HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use NORVASC safely and effectively. See full prescribing information for NORVASC.
NORVASC® (amlodipine besylate) Tablets for oral administration
Initial U.S. Approval: 1992
INDICATIONS AND USAGE
NORVASC is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:
DOSAGE AND ADMINISTRATION
Important Limitation: Doses in excess of 5 mg daily have not been studied in pediatric patients. (2.2)
DOSAGE FORMS AND STRENGTHS
WARNINGS AND PRECAUTIONS
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 Pfizer at 1-800-438-1985 or www.pfizer.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
See 17 for FDA-approved patient labeling.
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