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IMPORTANT SAFETY INFORMATION
KATERZIA is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:
- Hypertension in adults and children 6 years of age and older, to lower blood pressure:
- Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
- Coronary Artery Disease:
- 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%.
ADDITIONAL IMPORTANT SAFETY INFORMATION
Katerzia is contraindicated in patients with known sensitivity to amlodipine or to the inactive ingredients.
Warnings and Precautions:
- Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely.
- 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.
- Because amlodipine is extensively metabolized by the liver, and the plasma elimination half-life is 56 hours in patients with impaired hepatic function, titrate slowly when administering Katerzia to patients with severe hepatic impairment.
Adverse Reactions: See full Prescribing Information for additional adverse reactions.
- The most common dose-related adverse reaction to amlodipine is edema.
- Incidents of dose-related dizziness, flushing, and palpitation also have been observed.
- For several reported adverse experiences that appear to be dose- and drug-related (edema, flushing, palpitations), there was a higher incidence associated with amlodipine treatment in women than in men.
- Other adverse experiences not dose-related but reported are fatigue, nausea, abdominal pain, and somnolence.
Impact of Amlodipine on Other Drugs
- Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily.
- Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended. Adjust the dose accordingly when appropriate.
Impact of Other Drugs on Amlodipine
- Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A inhibitors to determine the need for dose adjustment.
- Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A inducers.
Important Limitations in Specific Populations:
- The effective antihypertensive oral dose in pediatric patients ages 6 to 17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients.
- The effect of amlodipine in patients less than 6 years of age is not known.
- In general, dose selection for elderly patients should be cautious, usually starting with a lower initial dose.
- A lower initial dose may be required for patients with hepatic insufficiency.
- Limited data on post-marketing use of amlodipine in pregnant women are not sufficient to inform a drug-associated risk for major birth defects or miscarriages. There are risks to the mother and fetus associated with poorly controlled hypertension during pregnancy. See full Prescribing Information.
- Limited available data from a published clinical lactation study reports that amlodipine is present in human milk. No adverse effects of amlodipine on the breastfed infant have been observed.
SHAKE BEFORE USING.
Refrigerate at 2°C to 8°C/36°F to 46°F. Avoid freezing and excessive heat. Protect from light.
Please see full Prescribing Information for complete information.
To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals at 1-855-379-0383, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
Keep this and all medications out of the reach of children.