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ACCUPRIL (QUINAPRIL HYDROCHLORIDE): SPECIAL POPULATIONS

Pregnancy

Pregnancy Categories C (first trimester) and D (second and third trimesters).

Nursing Mothers

Because Accupril (Quinapril) is secreted in human milk, caution should be exercised when this drug is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of Accupril (Quinapril) tablets in pediatric patients have not been established.

Geriatric Use

Clinical studies of Accupril (Quinapril HCl) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Elderly patients exhibited increased area under the plasma concentration time curve and peak levels for quinaprilat compared to values observed in younger patients; this appeared to relate to decreased renal function rather than to age itself.

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