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pediatrician with smiling mother and baby in exam room
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The Prescription Liquid Amlodipine

With Katerzia, your patients with pediatric hypertension get

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Once-daily dosing: Studies show antihypertensive effect is maintained over 24 hours with a single dose1
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Amlodipine efficacy, producing significant reductions in blood pressure in children and teens aged 6 to 17 years1,*
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A sweet-tasting liquid, Katerzia is the shake-and-pour prescription amlodipine for children (and adults)1
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Low out-of-pocket cost. Katerzia is Medicaid approved in all 50 states, with most commercially insured patients paying no more than $0† per prescription

*The effective antihypertensive oral dose in pediatric patients aged 6 to 17 years is 2.5 to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients.
†Eligibility restrictions and terms and conditions may apply.

A bottle of FDA-approved Katerzia liquid amlodipine

Amlodipine liquid is recommended by the American Academy of Pediatrics for chronic hypertension in children and teens aged 6 years and older.2

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A young patient with hypertension smiles and hangs upside down from a tree.
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Medicines Can’t Work if Kids Don’t Take Them

Compliance is generally recognized as a challenge for children, with studies estimating that 50% to 88% of children taking prescription medications are not adherent.3

Among patients with hypertension, taking medicine as prescribed has been shown to reduce the cost of care and the risk of fatal and nonfatal cardiovascular events.1,3-5

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.6,7

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Liquid Formulations and Pediatric Adherence

A veteran nurse practitioner from a high-volume pediatric nephrology center discusses the value of liquid formulations in treating pediatric hypertension.
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Avoid the Variability of Compounding, Crushing, and Sprinkling

As an FDA-approved drug, Katerzia ensures uniform concentration, sweet taste, and consistency from fill to fill and pharmacy to pharmacy, regardless of where your patients get their prescriptions.8

Unlike crushing and sprinkling tablets over food or in drinks, oral liquid formulations like Katerzia may eliminate swallowing difficulties for patients and allow caregivers to see that their child has taken the full prescribed dose.1,6,9

With Katerzia, patients don’t have to go out of their way for specialty compounding services.1 Katerzia generally has broader coverage with fewer restrictions compared with compounded formulas, so patients are less likely to encounter surprise costs or objections.10


FDA=US Food and Drug Administration.
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Compounding vs Dispensing:
a Comparison

This video highlights the differences between liquid formulations compounded at a pharmacy and those manufactured in a cGMP facility.

cGMP=Current Good Manufacturing Practice.

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Benefits of Liquid Formulations in Pediatric Patients

Bonnie Smeryage, a nurse practitioner in a busy pediatric nephrology practice, discusses the need for alternative drug delivery options in younger patients and the role that liquid formulations play for the patients and families she sees.
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cGMP=Current Good Manufacturing Practice.

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

Azurity Pharmaceuticals is committed to ensuring that patients who are prescribed Katerzia are able to access and afford their medicines.
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Co-pay costs as low as $0* per prescription on most commercial health insurance plans
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Medicaid coverage in all 50 states; several, including California, have no prior authorization requirement
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Discounts without coupons, cards, or preregistration automatically applied at the pharmacy counter for qualified Katerzia prescriptions*
Azurity Solutions offers support services for your patients and your practice.
Learn More
*Eligibility restrictions and terms and conditions may apply.
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Find the Katerzia 
Pharmacy Closest to You

With Katerzia available at more than 70,000 pharmacies nationwide,* your patients save time and you get to work with the local pharmacist you know and trust.

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*Approximate participating pharmacies for eVoucherRx™ and Voucher on Demand™.
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Stay Connected With Information and Resources

Get all the facts about Katerzia (amlodipine) liquid, patient resources, and updates for your patients and practice!
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Stay Up to Date on the Latest News About Katerzia

Stay in the loop on the latest information about Katerzia and Azurity Solutions for physicians and patients by joining our secure email list.
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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. 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. 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. Shani M, Lustman A, Vinker S. Adherence to oral antihypertensive medications, are all medications equal? J Clin Hypertens. 2019;21(2):243-248. 5. El-Rachidi S, LaRochelle JM, Morgan JA. Pharmacists and pediatric medication adherence: bridging the gap. Hosp Pharm. 2017;52(2):124-131. 6. Chappell F. Medication adherence in children remains a challenge. Prescriber. 2015;26(12):31-34. 7. 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. 8. Gudeman J, Jozwiakowski M, Chollet J, Randell M. Potential risks of pharmacy compounding. Drugs R D. 2013;13(1):1-8. 9. 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. 10. 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.
PP-KAT-US-0063

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.