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NORVASC® (amlodipine besylate)

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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:

  • Hypertension (1.1)
    • NORVASC 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.
  • Coronary Artery Disease (1.2)
    • 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 NORVASC, 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 Pfizer at 1-800-438-1985 or www.pfizer.com 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: 1/2019

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Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch