UNIVASC is indicated for treatment of patients with hypertension. It may be used alone or in combination with thiazide diuretics.

In using UNIVASC, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that UNIVASC does not have a similar risk (see WARNINGS).

In considering use of UNIVASC, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Angioedema).

Hypertension

The recommended initial dose of UNIVASC in patients not receiving diuretics is 7.5 mg, one hour prior to meals, once daily. Dosage should be adjusted according to blood pressure response. The antihypertensive effect of UNIVASC may diminish towards the end of the dosing interval. Blood pressure should, therefore, be measured just prior to dosing to determine whether satisfactory blood pressure control is obtained. If control is not adequate, increased dose or divided dosing can be tried. The recommended dose range is 7.5 to 30 mg daily, administered in one or two divided doses one hour before meals. Total daily doses above 60 mg a day have not been studied in hypertensive patients.

In patients who are currently being treated with a diuretic, symptomatic hypoten-sion may occasionally occur following the initial dose of UNIVASC. The diuretic should, if possible, be discontinued for 2 to 3 days before therapy with UNIVASC is begun, to reduce the likelihood of hypotension (see WARNINGS). If the patient's blood pressure is not controlled with UNIVASC alone, diuretic therapy may then be reinstituted. If diuretic therapy cannot be discontinued, an initial dose of 3.75 mg of UNIVASC should be used with medical supervision until blood pressure has stabilized (see WARNINGS and PRECAUTIONS: DRUG INTERACTIONS).

Dosage Adjustment in Renal Impairment

For patients with a creatinine clearance ≤ 40 mL/min/1.73 m 2, an initial dose of 3.75 mg once daily should be given cautiously. Doses may be titrated upward to a maximum daily dose of 15 mg.

UNIVASC (moexipril hydrochloride) 7.5 mg tablets are pink colored, biconvex, film-coated and scored with engraved code 707 on the unscored side and SP above and 7.5 below the score. They are supplied as follows:

Bottles of 90 (Unit-of-Use)...........NDC 0091-3707-09
Bottles of 100...............................NDC 0091-3707-01

UNIVASC (moexipril hydrochloride) 15 mg tablets are salmon colored, biconvex, film-coated, and scored with engraved code 715 on the unscored side and SP above and 15 below the score. They are supplied as follows:

Bottles of 90 (Unit-of-Use)..............NDC 0091-3715-09
Bottles of 100..................................NDC 0091-3715-01

Store, tightly closed, at controlled room temperature. Protect from excessive moisture.

If product package is subdivided, dispense in tight containers as described in USP-NF.

SCHWARZ PHARMA, Milwaukee, Wisconsin 53201. FDA Rev date: 10/29/2003

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