Usual Adult Dose for Hypertension

Initial dose: With a diuretic: 5 mg orally once a day; without a diuretic: 10 mg orally once a day
Maintenance dose: 20 to 40 mg/day orally as a single dose or in two equally divided doses
Maximum dose: 80 mg/day

Comments:

• The divided dose regimen was more effective in controlling pre-dosing blood pressure.
• If discontinuing a diuretic prior to initiating this drug to reduce the likelihood of hypotension, conclude diuretic therapy 2 to 3 days prior to starting this drug.

Usual Pediatric Dose for Hypertension

6 YEARS OR OLDER:
Initial dose: 0.2 mg/kg orally once a day as monotherapy
Maximum dose: 0.6 mg/kg; 40 mg/day

Comments:

• Doses between 0.1 and 0.6 mg/kg once a day have been studied; doses greater than 0.1 mg/kg were shown to reduce blood pressure; doses above 0.6 mg/kg or 40 mg/day have not been studied in pediatric patients.
• Prepare a suspension for pediatric patients who cannot swallow tablets or for whom the calculated dosage does not correspond to available tablet strengths.

Renal Dose Adjustments

Mild to moderate renal dysfunction (CrCl 30 mL/min/1.73 m2 or greater): No adjustment recommended

Severe renal dysfunction (CrCl less than 30 mL/min/1.73 m2):

• Pediatrics: Not recommended
• Adults: Initial dose: 5 mg orally once a day; Maximum dose: 40 mg/day

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNING:

• FETAL TOXICITY: If pregnancy is detected, discontinue this drug as soon as possible. Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus.

Dialysis

Data not available

Other Comments

Reconstitution/preparation techniques: Prepare a suspension for pediatric patients who cannot swallow tablets or for whom the calculated dosage does not correspond to available tablet strengths; manufacturer product information should be consulted.

General: This drug undergoes substantial renal excretion; elderly patients are more likely to have decreased renal function and care should be taken in dose selection.

Monitoring:

• Assess renal function and serum electrolytes prior to initiating therapy and periodically during treatment.
• Monitor congestive heart failure patients closely for the first 2 weeks of treatment with this drug and following a dose increase of this drug or a concomitant diuretic.

• 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.
• 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.
• Encourage patients to report any lightheadedness that may occur during treatment initiation and to stop taking this drug until consulting a physician if syncope occurs.
• Warn patients against using potassium supplements or potassium containing salt substitutes without consulting a physician.