZAROXOLYN should be dispensed in tight, light-resistant containers.

Nature and contents of container

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 number(s)

Submission Control No.: 211229

Date of revision of the text

February 26, 2018

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