Description
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Drug Label Highlights
These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS.
AMLODIPINE besylate tablets for oral administration
Initial U.S. Approval: 1992
Indications And Usage
Amlodipine besylate tablets is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:
Amlodipine besylate tablets is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
Chronic Stable Angina
Vasospastic Angina (Prinzmetal’s or Variant Angina)
Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%
Dosage And Administration
Adult recommended starting dose: 5 mg once daily with maximum dose 10 mg once daily. (2.1)
Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily. (2.1)
Pediatric starting dose: 2.5 mg to 5 mg once daily. (2.2)
Important Limitation: Doses in excess of 5 mg daily have not been studied in pediatric patients. (2.2)
Dosage Forms And Strengths
Tablets: 2.5 mg, 5 mg, and 10 mg (3)
Contraindications
Known sensitivity to amlodipine (4)
Warnings And Precautions
- Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely. (5.1)
- 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. (5.2)
- Titrate slowly in patients with severe hepatic impairment. (5.3)
Adverse Reactions
Most common adverse reaction to amlodipine is edema which occurred in a dose related manner. Other adverse experiences not dose related but reported with an incidence >1.0% are fatigue, nausea, abdominal pain, and somnolence. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Drug Interactions
Do not exceed doses greater than 20 mg daily of simvastatin. (7.2)
Use In Specific Populations
Pediatric: Effect on patients less than 6 years old is not known. (8.4)
Geriatric: Start dosing at the low end of the dose range. (8.5)
See 17 for FDA-approved patient labeling.
Revised: 10/2021
DailyMed highlights last updated: 2026-06-24 22:05:49










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