Usual Adult Dose for Congestive Heart Failure

Immediate-release tablets:

• Initial dose: 3.125 mg orally twice a day for 2 weeks
• Titration: If tolerated, increase dosage to 6.25, 12.5, and 25 mg orally twice a day over successive intervals of at least 2 weeks
• Maximum dose: 25 mg orally twice a day in patients weighing 85 kg or less and 50 mg orally twice a day in patients weighing 85 kg or greater

Extended-release capsules:

• Initial dose: 10 mg orally once a day for 2 weeks
• Titration: If tolerated, increase dosage to 20 mg, 40 mg, and 80 mg orally once a day over successive intervals of at least 2 weeks
• Maximum dose: 80 mg orally once a day

Comments:

• This drug should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects.
• Prior to initiation of therapy, fluid retention should be minimized.

Use: For the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin (usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and to reduce the risk of hospitalization)

Usual Adult Dose for Left Ventricular Dysfunction

Immediate-release tablets:

• Initial dose: 6.25 mg orally twice a day for 3 to 10 days
• Titration: If tolerated, increase dosage to 12.5 mg orally twice a day, then again to 25 mg orally twice a day after successive intervals of at least 3 to 10 days
• Maintenance dose: 25 mg orally twice a day
• Alternative dose: A lower starting dose may be used (3.125 mg orally twice a day) and/or the rate of up-titration may be slowed if clinically indicated (e.g., due to low blood pressure or heart rate, or fluid retention)

Extended-release capsules:
Initial dose: 20 mg orally once a day for 3 to 10 days

• Titration: If tolerated, increase dosage to 40 mg orally once a day, then again to 80 mg orally once a day after successive intervals of at least 3 to 10 days
• Maintenance dose: 80 mg orally once a day
• Alternative dose: A lower starting dose may be used (10 mg orally once a day) and/or the rate of up-titration may be slowed if clinically indicated (e.g., due to low blood pressure or heart rate, or fluid retention)

Comments:

• This drug should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects.
• Prior to initiation of therapy, fluid retention should be minimized.
• The recommended dosing regimen does not need to be altered in patients who received treatment with an IV or oral beta blocker during the acute phase of the myocardial infarction.

Use: To reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure)

Usual Adult Dose for Hypertension

Immediate-release tablets:

• Initial dose: 6.25 mg orally twice a day (if this dose is tolerated, using standing systolic pressure measured about 1 hour after dosing as a guide) maintain for 7 to 14 days
• Titration: Increase to 12.5 mg orally twice a day if needed for 10 to 14 days, then to 25 mg orally twice a day if needed
• Maximum dose: 50 mg orally twice a day

Extended-release capsules:

• Initial dose: 20 mg orally once a day (if this dose is tolerated, using standing systolic pressure measured about 1 hour after dosing as a guide) maintain for 7 to 14 days
• Titration: If tolerated, increase dose to 40 mg orally once a day for 7 to 14 days, then to 80 mg orally once a day if needed
• Maximum dose: 80 mg orally once a day

Comments:

• This drug should be taken with food to slow the rate of absorption and reduce the incidence of orthostatic effects.
• Prior to initiation of therapy, fluid retention should be minimized.
• The full antihypertensive effect of this drug is seen within 7 to 14 days.
• Concomitant administration with a diuretic can be expected to produce additive effects and exaggerate the orthostatic action of this drug.

Use: For the management of essential hypertension (alone or in combination with other antihypertensive agents, especially thiazide type diuretics)

Renal Dose Adjustments

Patients with underlying renal dysfunction may require extra monitoring during dosage increases; the dose should be reduced or therapy discontinued if a worsening of renal function occurs.

Liver Dose Adjustments

Severe hepatic impairment: Contraindicated

Precautions

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

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis: This drug does not appear to be cleared significantly by hemodialysis due to its high degree of plasma protein binding.
Peritoneal dialysis: Data not available

Other Comments

Administration advice:

• This drug should be taken with food.
• The extended release formulation should be taken once daily in the morning and should not be crushed, chewed, or divided.

Patient advice:

• Patients should be advised that initiation of treatment and (to a lesser extent) dosage increases may be associated with transient symptoms of dizziness or lightheadedness (and rarely syncope) within the first hour after dosing. During these periods, patients should avoid situations such as driving or hazardous tasks, where symptoms could result in injury.