Monopril

[Fosinopril]

Hypertension

Administration of MONOPRIL (fosinopril sodium tablets) to patients with mild-to-moderate hypertension results in a reduction of both supine and standing blood pressure to about the same extent with no compensatory tachycardia. Symptomatic postural hypotension is infrequent, although it can occur in patients who are salt-and/ or volume-depleted (see WARNINGS). Use of MONOPRIL in combination with thiazide diuretics gives a blood pressure-lowering effect greater than that seen with either agent alone.

Following oral administration of single doses of 10-40 mg, MONOPRIL lowered blood pressure within one hour, with peak reductions achieved 2-6 hours after dos-ing. The antihypertensive effect of a single dose persisted for 24 hours. Following four weeks of monotherapy in placebo-controlled trials in patients with mild-to-mod-erate hypertension, once-daily doses of 20-80 mg lowered supine or seated systolic and diastolic blood pressures 24 hours after dosing by an average of 8-9/ 6-7 mmHg more than placebo.

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The trough effect was about 50-60% of the peak diastolic response and about 80% of the peak systolic response. In most trials, the antihypertensive effect of MONOPRIL increased during the first several weeks of repeated measurements. The antihypertensive effect of MONOPRIL has been shown to continue during long-term therapy for at least 2 years. Abrupt withdrawal of MONOPRIL has not resulted in a rapid increase in blood pressure. Limited experience in controlled and uncontrolled trials combining fosinopril with a calcium channel blocker or a loop diuretic has indicated no unusual drug-drug interactions.

Other ACE inhibitors have had less than additive effects with beta-adrener-gic blockers, presumably because both drugs lower blood pressure by inhibiting parts of the renin-angiotensin system. ACE inhibitors are generally less effective in blacks than in non-blacks. The effectiveness of MONOPRIL was not influenced by age, sex, or weight. In hemodynamic studies in hypertensive patients, after three months of therapy, responses (changes in BP, heart rate, cardiac index, and PVR) to various stimuli (e. g., isometric exercise, 45° head-up tilt, and mental challenge) were unchanged com-pared to baseline, suggesting that MONOPRIL does not affect the activity of the sympathetic nervous system.

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