Class: Dihydropyridines
VA Class: CV200
CAS Number: 111470-99-6
Brands: Azor (combination), Caduet, Exforge (combination), Lotrel, Norvasc
Introduction
Amlodipine is a calcium-channel blocking agent; a dihydropyridine derivative with an intrinsically long duration of action.1 2 3
Uses for Amlodipine Besylate
Hypertension
Amlodipine is used for management of hypertension (alone or in combination with other classes of antihypertensive agents);1 2 3 4 5 6 12 21 49 112 113 may be used in fixed combination with benazepril, olmesartan, or valsartan when such combined therapy is indicated.21 112 113
Calcium-channel blocking agents are one of several preferred initial therapies in hypertensive patients with a high risk of developing CAD, including those with diabetes mellitus;82 in geriatric patients with isolated systolic hypertension;49 53 and in patients with coexisting angina.12 49
Amlodipine can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.82
Amlodipine should not be used for acute management of hypertensive crises.1 7 8 12 49
Addition of benazepril to amlodipine usually does not provide additional antihypertensive effects in blacks but appears to reduce development of amlodipine-associated edema regardless of race.21
May use amlodipine/atorvastatin fixed-combination preparation when treatment with both amlodipine (for hypertension) and atorvastatin (for dyslipidemias and prevention of cardiovascular events) is appropriate.107
CAD
Amlodipine is used for management of Prinzmetal variant angina and chronic stable angina pectoris;1 2 3 4 7 8 9 has been used alone or in combination with other antianginal agents.1 2 3 4 9 Calcium-channel blockers are considered the drugs of choice in management of Prinzmetal variant angina.b
Amlodipine is used in patients with recently documented CAD (by angiography) and without heart failure or an ejection fraction <40% to reduce the risk of coronary revascularization procedure and hospitalization due to angina.1
May use amlodipine/atorvastatin fixed-combination preparation when treatment with both amlodipine (for CAD) and atorvastatin (for dyslipidemias and prevention of cardiovascular events) is appropriate.107
Amlodipine Besylate Dosage and Administration
General
Hypertension
Manufacturers state that amlodipine/benazepril and amlodipine/olmesartan fixed-combination preparations should not be used for initial treatment of hypertension.21 112
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.113 Consider potential benefits and risks of initiating therapy with the fixed combination of amlodipine and valsartan, including whether the patient is likely to tolerate the lowest available dosage of the combined drugs.113
If the patient's baseline BP is 160/100 mm Hg, the estimated probability of achieving SBP control (SBP <140 mm Hg) is 47, 67, or 80% and of achieving DBP control (DBP <90 mm Hg) is 62, 80, or 85% with valsartan alone, amlodipine alone, or amlodipine combined with valsartan, respectively.113
Administration
Oral Administration
Administer amlodipine orally without regard to meals.1 2 3 5
Dosage
Amlodipine is available as amlodipine besylate; dosage expressed in terms of amlodipine.1
Pediatric Patients
Hypertension
Amlodipine Therapy for Hypertension
Oral
Children ≥6 years of age: Usual effective amlodipine dosage is 2.5–5 mg once daily.1 105
Adults
Hypertension
Amlodipine Therapy for Hypertension
Oral
Initially as monotherapy, amlodipine 2.5–5 mg once daily.1 2 4 6 49 In small or frail individuals, initiate therapy with 2.5 mg once daily.1
When adding amlodipine to an existing antihypertensive regimen, use initial dosage of 2.5 mg once daily.1
Increase amlodipine dosage gradually over 7–14 days until optimum control of BP is obtained (up to a maximum dosage of 10 mg daily).1 May increase more rapidly if symptoms so warrant and patient’s tolerance and response are frequently assessed.1
Usual maintenance dosage of amlodipine is 5–10 mg once daily.1 2 6 12 49
Amlodipine/Benazepril Fixed-combination Therapy for Hypertension
Oral
In studies using amlodipine/benazepril fixed combination in dosages of amlodipine 2.5–10 mg daily and benazepril hydrochloride 10–40 mg daily, BP response increased with increasing amlodipine dosage in all patient groups and increased with increasing benazepril dosage in nonblack patient groups.21
If BP is not adequately controlled by monotherapy with amlodipine (or another dihydropyridine-derivative calcium-channel blocker) or benazepril (or another ACE inhibitor), can switch to amlodipine/benazepril fixed combination.21
If BP is adequately controlled by monotherapy with amlodipine, but edema has developed, can switch to amlodipine/benazepril fixed combination to achieve similar or better BP control without edema.21 May be prudent to reduce amlodipine dosage, especially in nonblack patients, when benazepril is initiated to avoid excessive antihypertensive response.21
If BP is controlled with amlodipine and benazepril (administered separately), can switch to the fixed-combination preparation containing the corresponding individual doses for convenience.21
Adjust dosage of amlodipine/benazepril fixed combination according to patient's response; consider that steady-state plasma concentrations of amlodipine and benazepril are reached after 7 and 2 days, respectively.21
In small or frail patients, initial amlodipine dosage of 2.5 mg (available in fixed combination with benazepril hydrochloride 10 mg) once daily.21
Amlodipine/Olmesartan Fixed-combination Therapy for Hypertension
Oral
If BP is not adequately controlled by monotherapy with amlodipine (or another dihydropyridine-derivative calcium-channel blocker) or olmesartan (or another angiotensin II receptor antagonist), can switch to the fixed-combination preparation containing amlodipine 5 mg and olmesartan medoxomil 20 or 40 mg or, alternatively, amlodipine 10 mg and olmesartan medoxomil 20 or 40 mg.112
Can use the fixed combination as a substitute for the individually titrated drugs.112 Can switch to the fixed-combination preparation containing the corresponding individual doses of amlodipine and olmesartan; alternatively, can increase the dosage of one or both components for additional antihypertensive effects.112
Adjust dosage of amlodipine/olmesartan fixed combination, up to a maximum dosage of amlodipine 10 mg daily and olmesartan medoxomil 40 mg daily, according to patient's response after ≥2 weeks at the current dosage.112
Amlodipine/Valsartan Fixed-combination Therapy for Hypertension
Oral
In studies using amlodipine/valsartan fixed combination in dosages of amlodipine 5–10 mg daily and valsartan 160–320 mg daily, BP response increased with increasing dosages of the drugs.113
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 the fixed-combination preparation containing amlodipine 5 mg and valsartan 160 or 320 mg or, alternatively, amlodipine 10 mg and valsartan 160 or 320 mg.113
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.113
If BP is controlled with amlodipine and valsartan (administered separately), can switch to the fixed-combination preparation containing the corresponding individual doses for convenience.113
When used for initial therapy of hypertension in patients likely to require combination therapy with multiple antihypertensive agents, recommended initial dosage is amlodipine 5 mg and valsartan 160 mg daily in those who are not volume depleted.113
Increase to maximum dosage of amlodipine 10 mg and valsartan 320 mg daily, if needed, to control BP.113 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.113
Amlodipine/Atorvastatin Fixed-combination Therapy for Hypertension (Amlodipine) and for Dyslipidemias and Prevention of Cardiovascular Events (Atorvastatin)
Oral
Use the fixed combination as a substitute for the individually titrated drugs.107 Can switch to the fixed-combination preparation containing the corresponding individual doses of amlodipine and atorvastatin; alternatively, can increase the dosage of one or both components for additional antihypertensive and/or antilipemic effects.107
Use the fixed combination to provide additional therapy for patients currently receiving one component of the preparation.107 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.107
Use the fixed combination to initiate treatment in patients requiring therapy for hypertension and dyslipidemias.107 Select initial dosage of the fixed combination based on recommended dosages of the individual components.107
CAD
Amlodipine Therapy for Angina
Oral
Usual amlodipine dosage is 5–10 mg once daily;1 2 adequate control usually requires a maintenance dosage of 10 mg daily.1
Amlodipine Therapy for Angiographically Documented CAD
Oral
Recommended amlodipine dosage is 5–10 mg once daily;1 adequate control usually requires a maintenance dosage of 10 mg daily.1
Amlodipine/Atorvastatin Fixed-combination Therapy for CAD (Amlodipine) and for Dyslipidemias and Prevention of Cardiovascular Events (Atorvastatin)
Oral
Use the fixed combination as a substitute for the individually titrated drugs.107 Can switch to the fixed-combination preparation containing the corresponding individual doses of amlodipine and atorvastatin; alternatively, can increase the dosage of one or both components for additional antianginal and/or antilipemic effects.107
Use the fixed combination to provide additional therapy for patients currently receiving one component of the preparation.107 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.107
Use the fixed combination to initiate treatment in patients requiring therapy for angina and dyslipidemias.107 Select initial dosage of the fixed combination based on recommended dosages of the individual components.107
Prescribing Limits
Pediatric Patients
Hypertension
Oral
Children ≥6 years of age: Safety and efficacy of amlodipine dosages >5 mg daily not established.1
Adults
Hypertension
Oral
Maximum 10 mg of amlodipine once daily.1 107 112 113
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.21 107 112 113
Hepatic Impairment
Hypertension
Initially, amlodipine 2.5 mg daily (as initial or add-on therapy).1 21 107 112
Angina
Initially, amlodipine 5 mg daily.1 107
Renal Impairment
Amlodipine dosage modification not necessary.1 2 3 5 112 113
Preparations containing amlodipine in fixed combination with benazepril are not recommended in patients with Clcr ≤30 mL/minute or Scr >3 mg/dL.21
Geriatric Patients
Hypertension
Initially, amlodipine 2.5 mg daily (as initial or add-on therapy).1 21 107 112 113 Adjust subsequent dosage based on patient response and tolerance.1
Angina
Initially, amlodipine 5 mg daily.1 107
Cautions for Amlodipine Besylate
Contraindications
Known hypersensitivity to amlodipine.1 21 107
When amlodipine is used in fixed combination with atorvastatin, benazepril, olmesartan, or valsartan, consider contraindications associated with the concomitant agent.21 107 112 113
Warnings/Precautions
Warnings
Increased Angina and/or AMI
Rarely, increased frequency, duration, and/or severity of angina or AMI, particularly in patients with severe obstructive CAD, upon initiation or dosage increase of calcium-channel blockers.1
General Precautions
Use of Fixed Combinations
When amlodipine is used in fixed combination with atorvastatin, benazepril, olmesartan, or valsartan, consider cautions, precautions, contraindications, and interactions associated with the concomitant agent.21 107 112 113 Consider cautionary information applicable to specific populations (e.g., pregnant or nursing women, individuals with hepatic or renal impairment, geriatric patients) for each drug in the fixed combination.21 107 112 113
Hypotension
Possible acute hypotension.1 Use amlodipine with caution, particularly in patients with severe aortic stenosis.1
CHF
Use amlodipine with caution in patients with CHF; no adverse effects on survival, cardiac morbidity, or worsened heart failure reported in controlled studies.1
Specific Populations
Pregnancy
Category C.1
Lactation
Not known whether amlodipine is distributed into milk; manufacturer recommends discontinuance of nursing if amlodipine is used.1
Pediatric Use
Safety and efficacy of amlodipine in children <6 years of age not established.1
Safety and efficacy of amlodipine in fixed combination with atorvastatin, benazepril, olmesartan, or valsartan not established in children.21 107 112 113
Geriatric Use
Select amlodipine dosage with caution; initiate with dosage at lower end of recommended range.1 21 112 113 (See Geriatric Patients under Dosage and Administration and see Special Populations under Pharmacokinetics.)
Amlodipine in fixed combination with benazepril, olmesartan, or valsartan: No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.21 112 113
Amlodipine in fixed combination with atorvastatin: Safety and efficacy not established in geriatric patients.107
Hepatic Impairment
Use amlodipine with caution and consider dosage reduction in patients with severe hepatic impairment.1 21 112 113 (See Hepatic Impairment under Dosage and Administration and see Special Populations under Pharmacokinetics.)
Common Adverse Effects
Amlodipine: Headache, edema.1 Edema may be less frequent with concomitant benazepril or olmesartan therapy.21 112
Interactions for Amlodipine Besylate
The following information addresses potential interactions with amlodipine. When amlodipine is used in fixed combination with atorvastatin, benazepril, olmesartan, or valsartan, consider interactions associated with the concomitant agent.21 107 112 113
Specific Drugs and Food
Drug or Food | Interaction |
|---|---|
Alcohol | No change in alcohol pharmacokinetics1 |
Antacids (e.g., aluminum hydroxide and magnesium hydroxide) | Pharmacokinetic interaction unlikely1 |
Atorvastatin | No clinically important change in atorvastatin pharmacokinetics1 |
Cimetidine | Pharmacokinetic interaction unlikely1 |
Digoxin | No effects on serum digoxin concentrations or clearance1 |
Grapefruit juice | Altered bioavailability possible;64 65 74 75 no clinically important changes in another study1 |
Sildenafil | Pharmacokinetic interaction unlikely; additional reduction of BP possible1 |
Warfarin | No change in PT1 |
Amlodipine Besylate Pharmacokinetics
Absorption
Bioavailability
Peak plasma amlodipine concentrations attained 6–12 hours after oral administration.1 Absolute bioavailability ranges from 64–90%.1
Duration
Antihypertensive effects of amlodipine persist for at least 24 hours after administration.1
Food
Food does not affect bioavailability of amlodipine besylate tablets.1
Distribution
Extent
Not known whether amlodipine is distributed into milk.1
Plasma Protein Binding
Amlodipine: Approximately 93%.1
Elimination
Metabolism
Amlodipine is extensively metabolized to inactive metabolites in the liver.1
Elimination Route
Amlodipine is excreted in urine as metabolites (60%) and unchanged drug (10%).1
Half-life
Terminal elimination half-life of amlodipine is 30–50 hours.1
Special Populations
In geriatric patients, amlodipine clearance decreased and AUC increased about 40–60%.1
In patients with hepatic impairment, amlodipine clearance decreased and AUC increased about 40–60%.1
In patients with moderate to severe heart failure, amlodipine clearance decreased and AUC increased about 40–60%.1
Stability
Storage
Oral
Tablets
Amlodipine: Tight, light-resistant containers at 15–30°C.1
Amlodipine/atorvastatin, amlodipine/olmesartan, and amlodipine/valsartan fixed combinations: 25°C (may be exposed to 15–30°C).107 112 113
Capsules
Amlodipine/benazepril fixed combination: Tight container at 25ºC (may be exposed to 15–30ºC).21
ActionsActions
Amlodipine inhibits transmembrane influx of extracellular calcium ions across the membranes of myocardial cells and vascular smooth muscle cells, without changing serum calcium concentrations.1
Amlodipine is a peripheral arterial vasodilator; acts directly on vascular smooth muscle causing reduction in peripheral vascular resistance and BP.1
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.1
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.1
Advice to Patients
When amlodipine is used in fixed combination with atorvastatin, benazepril, olmesartan, or valsartan, importance of informing patients of important cautionary information about the concomitant agent.21 107 112 113
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of advising patients of other important precautionary information.1 (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 2.5 mg (of amlodipine)* | Amlodipine Besylate Tablets | |
Norvasc | Pfizer | |||
5 mg (of amlodipine)* | Amlodipine Besylate Tablets | |||
Norvasc | Pfizer | |||
10 mg (of amlodipine)* | Amlodipine Besylate Tablets | |||
Norvasc | Pfizer |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Capsules | 2.5 mg (of amlodipine) with Benazepril Hydrochloride 10 mg* | Amlodipine Besylate and Benazepril Hydrochloride Capsules (combination) | |
Lotrel | Novartis | |||
5 mg (of amlodipine) with Benazepril Hydrochloride 10 mg* | Amlodipine Besylate and Benazepril Hydrochloride Capsules (combination) | |||
Lotrel | Novartis | |||
5 mg (of amlodipine) with Benazepril Hydrochloride 20 mg* | Amlodipine Besylate and Benazepril Hydrochloride Capsules (combination) | |||
Lotrel | Novartis | |||
5 mg (of amlodipine) with Benazepril Hydrochloride 40 mg | Lotrel | Novartis | ||
10 mg (of amlodipine) with Benazepril Hydrochloride 20 mg* | Amlodipine Besylate and Benazepril Hydrochloride Capsule (combination) | |||
Lotrel | Novartis | |||
10 mg (of amlodipine) with Benazepril Hydrochloride 40 mg | Lotrel | Novartis | ||
Tablets | 5 mg (of amlodipine) with Olmesartan Medoxomil 20 mg | Azor | Daiichi-Sankyo | |
5 mg (of amlodipine) with Olmesartan Medoxomil 40 mg | Azor | Daiichi-Sankyo | ||
10 mg (of amlodipine) with Olmesartan Medoxomil 20 mg | Azor | Daiichi-Sankyo | ||
10 mg (of amlodipine) with Olmesartan Medoxomil 40 mg | Azor | Daiichi-Sankyo | ||
Tablets, film-coated | 2.5 mg (of amlodipine) with Atorvastatin Calcium 10 mg (of atorvastatin) | Caduet | Pfizer | |
2.5 mg (of amlodipine) with Atorvastatin Calcium 20 mg (of atorvastatin) | Caduet | Pfizer | ||
2.5 mg (of amlodipine) with Atorvastatin Calcium 40 mg (of atorvastatin) | Caduet | Pfizer | ||
5 mg (of amlodipine) with Atorvastatin Calcium 10 mg (of atorvastatin) | Caduet | Pfizer | ||
5 mg (of amlodipine) with Atorvastatin Calcium 20 mg (of atorvastatin) | Caduet | Pfizer | ||
5 mg (of amlodipine) with Atorvastatin Calcium 40 mg (of atorvastatin) | Caduet | Pfizer | ||
5 mg (of amlodipine) with Atorvastatin Calcium 80 mg (of atorvastatin) | Caduet | Pfizer | ||
5 mg (of amlodipine) with Valsartan 160 mg | Exforge | Novartis | ||
5 mg (of amlodipine) with Valsartan 320 mg | Exforge | Novartis | ||
10 mg (of amlodipine) with Atorvastatin Calcium 10 mg (of atorvastatin) | Caduet | Pfizer | ||
10 mg (of amlodipine) with Atorvastatin Calcium 20 mg (of atorvastatin) | Caduet | Pfizer | ||
10 mg (of amlodipine) with Atorvastatin Calcium 40 mg (of atorvastatin) | Caduet | Pfizer | ||
10 mg (of amlodipine) with Atorvastatin Calcium 80 mg (of atorvastatin) | Caduet | Pfizer | ||
10 mg (of amlodipine) with Valsartan 160 mg | Exforge | Novartis | ||
10 mg (of amlodipine) with Valsartan 320 mg | Exforge | Novartis |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Amlodipine Besy-Benazepril HCl 2.5-10MG Capsules (TEVA PHARMACEUTICALS USA): 30/$69.99 or 90/$199.96
Amlodipine Besy-Benazepril HCl 5-20MG Capsules (SANDOZ): 30/$69.99 or 90/$195.97
AmLODIPine Besylate 10MG Tablets (GREENSTONE): 90/$23.99 or 180/$36.97
AmLODIPine Besylate 2.5MG Tablets (MYLAN): 90/$16.99 or 100/$17.77
AmLODIPine Besylate 5MG Tablets (GREENSTONE): 90/$22.99 or 180/$39.98
Caduet 10-10MG Tablets (PFIZER U.S.): 30/$150.98 or 90/$425.98
Caduet 10-20MG Tablets (PFIZER U.S.): 30/$203.99 or 90/$587.94
Caduet 10-40MG Tablets (PFIZER U.S.): 30/$204.98 or 90/$584.95
Caduet 10-80MG Tablets (PFIZER U.S.): 30/$214.99 or 90/$584.95
Caduet 2.5-10MG Tablets (PFIZER U.S.): 30/$153.25 or 90/$443.91
Caduet 2.5-20MG Tablets (PFIZER U.S.): 30/$205.98 or 90/$589.96
Caduet 2.5-40MG Tablets (PFIZER U.S.): 30/$186 or 90/$532.75
Caduet 5-10MG Tablets (PFIZER U.S.): 30/$155 or 90/$434.97
Caduet 5-20MG Tablets (PFIZER U.S.): 30/$205.98 or 90/$584.95
Caduet 5-40MG Tablets (PFIZER U.S.): 30/$204.98 or 90/$584.95
Caduet 5-80MG Tablets (PFIZER U.S.): 30/$204.98 or 90/$584.95
Lotrel 10-20MG Capsules (NOVARTIS): 30/$158.99 or 90/$461.99
Lotrel 10-40MG Capsules (NOVARTIS): 30/$164.85 or 90/$469.19
Lotrel 2.5-10MG Capsules (NOVARTIS): 30/$123.99 or 90/$345.98
Lotrel 5-10MG Capsules (NOVARTIS): 30/$123.99 or 90/$340.97
Lotrel 5-20MG Capsules (NOVARTIS): 30/$128.99 or 90/$360.95
Lotrel 5-40MG Capsules (NOVARTIS): 30/$123 or 90/$348.73
Norvasc 10MG Tablets (PFIZER U.S.): 30/$99.55 or 90/$272
Norvasc 2.5MG Tablets (PFIZER U.S.): 30/$76.06 or 90/$199.51
Norvasc 5MG Tablets (PFIZER U.S.): 30/$76.06 or 90/$205.02
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions April 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
References
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