Dosing & Uses
tablet
- 1.25mg
- 2.5mg (functionally scored)
- 5mg (functionally scored)
Hypertension
Indicated as monotherapy or in combination with other antihypertensive agents for hypertension
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarction
Initial: 2.5 mg PO qDay;: may increase to up to 5 mg PO qDay
Small, fragile, or elderly patients, or patients with hepatic insufficiency, may be started on 1.25 mg qDay and this dose may be used when adding to other antihypertensive therapy
Adjust dosage according to blood pressure goals
In general, wait 7-14 days between titration steps; titrate more rapidly, if clinically warranted, provided the patient is assessed frequently
Dosage Modifications
Renal impairment
- Pharmacokinetics of amlodipine are not significantly influenced
- No dosage adjustment required in patients with renal failure
Hepatic impairment
- Patients with hepatic insufficiency may be started on 1.25 mg qDay
- Elderly patient and patients with hepatic insufficiency have decreased clearance of amlodipine with a resulting increase in AUC of ~40-–60%, and a lower initial dose may be required
tablet
- 1.25mg
- 2.5mg (functionally scored)
- 5mg (functionally scored)
Hypertension
Indicated as monotherapy or in combination with other antihypertensive agents for hypertension in children and adolescents aged ≥6 years
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarction
<6 years: Safety and efficacy not established
6-17 years
- 1.25-2.5 mg PO qDay
- Doses >2.5 mg/day have not been studied in pediatric patients
Dosage Modifications
Renal impairment
- Pharmacokinetics of amlodipine are not significantly influenced
- No dosage adjustment required in patients with renal failure
Hepatic impairment
- Patients with hepatic insufficiency may be started on 1.25 mg qDay
- Patients with hepatic insufficiency have decreased clearance of amlodipine with a resulting increase in AUC of ~40-60%, and a lower initial dose may be required
Hypertension
Indicated as monotherapy or in combination with other antihypertensive agents for hypertension
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarction
Small, fragile, or elderly patients may be started on 1.25 mg qDay and this dose may be used when adding to other antihypertensive therapy
Adjust dosage according to blood pressure goals
In general, wait 7-14 days between titration steps; titrate more rapidly if clinically warranted, provided the patient is assessed frequently
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse Effects
>10%
- Edema (5.4-14.6%)
1-10%
- Fatigue (4.5%)
- Flushing (1.5-4.5%)
- Palpitations (0.7-4.5%)
- Dizziness (1.1-3.4%)
- Palpitations (1.4-3.3%)
- Nausea (2.9%)
- Flushing (0.7-2.6%)
- Abdominal pain (1.6%)
- Somnolence (1.3-1.6%)
- Somnolence (1.4%)
Frequency Not Defined
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, erythematous rash, maculopapular rash
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
Gynecomastia
Jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis)
Warnings
Contraindications
Hypersensitivity
Cautions
Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis; owing to the gradual onset of action, acute hypotension is unlikely
Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease
Amlodipine is extensively metabolized by the liver; plasma elimination half-life is 56 hr in patients with impaired hepatic function; titrate slowly when administering amlodipine to patients with severe hepatic impairment
Drug interaction overview
- Levoamlodipine is a CYP3A4 substrate
-
Effects of other drugs on amlodipine
- Coadministration with moderate or strong CYP3A inhibitors results in increased systemic exposure to amlodipine and may require dose reduction; monitor for symptoms of hypotension and edema when amlodipine is coadministered with CYP3A inhibitors
- No information is available on the quantitative effects of CYP3A inducers on amlodipine; closely monitor blood pressure when amlodipine is coadministered with CYP3A inducers
- Monitor for hypotension when sildenafil is coadministered with amlodipine
-
Effects of amlodipine on other drugs
- Coadministration of simvastatin with amlodipine increases the systemic exposure of simvastatin; limit simvastatin dose in patients on amlodipine to 20 mg/day
- Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when coadministered; frequently monitor trough blood levels of cyclosporine and tacrolimus and adjust dose when appropriate
Pregnancy & Lactation
Pregnancy
Limited available data based on postmarketing reports with use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage
There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy
Animal data
- In animal reproduction studies, there was no evidence of adverse developmental effects when pregnant rats and rabbits were treated with oral amlodipine during organogenesis at doses ~10 and 20 times the maximum recommended human dose (MRHD)
- In rats, litter size was significantly decreased (by about 50%), and the number of intrauterine deaths was significantly increased (about 5-fold)
- Amlodipine has been shown to prolong both the gestation period and the duration of labor in rats at this dose
Clinical considerations
- Hypertension in pregnancy increases the maternal risk for preeclampsia, gestational diabetes, premature delivery, and delivery complications (eg, need for cesarean delivery, postpartum hemorrhage)
- Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death
- Carefully monitor pregnant women with hypertension and managed 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 of 4.2%.
No adverse effects of amlodipine on the breastfed infant have been observed
No information available on the 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
Amlodipine, a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker), inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle
A peripheral arterial vasodilator that acts directly on vascular smooth muscle and causes a reduction in peripheral vascular resistance and reduction in blood pressure
Absorption
Peak plasma time: 6-12 hr
Absolute bioavailability: 64-90%
Steady-state: 7-8 days (consecutive day dosing)
Distribution
Protein bound: ~93%
Metabolism
Extensively (about 90%) converted to inactive metabolites via hepatic metabolism
Elimination
Half-life: 30-50 hr
Administration
Oral Administration
Take with or without food
Storage
Store bottles at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF); dispense in tight, light-resistant containers
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Patient Handout
Formulary
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