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warnings and cautions
5 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 ) 5.1 Hypotension Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely. 5.2 Increased Angina or Myocardial Infarction Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of KATERZIA, particularly in patients with severe obstructive coronary artery disease. 5.3 Patients with Hepatic Failure Because KATERZIA 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 KATERZIA to patients with severe hepatic impairment.
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adverse reactions
6 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 Azurity Pharmaceuticals, Inc., at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials 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. Amlodipine has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with amlodipine was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with amlodipine were of mild or moderate severity. In controlled clinical trials directly comparing amlodipine (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of amlodipine because of adverse reactions was required in about 1.5% of patients and was not different from placebo (about 1%). The most commonly reported adverse reactions more frequent than placebo are reflected in the table below. The incidence (%) of adverse reactions that occurred in a dose related manner are as follows: Table 1: Most Common Dose-Related Adverse Events Compared to Placebo Amlodipine Placebo 2.5 mg 5 mg 10 mg N=520 N=275 N=296 N=268 Edema 1.8 3.0 10.8 0.6 Dizziness 1.1 3.4 3.4 1.5 Flushing 0.7 1.4 2.6 0.0 Palpitation 0.7 1.4 4.5 0.6 Other adverse reactions that were not clearly dose related but were reported with an incidence greater than 1.0% in placebo-controlled clinical trials included the following: Table 2: Other Adverse Events with a Reported Incidence Greater Than 1% Amlodipine (%) Placebo (%) (N=1730) (N=1250) Fatigue 4.5 2.8 Nausea 2.9 1.9 Abdominal Pain 1.6 0.3 Somnolence 1.4 0.6 For several adverse experiences that appear to be drug and dose related, there was a greater incidence in women than men associated with amlodipine treatment as shown in the following table: Table 3: Comparison of Drug and Dose-Related Adverse Events Reported by Men and Women Amlodipine Placebo Male=% Female=% Male=% Female=% (N=1218) (N=512) (N=914) (N=336) ...
adverse reactions table
Table 1: Most Common Dose-Related Adverse Events Compared to PlaceboAmlodipinePlacebo2.5 mg5 mg10 mgN=520N=275N=296N=268Edema1.83.010.80.6Dizziness1.13.43.41.5Flushing0.71.42.60.0Palpitation0.71.44.50.6