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A mother and her young son play and laugh together outside.
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Proven Antihypertensive Effect in a 
Shake-and-Pour Liquid Formulation1

A prescription option for amlodipine users who need an alternative to pills and tablets

Liquid Katerzia Provides1

Katerzia Bottle Icon Purple

An Alternative to Compounding for You:

Everything you need, all in one box, to dispense shake-and-pour prescription amlodipine.
Katerzia Droplets Purple

Consistent, Once-Daily Dosing for Patients:

A consistent dose every time; proven antihypertensive effect maintained over 24 hours.
Katerzia Pressure Cuff Purple

Kid-Proven Efficacy and Safety:

Shown to produce significant reductions in systolic blood pressure in kids and teens aged 6 to 17 years.
Katerzia Piggy Bank Purple

Low Out-of-Pocket Cost for Most Patients:

As low as $0* per prescription with most Medicaid and commercial insurance plans.
*Eligibility restrictions and terms and conditions may apply.
A young hypertension patient in a white shirt flexes his bicep.
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Making It Easier for Patients to Take the Medicines They Need

The age at which children master swallowing tablets or pills can vary, and swallowing difficulty is a multifactorial issue that can occur at any age.2

Studies estimate that 50% to 88% of children taking prescription medication are not adherent at some point.3 Nonadherence, in turn, is associated with increased complications, morbidity, poorer quality of life, and increased use of healthcare resources.4

Patients who take medicine as prescribed have better outcomes and lower costs of care.3

Multiple studies of children and teens under care for a variety of conditions have shown that sweet-tasting and easy-to-swallow formulations can make the difference between treatment success and failure.2,4

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American Academy of Pediatrics Recommends
FDA-Approved Amlodipine Liquid for
Management of Chronic Hypertension5

Why Risk the Variability and Inconvenience of 
Compounding, Crushing, and Sprinkling?

FDA-approved prescription medicines such as Katerzia have been shown to have fewer quality issues and less variability in potency than similar compounded formulations. Manufacturing under current Good Manufacturing Practices helps to ensure uniform taste, concentration, and consistency from fill to fill and pharmacist to pharmacist.6

Oral liquid formulations like Katerzia may make it easier to see that a patient has received the full prescribed dose of their medication.1,4,7

Finally, prescription drugs like Katerzia generally have broader coverage with fewer restrictions compared with specialty compounded formulas,8 so patients are less likely to encounter surprise costs or objections.

A doctor consults with a smiling young patient who is experiencing pediatric hypertension
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Easy Access and Affordability for Patients and Parents

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Medicaid coverage in all 50 states (many, including California, with no prior authorization requirement)
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Co-pay costs as low as $0* per prescription on most commercial health insurance plans
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Discounts without coupons, cards, or preregistration automatically applied at more than 70,000 participating pharmacies for qualified Katerzia prescriptions†
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No compounding coverage restrictions or exceptions: Katerzia is one prescription, one approval, and one co-pay
Azurity Solutions offers support services for your patients and your pharmacy.
Learn More
*Approximate participating pharmacies for eVoucherRx™ and Voucher on Demand™.
†Eligibility restrictions and terms and conditions may apply.
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A Prescriber’s Perspective on Prescription Liquid Formulations

Working in a busy pediatric nephrology office, Bonnie Smeryage, NP, sees firsthand the benefits of liquid formulations for patients and parents.
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Did you know that Azurity Pharmaceuticals offers many FDA-approved liquid formulations? Visit Azurity.com to learn more.

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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.

References: 1. Katerzia [package insert]. Wilmington, MA: Azurity Pharmaceuticals Inc.; 2020. 2. Zajicek A, Fossler MJ, Barrett JS, et al. A report from the Pediatric Formulations Task Force: perspectives on the state of child-friendly dosage forms. AAPS J. 2013;15(4):1072-1081. 3. McGrady ME, Hommel KA. Medication adherence and health care utilization in pediatric chronic illness: a systematic review. Pediatrics. 2013;132(4):730-740. 4. Chappell F. Medication adherence in children remains a challenge. Prescriber. 2015;26(12):31-34. 5. Flynn JT, Kaelber DC, Baker-Smith CM, et al; Subcommittee on Screening and Management of High Blood Pressure in Children. Clinical practice guideline for screening and management of high blood pressure in children. Pediatrics. 2017;140(3):e20171904. 6. Gudeman J, Jozwiakowski M, Chollet J, Randell M. Potential risks of pharmacy compounding. Drugs R D. 2013;13(1):1-8. 7. Nidanapu RP, Rajan S, Mahadevan S, Gitanjali B. Tablet splitting of antiepileptic drugs in pediatric epilepsy: potential effect on plasma drug concentrations. Paediatr Drugs. 2016;18(6):451-463. 8. US Government Accountability Office. Compounded Drugs: Payment Practices Vary Across Public Programs and Private Insurers, and Medicare Part B Policy Should be Clarified. Report GAO-15-85. October 2014. https://www.gao.gov/products/gao-15-85. Accessed November 2, 2022.
Product labeling, packaging, and imagery are for representation purposes only.

Healthcare provider and patient images on this website are not actual healthcare providers and patients.

The Information contained herein, including product information, is intended only for residents of the United States.

© 2024 Azurity Pharmaceuticals, Inc. All Rights Reserved. All Trademarks referred to are the property of their respective owners.
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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:

See More

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.