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Amlodipine: Drug information

Copyright 1978-2018 Lexicomp, Inc. All rights reserved.

(For additional information see "Amlodipine: Patient drug information" and see "Amlodipine: Pediatric drug information")

For abbreviations and symbols that may be used in Lexicomp (show table)

Brand Names: US AmLODIPine Bes+SyrSpend SF; Norvasc

Brand Names: Canada Accel-Amlodipine; ACT-Amlodipine; Amlodipine-Odan; Apo-Amlodipine; Auro-Amlodipine; Bio-Amlodipine; Dom-
Amlodipine; GD-Amlodipine; JAMP-Amlodipine; Mar-Amlodipine; Mint-Amlodipine; Mylan-Amlodipine; Norvasc; PHL-Amlodipine; PMS-Amlodipine; Q-
Amlodipine; RAN-Amlodipine; ratio-Amlodipine; Riva-Amlodipine; Sandoz Amlodipine; Septa-Amlodipine; Teva-Amlodipine

Pharmacologic Category Antianginal Agent; Antihypertensive; Calcium Channel Blocker; Calcium Channel Blocker, Dihydropyridine

Dosing: Adult
Coronary artery disease (CAD) (chronic stable angina, vasospastic angina, angiographically documented CAD [without heart failure or
ejection fraction <40%]): Oral: 5 to 10 mg once daily

Hypertension: Oral: Initial: 5 mg once daily or 2.5 mg once daily in small or frail patients, or when adding amlodipine to other antihypertensive
therapy; maximum dose: 10 mg once daily. In general, titrate every 7 to 14 days. Titrate more rapidly, however, if clinically warranted, provided the
patient is assessed frequently. Usual dosage range (ASH/ISH [Weber 2014]): 5 to 10 mg once daily. Target dose (JNC8 [James 2013]): 10 mg
once daily.

Dosing: Pediatric
(For additional information see "Amlodipine: Pediatric drug information")

Hypertension: Children ≥6 years and Adolescents: Oral: 2.5 to 5 mg once daily

Dosing: Geriatric Dosing should start at the lower end of dosing range and titrated to response due to possible increased incidence of hepatic,
renal, or cardiac impairment. Elderly patients also show decreased clearance of amlodipine.

Coronary artery disease (CAD) (chronic stable angina, vasospastic angina, angiographically documented CAD without heart failure or
ejection fraction <40%): Oral: Initial: 5 mg once daily

Hypertension: Oral: Initial: 2.5 mg once daily; maximum dose: 10 mg once daily. In general, titrate every 7 to 14 days. Titrate more rapidly,
however, if clinically warranted, provided the patient is assessed frequently. Usual dosage range (ASH/ISH [Weber 2014]): 5 to 10 mg once daily.
Target dose (JNC8 [James 2013]): 10 mg once daily.

Dosing: Renal Impairment

No dosage adjustment necessary (Doyle 1989; Kungys 2003).

End-stage renal disease (ESRD) on dialysis: Hemodialysis and peritoneal dialysis do not enhance elimination; supplemental dose is not
necessary (Kungys 2003).

Dosing: Hepatic Impairment

Coronary artery disease (CAD) (chronic stable angina, vasospastic angina, angiographically documented CAD without heart failure or ejection
fraction <40%): Initial: 5 mg once daily; titrate slowly in patients with severe hepatic impairment.

Hypertension: Initial: 2.5 mg once daily; titrate slowly in patients with severe hepatic impairment.

Dosage Forms Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Oral:

AmLODIPine Bes+SyrSpend SF: 1 mg/mL (120 mL)

Tablet, Oral:

Norvasc: 2.5 mg, 5 mg, 10 mg

Generic: 2.5 mg, 5 mg, 10 mg

Generic Equivalent Available (US) May be product dependent

Dosage Forms Considerations

AmLODIPine Bes+SyrSpend SF oral suspension is a compounding kit. Refer to manufacturer's labeling for compounding instructions.

Administration Oral: Administer without regard to meals.

Use
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Coronary artery disease (CAD):

Chronic stable angina: Treatment of symptomatic chronic stable angina. May be used alone or in combination with other antianginal agents.

Vasospastic angina (Prinzmetal or variant angina): Treatment of confirmed or suspected vasospastic angina. May be used alone or in
combination with other antianginal agents.

Angiographically documented CAD: Reduce the risk of hospitalization secondary to angina and to reduce the risk of a coronary
revascularization procedure in patients with recently documented CAD by angiography (without heart failure or an ejection fraction of <40%).

The ACCF/AHA 2013 guidelines for management of heart failure state that, with the exception of amlodipine, calcium channel blockers
should be avoided and withdrawn whenever possible in patients with heart failure with reduced ejection fraction (HFrEF). While amlodipine,
like other calcium channel blockers, has no benefit on functioning or survival, it may be used for the treatment of hypertension or ischemic
heart disease in patients with HFrEF (ACCF/AHA [Yancy 2013]).

Hypertension: Treatment of hypertension. May be used alone or in combination with other antihypertensive agents.

Guideline recommendations:

The 2014 guideline for the management of high blood pressure in adults (JNC 8) recommends initiation of pharmacologic treatment to
lower blood pressure for the following patients (JNC8 [James 2013]):

• Patients ≥60 years, with systolic blood pressure (SBP) ≥150 mm Hg or diastolic blood pressure (DBP) ≥90 mm Hg.

• Patients <60 years, with SBP ≥140 mm Hg or DBP ≥90 mm Hg.

• Patients ≥18 years with diabetes, with SBP ≥140 mm Hg or DBP ≥90 mm Hg.

• Patients ≥18 years with chronic kidney disease (CKD), with SBP ≥140 mm Hg or DBP ≥90 mm Hg.

Chronic kidney disease (CKD) and hypertension: In patients with chronic kidney disease (CKD), regardless of race or diabetes status, the use
of an ACE inhibitor (ACEI) or angiotensin receptor blocker (ARB) as initial therapy is recommended to improve kidney outcomes. In the
general nonblack population (without CKD) including those with diabetes, initial antihypertensive treatment should consist of a thiazide-type
diuretic, calcium channel blocker, ACEI, or ARB. In the general black population (without CKD) including those with diabetes, initial
antihypertensive treatment should consist of a thiazide-type diuretic or a calcium channel blocker instead of an ACEI or ARB.

Diabetes and hypertension: The American Diabetes Association (ADA) guidelines suggest that for patients with hypertension and diabetes
without albuminuria, any of the 4 classes of blood pressure medications (eg, ACE inhibitors, angiotensin receptor blockers, thiazide-like
diuretics, dihydropyridine calcium channel blockers) may be used and have shown beneficial cardiovascular outcomes (ADA 2017a).

Medication Safety Issues

Sound-alike/look-alike issues:

AmLODIPine may be confused with aMILoride

Norvasc may be confused with Navane, Norvir, Vascor

International issues:

Norvasc [U.S., Canada, and multiple international markets] may be confused with Vascor brand name for imidapril [Philippines] and
simvastatin [Malaysia, Singapore, and Thailand]

Adverse Reactions
>10%:

Cardiovascular: Peripheral edema (2% to 11% dose related; female 15%; male 6%; HF patients 27% to 28% [Packer 1996; Packer 2013])

Respiratory: Pulmonary edema (HF patients 7% to 15% [Packer 1996; Packer 2013])

1% to 10%:

Cardiovascular: Palpitations (≤5%, dose related), flushing (≤3%, dose related, more frequent in females)

Central nervous system: Fatigue (5%), dizziness (1% to 3%, dose related), male sexual disorder (≤2%), drowsiness (1%)

Dermatologic: Pruritus (≤2%), skin rash (≤2%)

Gastrointestinal: Nausea (3%), abdominal pain (2%)

Neuromuscular & skeletal: Muscle cramps (≤2%), weakness (≤2%)

Respiratory: Dyspnea (≤2%)

<1%, postmarketing, and/or case reports: Abnormal dreams, acute interstitial nephritis (Ejaz 2000), angioedema, anorexia, anxiety, arthralgia,
atrial fibrillation, back pain, bradycardia, cardiac arrhythmia, chest pain, cholestasis, conjunctivitis, constipation, depersonalization, depression,
diaphoresis, diarrhea, difficulty in micturition, diplopia, dysphagia, epistaxis, erythema multiforme, erythematous rash, exfoliative dermatitis,
extrapyramidal reaction, eye pain, female sexual disorder, flatulence, gingival hyperplasia, gynecomastia, hepatitis, hot flash, hyperglycemia,
hypersensitivity angiitis, hypersensitivity reaction, hypoesthesia, increased serum transaminases, increased thirst, insomnia, jaundice, leukopenia,
maculopapular rash, malaise, myalgia, nervousness, nocturia, nonthrombocytopenic purpura, orthostatic hypotension, osteoarthritis, pain,
pancreatitis, paresthesia, peripheral ischemia, peripheral neuropathy, phototoxicity, purpura, rigors, syncope, tachycardia, thrombocytopenia,
tinnitus, tremor, urinary frequency, vasculitis, ventricular tachycardia, vertigo, visual disturbance, vomiting, weight gain, weight loss, xerostomia

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Contraindications
Hypersensitivity to amlodipine or any component of the formulation

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to other dihydropyridines; severe hypotension (SBP <90 mm
Hg); breastfeeding

Warnings/Precautions
Concerns related to adverse effects:

• Angina/MI: Increased angina and/or MI have occurred with initiation or dosage titration of dihydropyridine calcium channel blockers. Reflex
tachycardia may occur resulting in angina and/or MI in patients with obstructive coronary disease, especially in the absence of concurrent
beta-blockade.

• Hypotension: Symptomatic hypotension can occur; acute hypotension upon initiation is unlikely due to the gradual onset of action. Blood
pressure must be lowered at a rate appropriate for the patient's clinical condition.

• Peripheral edema: The most common side effect is peripheral edema; occurs within 2 to 3 weeks of starting therapy.

Disease-related concerns:

• Aortic stenosis: Use amlodipine with extreme caution in patients with severe aortic stenosis; may reduce coronary perfusion resulting in
ischemia.

• Hepatic impairment: Use with caution in patients with hepatic impairment; may require lower starting dose; titrate slowly in patients with
severe hepatic impairment.

• Hypertrophic cardiomyopathy (HCM) with outflow tract obstruction: Use amlodipine with caution in patients with HCM and outflow tract
obstruction since reduction in afterload may worsen symptoms associated with this condition (ACCF/AHA [Gersh 2011]).

Special populations:

• Elderly: Initiate at a lower dose in the elderly.

Other warnings/precautions:

• Titration: Peak antihypertensive effect is delayed; dosage titration should occur after 7 to 14 days on a given dose.

Metabolism/Transport Effects Substrate of CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant
drug interaction potential; Inhibits BCRP/ABCG2, CYP2A6 (weak), CYP2C8 (weak), CYP2C9 (weak), CYP3A4 (weak)

Drug Interactions

(For additional information: Launch drug interactions program)

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Alpha1-Blockers: May enhance the hypotensive effect of Calcium Channel Blockers. Risk C: Monitor therapy

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at
chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure
lowering therapy cannot be withheld, amifostine should not be administered. Risk D: Consider therapy modification

Amodiaquine: CYP2C8 Inhibitors may increase the serum concentration of Amodiaquine. Risk X: Avoid combination

Amphetamines: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Antifungal Agents (Azole Derivatives, Systemic): May enhance the adverse/toxic effect of Calcium Channel Blockers. Specifically, itraconazole
may enhance the negative inotropic effects of verapamil or diltiazem. Antifungal Agents (Azole Derivatives, Systemic) may decrease the
metabolism of Calcium Channel Blockers. Fluconazole and isavuconazonium likely exert weaker effects than other azoles and are addressed in
separate monographs. Management: Concurrent use of felodipine or nisoldipine with itraconazole is specifically contraindicated. Frequent
monitoring is warranted with any such combination; calcium channel blocker dose reductions may be required. Exceptions: Fluconazole;
Isavuconazonium Sulfate. Risk D: Consider therapy modification

Antihepaciviral Combination Products: May increase the serum concentration of AmLODIPine. Management: Reduce amlodipine dose by at least
50% and monitor for increased amlodipine effects (eg, hypotension) if an antihepaciviral combination product is initiated. Risk D: Consider therapy
modification

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic
Agents (Second Generation [Atypical]). Risk C: Monitor therapy

Aprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

ARIPiprazole: CYP3A4 Inhibitors (Weak) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole
pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy and/or indication. Consult full
interaction monograph for specific recommendations. Risk C: Monitor therapy

Atosiban: Calcium Channel Blockers may enhance the adverse/toxic effect of Atosiban. Specifically, there may be an increased risk for pulmonary
edema and/or dyspnea. Risk C: Monitor therapy

Barbiturates: May increase the metabolism of Calcium Channel Blockers. Management: Monitor for decreased therapeutic effects of calcium
channel blockers with concomitant barbiturate therapy. Calcium channel blocker dose adjustments may be necessary. Nimodipine Canadian
labeling contraindicates concomitant use with phenobarbital. Risk C: Monitor therapy

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Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Bosentan: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Brigatinib: May diminish the antihypertensive effect of Antihypertensive Agents. Brigatinib may enhance the bradycardic effect of Antihypertensive
Agents. Risk C: Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Calcium Channel Blockers (Nondihydropyridine): Calcium Channel Blockers (Dihydropyridine) may enhance the hypotensive effect of Calcium
Channel Blockers (Nondihydropyridine). Calcium Channel Blockers (Nondihydropyridine) may increase the serum concentration of Calcium
Channel Blockers (Dihydropyridine). Risk C: Monitor therapy

Calcium Salts: May diminish the therapeutic effect of Calcium Channel Blockers. Risk C: Monitor therapy

CarBAMazepine: May increase the metabolism of Calcium Channel Blockers (Dihydropyridine). Management: Consider calcium channel blocker
(CCB) dose adjustments or alternative therapy in patients receiving concomitant carbamazepine. Nimodipine Canadian labeling contraindicates
concurrent use with carbamazepine. Risk D: Consider therapy modification

Ceritinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of ceritinib with a narrow
therapeutic index CYP3A substrate (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus,
tacrolimus) should be avoided when possible. Risk C: Monitor therapy

Clopidogrel: Calcium Channel Blockers may diminish the therapeutic effect of Clopidogrel. Risk C: Monitor therapy

Conivaptan: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

CycloSPORINE (Systemic): Calcium Channel Blockers (Dihydropyridine) may increase the serum concentration of CycloSPORINE (Systemic).
CycloSPORINE (Systemic) may increase the serum concentration of Calcium Channel Blockers (Dihydropyridine). Risk C: Monitor therapy

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative
for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Risk D:
Consider therapy modification

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of AmLODIPine. Risk C: Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of AmLODIPine. Risk C: Monitor therapy

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the
CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly
therapeutic effects). Risk D: Consider therapy modification

Dapoxetine: May enhance the orthostatic hypotensive effect of Calcium Channel Blockers. Risk C: Monitor therapy

Dasatinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Dofetilide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Dofetilide. Risk C: Monitor therapy

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Risk C: Monitor therapy

Efavirenz: May decrease the serum concentration of Calcium Channel Blockers. Risk C: Monitor therapy

Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Concurrent use of
enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4
substrate should be performed with caution and close monitoring. Risk D: Consider therapy modification

Flibanserin: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Flibanserin. Risk C: Monitor therapy

Fluconazole: May increase the serum concentration of Calcium Channel Blockers. Risk C: Monitor therapy

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Fosphenytoin: Calcium Channel Blockers may increase the serum concentration of Fosphenytoin. Management: Monitor for phenytoin toxicity with
concomitant use of a calcium channel blocker (CCB) or decreased phenytoin effects with CCB discontinuation. Monitor for decreased CCB
therapeutic effects. Nimodipine Canadian labeling contraindicates use with phenytoin. Risk D: Consider therapy modification

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Herbs (Hypertensive Properties): May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

HYDROcodone: CYP3A4 Inhibitors (Weak) may increase the serum concentration of HYDROcodone. Risk C: Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Risk
C: Monitor therapy

Idelalisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination

Levodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa. Risk C: Monitor therapy

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Lomitapide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Lomitapide. Management: Patients on lomitapide 5 mg/day may
continue that dose. Patients taking lomitapide 10 mg/day or more should decrease the lomitapide dose by half. The lomitapide dose may then be
titrated up to a max adult dose of 30 mg/day. Risk D: Consider therapy modification

Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Macrolide Antibiotics: May decrease the metabolism of Calcium Channel Blockers. Management: Consider using a noninteracting macrolide.
Felodipine Canadian labeling specifically recommends avoiding its use in combination with clarithromycin. Exceptions: Azithromycin (Systemic);
Fidaxomicin; Roxithromycin; Spiramycin. Risk D: Consider therapy modification

Magnesium Salts: Calcium Channel Blockers may enhance the adverse/toxic effect of Magnesium Salts. Magnesium Salts may enhance the
hypotensive effect of Calcium Channel Blockers. Risk C: Monitor therapy

Melatonin: May diminish the antihypertensive effect of Calcium Channel Blockers (Dihydropyridine). Risk C: Monitor therapy

Methylphenidate: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Minimize doses of
CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid
cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Risk D: Consider therapy modification

Mitotane: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates
may need to be adjusted substantially when used in patients being treated with mitotane. Risk D: Consider therapy modification

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Netupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Neuromuscular-Blocking Agents (Nondepolarizing): Calcium Channel Blockers may enhance the neuromuscular-blocking effect of
Neuromuscular-Blocking Agents (Nondepolarizing). Risk C: Monitor therapy

Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

NiMODipine: CYP3A4 Inhibitors (Weak) may increase the serum concentration of NiMODipine. Risk C: Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Risk C: Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood
pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D:
Consider therapy modification

Palbociclib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Phenytoin: Calcium Channel Blockers may increase the serum concentration of Phenytoin. Phenytoin may decrease the serum concentration of
Calcium Channel Blockers. Management: Avoid use of nimodipine or nifedipine with phenytoin. Monitor for phenytoin toxicity and/or decreased
calcium channel blocker effects with any concurrent use. Risk D: Consider therapy modification

Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Risk C: Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Pimozide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Pimozide. Risk X: Avoid combination

Pitolisant: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Combined use of pitolisant with
a CYP3A4 substrate that has a narrow therapeutic index should be avoided. Other CYP3A4 substrates should be monitored more closely when
used with pitolisant. Risk D: Consider therapy modification

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

QuiNIDine: Calcium Channel Blockers (Dihydropyridine) may decrease the serum concentration of QuiNIDine. Calcium Channel Blockers
(Dihydropyridine) may increase the serum concentration of QuiNIDine. QuiNIDine may increase the serum concentration of Calcium Channel
Blockers (Dihydropyridine). Risk C: Monitor therapy

Rifamycin Derivatives: May decrease the serum concentration of Calcium Channel Blockers. This primarily affects oral forms of calcium channel
blockers. Management: The labeling for some US and Canadian calcium channel blockers contraindicate use with rifampin, however
recommendations vary. Consult appropriate labeling. Risk D: Consider therapy modification

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Simeprevir: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Simvastatin: AmLODIPine may increase the serum concentration of Simvastatin. Management: Avoid the concurrent use of amlodipine with
simvastatin when possible. If used together, avoid doses of simvastatin greater than 20 mg/day (for adults). Risk D: Consider therapy modification

St John's Wort: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for
one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Risk D: Consider
therapy modification

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Stiripentol: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4
substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any
CYP3A4 substrate used with stiripentol requires closer monitoring. Risk D: Consider therapy modification

Tacrolimus (Systemic): Calcium Channel Blockers (Dihydropyridine) may increase the serum concentration of Tacrolimus (Systemic). Risk C:
Monitor therapy

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Yohimbine: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Food Interactions Grapefruit juice may modestly increase amlodipine levels. Management: Monitor closely with concurrent use.

Pregnancy Implications
Amlodipine crosses the placenta. Cord blood concentrations were approximately one-third of maternal serum at delivery, and concentrations in the
newborn were below the limit of quantification (<0.1 ng/mL) when measured in eight infants within 48 hours of delivery (Morgan 2017). Information
related to the use of amlodipine in pregnancy is limited (Ahn 2007; Nahapetian 2008; Vigil-De Gracia 2014; Yu 2015). Due to pregnancy induced
pharmacologic changes, amlodipine pharmacokinetics may be altered immediately postpartum; large individual patient variability was observed (Naito
2015b).

Untreated chronic maternal hypertension is associated with adverse events in the fetus, infant, and mother. If treatment for hypertension during
pregnancy is needed, agents other than amlodipine are preferred (ACOG 2013).

Breast-Feeding Considerations
Amlodipine is present in breast milk.

The relative infant dose (RID) of amlodipine is 4.18 % (interquartile range 3.12 to 7.25%) when calculated using a median breast milk concentration
and compared to a weight adjusted maternal dose of 6.01 mg ± 2.31 mg/day. In general, breastfeeding is considered acceptable when the RID is
<10%; when an RID is >25% breastfeeding should generally be avoided (Anderson 2016; Ito 2000). Using a median predose milk concentration (11.5
ng/mL; IQR 9.84 to 18 ng/mL), authors of a study calculated the estimated daily infant dose via breast milk to be 4.17 mcg/kg/day (IQR 3.05 to 6.32
mcg/kg/day). This milk concentration was obtained following maternal administration of amlodipine at a median daily dose of 6.01 mg ± 2.31 mg; the
women (n=31) were ~3 weeks postpartum and sampling occurred prior to a dose and ~10 days after treatment initiation. The maximum RID calculated
was 15.2%. Adverse events were not observed in the breastfed infants (Naito 2015a).

Monitoring Parameters Heart rate, blood pressure

Reference Range
Hypertension: The 2014 guideline for the management of high blood pressure in adults (Eighth Joint National Committee [JNC 8]):

• Patients ≥60 years: Goal of therapy is SBP <150 mm Hg and DBP <90 mm Hg.

• Patients <60 years: Goal of therapy is SBP <140 mm Hg and DBP <90 mm Hg.

• Patients ≥18 years with diabetes: Goal of therapy is SBP <140 mm Hg and DBP <90 mm Hg.

• Patients ≥18 years with chronic kidney disease (CKD): Goal of therapy is SBP <140 mm Hg and DBP <90 mm Hg.

Diabetes and hypertension: The American Diabetes Association (ADA) guidelines (ADA 2017a; ADA 2017b):

• Patients ≥18 to ≤65 years: Goal of therapy is SBP <140 mm Hg and DBP <90 mm Hg.

• Patients ≥18 to ≤65 years and at high risk of cardiovascular disease: Goal of therapy is SBP <130 mm Hg and DBP <80 mm Hg (if can be
achieved without undue treatment burden).

• Patients ≥65 years (healthy or complex/intermediate health): Goal of therapy is SBP <140 mm Hg and DBP <90 mm Hg.

• Patients ≥65 years (very complex/poor health): Goal of therapy is SBP <150 mm Hg and DBP <90 mm Hg.

Mechanism of Action Inhibits calcium ion from entering the “slow channels” or select voltage-sensitive areas of vascular smooth muscle and
myocardium during depolarization, producing a relaxation of coronary vascular smooth muscle and coronary vasodilation; increases myocardial
oxygen delivery in patients with vasospastic angina. Amlodipine directly acts on vascular smooth muscle to produce peripheral arterial vasodilation
reducing peripheral vascular resistance and blood pressure.

Pharmacodynamics/Kinetics
Onset of action: Antihypertensive effect: Significant reductions in blood pressure at 24 to 48 hours after first dose; slight increase in heart rate
within 10 hours of administration may reflect some vasodilating activity (Donnelly 1993)

Duration: Antihypertensive effect: At least 24 hours (Donnelly 1993); has been shown to extend to at least 72 hours when discontinued after 6 to 7
weeks of therapy (Biston 1999)

Absorption: Well absorbed (Meredith 1992)

Distribution: Mean Vd:

Children >6 years: Similar to adults on a mg per kg basis; Note: Weight-adjusted Vd in younger children (<6 years of age) may be greater
than in older children (Flynn 2006)

Adults: 21 L/kg (Scholz 1997)

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Protein binding: ~93%

Metabolism: Hepatic (~90%) to inactive metabolites

Bioavailability: 64% to 90%

Half-life elimination: Terminal (biphasic): 30 to 50 hours; increased with hepatic dysfunction

Time to peak, plasma: 6 to 12 hours

Excretion: Urine (10% of total dose as unchanged drug, 60% of total dose as metabolites)

Clearance: May be decreased in patients with hepatic insufficiency or moderate to severe heart failure; weight-adjusted clearance in children >6
years of age is similar to adults; Note: Weight-adjusted clearance in younger children (<6 years of age) may be greater than in older children
(Flynn 2006)

Pricing: US
Suspension (AmLODIPine Bes+SyrSpend SF Oral)

1 mg/mL (120 mL): $196.88

Tablets (AmLODIPine Besylate Oral)

2.5 mg (90): $155.68

5 mg (90): $155.68

10 mg (90): $213.60

Tablets (Norvasc Oral)

2.5 mg (90): $613.92

5 mg (100): $682.12

10 mg (90): $841.70

Disclaimer: The pricing data provide a representative AWP and/or AAWP price from a single manufacturer of the brand and/or generic product,
respectively. The pricing data should be used for benchmarking purposes only, and as such should not be used to set or adjudicate any prices for
reimbursement or purchasing functions. Pricing data is updated monthly.

Brand Names: International A-B Vask (ID); Actapin (HK, ID, SG); Adipin (BD, VN); Aforbes (PH); Agen (CZ, EE, LV); Aladyn (UA); Alopine
(TW); Alozur (HU); Amaday (PH); Ambesyl (PH); Amcal (PH); Amcard (IN); Amcardia (TH); Amdepin (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML,
MR, MU, MW, MY, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM); Amdhapine (SG); Amdipin (CO, PE); Amdixal (ID); Amedin (HK); Amilo (TW); Amlate
(ZA); Amlibon (MY); Amlibon BES (CR, DO, GT, HN, NI, PA, SV); Amlo-H10 (ZW); Amlo-H5 (ZW); Amlo-M (KR); Amlober (NL); Amloc (AR, CL);
Amlocar (PE); Amlocor (ZW); Amlod (HK, TH); Amlodac (MY, TW); Amlodar (AE, KW, LB); Amlode (IE); Amlodigamma (HK); Amlodin (JP); Amlodine
(LK, PH, TW); Amloget (VN); Amlogrix (ID); Amlong (HK, MY, SG); Amlopin (BD, HR, KR, PL); Amlopine (TH); Amlopres (HK); Amlopress (SA); Amlor
(BE, EC, ES, FR, IL, LU, SA); Amlorine (ET); Amlostar (KR); Amlosyn (CO); Amlotan (IE); Amlotens (SG); Amlotrene (PH); Amlovas (VN); Amlovasc
(CH); Amlovasc 5 (TH); Amlozen (HK); Amodin (KR); Amodipin (KR); Amopress (QA); Ampliron (PY); Amtas (ET, SG); Amvasc (AE, QA); Amze (AR,
PY); An Nei Zhen (CN); Anoldin (MY); Anydipine (KR); Ao Wan Lu (CN); Arainno (ES); Asomex-5.0 (ET); Astudal (ES); Avevasc (MY, SG); Avistar
(CR, DO, GT, HN, MX, NI, PA, SV); Awar (ES); Bezam (PH); Cab (BD); Calbivas (ID); Calbloc (PH); Calchek (IN, LK); Calvase (NZ); Cardilopin (VN);
Cardol (PH); Cobisk (KR); Comdipin (ID); Cordarene (BR); Covasc (LK, MY, PH); CP-Lovac (HK); Cydipin (ID); DAILYvasc (PH); Derox-5 (PH); Deten
(TH); Dipsope (VN); Du.Q (TW); Duactin 5 (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, SA, SY, YE); Ertensi (ID); Evasc (KR); Fulopin (ID); Gensia
(ID); Gravask (ID); Hovasc (HK, LK, MY); Hypodipine (QA); Istin (GB, IE, MT); Istolde (IE); Lama (IN); Lodibes (PH); Lodin (PH); Lodipam (VN); Lofral
(HK, JO, MY, QA); Lomanor (ZW); Lotense (LB, MY); Lovas (TH); Lowdipine (KR); Lowrac (QA); Lupin (ID); Narvin (TH); Nexus (CR, DO, GT, HN, NI,
PA, SV); Noloten (EC); Nopidin (BD); Nor-Lodipina (DO, GT, HN, NI, SV); Nordip (AU); Nordipine (MY); Normodipine (HU, SG); Norvapine (AU);
Norvas (CO, ES, MX); Norvasc (AT, AU, BB, BF, BG, BJ, BM, BR, BS, BZ, CH, CI, CL, CN, CR, CY, CZ, DE, DK, DO, EC, EE, EG, ET, FI, GH, GM,
GN, GR, GT, GY, HK, HN, HU, IL, IS, IT, JM, JO, JP, KE, KR, KW, LR, LT, LV, MA, ML, MR, MU, MW, MY, NE, NG, NI, NL, NO, NZ, PA, PE, PH, PK,
PT, RO, RU, SC, SD, SE, SG, SI, SK, SL, SN, SR, SV, TH, TN, TR, TT, TW, TZ, UG, UY, VE, ZA, ZM, ZW); Norvasc ODT (SG); Norvask (ID, UA);
Novaspin (KR); Odasyl (PH); Opivask (ID); Ozlodip (AU); Perivasc (AU); Prelod (TH); Presilam (CL); Provasc (PH); Remedopin S (VN); Sinnorvapin
(KR); Sinop (AR); Sistopress (MX); Stadovas (HK, MY); Stamlo (SG, UA); Stamlo-10 (LK); Tenox (SG); Tensivask (ID); Terloc (PY); Varodipine (SG);
Vascodipine (QA); Vascor (JO); Vasocal (CR, DO, GT, HN, NI, PA, SV); Vasotop (EC); Vasten (CO); Vazotal (UA); Zynor (HK, MY)

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