Rx Item-KATERZIA amlodipine benzoate ORAL 1 MG/ML SUS 150 ML BY CUTIS PHARMA

KATERZIA (amlodipine) is a white to off-white, aqueous oral suspension that contains 1 mg of amlodipine per milliliter (equivalent to 1.30 mg of amlodipine benzoate). It is supplied as 150 mL in a 185 mL high-density polyethylene (HDPE) bottle with a child-resistant cap and tamper-evident seal. SHAKE BEFORE USING. These highlights do not include all the information needed to use KATERZIA 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 in combination with other antihypertensive and antianginal agents for the treatment of:

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Hypertension (1.1)

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KATERZIA 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.

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Coronary Artery Disease (1.2)

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Chronic Stable Angina
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Vasospastic Angina (Prinzmetal's or Variant Angina)
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Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%.

DOSAGE AND ADMINISTRATION

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Adult recommended starting dose: 5 mg orally once daily with maximum dose 10 mg once daily. (2.1)

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Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily. (2.1)

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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 studied in pediatric patients. (2.2)

SHAKE BEFORE USING
DOSAGE FORMS AND STRENGTHS

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Oral suspension: 1 mg/mL. (3)

CONTRAINDICATIONS

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Known sensitivity to amlodipine. (4)

WARNINGS AND PRECAUTIONS

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Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely. (5.1)
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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)
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Titrate slowly in patients with severe hepatic impairment. (5.3)

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 Silvergate Pharmaceuticals, Inc., at 1-855-379-0383 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS

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Do not exceed doses greater than 20 mg daily of simvastatin. (7.2)

USE IN SPECIFIC POPULATIONS

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Pediatric: Effect on patients less than 6 years old is not known. (8.4)
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Geriatric: Start dosing at the low end of the dose range. (8.5)

Revised: 7/2019

NDC 52652-5001-1

Storage
KATERZIA (amlodipine) oral suspension, 1 mg/mL, should be stored refrigerated (2�C to 8�C/36�F to 46�F). Avoid freezing and excessive heat. Protect from light.

Rx Item-KATERZIA amlodipine benzoate ORA
RX903474

Rx Item-KATERZIA amlodipine benzoate ORA
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