Usual Adult Dose for Hypertension

Non-Black Patients:

• Initial dose: 1 mg orally once a day in patients not receiving a diuretic
• Maintenance dose: 2 to 4 mg orally once a day

Black Patients:

• Initial dose: 2 mg orally once a day in patients not receiving a diuretic
• Maintenance dose: 2 to 4 mg orally once a day

Concomitant Use of a Diuretic:

• Initial dose: 0.5 mg orally once a day

Comments:

• Stop the diuretic 2 to 3 days prior to beginning therapy with this drug; it may be resumed at a later time if clinically indicated.
• If stopping the diuretic is not possible, dose adjustments and careful medical supervision are recommended for several hours until blood pressure has stabilized; the dose of this drug should be subsequently titrated to the optimal response.
• Adjustments are generally made at intervals of at least 1 week and are based on blood pressure response.
• Patients inadequately treated with once a day dosing at 4 mg may be treated with twice a day dosing; there is little clinical experience with doses above 8 mg.

Use: For the treatment of hypertension either alone or in combination with other antihypertensive medications

Usual Adult Dose for Congestive Heart Failure

Initial dose: 1 mg orally once a day
Target dose: 4 mg orally once a day

Comments:

• If the 4 mg dose is not well tolerated, patients may continue therapy with the greatest tolerated dose.

Use: For use in stable patients who have evidence of left-ventricular systolic dysfunction or who are symptomatic from congestive heart failure within the first few days after an acute myocardial infarction

Usual Adult Dose for Left Ventricular Dysfunction

Initial dose: 1 mg orally once a day
Target dose: 4 mg orally once a day

Comments:

• If the 4 mg dose is not well tolerated, patients may continue therapy with the greatest tolerated dose.

Use: For use in stable patients who have evidence of left-ventricular systolic dysfunction or who are symptomatic from congestive heart failure within the first few days after an acute myocardial infarction

Usual Adult Dose for Myocardial Infarction

Initial dose: 1 mg orally once a day
Target dose: 4 mg orally once a day

Comments:

• If the 4 mg dose is not well tolerated, patients may continue therapy with the greatest tolerated dose.

Use: For use in stable patients who have evidence of left-ventricular systolic dysfunction or who are symptomatic from congestive heart failure within the first few days after an acute myocardial infarction

Renal Dose Adjustments

Severe renal dysfunction (CrCl less than 30 mL/min):

• Initial dose: 0.5 mg orally once a day

Liver Dose Adjustments

Hepatic cirrhosis:

• Initial dose: 0.5 mg orally once a day

Precautions

US BOXED WARNING: FETAL TOXICITY:

• When pregnancy is detected, discontinue this drug as soon as possible.
• Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Monitoring:
Cardiovascular: Monitor blood pressure for response to therapy periodically.
Hematologic: Periodically monitor white blood cell counts in patients with collagen-vascular disease and/ or renal disease
Renal: Monitor renal function prior to initiating and periodically during therapy.

Patient advice:

• Advise patients to immediately report any signs or symptoms of angioedema (breathing difficulty or swelling of face, eyes, lips, or tongue) and to stop taking this drug until consulting a physician.
• Tell patients to promptly report any sign of infection (e.g., sore throat, fever), which may be a sign of neutropenia.
• Caution patients to consult their physician if excessive perspiration, dehydration, vomiting, or diarrhea occurs as it may lead to excessive blood pressure reduction due to reduced fluid volume.
• Advise patients against using potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes without consulting their physician.
• Caution heart failure patients against rapid increases in physical activity.
• Females of childbearing age should be informed of the consequences of exposure to this drug during pregnancy; ask these patients to report pregnancies as soon as possible.