HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to useKATERZIA safely and effectively. See full prescribing information for
KATERZIA.
KATERZIA(amlodipine)oral suspension, for oral use.
Initial U.S. Approval: 1992
INDICATIONS AND USAGE
KATERZIA is a calcium channel blocker and may be used alone or incombination with other antihypertensive and antianginal agents for thetreatment of:
•Hypertension (1.1)
oKATERZIA is indicated for the treatment of hypertension in adults
and children 6 years 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 (1.2)
oChronic Stable Angina
oVasospastic Angina (Prinzmetal’s or Variant Angina)
oAngiographically Documented Coronary Artery Disease in patientswithout heart failure or an ejection fraction < 40%.
DOSAGE AND ADMINISTRATION
•Adult recommended starting dose: 5 mg orally once daily withmaximum dose 10 mg once daily. (2.1)
oSmall, fragile, or elderly patients, or patients with hepaticinsufficiency may be started on 2.5 mg once daily. (2.1)
•Pediatric starting dose: 2.5 mg to 5 mg once daily. (2.2)
Important Limitation: Doses in excess of 5 mg daily have not been studiedin pediatric patients. (2.2)
SHAKE BEFORE USING
DOSAGE FORMS AND STRENGTHS
•Oral suspension: 1 mg/mL. (3)
CONTRAINDICATIONS
•Known sensitivity to amlodipine. (4)
WARNINGS AND PRECAUTIONS
•Symptomatic hypotension is possible, particularly in patients with severeaortic stenosis. However, acute hypotension is unlikely. (5.1)
•Worsening angina and acute myocardial infarction can develop afterstarting or increasing the dose of amlodipine, particularly in patientswith severe obstructive coronary artery disease. (5.2)
•Titrate slowly in patients with severe hepatic impairment. (5.3)
ADVERSE REACTIONS
Most common adverse reaction to amlodipine is edema which occurred in adose related manner. Other adverse experiences not dose related but reportedwith an incidence >1.0% are fatigue, nausea, abdominal pain, andsomnolence. (6)
To report SUSPECTED ADVERSE REACTIONS, contact SilvergatePharmaceuticals, Inc., at 1-855-379-0383 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
DRUG INTERACTIONS
•Do not exceed doses greater than 20 mg daily of simvastatin. (7.2)
USE IN SPECIFIC POPULATIONS
•Pediatric: Effect on patients less than 6 years old is not known. (8.4)
•Geriatric: Start dosing at the low end of the dose range. (8.5)
Revised: 7/2019
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FULL PRESCRIBING INFORMATION: CONTENTS*
1INDICATIONS AND USAGE
1.1Hypertension
1.2Coronary Artery Disease (CAD)
2DOSAGE AND ADMINISTRATION
2.1Adults
2.2Children
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1Hypotension
5.2Increased Angina or Myocardial Infarction
5.3Patients with Hepatic Failure
6ADVERSE REACTIONS
6.1Clinical Trials Experience
6.2Postmarketing Experience
7DRUG INTERACTIONS
7.1Impact of Other Drugs on Amlodipine
7.2Impact of Amlodipine on Other Drugs
8USE IN SPECIFIC POPULATIONS
8.1Pregnancy
8.2Lactation
8.4Pediatric Use
8.5Geriatric Use
8.6Hepati |
