IMPORTANT SAFETY INFORMATION
KATERZIA® (amlodipine) Oral Suspension, 1 mg/mL
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.
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 KATERZIA, particularly in
patients with severe obstructive coronary artery disease.
Because
KATERZIA 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 (6).
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 drug and dose related (edema, flushing, palpitations), there
was a greater incidence in women than in men associated with amlodipine
treatment.
Other adverse experiences not dose-related but reported
are fatigue, nausea, abdominal pain, and somnolence.
Drug Interactions:
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.
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 and adjust the dose when appropriate.
Use in Specific Populations:
See Full Prescribing Information for Additional Information (8).
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.
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.
Pediatric Use
Amlodipine (2.5 to 5 mg
daily) is effective in lowering blood pressure in patients 6 to 17 years.
The effect of amlodipine on blood pressure 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.
This Important Safety Information does not include all the information
needed to use KATERZIA safely and effectively. Visit
KATERZIA.com
for
Full Prescribing Information.
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.
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