Guideline-recommended liquid formulations of hypertension medicines you know and trust1
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PP-KAT-US-0062 06/23
KATERZIA is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:
KATERZIA is contraindicated in patients with known sensitivity to amlodipine.
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.
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.
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.
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.
See Full Prescribing Information for complete boxed warning.
QBRELIS is an angiotensin-converting enzyme (ACE) inhibitor indicated for:
QBRELIS is contraindicated in patients who are hypersensitive to lisinopril or any component of QBRELIS, or in patients with a history of hypersensitivity related to previous ACE inhibitor treatment.
QBRELIS is contraindicated in patients with hereditary or idiopathic angioedema.
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.
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 QBRELIS, at any time during treatment. 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 non-Black patients.
Intestinal angioedema has been reported with ACE inhibitors. Discontinue QBRELIS and obtain appropriate therapy.
Anaphylactoid Reactions: Sudden and potentially life-threatening anaphylactoid reactions have occurred in some patients dialyzed with high-flux membranes 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 and in patients undergoing desensitizing treatment with hymenoptera venom.
Impaired Renal Function: Monitor renal function in patients treated with QBRELIS. Changes in renal function, including acute renal failure, can be caused by drugs that inhibit the renin-angiotensin system (RAS). Patients whose renal function may depend in part on the activity of the RAS (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, post-MI 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. QBRELIS should be started under close medical supervision and followed closely for the first 2 weeks of treatment and whenever the dose of QBRELIS and/or a diuretic is increased. Avoid the use of QBRELIS in hemodynamically unstable patients after acute MI.
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 it is considered to be due to this mechanism, it can be corrected by volume expansion.
Hyperkalemia: Serum potassium should be monitored 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 and progresses to fulminant hepatic necrosis and sometimes death. If jaundice or marked elevations of hepatic enzymes develop, discontinue the ACE inhibitor and receive appropriate medical treatment.
See Full Prescribing Information for additional Adverse Reactions (6).
Common adverse reactions where rate on lisinopril exceeds the rate on placebo by at least 2% by use are:
Initiation of QBRELIS in patients on diuretics may result in excessive reduction of blood pressure. This can be minimized by either decreasing or discontinuing the diuretic or increasing salt intake prior to initiating QBRELIS treatment.
QBRELIS attenuates potassium loss caused by thiazide-type diuretics. If concomitant use of such agents is indicated, monitor the patient’s serum potassium frequently.
Concomitant administration of QBRELIS and antidiabetic medicines may cause an increased blood-glucose-lowering effect.
In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, use of non-steroidal anti-inflammatory agents (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors, with ACE inhibitors, including lisinopril, may result in deterioration of renal function, including possible acute renal failure. Monitor renal function periodically in patients receiving lisinopril and NSAID therapy.
Dual Inhibition of the Renin-Angiotensin System (RAS): Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure), compared to monotherapy. Closely monitor BP, renal function and electrolytes in patients receiving QBRELIS and agents that effect the RAS.
Avoid use of aliskiren with QBRELIS in patients with renal impairment.
Lithium toxicity has been reported in patients receiving lithium concomitantly with drugs that cause elimination of sodium, including ACE inhibitors. It is usually reversible upon discontinuation of lithium and the ACE inhibitor. Monitor serum lithium levels during concurrent use.
Nitritoid reactions have been reported rarely in patients with injectable gold (sodium aurothiomalate) and concomitant lisinopril therapy.
mTOR or neprilysin inhibitors: Patients receiving coadministration of an ACE inhibitor and a mTOR inhibitor (e.g., temsirolimus, sirolimus, everolimus) or a neprilysin inhibitor (e.g., sacubitril) may be at increased risk for angioedema.
See Full Prescribing Information for Additional Information (8).
Pregnancy
QBRELIS can cause fetal
harm.
See Full Prescribing Information for Additional Information (5.1,
8.1).
Lactation
Because of the potential for
severe adverse reactions in the breastfed infant, advise women not to
breastfeed while taking QBRELIS.
Pediatric Use
QBRELIS is not
recommended in children under the age of 6 years or in pediatric patients
with glomerular filtration rate < 30 mL/min/1.73m2.
This Important Safety Information does not include all the information needed to use QBRELIS safely and effectively. Visit QBRELIS.com for Full Prescribing Information.
