Label Changes for:

Norvasc (amlodipine besylate) Tablets

October 2011

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2010 and October 2011

 

October 2011

 

DRUG INTERACTIONS

Simvastatin
  • added...... Co-administration of multiple doses of 10 mg of amlodipine with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.

 

February 2010

 

WARNINGS AND PRECAUTIONS

Hypotension
  • Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension in unlikely.
Increased Angina or Myocardial Infarction
  • Worsening of angina and acute myocardial infarction can develop after starting or increasing the dose of Norvasc, particularly in patients with severe obstructive coronary artery disease.
Patients With Hepatic Failure
  • Because Norvasc is extensively metabolized by the liver and the plasma elimination half-life (t 1/2) is 56 hours in patients with impaired hepatic function, titrate slowly when administering NORVASC to patients with severe hepatic impairment.

ADVERSE REACTIONS

Clinical Trial Experience
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Postmarketing Experience
  • Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

 

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