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    IMPORTANT SAFETY INFORMATION

     

    INDICATIONS

    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

    Contraindications:

    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.

    Drug Interactions:

    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:

    Pediatric Use

    • 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.

    Geriatric Use

    • In general, dose selection for elderly patients should be cautious, usually starting with a lower initial dose.

    Hepatic Impairment

    • A lower initial dose may be required for patients with hepatic insufficiency.

    Pregnancy

    • 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.

    Lactation

    • 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.