ZAROXOLYN Tablet (2020)
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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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