Guideline-recommended liquid formulations of hypertension medicines you know and trust1
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The information contained herein, including product information, is intended only for residents of the United States.
© 2026 Azurity Pharmaceuticals, Inc. All Rights Reserved. All trademarks referred to are the property of their respective owners.
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KATERZIA is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:
Important Limitation: Doses in excess of 5 mg daily have not been studied in pediatric patients.
A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device. Ask your pharmacist or doctor for assistance in selecting a measuring device. Shake well before using.
KATERZIA is contraindicated in patients with known sensitivity to amlodipine.
Hypotension. Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely.
Increased Angina or Myocardial Infarction. 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.
Patients with Hepatic Failure. Because KATERZIA is extensively metabolized by the liver and the plasma elimination half-life (t1/2) is
56 hours in patients with impaired hepatic function, titrate slowly when administering KATERZIA to patients with severe hepatic impairment.
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.
These are not all the possible side effects of KATERZIA. Please see Full Prescribing Information for a full list.
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.
Please see Full Prescribing Information for a full list and Specific Drugs and Interactions.
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.
The Important Safety Information does not include all the information needed to use KATERZIA safely and effectively. Please see accompanying full Prescribing Information for KATERZIA.
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.
KATERZIA® is a trademark of Azurity Pharmaceuticals, Inc.
©2025 Azurity Pharmaceuticals, Inc.
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QBRELIS is an angiotensin-converting enzyme (ACE) inhibitor indicated for:
See Full Prescribing Information for complete boxed warning.
QBRELIS is contraindicated in patients with:
Do not co-administer aliskiren with QBRELIS in patients with diabetes.
QBRELIS is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer QBRELIS within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor.
Fetal Toxicity. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue QBRELIS as soon as possible.
Angioedema and Anaphylactoid Reactions.
Head and Neck Angioedema
Angioedema of the face, extremities, lips, tongue, glottis and/or larynx, including some fatal reactions, have occurred in patients treated with ACE inhibitors, including lisinopril, at any time during treatment. Patients with involvement of the tongue, glottis or larynx are likely to experience airway obstruction, especially those with a history of airway surgery. QBRELIS should be promptly discontinued and appropriate therapy and monitoring should be provided until complete and sustained resolution of signs and symptoms of angioedema has occurred. Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor. ACE inhibitors have been associated with a higher rate of angioedema in Black than in non-Black patients.
Patients receiving coadministration of an ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema.
Intestinal Angioedema
Intestinal angioedema has occurred in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal. In some cases, the angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor.
Anaphylactoid Reactions
Anaphylactoid Reactions During Desensitization
Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions.
Anaphylactoid Reactions During Dialysis
Sudden and potentially life threatening anaphylactoid reactions have occurred in some patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. In such patients, dialysis must be stopped immediately, and aggressive therapy for anaphylactoid reactions must be initiated. Symptoms have not been relieved by antihistamines in these situations. In these patients, consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption.
Impaired Renal Function. Monitor renal function periodically in patients treated with QBRELIS. Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, post-myocardial infarction or volume depletion) may be at particular risk of developing acute renal failure on QBRELIS. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on QBRELIS.
Hypotension. QBRELIS can cause symptomatic hypotension, sometimes complicated by oliguria, progressive azotemia, acute renal failure or death. Patients at risk of excessive hypotension include those with the following conditions or characteristics: heart failure with systolic blood pressure below 100 mmHg, ischemic heart disease, cerebrovascular disease, hyponatremia, high dose diuretic therapy, renal dialysis, or severe volume and/or salt depletion of any etiology.
In these patients, QBRELIS should be started under very close medical supervision and such patients should be followed closely for the first two weeks of treatment and whenever the dose of QBRELIS and/or diuretic is increased. Avoid use of QBRELIS in patients who are hemodynamically unstable after acute MI. Symptomatic hypotension is also possible in patients with severe aortic stenosis or hypertrophic cardiomyopathy.
Surgery/Anesthesia
In patients undergoing major surgery or during anesthesia with agents that produce hypotension, QBRELIS may block angiotensin II formation secondary to compensatory renin release. If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion.
Hyperkalemia. Serum potassium should be monitored periodically in patients receiving QBRELIS. Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus, and the concomitant use of potassium-sparing diuretics, potassium supplements and/or potassium-containing salt substitutes.
Hepatic Failure. ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice or hepatitis and progresses to fulminant hepatic necrosis and sometimes death. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical treatment.
The most common adverse reactions (events 2% greater than placebo) by use are:
These are not all the possible side effects of QBRELIS. Please see Full Prescribing Information for a full list.
Diuretics: Excessive drop in blood pressure.
NSAIDS: Increased risk of renal impairment and loss of antihypertensive efficacy.
Dual inhibition of the renin angiotensin system: Increased risk of renal impairment, hypotension and hyperkalemia.
Lithium: Symptoms of lithium toxicity.
Gold: Nitritoid reactions have been reported.
See Full Prescribing Information for Specific Drugs and Interactions.
Lactation: Advise not to breastfeed.
Race: Less antihypertensive effect in Blacks than non-Black
The Important Safety Information does not include all the information needed to use QBRELIS safely and effectively. Please see accompanying Full Prescribing Information for QBRELIS.
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.
QBRELIS® is a trademark of Azurity Pharmaceuticals, Inc.
©2025 Azurity Pharmaceuticals, Inc.
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