Usual Adult Dose for Hypertension

Extended-release tablets:

• Initial dose: 30 to 60 mg orally once a day
• Maintenance dose: 30 to 90 mg orally once a day
• Maximum dose: Up to 120 mg/day

• Doses may be increased gradually every 7 to 14 days.
• Some extended-release tablet manufacturers recommend a maximum dose of 90 mg/day.

• This drug should be used as part of a comprehensive cardiovascular risk management reduction program (e.g., lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, sodium intake limitations).
• The largest benefit observed with use is the reduction in stroke risk; however, there were also reductions in myocardial infarctions and cardiovascular mortality.

Usual Adult Dose for Angina Pectoris Prophylaxis

Immediate-release capsules:

• Initial dose: 10 mg orally 3 times a day
• Maintenance dose: 10 to 30 mg orally 3 to 4 times a day
• Maximum doe: 180 mg/day

• Initial dose: 30 to 60 mg orally once a day
• Maintenance dose: 30 to 90 mg orally once a day
• Maximum dose: Up to 120 mg/day

• Doses may be increased gradually every 7 to 14 days.
• Immediate-release doses above 120 mg/day are usually not needed.
• Some extended-release tablet manufacturers recommend a maximum dose of 90 mg/day.
• Trials up to 8 weeks have shown reduced angina frequency and increased exercise tolerance; however, sustained effectiveness and safety beyond 8 weeks is unknown.

• Management of vasospastic angina confirmed by classical pattern of angina at rest accompanied by ST segment elevation, angina or coronary artery spasm provoked by ergonovine, OR angiographically demonstrated coronary artery spasm
• Clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed (e.g., pain has a variable threshold on exertion or when angina is refractory to nitrates and/or adequate doses of beta blockers)
• Management of chronic stable angina/effort-associated angina without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and/or organic nitrates or who cannot tolerate those agents

Usual Adult Dose for Angina Pectoris

Immediate-release capsules:

• Initial dose: 10 mg orally 3 times a day
• Maintenance dose: 10 to 30 mg orally 3 to 4 times a day
• Maximum doe: 180 mg/day

• Initial dose: 30 to 60 mg orally once a day
• Maintenance dose: 30 to 90 mg orally once a day
• Maximum dose: Up to 120 mg/day

• Doses may be increased gradually every 7 to 14 days.
• Immediate-release doses above 120 mg/day are usually not needed.
• Some extended-release tablet manufacturers recommend a maximum dose of 90 mg/day.
• Trials up to 8 weeks have shown reduced angina frequency and increased exercise tolerance; however, sustained effectiveness and safety beyond 8 weeks is unknown.

• Management of vasospastic angina confirmed by classical pattern of angina at rest accompanied by ST segment elevation, angina or coronary artery spasm provoked by ergonovine, OR angiographically demonstrated coronary artery spasm
• Clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed (e.g., pain has a variable threshold on exertion or when angina is refractory to nitrates and/or adequate doses of beta blockers)
• Management of chronic stable angina/effort-associated angina without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta blockers and/or organic nitrates or who cannot tolerate those agents

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Immediate-release capsules: Data not available

Extended-release tablets:

• Mild liver dysfunction: Data not available
• Moderate to severe liver dysfunction: Use with caution; frequent monitoring recommended. Providers should consider starting patients on the lowest available dose.

Dose Adjustments

Immediate-release capsules:
Rapid titration in patients under frequent assessment:

• Day 1: 10 mg orally 3 times a day
• Day 2: 20 mg orally 3 times a day
• Day 3 and thereafter: 30 mg orally 3 times a day

• Switch at the nearest equivalent total daily dose (e.g., 30 mg orally 3 times a day [in IR capsules] may be switched to 90 mg orally once a day [in ER tablets])

• Doses should be gradually decreased and patients should be monitored for side effects.

Precautions

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

Administration advice:

• Immediate-release capsules should be swallowed whole, and may be taken with or without food.
• Modified-release formulations should be taken after meals.
• Extended-release formulations should be swallowed whole and should be taken on an empty stomach.
• Extended release formulations should not be divided, crushed, or chewed.
• Grapefruit juice should be avoided.

• Immediate-release capsules: Protect from light and moisture; avoid freezing.
• Extended-release tablets: Protect from light and moisture.

• Patients may take sublingual nitroglycerin concomitantly for acute angina.
• Prolonged/modified/extended release formulations may not be bioequivalent to immediate-release formulations.

• Cardiovascular: Blood pressure, heart rate, and signs/symptoms of angina, especially during initiation and titration

• Inform patients that this drug may cause drowsiness, dizziness, lethargy, blindness, 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 receiving extended-release tablet formulations should be advised to not be concerned if they find a tablet in their stool.
• 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.