Dosing & Uses
Dosage Forms & Strengths
tablet
- 2.5mg (Norvasc, generic)
- 5mg (Norvasc, generic)
- 10mg (Norvasc, generic)
oral suspension
- 1mg/mL (Katerzia)
Hypertension
Indicated for hypertension, to lower blood pressure
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions
5 mg/day PO initially; may be increased by 2.5 mg/day every 7-14 days; not to exceed 10 mg/day maintenance: 5-10 mg/day
Adjust dosage according to blood pressure goals
Coronary Artery Disease
Treatment of chronic stable angina and vasospastic angina (Prinzmetal or variant angina) and angiographically documented coronary artery disease (CAD) in patients without heart failure or ejection fraction (EF) <40%
5-10 mg/day PO initially; maintenance: 10 mg/day PO
Angina
5-10 mg/day PO; maintenance: 10 mg/day PO
Dosage Modifications
Renal impairment
- Pharmacokinetics of amlodipine are not significantly affected by renal impairment; therefore no dosage adjustment necessary
Hepatic impairment
- Lower initial dose may be required for patients with hepatic impairment
- Consider starting with 2.5 mg/day PO
Dosage Forms & Strengths
tablet
- 2.5mg (Norvasc, generic)
- 5mg (Norvasc, generic)
- 10mg (Norvasc, generic)
oral suspension
- 1mg/mL (Katerzia)
Hypertension
<6 years: Safety and efficacy not established
6-17 years
- Indicated for hypertension, to lower blood pressure
- Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions
- 2.5-5 mg/day PO; doses above 5 mg/day have been studied
Dosage Modifications
Renal impairment
- Pharmacokinetics of amlodipine are not significantly affected by renal impairment; therefore no dosage adjustment necessary
Hepatic impairment
- Lower initial dose may be required for patients with hepatic impairment
- Consider starting with 2.5 mg/day PO
Start dosing at low end of dosing range; elderly patients have greater frequency of decreased renal, hepatic or cardiac function
Hypertension
2.5-5 mg/day PO initially; may be increased by 2.5 mg/day every 7-14 days; not to exceed 10 mg/day PO; maintenance: 5-10 mg/day PO
Coronary Artery Disease
Treatment of chronic stable angina and vasospastic angina (Prinzmetal or variant angina) and angiographically documented CAD in patients without heart failure or EF <40%
2.5-10 mg/day PO initially; maintenance: 10 mg/day PO
Angina
2.5-10 mg/day PO; maintenance: 10 mg/day
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Edema (1.8-10.8%)
Pulmonary edema (7-15%)
1-10%
Headache (7.3%)
Fatigue (4.5%)
Palpitations (0.7-4.5%)
Dizziness (1.1-3.4%)
Nausea (2.9%)
Flushing (0.7-2.6%)
Abdominal pain (1.6%)
Somnolence (1.4%)
Male sexual disorder (1-2%)
Drowsiness (1%)
Pruritus (1-2%)
Skin rash (1-2%)
Muscle cramps (1-2%)
Muscle weakness (1-2%)
<1%
Cardiovascular: Arrhythmia (eg, ventricular tachycardia, atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, tachycardia, vasculitis
Central and peripheral nervous system: Hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo
Gastrointestinal: Anorexia, constipation, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia
General: Allergic reaction, asthenia, back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease
Musculoskeletal system: Arthralgia, arthrosis, muscle cramps, myalgia
Psychiatric: Sexual dysfunction (male and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization
Respiratory system: dyspnea, epistaxis
Skin and appendages: Angioedema, erythema multiforme, pruritus, rash, rash erythematous, rash maculopapular
Special senses: Abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus
Urinary system: Micturition frequency, micturition disorder, nocturia
Autonomic nervous system: Dry mouth, sweating increased
Metabolic and nutritional: hyperglycemia, thirst
Hemopoietic: leukopenia, purpura, thrombocytopenia
Postmarketing Reports
Extrapyramidal disorder
Jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis)
Gynecomastia
Warnings
Contraindications
Hypersensitivity
Cautions
Symptomatic hypotension is possible, particularly with severe aortic stenosis; owing to gradual onset of action, acute hypotension unlikely
Worsening of angina and acute myocardial infarction (MI) can develop after dose is started or increased, particularly with severe obstructive CAD
Extensively metabolized by the liver and plasma elimination half-life is 56 hr in patients with hepatic impairment; titrate slowly when treating patients with severe hepatic impairment
Drug interaction overview
- Sildenafil: Monitor for hypotension when sildenafil is coadministered with amlodipine
- CYP3A4 Inhibitors
- Coadministration with moderate or strong CYP3A inhibitors may increase systemic exposure to amlodipine and may require dose reduction
- Monitor for symptoms of hypotension and edema when amlodipine is coadministered with CYP3A inhibitors
- CYP3A4 inducers
- No information available on the quantitative effects of CYP3A4 inducers on amlodipine
- Closely monitor blood pressure when amlodipine is coadministered with CYP3A4 inducers
- Simvastatin
- Coadministration of simvastatin with amlodipine increases the systemic exposure of simvastatin
- Limit simvastatin dose in patients on amlodipine 20 mg/day
- Immunosuppressants
- Amlodipine may increase systemic exposure of cyclosporine or tacrolimus when coadministered
- Frequent monitoring trough blood levels of cyclosporine and tacrolimus and adjust dose when appropriate
Pregnancy & Lactation
Pregnancy
Limited available data based on postmarketing reports are insufficient to inform a drug-associated risk for major birth defects and miscarriage during pregnancy
Clinical considerations
- Hypertension in pregnancy increases maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (eg, need for cesarean section, postpartum hemorrhage)
- Hypertension increases fetal risk for intrauterine growth restriction and intrauterine death
- Carefully monitor pregnant women with hypertension and manage accordingly
Lactation
Limited available data from a published clinical lactation study reports that amlodipine is present in human milk at an estimated median relative infant dose
No adverse effects of amlodipine on breastfed infant reported
There is no available information on effects of amlodipine on milk production
Pregnancy Categories
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Mechanism of Action
Inhibits transmembrane influx of extracellular calcium ions across membranes of myocardial cells and vascular smooth muscle cells without changing serum calcium concentrations; this inhibits cardiac and vascular smooth muscle contraction, thereby dilating main coronary and systemic arteries
Increases myocardial oxygen delivery in patients with vasospastic angina
Absorption
Bioavailability: 64-90%
Onset: 24-96 hr
Duration: 24 hr (antihypertensive effect)
Peak plasma time: 6-12 hr
Steady-state plasma levels are reached after 7-8 days of consecutive dosing
Distribution
Protein bound: 93-98%
Vd: 21 L/kg
Metabolism
Extensively metabolized in liver by CYP3A4
Metabolites: Pyridine analogue (inactive)
Elimination
Half-life: 30-50 hr
Excretion: Urine (10% [parent]; 60% [inactive metabolites])
Administration
Oral Administration
Take with or without food
Suspension: Shake well before using
Storage
Tablets: Store bottles at controlled room temperature, 15-30°C (59-86°F) and dispense in tight, light-resistant containers
Oral suspension: Refrigerate at 2-8°C (36-46°F); avoid freezing and excessive heat; protect from light
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Patient Handout
Formulary
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