AmLODIPine (Lexi-Drugs)

Pronunciation

(am LOE di peen)

Brand Names: US

Norvasc

Brand Names: Canada

ACCEL-AmLODIPine [DSC]; ACT AmLODIPine; AG-AmLODIPine; APO-AmLODIPine; Auro-AmLODIPine; BIO-AmLODIPine; DOM-AmLODIPine; GD-AmLODIPine; JAMP-AmLODIPine; M-Amlodipine; Mar-AmLODIPine; MINT-AmLODIPine; MYLAN-AmLODIPine; Norvasc; NRA-Amlodipine; PHARMA-AmLODIPine; PHL-AmLODIPine [DSC]; PMS-AmLODIPine; Priva-AmLODIPine; Q-AmLODIPine [DSC]; RAN-AmLODIPine; RIVA-AmLODIPine; SANDOZ AmLODIPine; SANDOZ-AmLODIPine; Septa-AmLODIPine; TEVA-AmLODIPine; VAN-AmLODIPine

Dosing: Adult

Hypertension: Oral: Initial: 2.5 to 5 mg once daily; titrate every 1 to 2 weeks as needed based on patient response; maximum: 10 mg/day (ACC/AHA [Whelton 2018]); antihypertensive effect attenuates with higher doses and adverse effects may become more prominent (Mann 2018). Note: Initial therapy with a combination of antihypertensive medications may be necessary for patients >20/10 mm Hg above goal. Recommended combinations with a dihydropyridine calcium channel blocker (eg, amlodipine) include an ACE inhibitor (eg, benazepril), ARB (eg, valsartan), or thiazide diuretic (eg, chlorthalidone) (ACC/AHA [Whelton 2018]). Some experts preferentially recommend an ACE inhibitor or ARB in combination with a dihydropyridine calcium channel blocker (Jamerson 2008; Mann 2018). For patients <20/10 mm Hg above their goal and who have minimal or no response to the initial agent chosen for monotherapy, some experts recommend a sequential monotherapy strategy (Mann 2018); however, over time, many patients will require more than one agent.

Raynaud phenomenon (off-label use): Oral: 5 mg once daily; gradually increase dose based on patient response and tolerability; maximum dose: 20 mg/day (ESVM [Belch 2017]; Wigley 2018)

Stable coronary artery disease (CAD) with ongoing ischemic symptoms or chronic stable angina (alternative agent): Oral: 5 to 10 mg once daily. Note: Preferentially, a beta-blocker should be prescribed as initial therapy; calcium channel blockers may be added if there are ongoing symptoms on beta-blocker therapy or as an alternative if there are contraindications or unacceptable adverse effects with beta blockade (ACC/AHA [Fihn 2012]).

Vasospastic angina: Oral: 5 to 10 mg once daily. Note: Used alone or in combination with nitrates (ACC/AHA [Fihn 2012]).

Dosing: Geriatric

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

Hypertension: Oral: Initial: 2.5 mg once daily

Stable coronary artery disease (CAD) with ongoing ischemic symptoms or chronic stable angina (alternative agent); vasospastic angina: Oral: Initial: 5 mg once daily

Dosing: Renal Impairment: Adult

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: Adult

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

Stable coronary artery disease (CAD) with ongoing ischemic symptoms or chronic stable angina (alternative agent); vasospastic angina: Oral: Initial: 5 mg once daily; titrate slowly in patients with severe hepatic impairment.

Dosing: Pediatric

Hypertension: Oral:

Children 1 to 5 years: Limited data available: Note: A population pharmacokinetic study found that children <6 years of age had weight-adjusted clearance and Vd of amlodipine that were significantly greater than children ≥6 years of age. This may suggest the need for higher mg/kg/day doses in younger children (<6 years of age); however, the study included only a small number of younger children (n=11) (Flynn 2006). One retrospective pediatric study (n=55) that included only eight patients 1-6 years of age used initial doses of 0.05-0.1 mg/kg/day; doses were titrated upwards as needed; mean required dose was significantly higher in patients 1-6 years of age (0.3 ± 0.16 mg/kg/day) compared to older children (6 to 12 years: 0.16 ± 0.12 mg/kg/day; 12 to 20 years: 0.14 ± 0.1 mg/kg/day) (Flynn 2000a).

Children and Adolescents 6 to 17 years: 2.5 to 5 mg once daily; doses >5 mg daily have not been fully studied. In a randomized, placebo-controlled trial of amlodipine in children (n=268; mean age: 12.1 years; range: 6 to 16 years), a significant reduction in systolic blood pressure (compared to placebo) was observed in both the 2.5 mg once daily and the 5 mg once daily amlodipine groups. The authors recommend an initial dose of 0.06 mg/kg/day with a maximum dose of 0.34 mg/kg/day (not to exceed 10 mg/day) (Flynn 2004).

Dosing: Renal Impairment: Pediatric

Children ≥6 years and Adolescents: No dosage adjustment necessary (Doyle 1989; Kungys 2003).

Dosing: Hepatic Impairment: Pediatric

There are no pediatric-specific recommendations; based on experience in adult patients, dosing adjustment and slow titration suggested.

Use: Labeled Indications

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

Hypertension: Management of hypertension.

Stable coronary artery disease with ongoing ischemic symptoms: To reduce the risk of hospitalization secondary to angina and to reduce the risk of a coronary revascularization procedure in patients with documented coronary artery disease (CAD).

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

Use: Off-Label: Adult

  Raynaud phenomenonLevel of Evidence [G]

Based on the European Society for Vascular Medicine guidelines for the diagnosis and management of Raynaud phenomenon, amlodipine is a reasonable alternative to nifedipine for the management of this condition.

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Diabetes Mellitus:

American Diabetes Association, “Standards of Medical Care in Diabetes – 2018,” January 2018

Heart Failure:

ACCF/AHA, “2013 ACCF/AHA Guideline for the Management of Heart Failure,” June 2013.

“HFSA 2010 Comprehensive Heart Failure Practice Guideline,” July 2010

Hypertension:

“2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults,” November 2017.

“ACCF/AHA Expert Consensus Document on Hypertension in the Elderly,” 2011

AHA/ACC/CDC, “AHA/ACC/CDC Science Advisory: An Effective Approach to High Blood Pressure Control” November 2013

ASH/ISH “Clinical Practice Guidelines for the Management of Hypertension in the Community: A Statement by the American Society of Hypertension and the International Society of Hypertension,” January 2014

“National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents,” May 2005

Ischemic Heart Disease:

ACC/AHA/AATS/PCNA/SCAI/STS, “2014 Focused Update of the Guideline for the Diagnosis and Management of Patients with Stable Ischemic Heart Disease,” July 2014

ACCF/AHA/ACP/AATS/PCNA/SCAI/STS, “2012 Guideline for the Diagnosis and Management of Patients with Stable Ischemic Heart Disease,” November 2012

Raynaud Phenomenon:

ESVM, “The diagnosis and management of Raynaud’s phenomenon,” September 2017

Valvular Heart Disease:

AHA/ACC, “2014 AHA/ACC Guideline for the Management of Patients with Valvular Heart Disease,” March 2014

Administration: Oral

Administer without regard to meals.

Administration: Pediatric

Oral: May be administered without regard to food.

Storage/Stability

Store at 15°C to 30°C (59°F to 86°F).

Extemporaneously Prepared

A 1 mg/mL oral suspension may be made with tablets and either a 1:1 mixture of simple syrup and 1% methylcellulose or a 1:1 mixture of Ora-Plus® and Ora-Sweet®. Crush fifty 5 mg tablets in a mortar and reduce to a fine powder. Add small portions of the chosen vehicle and mix to a uniform paste; mix while adding the vehicle in incremental proportions to almost 250 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 250 mL. Label “shake well” and “refrigerate”. Stable for 56 days at room temperature or 91 days refrigerated.

Nahata MC, Morosco RS, and Hipple TF, “Stability of Amlodipine Besylate in Two Liquid Dosage Forms,” J Am Pharm Assoc (Wash) 1999, 39(3):375-7.[PubMed 10363465]

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience fatigue, loss of strength and energy, flushing, nausea, or abdominal pain. Have patient report immediately to prescriber signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), severe dizziness, passing out, angina, tachycardia, abnormal heartbeat, shortness of breath, excessive weight gain, muscle rigidity, tremors, abnormal movements, or swelling of arms or legs (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
  International issues:
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.

• Heart failure: With the exception of amlodipine, calcium channel blockers should be avoided whenever possible in patients with heart failure with reduced ejection fraction (HFrEF). Amlodipine may be used for the treatment of hypertension or ischemic heart disease in patients with HFrEF, but has no effect on functional status or mortality (ACCF/AHA [Yancy 2013]).

• 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.

Geriatric Considerations

Elderly may experience a greater hypotensive response. Constipation may be more of a problem in elderly. Calcium channel blockers are no more effective in elderly than other therapies, however, they do not cause significant CNS effects which is an advantage over some antihypertensive agents.

Pregnancy Considerations

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).

Briggs’ Drugs in Pregnancy & Lactation
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

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

Substrate of CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;Inhibits CYP3A4 (weak)

Drug Interactions 

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

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

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

Bromperidol: Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Bromperidol may diminish the hypotensive effect of Blood Pressure Lowering Agents. Risk X: Avoid combination

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

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). 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

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

Dexmethylphenidate: May diminish the therapeutic effect of Antihypertensive Agents. 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

Duvelisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). 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

Fosnetupitant: 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

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

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

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

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

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

Lorlatinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Avoid concurrent use of lorlatinib with any CYP3A4 substrates for which a minimal decrease in serum concentrations of the CYP3A4 substrate could lead to therapeutic failure and serious clinical consequences. Risk D: Consider therapy modification

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

Lovastatin: AmLODIPine may increase the serum concentration of Lovastatin. 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 increase the serum concentration of QuiNIDine. QuiNIDine may increase the serum concentration of Calcium Channel Blockers (Dihydropyridine). Calcium Channel Blockers (Dihydropyridine) may decrease the serum concentration of QuiNIDine. 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

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

Test Interactions

May lead to false-negative aldosterone/renin ratio (ARR) (Funder 2016).

Monitoring Parameters

Heart rate, blood pressure

Hypertension: The 2017 Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults (ACC/AHA [Whelton 2017]):

Confirmed hypertension and known CVD or 10-year ASCVD risk ≥10%: Target blood pressure <130/80 mm Hg is recommended.

Confirmed hypertension without markers of increased ASCVD risk: Target blood pressure <130/80 mm Hg may be reasonable.

Diabetes and hypertension: The American Diabetes Association (ADA) guidelines (ADA 2018):

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.

Advanced Practitioners Physical Assessment/Monitoring

Assess therapeutic effectiveness (blood pressure, angina pattern, weight, and peripheral edema).

Nursing Physical Assessment/Monitoring

Monitor blood pressure, pulse, frequency and intensity of angina, weight, and peripheral edema.

Dosage Forms Considerations

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

Dosage Forms: US

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

Tablet, Oral:

Norvasc: 2.5 mg, 5 mg, 10 mg

Generic: 2.5 mg, 5 mg, 10 mg

Dosage Forms: Canada

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

Tablet, Oral:

Norvasc: 5 mg, 10 mg

Generic: 2.5 mg, 5 mg, 10 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • C08CA01
Generic Available (US)

Yes

Pricing: US

Tablets (amLODIPine Besylate Oral)

2.5 mg (per each): $0.09 – $1.92

5 mg (per each): $0.09 – $1.84

10 mg (per each): $0.11 – $2.39

Tablets (Norvasc Oral)

2.5 mg (per each): $7.84

5 mg (per each): $7.84

10 mg (per each): $10.75

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

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)

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)

Pharmacodynamics/Kinetics: Additional Considerations

Hepatic function impairment: AUC may increase ~40% to 60%.

Geriatric: AUC may increase ~40% to 60%.

Moderate to severe heart failure: AUC may increase ~40% to 60%.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Rare occurrence of gingival hyperplasia with amlodipine than with other calcium channel blockers (usually resolves upon discontinuation); consultation with physician is suggested if gingival hyperplasia is observed. Rare occurrences of xerostomia, orthostatic hypotension, and erythema multiforme (severe oral ulcerations that respond well to systemic steroid therapy).

Effects on Bleeding

No information available to require special precautions

Index Terms

AmLODIPine Bes+SyrSpend SF; Amlodipine Besylate

FDA Approval Date
July 31, 1992
References

Ahn HK, Nava-Ocampo AA, Han JY, et al, “Exposure to Amlodipine in the First Trimester of Pregnancy and During Breastfeeding,” Hypertens Pregnancy, 2007, 26(2):179-87.[PubMed 17469008]

American Diabetes Association (ADA). Standards of medical care in diabetes—2018. Diabetes Care. 2018;41(suppl 1):S1-S159. http://care.diabetesjournals.org/content/41/Supplement_1. Accessed June 18, 2018.

American College of Obstetricians and Gynecologists (ACOG), Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists’ Task Force on Hypertension in Pregnancy. Obstet Gynecol. 2013;122(5):1122-1131. doi: 10.1097/01.AOG.0000437382.03963.88.[PubMed 24150027]

Anderson PO, Sauberan JB. Modeling drug passage into human milk. Clin Pharmacol Ther. 2016;100(1):42-52. doi: 10.1002/cpt.377.[PubMed 27060684]

Aronow WS, Fleg JL, Pepine CJ, et al, “ACCF/AHA 2011 Expert Consensus Document on Hypertension in the Elderly: A Report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents,” Circulation, 2011, 123(21):2434-506.[PubMed 21518977]

Belch J, Carlizza A, Carpentier PH, et al. ESVM guidelines – the diagnosis and management of Raynaud’s phenomenon. Vasa. 2017;46(6):413-423. doi: 10.1024/0301-1526/a000661.[PubMed 28895508]

Biston P, Mélot C, Degaute JP, et al. Prolonged antihypertensive effect of amlodipine: a prospective double-blind randomized study. Blood Press. 1999;8(1):43-48.[PubMed 10412882]

Donnelly R, Meredith PA, Miller SH, et al. Pharmacodynamic modeling of the antihypertensive response to amlodipine. Clin Pharmacol Ther. 1993;54(3):303-310.[PubMed 8375125]

Doyle GD, Donohue J, Carmody M, Laher M, Greb H, Volz M. Pharmacokinetics of amlodipine in renal impairment. Eur J Clin Pharmacol. 1989;36(2):205-208.[PubMed 2524389]

Ejaz AA, Fitzpatrick PM, Haley WE, Wasiluk A, Durkin AJ, Zachariah PK. Amlodipine besylate induced acute interstitial nephritis. Nephron. 2000;85(4):354-356.[PubMed 10940749]

Fihn SD, Gardin JM, Abrams J, et al; American College of Cardiology Foundation/American Heart Association Task Force. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons [published correction appears in Circulation. 2014;129(16):e463]. Circulation. 2012;126(25):e354-e471. doi: 10.1161/CIR.0b013e318277d6a0.[PubMed 23166211]

Flynn JT, Nahata MC, Mahan JD Jr, Portman RJ; PATH-2 Investigators. Population pharmacokinetics of amlodipine in hypertensive children and adolescents. J Clin Pharmacol. 2006;46(8):905-916.[PubMed 16855075]

Funder JW, Carey RM, Mantero F, et al. The management of primary aldosteronism: case detection, diagnosis, and treatment: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016;101(5):1889-1916. doi: 10.1210/jc.2015-4061.[PubMed 26934393]

Gersh BJ, Maron BJ, Bonow RO, et al. 2011 ACCF/AHA Guideline for the Diagnosis and Treatment of Hypertrophic Cardiomyopathy: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011;124(24):e783-831.[PubMed 22068434]

Ito S. Drug therapy for breast-feeding women [published correction appears in N Engl J Med. 2000;343(18):1348]. N Engl J Med. 2000;343(2):118-126.[PubMed 10891521]

Jamerson K, Weber MA, Bakris GL, et al; ACCOMPLISH Trial Investigators. Benazepril plus amlodipine or hydrochlorothiazide for hypertension in high-risk patients. N Engl J Med. 2008;359(23):2417-2428. doi: 10.1056/NEJMoa0806182.[PubMed 19052124]

Kungys G, Naujoks H, Wanner C. Pharmacokinetics of amlodipine in hypertensive patients undergoing haemodialysis. Eur J Clin Pharmacol. 2003;59(4):291-295.[PubMed 12845505]

Mann JFE. Choice of drug therapy in primary (essential) hypertension. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed July 3, 2018.

Meredith PA and Elliott HL, “Clinical Pharmacokinetics of Amlodipine,” Clin Pharmacokinet , 1992, 22(1):22-31.[PubMed 1532771]

Morgan JL, Kogutt BK, Meek C et al. Pharmacokinetics of amlodipine besylate during pregnancy-how much infant exposure occurs? Am J Obstet Gynecol. 2017;216:S515-S516.

Nahapetian A, Oudiz RJ. Serial hemodynamics and complications of pregnancy in severe pulmonary arterial hypertension. Cardiology. 2008;109(4):237-240.[PubMed 17873487]

Naito T, Kubono N, Deguchi S, et al. Amlodipine passage into breast milk in lactating women with pregnancy-induced hypertension and its estimation of infant risk for breastfeeding. J Hum Lact. 2015a;31(2):301-306. doi: 10.1177/0890334414560195.[PubMed 25447596]

Naito T, Kubono N, Ishida T, et al. CYP3A activity based on plasma 4β-hydroxycholesterol during the early postpartum period has an effect on the plasma disposition of amlodipine. Drug Metab Pharmacokinet. 2015b;30(6):419-424. doi: 10.1016/j.dmpk.2015.08.008.[PubMed 26654672]

Norvasc (amlodipine) [prescribing information]. New York, NY: Pfizer Labs; January 2019.

Norvasc (amlodipine) [product monograph]. Kirkland, Quebec, Canada: Pfizer Canada Inc; September 2017.

Packer M, Carson P, Elkayam U, et al; PRAISE-2 Study Group. Effect of amlodipine on the survival of patients with severe chronic heart failure due to a nonischemic cardiomyopathy: results of the PRAISE-2 study (prospective randomized amlodipine survival evaluation 2). JACC Heart Fail. 2013;1(4):308-314. doi: 10.1016/j.jchf.2013.04.004.[PubMed 24621933]

Packer M, O’Connor CM, Ghali JK, et al, “Effect of Amlodipine on Morbidity and Mortality in Severe Chronic Heart Failure. Prospective Randomized Amlodipine Survival Evaluation Study Group,” N Engl J Med, 1996, 335(15):1107-14.[PubMed 8813041]

Scholz H. Pharmacological aspects of calcium channel blockers. Cardiovasc Drugs Ther. 1997;10:869-872.[PubMed 9126675]

Vigil-De Gracia P, Dominguez L, Solis A. Management of chronic hypertension during pregnancy with furosemide, amlodipine or aspirin: a pilot clinical trial. J Matern Fetal Neonatal Med. 2014;27(13):1291-1294. doi:10.3109/14767058.2013.852180.[PubMed 24102416]

Weber MA, Schiffrin EL, White WB, et al, Clinical practice guidelines for the management of hypertension in the community: a statement by the American Society of Hypertension and the International Society of Hypertension. J Clin Hypertens (Greenwich). 2014;16(1):14-26.[PubMed 24341872]

Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines [published correction appears in Hypertension. 2018;71(6):e140-e144]. Hypertension. 2018;71(6):e140-e144. doi: 10.1161/HYP.0000000000000065.[PubMed 29133356]

Wigley FM. Initial treatment of the Raynaud phenomenon. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed August 28, 2018.

Yancy CW, Jessup M, Bozkurt B, et al; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013;128(16):e240-e327.[PubMed 23741058]

Yu P, Diao W, Tang Q, Jiang X. A successful pregnancy and parturition in a patient with anuria undergoing maintenance hemodialysis for 6 years: a case report of a 3-year-follow-up. BMC Pregnancy Childbirth. 2015;15:218. doi: 10.1186/s12884-015-0642-9.[PubMed 26370296]

Brand Names: International

A-B Vask (ID); Actapin (HK, ID, SG); Adipin (BD, VN); Aforbes (PH); Agen (CZ, EE, LB, LV); Aladin (UA); Alkapress (EG); 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 (EG, TW); Amlate (ZA); Amlibon (MY, VN); 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); Amlocard (LB); Amlocor (ZW); Amlod (HK, TH); Amlodac (MY, TW); Amlodar (AE, KW, LB); Amlode (IE); Amlodigamma (HK); Amlodin (JP); Amlodine (LK, PH, TW); Amlodno (NL); Amloget (VN); Amlogrix (ID); Amlong (HK, MY, SG); Amlopin (BD, HR, KR, PL); Amlopine (TH); Amlopres (HK, MY); Amlopress (SA); Amlor (BE, EC, ES, FR, LU, SA); Amlorine (ET); Amlostar (KR); Amlosyn (CO); Amlotan (IE); Amlotens (SG); Amlotrene (PH); Amlovas (VN); Amlovasc (CH); Amlovasc 5 (TH); Amlow (IL); Amlozen (HK); Amodin (KR); Amodipin (KR); Amopress (QA); Ampliron (PY); Amtas (ET, SG); Amvasc (AE, BH, 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, IQ, IR, JO, KW, 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); Konipid (ID); Lama (IN); Licodipin (ID); Lodibes (PH); Lodin (PH); Lodip (PH); Lodipam (VN); Lofral (HK, JO, MY, QA); Lomanor (ZW); Lotense (BH, LB, MY); Lovas (TH); Lowdipine (KR); Lowrac (QA); Lowvasc (BH, 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, BH, 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, UA, UG, UY, VE, ZA, ZM, ZW); Norvasc ODT (SG); Norvask (ID); Novaspin (KR); Odasyl (PH); Opivask (ID); Ozlodip (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); Tensiblat (ID); Tensivask (ID); Terloc (PY); Varodipine (SG); Vascodipine (QA); Vascor (JO); Vasocal (CR, DO, GT, HN, NI, PA, SV); Vasotop (EC); Vasten (CO); Zynor (HK, MY)

Amlodipine (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(am LOE di peen)

Brand Names: US

Norvasc

Brand Names: Canada

Norvasc

What is this drug used for?
  • It is used to treat high blood pressure.
  • It is used to treat chest pain or pressure.
  • Do not use this drug to treat sudden chest pain. It will not help. Talk with your doctor.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to amlodipine or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • This drug may interact with other drugs or health problems.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • Have your blood pressure checked often. Talk with your doctor.
  • It is rare, but worse chest pain and heart attack can happen after this drug is first started or after the dose is raised. The risk may be greater in people who have very bad heart blood vessel disease. Talk with the doctor.
  • If you are taking this drug and have high blood pressure, talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
  • Talk with your doctor before you drink alcohol.
  • This drug may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this drug with your other drugs.
  • Liver problems have happened with this drug. Sometimes, liver problems have needed to be treated in the hospital. Talk with the doctor.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Very bad dizziness or passing out.
  • Chest pain that is new or worse.
  • A fast heartbeat.
  • A heartbeat that does not feel normal.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Stiff muscles, shakiness, or muscle movements that are not normal.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Dizziness.
  • Feeling sleepy.
  • Feeling tired or weak.
  • Flushing.
  • Upset stomach.
  • Belly pain.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • Take this drug at the same time of day.
  • Take with or without food.
  • To gain the most benefit, do not miss doses.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
What do I do if I miss a dose?
  • Take a missed dose as soon as you think about it.
  • If it has been 12 hours or more since the missed dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Amlodipine (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(am LOE di peen)

Brand Names: US

Norvasc

Brand Names: Canada

Norvasc

What is this drug used for?
  • It is used to treat high blood pressure.
  • It may be given to your child for other reasons. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • This drug may interact with other drugs or health problems.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
  • To lower the chance of feeling dizzy or passing out, have your child rise slowly if your child has been sitting or lying down. Have your child be careful going up and down stairs.
  • Have your child’s blood pressure checked often. Talk with your child’s doctor.
  • It is rare, but worse chest pain and heart attack can happen after this drug is first started or after the dose is raised. The risk may be greater in people who have very bad heart blood vessel disease. Talk with the doctor.
  • If your child is taking this drug and has high blood pressure, talk with the doctor before giving OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • This drug may affect how much of some other drugs are in the body. If your child is taking other drugs, talk with the doctor. Your child may need to have blood work checked more closely while taking this drug with other drugs.
  • Liver problems have happened with this drug. Sometimes, liver problems have needed to be treated in the hospital. Talk with the doctor.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Very bad dizziness or passing out.
  • Chest pain that is new or worse.
  • A fast heartbeat.
  • A heartbeat that does not feel normal.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Stiff muscles, shakiness, or muscle movements that are not normal.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Dizziness.
  • Feeling sleepy.
  • Feeling tired or weak.
  • Flushing.
  • Upset stomach.
  • Belly pain.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • Give this drug at the same time of day.
  • Give this drug with or without food.
  • To gain the most benefit, do not miss giving your child doses.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
What do I do if my child misses a dose?
  • Give a missed dose as soon as you think about it.
  • If it has been 12 hours or more since the missed dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.