Prinivil

[lisinopril]

General

When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury or even death to the developing fetus. When pregnancy is detected, PRINIVIL ® should be dis-continued as soon as possible (see WARNINGS, Use in Pregnancy, and INFORMATION FOR PATIENTS).

In using PRINIVIL ® , attention should be given to the risk of angioedema (see WARNINGS).

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DOSAGE AND ADMINISTRATION

Since absorption of PRINIVIL ® tablets (lisinopril tablets, Merck Frosst Std.) is not affected by food, the tablets may be administered before, during or after meals. PRINIVIL ® should be administered in a single daily dose. PRINIVIL ® should be taken at the same time each day. Dosage must be individualized.

Essential Hypertension

In patients with essential hypertension, not on diuretic therapy, the usual recommended starting dose is 10 mg once a day. Dosage should be adjusted according to blood pressure response: the usual dosage range is 10 to 40 mg per day, administered in a single daily dose. In some patients, acheivement of optimal blood pressure reduction may require two to four weeks of therapy.

The antihypertensive effect may diminish toward the end of the dosing interval regardless of the administered dose, but most commonly with a dose of 10 mg daily. This can be evaluated by measuring blood pressure just prior to dosing to determine whether satisfactory control is being maintained for 24 hours. If it is not, an increase in dose should be considered. The maximum dose used in long-term controlled clinical trials was 80 mg/ day.

If blood pressure is not controlled with PRINIVIL ® alone, a low dose of a diuretic may be added. Hydrochlorothiazide 12.5 mg has been shown to provide an additive effect. After the addition of a diuretic, it may be possible to reduce the dose of PRINIVIL ® .

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