Monopril

[Fosinopril]

Indications & Dosage
INDICATIONS AND USAGE

MONOPRIL is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. MONOPRIL is indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION).

In using MONOPRIL (consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that MONOPRIL does not have a similar risk (see WARNINGS). In considering use of MONOPRIL, 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 high-er rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema).

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USE IN PREGNANCY

When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When
pregnancy is detected, MONOPRIL should be discontinued as soon as pos-sible. See WARNINGS: Fetal/ Neonatal Morbidity and Mortality.

DOSAGE AND ADMINISTRATION

Hypertension

The recommended initial dose of MONOPRIL is 10 mg once a day, both as monotherapy and when the drug is added to a diuretic. Dosage should then be adjusted according to blood pressure response at peak (2-6 hours) and trough (about 24 hours after dosing) blood levels. The usual dosage range needed to maintain a response at trough is 20-40 mg but some patients appear to have a further response to 80 mg. In some patients treated with once daily dosing, the antihyper-tensive effect may diminish toward the end of the dosing interval.

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