Usual Adult Dose for Hypertension

Initial dose: 5 mg orally once a day
Maintenance dose: 5 to 10 mg orally once a day
Maximum dose: 10 mg/day

Comments:

• Patients who are small or fragile may be started on 2.5 mg orally once a day.
• The dosage should be adjusted according to patient response. In general, titration should proceed over 7 to 14 days. If clinically warranted, titration may proceed more rapidly, provided the patient is assessed frequently.

• Alone or in combination with other antihypertensive agents to treat hypertension

Usual Adult Dose for Angina Pectoris

Maintenance dose: 5 to 10 mg orally once a day
Maximum dose: 10 mg/day

Comments:

• In clinical studies, most patients with angina or coronary artery disease (CAD) required 10 mg orally once a day.
• The dosage should be adjusted according to patient response. In general, titration should proceed over 7 to 14 days. If clinically warranted, titration may proceed more rapidly, provided the patient is assessed frequently.

• Alone or in combination with other antianginal agents for the symptomatic treatment of chronic stable angina
• Alone or in combination with other antianginal agents for the treatment of confirmed/suspected vasospastic angina
• To reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure in patients with recently documented CAD by angiography and without heart failure or an ejection fraction less than 40%

Usual Adult Dose for Coronary Artery Disease

Maintenance dose: 5 to 10 mg orally once a day
Maximum dose: 10 mg/day

Comments:

• In clinical studies, most patients with angina or coronary artery disease (CAD) required 10 mg orally once a day.
• The dosage should be adjusted according to patient response. In general, titration should proceed over 7 to 14 days. If clinically warranted, titration may proceed more rapidly, provided the patient is assessed frequently.

• Alone or in combination with other antianginal agents for the symptomatic treatment of chronic stable angina
• Alone or in combination with other antianginal agents for the treatment of confirmed/suspected vasospastic angina
• To reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure in patients with recently documented CAD by angiography and without heart failure or an ejection fraction less than 40%

Usual Geriatric Dose for Hypertension

Initial dose: 2.5 mg orally once a day
Maintenance dose: 2.5 to 10 mg orally once a day
Maximum dose: 10 mg/day

Comment:

• The dosage should be adjusted according to patient response. In general, titration should proceed over 7 to 14 days. If clinically warranted, titration may proceed more rapidly, provided the patient is assessed frequently.

• Alone or in combination with other antihypertensive agents to treat hypertension

Usual Geriatric Dose for Angina Pectoris

Initial dose: 5 mg orally once a day
Maintenance dose: 5 to 10 mg orally once a day
Maximum dose: 10 mg/day

Comments:

• In clinical studies, most patients with angina or coronary artery disease (CAD) required 10 mg orally once a day.
• The dosage should be adjusted according to patient response. In general, titration should proceed over 7 to 14 days. If clinically warranted, titration may proceed more rapidly, provided the patient is assessed frequently.

• Alone or in combination with other antianginal agents for the symptomatic treatment of chronic stable angina
• Alone or in combination with other antianginal agents for the treatment of confirmed/suspected vasospastic angina
• To reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure in patients with recently documented CAD by angiography and without heart failure or an ejection fraction less than 40%

Usual Pediatric Dose for Hypertension

6 to 17 years:

• Maintenance dose: 2.5 to 5 mg orally once a day
• Maximum dose: 5 mg/day

• Doses higher than 5 mg have not been studied in pediatric patients.

• Alone or in combination with other antihypertensive agents to treat hypertension

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Hypertension:

• Initial dose: 2.5 mg orally once a day

• Initial dose: 5 mg orally once a day

• Most patients with angina or CAD will require a dosage of 10 mg/day.
• The dosage should be adjusted according to patient response. In general, titration should proceed over 7 to 14 days. If clinically warranted, titration may proceed more rapidly, provided the patient is assessed frequently.

Dose Adjustments

Patients using other concomitant antihypertensive drugs:

• Recommended initial dose: 2.5 mg orally once a day

Precautions

Safety and efficacy have not been established in patients younger than 6 years.

Consult WARNINGS section for additional precautions.

Dialysis

No adjustment recommended.

Other Comments

Administration advice:

• The oral tablet formulation may be taken with or without food.
• The oral solution should not be shaken or mixed with food/beverages prior to administration.

• The manufacturer product information should be consulted.

• The oral solution formulation contains glycerol, which could result in upset stomach, headache, and/or diarrhea.
• This drug has been used safely in patients with chronic obstructive pulmonary disease, well-compensated heart failure, peripheral vascular disease, diabetes mellitus, and with abnormal lipid profiles.
• The magnitude of blood pressure reduction is correlated with the height of pretreatment elevation (e.g., patients with moderate hypertension had a 50% greater response in than patients with mild hypertension).

• Blood pressure
• Periodic liver function tests

• Inform patients that this drug may cause drowsiness, dizziness, headache, or nausea, and they should avoid driving or operating machinery until the full effects of the drug are seen.
• Instruct patients to immediately report any signs/symptoms of Stevens-Johnson syndrome, hepatitis/jaundice, or hypersensitivity reactions.
• Patients should be advised to speak to a healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.
• Patients should be advised to report all concurrent prescription and nonprescription medications or herbal products they are taking.

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