Brand names: Katerzia, Norliqva, Norvasc
Drug class: Dihydropyridines

Medically reviewed by Drugs.com on Aug 10, 2025. Written by ASHP.

Introduction

Calcium-channel blocking agent; a dihydropyridine derivative with an intrinsically long duration of action.

Uses for amLODIPine

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents), to lower BP, in adults and children ≥6 years of age.

Commercially available for treatment of hypertension as single-entity preparations and also in fixed combination with benazepril (e.g., Lotrel), olmesartan (e.g., Azor), olmesartan and hydrochlorothiazide (e.g., Tribenzor), telmisartan, valsartan (e.g., Exforge), and valsartan and hydrochlorothiazide (e.g., Exforge HCT). Amlodipine in fixed combination with atorvastatin (Caduet) is used in patients for whom treatment with both amlodipine and atorvastatin is appropriate.

Comprehensive guidelines for the management of hypertension in adults have been published by various authoritative groups.

Lifestyle/behavioral modifications (e.g., weight reduction in patients who are overweight or obese, dietary changes, sodium reduction, potassium supplementation, increased physical activity, moderation of alcohol intake, smoking cessation) are recommended as first-line therapy to lower BP and reduce total cardiovascular risk.

Calcium-channel blockers are recommended as one of several preferred pharmacologic agents for initial management of hypertension in adults; other preferred options include ACE inhibitors, angiotensin II receptor antagonists, and thiazide or thiazide-like diuretics. While there may be individual differences with respect to recommendations for initial drug selection and use in specific patient populations, current evidence indicates that these antihypertensive drug classes all generally produce comparable cardiovascular risk reduction benefits.

Individualize choice of therapy; consider patient characteristics (e.g., age, ethnicity/race, comorbidities, cardiovascular risk) as well as drug-related factors (e.g., ease of administration, availability, adverse effects, cost).

Calcium-channel blockers may be preferred in hypertensive patients with certain coexisting conditions (e.g., ischemic heart disease) and in geriatric patients, including those with isolated systolic hypertension.

Calcium-channel blockers also may be particularly useful in the management of hypertension in black patients; these patients tend to have a greater BP response to calcium-channel blockers and thiazide diuretics than to other antihypertensive drug classes (e.g., ACE inhibitors, angiotensin II receptor antagonists).

Specific guidelines for the management of hypertension in pregnancy have been published by experts such as the American Heart Association (AHA) and the American College of Obstetrics and Gynecologists (ACOG).

Specific guidelines for the management of high BP in children and adolescents have been published by the American Academy of Pediatrics (AAP).

Coronary Artery Disease (CAD)

Management of chronic stable angina and confirmed or suspected vasospastic angina (Prinzmetal or variant); may be used alone or in combination with other antianginal agents.

Also used in patients with angiographically documented CAD (who do not have heart failure or an ejection fraction <40%) to reduce the risk of a coronary revascularization procedure and hospitalization due to angina.

Commercially available as single-entity preparations for this use. Also available in fixed combination with atorvastatin (Caduet) for use in patients for whom treatment with both amlodipine and atorvastatin is appropriate.

The 2023 AHA/ACC clinical practice guideline for the management of chronic coronary disease addresses the treatment of patients with stable angina symptoms (or ischemic equivalents). Use of beta-blockers, nondihydropyridine calcium-channel blocking agents, or long-acting nitrates is recommended for relief of angina or equivalent symptoms.

Pulmonary Arterial Hypertension

Expert consensus guidelines state that a calcium-channel blocker may be used to treat patients with pulmonary arterial hypertension (PAH)^{† [off-label]} who have demonstrated acute vasoreactivity and who do not have right-sided heart failure or any contraindications to such therapy. Long-acting nifedipine or diltiazem, or amlodipine is suggested; verapamil should be avoided due to its potential negative inotropic effects.

Raynaud's Phenomenon

Calcium channel blockers have been used in the management of Raynaud’s phenomenon^{† [off-label]}. Dihydropyridine calcium channel blockers (e.g., nifedipine, amlodipine) are used more frequently than nondihydropyridine calcium channel blockers; among the dihydropyridine class, nifedipine has the most evidence for use.

amLODIPine Dosage and Administration

General

Pretreatment Screening

• In patients being treated for hypertension, obtain baseline BP measurements.

Patient Monitoring

• In patients being treated for hypertension, follow-up evaluation of adherence and response to drug treatment should occur at monthly intervals until BP control is achieved.

• Periodically reinforce adherence to lifestyle modifications (e.g., heart-healthy diet, sodium intake reduction, increased physical activity).

• Monitor for signs and symptoms of edema, especially in patients with heart failure with reduced ejection fraction.

Dispensing and Administration Precautions

• The ISMP includes amLODIPine and aMILoride on the ISMP List of Confused Drug Names and recommends special safeguards to ensure the accuracy of prescriptions for these drugs.

Administration

Oral Administration

Administer orally (as tablets, solution, or suspension) without regard to meals, preferably at the same time each day.

Also commercially available in fixed combination with benazepril (e.g., Lotrel), olmesartan medoxomil (e.g., Azor), olmesartan and hydrochlorothiazide (e.g., Tribenzor), telmisartan, valsartan (e.g., Exforge), valsartan and hydrochlorothiazide (e.g., Exforge HCT), and atorvastatin (e.g., Caduet). See full prescribing information for additional administration instructions for each specific combination product.

If a dose is missed, administer as soon as possible. If >12 hours have elapsed, resume treatment with next dose.

Amlodipine benzoate oral suspension (Katerzia): Shake the suspension well and measure each dose with a calibrated measuring device; do not use a household teaspoon or tablespoon.

Dosage

Available as amlodipine besylate and amlodipine benzoate; dosage expressed in terms of amlodipine.

Pediatric Patients

Hypertension

Amlodipine Monotherapy

Oral

Initiate drug at the low end of the dosage range; may increase dosage every 2–4 weeks until BP controlled, maximum dosage reached, or adverse effects occur.

Children 1–5 years of age^{† [off-label]}: Some experts recommend an initial dosage of 0.1 mg/kg once daily and a maximum dosage of 0.6 mg/kg once daily (up to 5 mg daily).

Children ≥6 years of age: Some experts recommend an initial dosage of 2.5 mg once daily and a maximum dosage of 10 mg once daily. However, manufacturer states safety and efficacy of dosages >5 mg daily not established in pediatric patients. Manufacturer states usual effective amlodipine dosage is 2.5–5 mg once daily.

Adults

Hypertension

Amlodipine Monotherapy

Oral

Manufacturers state usual initial dosage is 5 mg once daily. In geriatric patients and small or frail individuals, initiate therapy with 2.5 mg once daily.

When adding amlodipine to an existing antihypertensive regimen, may use initial dosage of 2.5 mg once daily.

Increase amlodipine dosage gradually, generally at 7- to 14-day intervals, until optimum control of BP is obtained (up to a maximum dosage of 10 mg daily). May increase more rapidly if warranted and patient’s tolerance and response are frequently assessed.

Usual maintenance dosage is 2.5–10 mg once daily.

Amlodipine/Benazepril Fixed-combination

Oral

Manufacturers state that amlodipine/benazepril fixed-combination preparation usually should be used only after therapy with either drug component alone has failed to achieve the desired antihypertensive effect without development of edema.

The fixed-combination preparation also can be used as a substitute for the individually titrated drugs.

Recommended initial dosage is amlodipine 2.5 mg and benazepril hydrochloride 10 mg once daily.

Adjust dosage of amlodipine/benazepril fixed combination according to patient’s response, up to maximum of amlodipine 10 mg and benazepril hydrochloride 40 mg once daily; antihypertensive effect of a given dosage is largely attained with 2 weeks.

Amlodipine/Olmesartan Fixed-combination

Oral

Fixed-combination amlodipine/olmesartan tablets may be used for initial treatment of hypertension in patients likely to require combination therapy with multiple antihypertensive agents to control BP.

When used for initial therapy of hypertension, recommended initial dosage is amlodipine 5 mg and olmesartan medoxomil 20 mg once daily. May increase dosage after 1–2 weeks for additional BP control, up to maximum of amlodipine 10 mg and olmesartan medoxomil 40 mg once daily.

Amlodipine/Olmesartan/Hydrochlorothiazide Fixed-combination

Oral

Manufacturer states that amlodipine/olmesartan/hydrochlorothiazide fixed-combination preparation should not be used for initial treatment of hypertension.

Individualize amlodipine/olmesartan/hydrochlorothiazide fixed-combination preparation dose selection based on previous therapy.

May increase dosage of the fixed combination after 2 weeks if additional BP control is needed (up to maximum of amlodipine 10 mg, olmesartan medoxomil 40 mg, and hydrochlorothiazide 25 mg once daily).

Amlodipine/Telmisartan Fixed-combination

Oral

Fixed-combination amlodipine/telmisartan tablets may be used for initial treatment of hypertension. Consider potential benefits and risks of initiating therapy with the fixed combination, including whether the patient is likely to tolerate the lowest available dosage of the combined drugs. Usual dosage for initial therapy is amlodipine 5 mg and telmisartan 40 mg once daily; initial dosage of amlodipine 5 mg and telmisartan 80 mg once daily may be used in patients requiring larger BP reductions.

Can use the fixed combination as a substitute for the individually administered drugs; switch to the fixed-combination preparation containing the corresponding individual doses of amlodipine and telmisartan or increase the dosage of one or both components for additional antihypertensive effects.

If dose-limiting adverse effects (e.g., edema) have developed during monotherapy with amlodipine 10 mg, can switch to the fixed-combination preparation containing amlodipine 5 mg and telmisartan 40 mg to achieve similar BP control.

Increase to maximum dosage of amlodipine 10 mg and telmisartan 80 mg once daily, if needed, to control BP. May adjust dosage at intervals of at least 2 weeks, since most of the antihypertensive effect of a given dosage is achieved within 2 weeks after a change in dosage.

Initial therapy with fixed-combination preparation not recommended in patients ≥ 75 years of age and those with hepatic impairment.

Amlodipine/Valsartan Fixed-combination

Oral

Fixed-combination amlodipine/valsartan tablets may be used for initial treatment of hypertension in patients likely to require combination therapy with multiple antihypertensive agents to control BP. Consider potential benefits and risks of initiating therapy with the fixed combination, including whether the patient is likely to tolerate the lowest available dosage of the combined drugs. Recommended initial dosage is amlodipine 5 mg and valsartan 160 mg once daily in those who are not volume depleted.

If BP is controlled with amlodipine and valsartan (administered separately), can switch to the fixed-combination preparation containing the corresponding individual doses for convenience.

If BP is not adequately controlled by monotherapy with amlodipine (or another dihydropyridine-derivative calcium-channel blocker) or valsartan (or another angiotensin II receptor antagonist), can switch to amlodipine/valsartan fixed combination.

If dose-limiting adverse effects have developed during monotherapy with amlodipine or valsartan, can switch to a fixed-combination preparation containing a lower dose of that drug to achieve similar BP control; adjust dosage according to patient’s response after 3–4 weeks of therapy.

Increase to maximum dosage of amlodipine 10 mg and valsartan 320 mg once daily, if needed, to control BP. May adjust dosage at intervals of 1–2 weeks, since most of the antihypertensive effect of a given dosage is achieved within 2 weeks after a change in dosage.

Amlodipine/Valsartan/Hydrochlorothiazide Fixed-combination

Oral

Manufacturers state amlodipine/valsartan/hydrochlorothiazide fixed-combination preparation should not be used for initial treatment of hypertension.

Can switch to fixed-combination amlodipine/valsartan/hydrochlorothiazide tablets if BP is not adequately controlled by combined therapy with any 2 of the following drug classes: calcium-channel blockers, angiotensin II receptor antagonists, and diuretics.

In patients who experience dose-limiting adverse effects of amlodipine, valsartan, or hydrochlorothiazide while receiving any dual combination of these drugs, may switch to the triple fixed-combination preparation containing a lower dose of that component.

Can use the fixed combination as a substitute for the individually titrated drugs.

May increase dosage of the fixed combination after 2 weeks if additional BP control is needed (up to maximum of amlodipine 10 mg, valsartan 320 mg, and hydrochlorothiazide 25 mg once daily).

Fixed-combination preparation may be used with other antihypertensive agents.

Amlodipine/Atorvastatin Fixed-combination Therapy for Hypertension (Amlodipine) and for Dyslipidemias and Prevention of Cardiovascular Events (Atorvastatin)

Oral

Can use the fixed combination as a substitute for the individually titrated drugs; switch to the fixed-combination preparation containing the corresponding individual doses of amlodipine and atorvastatin or increase the dosage of one or both components for additional antihypertensive and/or antihyperlipidemic effects.

Can use the fixed combination to provide additional therapy for patients currently receiving one component of the preparation. Select initial dosage based on the current dosage of the component being used and the recommended initial dosage for the added monotherapy.

Can use the fixed combination to initiate treatment in patients requiring therapy for hypertension and dyslipidemia. Select initial dosage of the fixed combination based on recommended dosages of the individual components (e.g., 5 mg of amlodipine and 10 to 20 mg of atorvastatin) based on patient-specific factors (e.g., age, drug interactions). Maximum dosage of amlodipine and atorvastatin in fixed-combination preparation is 10 and 80 mg daily, respectively

CAD

Amlodipine Therapy for Angina

Oral

Recommended amlodipine dosage is 5–10 mg once daily; adequate control usually requires a maintenance dosage of 10 mg daily.

Amlodipine Therapy for Angiographically Documented CAD

Oral

Recommended amlodipine dosage is 5–10 mg once daily; adequate control usually requires a maintenance dosage of 10 mg daily.

Amlodipine/Atorvastatin Fixed-combination Therapy for CAD (Amlodipine) and for Dyslipidemias and Prevention of Cardiovascular Events (Atorvastatin)

Oral

Can use the fixed combination as a substitute for the individually titrated drugs; switch to the fixed-combination preparation containing the corresponding individual doses of amlodipine and atorvastatin or increase the dosage of one or both components for additional antianginal and/or antihyperlipidemic effects.

Can use the fixed combination to provide additional therapy for patients currently receiving one component of the preparation. Select initial dosage of the fixed combination based on the current dosage of the component being used and the recommended initial dosage for the added monotherapy.

Can use the fixed combination to initiate treatment in patients requiring therapy for angina and dyslipidemia. Select initial dosage of the fixed combination based on recommended dosages of the individual components. Maximum dosage of amlodipine and atorvastatin in fixed-combination preparation is 10 and 80 mg daily, respectively

Special Populations

The following information addresses dosage of amlodipine in special populations. Dosages of drugs administered in fixed combination with amlodipine also may require adjustment in certain patient populations; the need for such dosage adjustments must be considered in the context of cautions, precautions, and contraindications specific to that population and drug.

Hepatic Impairment

Hypertension

Initially, amlodipine 2.5 mg once daily (as initial or add-on therapy). Titrate slowly.

Angina

Initially, amlodipine 5 mg daily. Manufacturers state that adequate control of angina usually requires a maintenance dosage of 10 mg daily.

Renal Impairment

Amlodipine dosage modification generally not necessary.

Geriatric Patients

Hypertension

Consider reduced initial amlodipine dosage. Some manufacturers recommend initial dosage of 2.5 mg once daily for geriatric patients.

Angina

Initially, amlodipine 5 mg daily. Adequate control usually requires a maintenance dosage of 10 mg once daily.

Cautions for amLODIPine

Contraindications

• Known hypersensitivity to amlodipine.

Warnings/Precautions

Hypotension

Possible symptomatic hypotension, particularly in patients with severe aortic stenosis. Acute hypotension unlikely because of gradual onset of action.

Increased Angina and/or Acute MI

Possible worsening of angina or acute MI, particularly in patients with severe obstructive CAD, or upon initiation or dosage increase of amlodipine.

Patients with Hepatic Failure

Amlodipine is extensively metabolized in the liver; clearance is decreased, AUC is increased, and plasma elimination half-life is increased to 56 hours.

Reduce initial dosage to 2.5 mg once daily and titrate the drug slowly in patients with severe hepatic impairment.

Use of Fixed Combinations

When amlodipine is used in fixed combination with other drugs (e.g., other antihypertensive agents, atorvastatin), consider boxed warnings, cautions, precautions, contraindications, and interactions associated with the concomitant agent(s).

Specific Populations

Pregnancy

Limited data on drug-associated risk for major birth defects and miscarriage. Limited data suggest amlodipine found in cord blood; may cross placenta in measurable quantities in the third trimester.

Hypertension in pregnancy increases maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, postpartum hemorrhage). Hypertension increases fetal risk for intrauterine growth restriction and intrauterine death. Carefully monitor and manage hypertension in pregnant women.

Lactation

Distributed into milk; relative infant dose 4.2%. No adverse effects observed on the breastfed infant; no available information on effects on milk production.

Females and Males of Reproductive Potential

No evidence of impaired fertility in animals.

Pediatric Use

Safety and efficacy of amlodipine in children <6 years of age not established.

Safety and effectiveness of amlodipine (2.5–5 mg daily) for treatment of hypertension established in pediatric patients 6–17 years of age.

Safety and efficacy of amlodipine in fixed combination with atorvastatin, benazepril, olmesartan (with or without hydrochlorothiazide), telmisartan, or valsartan (with or without hydrochlorothiazide) not established in pediatric patients.

Geriatric Use

Increased amlodipine exposure. Select amlodipine dosage with caution; initiate with dosage at lower end of recommended range (i.e., 2.5 mg daily).

Clinical studies included insufficient numbers of patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients; other clinical experience has not revealed age-related differences in response or tolerance.

Hepatic Impairment

Increased amlodipine exposure. Reduced initial dosage recommended. Titrate slowly in patients with severe hepatic impairment.

Renal Impairment

Amlodipine pharmacokinetics not significantly influenced; no dosage adjustment recommended.

Common Adverse Effects

Edema, dizziness, flushing, palpitations, fatigue, nausea, abdominal pain, somnolence. Adverse effects reported in clinical trial in pediatric patients with hypertension similar to those reported in adults.

Drug Interactions

Amlodipine is a weak CYP3A inhibitor.

The following information addresses potential interactions with amlodipine. When amlodipine is used in fixed combination with other drugs, consider interactions associated with the concomitant agent(s).

Drugs Affecting Hepatic Microsomal Enzymes

Moderate or strong CYP3A inhibitors: Increased amlodipine exposure. Amlodipine dosage reduction may be necessary. Monitor patients for symptoms of hypotension or edema.

CYP3A inducers: Data lacking; closely monitor BP.

Specific Drugs and Food

amLODIPine Pharmacokinetics

Absorption

Bioavailability

Amlodipine besylate tablets: Peak plasma amlodipine concentrations attained 6–12 hours after oral administration. Amlodipine besylate solution (Norliqva): Peak plasma amlodipine concentrations attained within 6.5 hours after oral administration. Absolute bioavailability ranges from 64–90%.

Duration

Antihypertensive effects persist for at least 24 hours after chronic once-daily use.

Steady-state plasma levels achieved in 7–8 days.

Food

Food does not affect bioavailability of amlodipine.

Amlodipine benzoate (Katerzia) suspension: No effect of high-fat, high-calorie breakfast on absorption.

Amlodipine besylate (Norliqva) solution: No effect of high-fat, high-calorie meal on peak plasma concentration and AUC.

Distribution

Extent

Distributed into milk; present in cord blood.

Plasma Protein Binding

Approximately 93%.

Elimination

Metabolism

Amlodipine is extensively (about 90%) metabolized to inactive metabolites in the liver.

Elimination Route

Excreted in urine as metabolites (60%) and unchanged drug (10%).

Half-life

Terminal elimination half-life is 30–50 hours.

Special Populations

In geriatric patients, amlodipine clearance decreased, and AUC increased about 40–60%.

In pediatric patients 6–17 years of age, weight-adjusted clearance and volume of distribution similar to adults.

In patients with hepatic impairment, amlodipine clearance decreased, and AUC increased about 40–60%; plasma elimination half-life 56 hours.

In patients with moderate to severe heart failure, amlodipine AUC increased about 40–60%.

Stability

Storage

Oral

Solution

Norliqva (amlodipine besylate): Original amber glass bottle at 20–25°C (excursions permitted to 15–30°C).

Suspension

Katerzia (amlodipine benzoate): 2–8°C; avoid freezing and excessive heat. Protect from light.

Tablets

Amlodipine: Tight, light-resistant containers at 15–30°C.

Actions

• Amlodipine inhibits transmembrane influx of extracellular calcium ions across the membranes of myocardial cells and vascular smooth muscle cells, without changing serum calcium concentrations.

• Amlodipine is a peripheral arterial vasodilator; acts directly on vascular smooth muscle causing reductions in peripheral vascular resistance and BP.

• Amlodipine reduces total peripheral resistance (afterload) and rate pressure product, and thus myocardial oxygen demand, at any given level of exercise in patients with exertional angina.

• Amlodipine blocks constriction and restores blood flow in coronary arteries in response to calcium, potassium, epinephrine, serotonin, and thromboxane A₂ analog in animal studies and human vessels in vitro.

Advice to Patients

• When amlodipine is used in fixed combination with other drugs, advise patients of important cautionary information about the concomitant agent(s).

• Advise patients that amlodipine is administered once a day, at any time of day, with or without food.

• Advise patients and caregivers on how to administer the oral suspension or solution formulations..

• If a dose of amlodipine is missed, advise patients to take the next dose as soon as possible. If it has been more than 12 hours since the dose was missed, do not take the dose; wait and take the next dose at the normal scheduled time.

• Advise patients to inform their clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.

• Advise women to inform clinicians if they suspect they are or plan to become pregnant or plan to breast-feed.

• Advise patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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