Source: Health Products and Food Branch (CA) Revision Year: 2020 Publisher: sanofi-aventis Canada Inc., 2905 Place Louis-R.-Renaud, Laval, Quebec, H7V 0A3
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 function. ZAROXOLYN (2.5 mg) has also been used in the management of mild to moderate essential hypertension, alone or in combination with other antihypertensive drugs of a different class.
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 an initial therapeutic response and to determine the minimal dose possible to maintain the desired therapeutic response.
Edema of cardiac failure: ZAROXOLYN 5-10 mg, once daily.
Edema of renal disease: ZAROXOLYN 5-20 mg, once daily.
The time interval for the initial dosage to show effect may vary; diuresis and saluresis usually begin within one hour and persist for 12 to 24 hours, depending on dosage. When a desired therapeutic effect has been obtained, it may be advisable to reduce the dose, if possible. The daily dose depends on the severity of the patient’s condition, sodium intake and responsiveness. A decision to change the daily dose should be based upon the results of thorough clinical and laboratory determinations. If antihypertensive drugs or diuretics are given concurrently with ZAROXOLYN, more careful dosage adjustment may be necessary. For patients with congestive cardiac failure who tend to experience paroxysmal nocturnal dyspnea, it is usually advisable to employ a dosage near the upper end of the range to ensure prolongation of diuresis and saluresis for a full 24-hour period.
Mild to moderate essential hypertension: ZAROXOLYN 2.5-5 mg, once daily.
The time interval required for the initial dosage regimen of ZAROXOLYN to show effect may vary from three to four days, to three to six weeks, in the treatment of elevated blood pressure. Doses should be adjusted at appropriate intervals to achieve maximum therapeutic effect.
Safety and effectiveness in children have not been established; therefore, metolazone is not recommended for use in the pediatric age group.
Orthostatic hypotension, dizziness, drowsiness, syncope, diuresis with accompanying electrolyte abnormalities, hemoconcentration and hemodynamic changes due to plasma volume depletion may occur. In some instances, depressed respiration may be observed. At high doses, lethargy of varying degree may appear and may progress to coma within a few hours. Also, GI irritation and hypermotility may occur. Temporary elevation of BUN has been reported, especially in patients with impairment of renal function.
There is no specific antidote available, but immediate evacuation of the stomach contents is advised. Care should be taken when evacuating the gastric contents to prevent aspiration, especially in the stuporous or comatose patient. Dialysis is not likely to be effective. Supportive measures should be initiated as required to maintain hydration, electrolyte balance, respiration and cardiovascular and renal functions.
Serum electrolyte change, and cardiovascular and renal functions, should be closely monitored.
ZAROXOLYN (metolazone) should be stored at room temperature and protected from light. ZAROXOLYN should be dispensed in tight, light-resistant containers.
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