INDICATIONS Fosinopril sodium is indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. Fosinopril sodium 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 fosinopril sodium, 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 wshow that fosinopril sodium does not have a similar risk (see WARNINGS.) In considering use of fosinopril sodium , 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). DOSAGE AND ADMINISTRATION Hypertension Adults The recommended initial dose of fosinopril sodium 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 antihypertensive effect may diminish toward the end of the dosing interval. If trough response is inadequate, dividing the daily dose should be considered. If blood pressure is not adequately controlled with fosinopril sodium alone, a diuretic may be added. Concomitant administration of fosinopril sodium with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics can lead to increases of serum potassium (see PRECAUTIONS.) In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally can occur following the initial dose of fosinopril sodium. To reduce the likelihood of hypotension, the diuretic should, if possible, be discontinued two to three days prior to beginning therapy with fosinopril sodium (see WARNINGS.) Then, if blood pressure is not controlled with fosinopril sodium alone, diuretic therapy should be resumed. If diuretic therapy can not be discontinued, an initial dose of 10 mg of fosinopril sodium should be used with careful medical supervision for several hours and until blood pressure has stabilized. See WARNINGS; PRECAUTIONS, Information for Patients and DRUG INTERACTIONS. Since concomitant administration of fosinopril sodium with potassium supplements, or potassium-containing salt substitutes or potassium-sparing diuretics may lead to increases in serum potassium, they should be used with caution. (See PRECAUTIONS). Pediatrics In children, doses of MONOPRIL between 0.1 and 0.6 mg/kg have been studied and shown to reduce blood pressure to a similar extent (see Pharmacodynamics and Clinical Effects). Based on this, the recommended dose of MONOPRIL in children weighing more than 50 kg is 5 to 10 mg once per day as monotherapy. An appropriate dosage strength is not available for children weighing less than 50 kg.