Katerzia

Last updated on RxList: 7/29/2019
Katerzia Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 7/29/2019

Katerzia (amlodipine) 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 and older, to lower blood pressure and coronary artery disease, including chronic stable angina, vasospastic angina (Prinzmetal's or variant angina), and angiographically documented coronary artery disease in patients without heart failure or an ejection fraction less than 40%. Common side effects of Katerzia include:

  • fluid retention (edema),
  • fatigue,
  • nausea,
  • abdominal pain,
  • drowsiness,
  • dizziness,
  • flushing, and
  • palpitations

The adult recommended starting dose of Katerzia is 5 mg orally once daily with a maximum dose of 10 mg once daily. Katerzia may interact with CYP3A inhibitors (moderate and strong), simvastatin, cyclosporine, and tacrolimus. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Katerzia; it is unknown how it would affect a fetus. There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy. Katerzia passes into breast milk but is not expected to be harmful to a nursing infant. Consult your doctor before breastfeeding.

Our Katerzia (amlodipine) Oral Suspension, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Katerzia Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, when you first start taking amlodipine, your angina may get worse or you could have a heart attack. Seek emergency medical attention or call your doctor right away if you have symptoms such as: chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Call your doctor at once if you have:

  • pounding heartbeats or fluttering in your chest;
  • worsening chest pain;
  • swelling in your feet or ankles;
  • severe drowsiness; or
  • a light-headed feeling, like you might pass out.

Common side effects may include:

  • dizziness, drowsiness;
  • feeling tired;
  • stomach pain, nausea; or
  • flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Katerzia (Amlodipine Oral Suspension)

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Katerzia Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Amlodipine has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with amlodipine was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with amlodipine were of mild or moderate severity. In controlled clinical trials directly comparing amlodipine (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of amlodipine because of adverse reactions was required in about 1.5% of patients and was not different from placebo (about 1%). The most commonly reported adverse reactions more frequent than placebo are reflected in the table below. The incidence (%) of adverse reactions that occurred in a dose related manner are as follows:

Table 1: Most Common Dose-Related Adverse Events Compared to Placebo

  Amlodipine Placebo
N=520
2.5 mg
N=275
5 mg
N=296
10 mg
N=268
Edema 1.8 3.0 10.8 0.6
Dizziness 1.1 3.4 3.4 1.5
Flushing 0.7 1.4 2.6 0.0
Palpitation 0.7 1.4 4.5 0.6

Other adverse reactions that were not clearly dose related but were reported with an incidence greater than 1.0% in placebo-controlled clinical trials included the following:

Table 2: Other Adverse Events with a Reported Incidence Greater Than 1%

  Amlodipine (%)
(N=1730)
Placebo (%)
(N=1250)
Fatigue 4.5 2.8
Nausea 2.9 1.9
Abdominal Pain 1.6 0.3
Somnolence 1.4 0.6

For several adverse experiences that appear to be drug and dose related, there was a greater incidence in women than men associated with amlodipine treatment as shown in the following table:

Table 3: Comparison of Drug and Dose-Related Adverse Events Reported by Men and Women

  Amlodipine Placebo
Male=%
(N=1218)
Female=%
(N=512)
Male=%
(N=914)
Female=%
(N=336)
Edema 5.6 14.6 1.4 5.1
Flushing 1.5 4.5 0.3 0.9
Palpitations 1.4 3.3 0.9 0.9

Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

General: gynecomastia. Hepatic: jaundice and hepatic enzyme elevations, some requiring hospitalization

Neurologic: extrapyramidal disorder

Read the entire FDA prescribing information for Katerzia (Amlodipine Oral Suspension)

© Katerzia Patient Information is supplied by Cerner Multum, Inc. and Katerzia Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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